UNMODERATED POSTER SESSION ABSTRACTS

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UNMODERATED POSTER SESSION ABSTRACTS

Basic Science P-001

The association between platelet function, platelet cGMP and response to sildenafil of the patients with erectile dysfunction Akand, M, Turkey; Yaman O; Ersoz G; Tekin D; Anafarta K Objective: To evaluate the effect of sildenafil on platelet functions and cGMP level of the patients with erectile dysfunction (ED), and examine a potential association between the response to the sildenafil and platelet functions and platelet cGMP levels of the patients with erectile dysfunction (ED). Methods: The response to sildenafil in 25 men with ED was monitored according to the patients’ erection scale (E1–E5). Platelet aggregation was measured by impedance technique, simultaneous ATP release was determined by bioluminescence. Platelet cGMP level was measured by EIA. Results: Analysis of the response to sildenafil revealed that individuals who showed a positive erectile response (E4–E5 scale) had statistically significant platelet cGMP increase (p = 0.028) and decrease in ADP-induced platelet aggregation (p = 0.04). However individuals who showed negative or poor response (E1–E3 scale) had no change at platelet cGMP levels and platelet functions.

P-003

Timing of sexual intercourse attempts in men with erectile dysfunction in clinical trials of tadalafil: A look at prior sildenafil users Burnett, A, USA; Mulhall, J; Morgentaler, A; Ahuja, S; Natanegara, F; Garcia, C; Shabsigh R Objective: Tadalafil is efficacious up to 36 hours post-dosing for the treatment of ED. The utilization of the duration of effectiveness of tadalafil was examined based on prior sildenafil citrate (sildenafil) use. Methods: In 9 double-blind, placebo-controlled studies, ED patients were randomized to a maximum of one dose per day of tadalafil 10 or 20 mg (N = 1,311) or placebo (N = 493). Patients were stratified based on their history of sildenafil use: naïve (N = 739) or prior users (N = 1,065). They recorded times of dosing and intercourse attempts after each dose. We determined the percentage of men who had at least 1, 4, 8, or 12 attempts (cumulative number) over 12 weeks between 4 and 36 hours after each dose. Patients could have attempted intercourse during one time interval after one dose, and in a different time interval after another dose. Results: Over the 12-week study period, most men on tadalafil or placebo attempted sexual intercourse at least once between 4 and 36 hours after a single dose. Approximately 1/3 of men on tadalafil attempted intercourse an average of at least one time per week in this time interval during the 12 weeks. These results were not different whether men were sildenafil-naïve or prior sildenafil users. (See attached table)

P-002

ED in male patient with end stage renal disease, multifactorial etiopathogeny Bucuras, V, Romania; Bucuras D; Golea O; Madincea M Objective: To evaluate the impact of hormonal, biochemica, psychological, risc factor profile on the degree and incidence of ED. Methods: In patients with end stage renal disease, the complementary action of vascular, neuronal, endocrine and psychological mechanisms induce an erectile dysfunction (ED) more frequently and severe compared with aged matched controls males. We evaluated 41 males (mean age 43 years) with ESRD, under chronical hemodialysis for a mean period of 1.45 years. The study group was evaluated by means of anamnesis, clinical examination, risk factors assessment, hormonal assays, IIEF, SHIM and psychological impact and Becks depresion scale. Results: The patients presented in 90, 25% risk factors (ean = 2.78), most frequent being beta-blocker use (36.5%), antihypertension drugs (34.1%), smoking (41.4%) and presence of HTA (63.4%). Hyperprolactinemia was present in 63.4% of cases. Males under 50 years had subclinical gonadal insufficiency. The statistic significant factors implicated in inducing ED were: age (10% impact), length of therapy (3.9%), psychological factor (19.5%), degree of depresion (11.3%), smoking (3.5%), testosterone level (7.2%), PTH (2%). The cumulative effect concerned 85.4% of ED determination. We observed significant correlations between SHIM score and length of therapy (r = 0.315, p < 0.05), respectively psychological impact (r = 0.44, p < 0.01), depresion value (r = -0.214, p < 0.01) and number of risk factors (r = -0.48, p < 0.01). Conclusion: The pathogeny of ED in such patients in complex, responsible for a much higher incidence and severity of ED compared with aparent healthy controls.

Conclusion: Men utilized the 36-hour duration of efficacy afforded by tadalafil regardless of their prior experience with sildenafil, a PDE5 inhibitor with different characteristics, for the treatment of ED.

P-004

Histomorphometry of penile smooth muscle fiber in severe erectile dysfunction Claro, J, Brazil; Aboim, J; Srougi, M; Ortiz, V Objective: Smooth muscle fiber has fundamental importance in erection. Alterations in its function or quantity may be associated with erectile dysfunction. We decided to assess the proportion of penile smooth muscle fiber in patients with severe erectile dysfunction. Methods: Twenty patients with severe erectile dysfunction were selected to form two groups of ten patients: one with normal arterial flow (age range: 44 to 78 years) and other with altered arterial flow (age range: 38 to 67 years). These groups were compared with a group formed by ten cadavers aged 18 to 25 years that were presumed to have been potent. Quantification of the smooth muscle fibers was done by means of an immunohistochemical study. Results: The proportion of smooth muscle fiber found was 41.15% for the control group. The patients with erectile dysfunction and normal arterial flow presented 27.24% and those with altered arterial flow presented 25.74%; 19 patients presented at least one chronic disease or risk factor for erectile dysfunction, with prominence for dia-

J Sex Med 2005; Supplement 1

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Unmoderated Poster Session Abstracts

betes mellitus, systemic arterial hypertension and smoking. The difference between the group taken to be the control and the patients with erectile dysfunction was statistically significant (p < 0.0001). In cases of aggression, it is the endothelial cells that are affected first, leading to the release of growth transforming factor and endothelin I, and diminishing the synthesis of nitric oxide and prostaglandins. This causes contraction in the smooth musculature and reduction in the blood supply. Conclusion: Among patients with severe erectile dysfunction, the arterial flow on its own does not present interference in the proportion of smooth muscle fiber. The diminution of the proportion of smooth muscle fiber may result from chronic diseases and vascular risk factors.

Results: The 2 (4%) patients under PD treatment responded to 25 mg Sildenafil, 25 (54%) patients under HD had a clear improvement of the IIEF score on questions relating to ED 1–5 and 20 (p = 0) and even in absolute value (p < 0.001) 11 (23%) under HD responded to 100 mg Sildenafil; only 4 (9%) patients under HD had no benefit from the oral Sildenafil therapy and they had to use PgE1; the 2 female patients dropped out of the follow-up as they underwent renal grafting. After apomorphine treatment, 6 of the 44 patients (13%) had a therapeutic response to 3 mg apomorphine only, no response to 2 mg dosage; the rest had no effects. Conclusion: The response to Sildenafil gave a therapeutic answer in 80% of the cases we treated, the apomorphine in 13%. We had a satisfactory response to the 50 mg dosage in 54% of the entire sample.

P-005

P-007

Cavernous body haemogas—Analysis during postoperative rehabilitation by vacuum device with or without oral therapy

Effect of doxazosin with/without rho-kinase inhibitor on human corpus cavernosum smooth muscle in the presence of bladder outlet obstruction

Colombo, F, Italy; Guarneri A; Kartalas-Goumas, I; Romanò, AL; Piedra Aguilera, J; Austoni E

Demir, O, Turkey; Murat, N; Aslan, G; Gidener, S; Esen, AA

Objective: For the last 4 years we have established a integrated postoperative treatment associating the use of vacuum devices to produce vascular-muscular, passive erection rehab exercising. This study aims at comparing the oxygenation status of the cavernosal tissue after the direct action of the vacuum pump and after the direct action of the vacuum pump preceded by a systemic vasoactive therapy given orally and by local transdermal administration. Methods: 30 operated patients were enrolled. 15 patients underwent intracavernosal blood samples immediately after tumescence induced by a vacuum device, while for the other 15 patients the blood sample was drawn after administration of Sildenafil 50 mg, one hour prior to sample, and preparative penile massage with 20% Papaverine gel, and use of vacuum device. Evaluations were carried out on any variation of parameters detected through cavernosal blood-gas testing. Results: Mean values of pO2 and O2 saturation rates were shown to be increased after both kinds of treatment, although a statistically significant difference between the two groups was noted with higher oxygenation levels found in the patients receiving integrated therapy. In fact, pO2 and O2 saturation levels in the group of patients undergoing integrated therapy with vacuum device exercising without constriction band were found to be 68 ± 8 and 93 ± 2 versus levels of 63.81 ± 4 and 91 ± 3 in the group of subjects using simple exercising (p > 0.05): no statistically significant variations were found in partial CO2 pressure between the two groups (37 ± 3 vs 37 ± 2). Conclusion: The results of our study show that in patients suffering from post-op erectile dysfunction exercising of erectile tissue by means of vacuum device improves oxygenation levels. The addition of Sildenafil offers a further increase of oxygenation in the cavernosal tissue and that may prove to be effective in the course of an early postoperative rehabilitation therapy.

P-006

The sexual dysfunction in patients under dialytic treatment, multicentre cross-over study in open apomorphine vs sildenafil Dachille, G, Italy; Ludovico, G; Vitarelli, A; Pagliarulo, V Objective: To define the incidence and possible treatment in patients undergoing haemodialytic (HD) and peritoneal dialysis (PD). Methods: There were 44 patients (42 men, 2 women), 42 were undergoing haemodialytic treatment (HD) and 2 were undergoing peritonaeal dialysis treatment (HP); the average age was 57 (range 34–71). All the patients were examined by a careful nephrologic anamnaesis and an uroandrological examination and IIEF test (International Index Erectile Function) which involved 15 questions for men, gynaecological examination and FSFI test (Female Sexual Function Index) which involved 19 questions for women, finally, subjects of both sexes underwent a LiSat test (Life Satisfaction).

J Sex Med 2005; Supplement 1

Objective: Recent evidence suggests that there is an association between benign prostate hyperplasia (BPH) and erectile dysfunction (ED). Increased contractility coupled with an impaired ability of cavernosal relaxation has been postulated in the molecular basis of this association. However the exact pathophysiological interaction between BPH and ED is not clearly known yet. In this study, we aimed to investigate the relationship of the adrenergic activity in cavernosal tissues in the presence of BPH using a-1 AR antagonist doxazosin and the Rho-kinase inhibitor Y-27632. Methods: Corpus cavernosum smooth muscle (CCSM) tissue was obtained from the patients (n = 10) who underwent penile prosthesis implantation. Patients were divided into two groups according to the presence of infravesical obstruction (IVO), as IVO (+) and (–) group. EC80 concentration for phenylephrine was calculated by evaluating the adrenergic activity responses with cumulatively applied phenylephrine. After obtaining a stable plateau of contraction, test compounds were put in the organ bath. The relaxant potencies of the doxazosin and Y-27632 were expressed as the percentage of inhibition of the plateau of contraction induced EC80 concentration of phenylephrine. The relaxation responses obtained in both groups were compared. Results: Phenylephrine generated 70% more contraction response in IVO (+) group than IVO (–) group. Doxazosin, and Y-27632 caused concentration-dependent relaxation on CCSM pre-contracted by phenylephrine. With doxazosin, significantly higher relaxation responses were obtained in the IVO (+) group in terms of pD2 and maximal relaxation response (p = 0.0012). Maximum relaxation responses following Y-27632 administration were found to be significantly higher in the IVO (+) group. Conclusion: The contractility of human corpus cavernosum is increased in the presence of infravesical obstruction. Doxazosin and Y27632 generates effective relaxation of CCSM in the presence of IVO. Doxazosin and Y-27632 may be the alternatives in the treatment of erectile dysfunction associated with BPH.

P-008

EMDA: A non-invasive treatment method in Peyronie’s disease—The preliminary results Deveci, S, Turkey; Peskircioglu, L; Cakar, B; Koyluoglu, E; Ozkardes, H Objective: To eveluate the efficacy and safety of transdermal EMDA (Electromotive drug administration) technique in Peyronie’s disease. Methods: Ten patients with Peyronie’s disease who previously underwent an ESWT with a partially succesful or unsuccesful outcome were included in the study. All patients recieved a combination of 10 mg verapamil and 4 mg deksametazon transdermally through EMDA technique at a constant current of 3 mA. The protocol was determined as 3 times a week for a three weeks of period. Pain during the erection was measured by visual analog scale, erectile function by IIEF-5 (5

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Unmoderated Poster Session Abstracts

P-009

collagenopathy and 0.014 ± 0.001 mkmol, 0.51 ± 0.04 mkmol% in the control group, p < 0.001). The increase in the relative content of alanine and tyrosine and decrease of arginine, proline and cysteine was also stated. The structurometric analysis showed the decrease in resistance of tunica in collagenopathy to plastic deformation: F of the experimental group—0.17 ± 0.02 H, control group—0.44 ± 0.06 H; H—0.52 ± 0.04 mm and 0.09 ± 0.01 mm, respectively (p < 0.01). Morphological analysis showed thinning and partial destruction of collagenous fibres. Conclusion: The chemical composition of collagen and elastin of penile tunica albuginea influences its viscosielastic properties and, as a result, the quality of erection. The exogenic and endogenic factor, which influence the protein synthesis of connective tissue, can lead to the decrease in resistance to plastic deformation and erectile dysfunction due to the impaired quality of intracavernous block.

Efficacy of tadalafil in men with erectile dysfunction due to traumatic spinal cord injury

P-011

Goetz, L, USA; McCammon, K; Wachs, B; Natanegara, F; Johnson, E; Hague, J; Ahuja, S; Wong, D

The natural history of Peyronie’s disease

item version of International Index of Erectile Function) and plaque size by USG. Results: By the time being out of 10 patients in the protocol 8 has completed the 9 sesssions. The painful erections in 5 patients completely disappeared. A decrease in plaque size in 4 patients was achieved. An increase in IIEF-5 scores was observed in 4 patients. No side effects were observed related to transdermal EMDA. Conclusion: Although only a few number of patients have completed the 9 sessions by the time being EMDA seems to be safe and effective in the treatment of Peyronie’s disease. These preliminary findinds are encouraging for ongoing trials on larger series.

Objective: To explore the efficacy and safety of tadalafil 20 mg in men with erectile dysfunction (ED) due to traumatic spinal cord injury (SCI). Methods: In a multicenter open-label study designed to look at the efficacy and safety of tadalafil 20 mg in various subgroups of patients amongst 1911 men with ED, we prospectively recruited an exploratory group of 49 patients with ED of >6 months duration due to traumatic SCI. These included patients with paraplegia and tetraplegia (quadriplegia). The study had a 12-week treatment period, with tadalafil 20 mg taken as needed (maximum of one pill/day), following a 4-week run-in period to determine baseline ED. The outcome measures included changes from baseline in International Index of Erectile Function (IIEF) domains and proportion of “yes” responses to Questions 2 and 3 of the Sexual Encounter Profile (SEP). Additional efficacy instruments included the Global Assessment Questions (GAQ). Results: Patients with ED following SCI taking tadalafil 20 mg showed a statistically significant (p < 0.001; paired t test) mean increase from baseline to endpoint in the IIEF Erectile Function (EF) domain of 11.9 (endpoint = 23.6), per-patient successful penetration rate (SEP Q2) of 36% (endpoint = 73%), per-patient successful intercourse rate (SEP Q3) of 52% (endpoint = 64%), the IIEF Intercourse Satisfaction domain of 4.8 (endpoint = 11.5), and the Overall Satisfaction domain of 3.0 (endpoint = 7.6). Additionally, 88% of patients responding to GAQ1 reported improved erections at the end of the study. The most common treatment emergent adverse events were headache (12%), dyspepsia (2%) and flushing (2%).

Grasso, M, Italy; Francesco, F; Salvatore, B; Patrizio R

P-010

Objective: Many physical or medical therapeutic approaches, systemic or local, have been suggested for treatment of Peyronie’s disease. These approaches claim a discrete percentage of success, in terms of clinical stabilization or improvement. The aim of our work was to evaluate the “natural history” of this disease. Methods: An hundred and twenty-five patients affected by induratio penis plastica, have been observed for at least five years. At the first visit all patients maintained sexual activity not requiring surgical approach. No medical and physical treatments have been performed on these patients. All patients underwent twelve months follow up evaluating the natural progression of the pathology. By means of ultrasound and clinical examination. Results: Regarding recurvatum, number and size of fibrous nodules, a consistent tendency to stabilization has been observed in the group of patients above 50 years of age. In fact 68% of the patients belonging to the group underneath the age of fifty showed a progressive worsening of the disease requiring penile prosthesis implant ± corporoplasty, while in the other group only 31.5% of the patients required surgery. The x2-test confirmed that the Peyronie’s disease worsening is statistically more probable in the group ageing under fifty (x2 = 14.25; P < 0.005). Conclusion: 1) The patients that received no treatment presented a discrete tendency towards a spontaneous stabilization. 2) The patients who are diagnosed before the age of fifty have a greater chance that the disease will worsen, requiring a surgical approach. 3) The data, regarding the spontaneous evolution of induratio penis plastica in not treated patients, should induce caution in awarding efficacy to new medical or physical approach.

Systemic collagenopathy as potential cause of erectile dysfunction

P-012

Gorpynchenko, I, Ukraine; Mirochnikov, Y Objective: To examine the effect of systemis pathology of connective tissue on the erection state in unpubertal male rats. Methods: Two groups of rats, unimodal in mass (age), were under study. The experimental groupe (12 rats) received daily 100 mg b-aminopropionitrilfumarat as intraabdominal injections during a month. The control group consisted of 11 rats. The following erection parameter were analysed: 2 mkg intracavernous papaverin injections, the latent period of erection, duration and angle of erection. Along with this, albuginea tunica was dissected, aminoacidic composition was determined; resistance to plastic deformation—measurement of strength (F) causing deformation and summary displacement (H). Morpholhgy of albuginea tunica (hematoxylin eosin staining) was studied too. Results: The parameters of erection in the experimental group of rats were statistically lower: the latent period was 125 ± 5 and 65 ± 10 sec, duration 5.7 ± 0.8 and 14.7 ± 1.3 min and angle -90 ± 5 and 45 ± 5°, respectively (p < 0.01). The aminoacid composition analysis revealed the statistical decrease in content of oxylysin in albuginea tunica of the experimental rats (0.0012 ± 0.003 mkmol and 0.04 ± 0.01 mkmol% in

Erectile Dysfunction Observational Study (EDOS): Study design and patient baseline characteristics Haro, JM, Spain; Gavart, S; Hatzichristou, D; Martin-Morales, A; Mirone, V; Needs, N; Ratcliffe, M; Riley, A; Schmitt, H; von Keitz, A Objective: EDOS is an ongoing 6-month, pan–European, prospective, observational study designed to assess the effectiveness and satisfaction of erectile dysfunction (ED) treatments in routine clinical practice, and to describe the patterns of treatment change over 6 months. The naturalistic data gathered from the EDOS study will complement the efficacy data from clinical trials. The purpose of this abstract is to describe the study design of EDOS and baseline findings. Methods: Patients include those who choose to initiate or change their treatment for ED within routine clinical practice. All treatments indicated for ED are allowed. Effectiveness will be assessed at baseline, 3 and 6 months using the SF-PAIRS, the Global Assessment Question, and further questions addressing patient satisfaction and erectile function. Results: As of May 2004, 884 investigators had enrolled 7949 patients across 9 countries. The majority of investigators are GPs (75.9%, n =

J Sex Med 2005; Supplement 1

42 599) and urologists (19%, n = 150). 125 (1.6%) patients were excluded from the analysis mainly for failing eligibility criteria. For the eligible 7,824 patients: the mean age is 56.6 years (range 18–90) and the mean BMI 27.2 kg/m2 (range 11.2–45.0). Regarding the duration of ED, 33.4% have duration of ED less than 1 year, 53.2% between 1 and 5 years, and 13.4% more than 5 years (based on 7756 responses). The investigators’ assessment of ED aetiology is organic in 29.3%, mixed in 48.6% and psychogenic in 21.1% (based on 7753 responses). The patients are distributed similarly among the IIEF-EF domain ED severity categories (n = 7620). Comorbidities included diabetes mellitus (23.2%, n = 1802), depression (16%, n = 1244) and prostatectomy or other pelvic surgery (7.8%, n = 608). Conclusion: The large sample size and the naturalistic design of EDOS provide demographic data that will help better understand current clinical practise for the treatment of ED in Europe.

P-013

Assessment of intron A and verapamil in vitro effect on tunica albuginea myofibroblasts proliferation in Peyronie disease (PD) Ivanchenko, L, Russia; Mazo, E; Moufagued, M; Terekhov, S Objective: The aim of our study was to evaluate the effects of Intron A and Verapamil on changes in tunica albuginea and Peyronies plaques cellular proliferation, by cultivation of primary cell cultures of penal tunica albuginae, to improve the clinical efficacy of the conservative treatment of this disease. Methods: The study was performed on cell cultures, derived intraoperationally from tunica albuginae of two healthy donors and from plaques of three patients with PD. Results: Analysis of the effects of Intron A on cellular proliferation revealed linear relation between the suppression of cellular proliferation and incubation period and concentration of Intron A. Even in the highest concentration (1,000 ME/ml) of Intron A cells remain normal morphology. The significant difference of cell cultures in sensitivity to Intron A, probably is the result of individual cell sensitivity and not due to Peyronie disease. The Verapamil “dose-effect” curve does not change with the increase of incubation time. Verapamil concentration from 2.5 to 39 mcg/ml did not significantly suppress proliferation (not greater than 10–15%), but with the doubling of concentration to 78 mcg/ml the curve turned down to zero. In this concentration cells destroyed. Conclusion: In vitro study revealed differences in the action of Intron A and Verapamil. Intron A blocks cells proliferation, but do not cause its death, it’s effect is dose- and time-dependent, and it also depends on individual cell sensitivity to this agent. Verapamil effect does not cumulate and it has narrow range of effective dose. High concentration of Verapamil results in cell death. We suggest that the use of Intron A in conservative therapy of PD is the most valid and effective treatment method. If the individual sensitivity to this agent is reduced, the course of treatment must be prolonged, taking into account it’s ability to cumulate the effect.

Unmoderated Poster Session Abstracts tine was significantly increased (1 mm—10.44 ± 0.66, 10 mm—12.4 ± 0.71, 100 mm—10.64 ± 0.71) compared to controls (0.58 ± 0.24). In cells incubated with nicotine, superoxide formation was significantly reduced by the NADPH oxidase inhibitors, apocynin (to 2.90 ± 0.67) and by DPI (to 1.53 ± 0.65). Conclusion: These data demonstrate that nicotine increases superoxide production in pig cavernosal cells, an effect mediated by activation/upregulation of NADPH oxidase. Since smoking is associated with vasculogenic erectile dysfunction (VED), and superoxide negates NO-mediated erection, this mechanism warrants further consideration as a possible aetiological factor in VED.

P-015

The effect of acidosis in the intra and extracellular compartments on nerve mediated contraction corpus cavernosum Kumar, P, United Kingdom; Li, C-Y; Ralph, D; Fry, Ch; Minhas, S Objective: One hypothesis for ischaemic priapism is reduced contractile function of cavernosal smooth muscle which may be secondary to an alteration in pH. This study aims to determine the effect of acidosis on nerve-mediated contraction in cavernosal smooth muscle. Methods: Isometric contractions were recorded from strips of guinea pig corpus cavernosum in response to electrical field stimulation. Strips were superfused at 37°C with a HCO3-/CO2 buffered solution. Acidosis in both the intra and extracellular compartments was generated by increasing the CO2 content of the superfusate gas mixture from 5% to 10%. [HCO3-] was reduced in the superfusate in order to create an acidotic extracellular environment at constant Ca2+ activity. Intracellular acidosis was mimicked by increasing the CO2 percentage and superfusate [HCO3-] in proportion. Data are mean ± s.d. Results: Acidosis induced in both compartments had no significant effect on the EFS response (after 60 mins. 103 ± 12%, 120 mins. 100 ± 11% of control, n = 6). Furthermore, tension remained unchanged after 60 mins. of return to normal pH (100 ± 11% of control). A reduction in extracellular pH alone significantly depressed tension (after 60 mins. 73 ± 12%, 120 mins. 68 ± 15% of control, n = 6). After reperfusion with control superfusate for 60 minutes tension partially recovered to 82 ± 11% of control. By contrast, alteration of intracellular pH significantly augmented tension after 60 mins. (110 ± 4% of control, n = 6) (p < 0.002). This increase was not sustained at 120 mins. (103 ± 6% of control, n = 6). Tension remained unchanged after 60 minutes of reperfusion (90 ± 8% of control) Conclusion: Corporal blood aspirates from patients with ischaemic priapism show evidence of hypoxia, glucopenia and acidosis. This study would suggest that the detrimental effect of extracellular acidosis on nerve-mediated contraction of cavernosal smooth muscle appears to be ameliorated by the effect of a reduction in intracellular pH. The mechanisms by which intracellular acidosis exerts this protective effect and whether this is sustained in the presence of the other components of ischaemia needs to be assessed.

P-014

Nicotine promotes superoxide formation in isolated corpus cavernosal smooth muscle cells Koupparis, A, United Kingdom; Jeremy, J; Muzaffhar, S; Persad, R Objective: To investigate the effect of nicotine on superoxide formation, and its enzymic source, in pig cavernosal vascular smooth muscle cells (CVSMCs). Methods: Cultured CVSMCs derived from normal pig cavernosum were incubated with nicotine (1 mm, 10 mm, 100 mm) for 24 hours at 37°C. Superoxide dismutase-inhibitable superoxide formation was assessed using the reduction of ferricytochrome c measured spectrophotometrically. The involvement of NADPH oxidase was determined using apocynin and DPI (both NADPH oxidase inhibitors). Results: Following a 24 hr incubation, superoxide formation (mmol/mg protein [mean ± SEM, n = 12]) in cells incubated with nico-

J Sex Med 2005; Supplement 1

P-016

Contractile activation of guinea pig corpus cavernosal tissue Li, C-Y, United Kingdom; Fry, Ch; Ralph, D; Minhas, S Objective: Erectile dysfunction (ED) is common, however, there remains significant gaps in our understanding of the problem. With the relative paucity of human tissue, the aim is to develop an in vitro small-animal model, the results from which may be extrapolated to human tissue. Methods: Human and guinea-pig corporal smooth muscle strips were superfused with Tyrode’s solution (5% CO2, 24 mM NaHCO3, pH 7.4). Isometric contractions were elicited by electrical field stimulation (EFS, 3 s train, 0.1 ms pulses, 1–80 Hz; abolished by 1 mM tetrodotoxin), or phenylephrine. Carbachol and selective muscarinic

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Unmoderated Poster Session Abstracts antagonists, gallamine (M2) and 4-DAMP (M3) were added to pre-contracted preparations. Muscarinic relaxation is expressed as a percentage of previously-induced contraction. Data are mean ± S.D. Results: Maximum force of nerve-mediated contractions for guineapig tissue, Tmax, was 1.43 ± 0.96 mN/mm2 and the frequency for halfmaximal contraction, f1/2, was 39 ± 2 Hz (n = 15). For human corporal tissue, Tmax was 0.52 ± 0.46 mN/mm2 and f1/2 42 ± 15 Hz (n = 5). Phenylephrine induced dose-dependant contractions with pEC50 values: guinea-pig, 5.80 ± 0.24 (n = 10); human, 5.87 ± 0.06 (n = 4). Carbachol relaxed both guinea-pig and human tissue, pre-contracted with 1.5 mM phenylephrine, in a dose-dependant manner, pIC50 = 6.54 ± 0.86 (n = 8), 6.41 ± 0.41 (n = 9), respectively. In guinea-pig preparations 4-DAMP (3–30 nM) decreased the pIC50 values from 7.69 ± 0.71 to 6.88 ± 0.28. Gallamine (10 nM) had no significant effect on pIC50. Conclusion: Guinea-pig is a useful animal model for human tissue as they display similar contractile responses. Carbachol relaxed muscle strips pre-contracted with phenylephrine, at least in part via M3 receptors. The validation of an animal model, as applied to human tissue, will enable better characterisation of the pathophysiology of ED.

P-017

Increased sensitivity of human corpus cavernosal tissue to phenylephrine in erectile dysfunction Li, C-Y, United Kingdom; Fry, Ch; Ralph, D; Minhas, S Objective: Increasing life expectancy is associated with greater incidence of erectile dysfunction (ED). Several drugs are used to treat ED, however these are only partially effective. The aim is to compare contractile activation between normal and diseased corporal smooth muscle. We hypothesise that ED tissue has an increased contractility. Methods: Human corporal muscle was obtained from patients undergoing surgery for penile carcinoma (normal) and penile implants for ED (diseased). Strips were superfused with Tyrode’s solution (5% CO2, 24 mM NaHCO3, pH 7.4). Isometric contractile responses were elicited either by electrical field stimulation (EFS, 3 s trains, 0.1 ms pulses, 1–40 Hz; abolished by 1 mM tetrodotoxin) or phenylephrine, with or without carbachol. Relaxations are expressed as a percentage of a previously-induced contraction. Data are mean ± S.D., differences between means (p < 0.05) were examined with a Mann-Whitney test. Results: Maximum force of nerve-mediated contraction, Tmax, for normal human corporal tissue was 0.52 ± 0.46 mN/mm2 and the frequency for half-maximal contraction, f1/2, was 42 ± 15 Hz (n = 5). In ED strips, the responses to EFS were mixed, demonstrating contractions (n = 9), relaxations (n = 6), or relaxations at lower frequencies and contractions at higher frequencies (n = 13). In the later group, relaxatory Tmax was 0.10 ± 0.2 mN/mm2 (f1/2 3 ± 2 Hz) and contractile Tmax was 0.91 ± 1.2 mN/mm2 (f1/2 28 ± 10 Hz, p < 0.05 compared to normal human). Phenylephrine induced dose-dependant contractions with pEC50 values: normal, 5.87 ± 0.06 (n = 4); ED 5.52 ± 0.66 (n = 17, p < 0.05). Carbachol relaxed tissue strips pre-contracted with 1.5 mM phenylephrine in a dose-dependant manner, with pIC50 = 6.41 ± 0.41 (n = 9) for ED and 6.74 for normal (n = 1). Conclusion: Diseased tissue exhibits increased contractile sensitivity to EFS, despite large superimposed relaxations. However this is not due to increased alpha-receptors sensitivity as the phenylephrine pEC50 was reduced in the ED group. Carbachol relaxed phenylephrine-induced contractions and demonstrates the presence of muscarinic receptors.

P-018

Functional alterations following cavernous nerve crush injury in the crush injury in the rat: Model dependency Mulhall, J, USA; Donohue, J; Mullerad, M; Li, P; Scardino, P Objective: The rat model of cavernous nerve (CN) injury has been developed in an effort to define the functional and structural

consequences of neural trauma in the corpus cavernosum. However, there is no universally accepted method of inducing nerve injury in this rat model, with transection and crush models being used currently. To address this issue, we induced CN injury using various techniques in an effort to compare the hemodynamic sequelae of these injuries. Methods: 25 adult male Sprague-Dawley rats were divided into 5 groups: (1) Sham: laparotomy only (2) Control: laparotomy and bilateral exposure of cavernous nerve without manipulation (3) Bilateral neurotomy (4) Bilateral nerve crush with bulldog vascular clamp and (5) Bilateral nerve crush with a hemostat. 10 days later, a second surgery was performed where systemic (mean arterial pressure, MAP) measurement was performed through carotid artery cannulation and intra-corporeal (intracavernosal pressure, ICP) hemodynamics were measured at the time of pelvic nerve stimulation proximal to the site of CN injury. Hemodynamic end-points assessed included, ICP/MAP ratio and rate of tumescence and detumescence. Results: The ICP/MAP ratio (mean ± 95% CI) in the sham group was 70 ± 4%. ICP/MAP ratios were significantly reduced in all CN injury groups compared to sham group: control: 41 ± 10% (p < 0.001); neurotomy: 35 ± 15% (p < 0.001); bulldog: 39 ± 13% (p < 0.001); hemostat: 31 ± 9% (p < 0.0001). The hemostat group had the most reproducible results with the greatest level of consistency and lowest variation in ICP/MAP ratio between animals. Of note, the control group also demonstrated significant functional alterations even without direct nerve manipulation. The rates of tumesence and detumesence were significantly reduced in all groups compared to the sham group. Conclusion: CN crush injury in a rat model using a hemostat results in the most consistent and reproducible injury. The consistency of erectile hemodynamic data and the avoidance of deliberate nerve transection make this an excellent model for the assessment of CN injury sequelae.

P-019

Investigation of novel therapeutic options to prevent irreversible cavernosal smooth muscle dysfunction in low flow priapism Muneer, A, United Kingdom; Cellek, S; Ralph, D; Minhas, S Objective: As the duration of low flow (ischaemic) priapism increases there can be a failure of penile detumescence despite corporal blood aspiration and the instillation of a-adrenergic agonists. The aim of this study was to use an in vitro model of low flow priapism to investigate novel pharmacotherapies in preventing irreversible smooth muscle dysfunction. Methods: Male white New Zealand rabbits were sacrificed and strips of rabbit corpus cavernosum were mounted horizontally between 2 ring electrodes, superfused with Kreb’s solution and precontracted using phenylephrine. Following a 4 hour perfusion period in ischaemic conditions, the strips were reperfused. Experiments were repeated in the presence of antioxidants, 500 mM glutathione and 100 mM Nacetylcysteine. Further experiments were conducted by adding 1) 10 mM digoxin, 2) 10 mM Ca2+, 3) 1 mM Bay K 8644. The nitric oxide synthase inhibitor L-NAME was also investigated. Results: Tone was expressed as a % of the initial tone (mean ± sem). After 4 hours simulated ischaemia, the tone recovered to 16.5 ± 2.3% (n = 10) indicating irreversible smooth muscle dysfunction. In the presence of antioxidants the tone recovered to 15.2 ± 3.9% using glutathione and 15.5 ± 1.7% using N-acetylcysteine (n = 4). Addition of 10 microM Ca2+ resulted in recovery of tone to 31.7 ± 9% (n = 4). Addition of digoxin, Bay K 8644 and L-NAME did not significantly improve the recovery of tone. Conclusion: The recovery of corporal smooth muscle tone is not significantly increased with the use of antioxidants, nitric oxide synthase inhibitors, Bay K 8644 or digoxin. Increasing extracellular Ca2+ concentration significantly increases the smooth muscle tone thus providing a potential therapeutic option.

J Sex Med 2005; Supplement 1

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Unmoderated Poster Session Abstracts

P-020

P-022

Tadalafil is efficacious for the treatment of erectile dysfunction in a population of patients with comorbid clinical depression

Relationship between thyroid diseases and erectile dysfunction

Nurnberg, G, USA; Segraves, T; Levine S; Frey, N; Natanegara, F; Wong, D; Ahuja, S

Objective: Aim of this study was to investigate the relationship between thyroid disease and semen and hormonal parameters in men with erectile dysfunction. Methods: 12 men aged 36 to 46 years, 7 with hyperthyroidism and 5 with hypothyroidism presenting with erectile dysfunction evaluated through medical history, clinical examination, penile Doppler and thyroid ultrasound. Semen characteristics, serum levels of sex hormone binding globulin (SHBG), triiodothyronine (T3), thyroxin (T4), free T3 (fT3), free T4 (fT4), tireoglobulin stimulating hormone (TSH), follicular stimulating hormone (FSH), luteining hormone (LH), prolactin (PRL), testosterone (T) and free T (fT) have been measured. Results: In men with hyperthyroidism T, estradiol, SHBG, LH, FSH were increased, fT, free estradiol were reduced as result fT/F estradiol ratio was reduced. Sperm density was not different from control but count and motility of sperm was lower and testicular volume reduced. It suggests that lowed T level has altered the androgen-dependent maturation of spermatozoa in the epididymis. There was a significant correlation between SHBG and severity of thyrotoxicosis showed by the change in thyroid hormones between euthyroidism and hyperthyroidism with a rise of SHBG accompanied by an increase in T concentration, a fall in non-SHBG-bound-T and normal serum fT, hyperresponse of LH and FSH to GnRH suggesting a direct effect of thyroid hormones on the gonadotropic cells sensibility to GnRH. In hypothyroid men the LH respost to GnRH was reduced, SHBG was normal or a bit reduced, T was reduced. Thyroid hormones act on Sertoli’s cells through androgen binding proteins (ABP), responsible to maintain high concentration of androgen hormones for germinal cells maturity. Conclusion: Latent thyroid dysfunction was diagnosed in 11.5% of men with erectile dysfunction of unknown origin. Treatment of patients with a exogenous hormones leads to an improvement on the quality of semen and on erectile dysfunction.

Objective: Sexual dysfunction may be an integral component of depression and/or its treatment. The objective of this open-label study was to determine the efficacy of 20-mg tadalafil for the treatment of erectile dysfunction (ED) in a population of men with ED and clinical depression. Methods: A 4-week run-in phase was followed by a 12-week “on demand” treatment phase with tadalafil 20 mg. Efficacy instruments included International Index of Erectile Function (IIEF), patient Sexual Encounter Profile (SEP) diary and Global Assessment Questions (GAQ). 1911 patients with ED were enrolled into 8 predefined groups. This abstract focuses on 178 patients with a clinical diagnosis of depression at the time of the first visit. Patients enrolled were 65 years old or younger (mean 53 years), 64% had moderate or severe baseline ED and those with a clinical diagnosis of diabetes were excluded. Patients with diabetes or older than 65 years were in separate predefined groups. Results: After 12 weeks of treatment with tadalafil 20 mg, patients exhibited a significant increase from baseline in mean IIEF Erectile Function domain score (change 11.7; endpoint: 25.5; P < 0.001). Patients also showed a significant increase (P < 0.001; scores shown as change and endpoint) on all secondary efficacy scores, including responses to successful penetration (SEP Q2 [35%, 86%]), successful completion of intercourse (SEP Q3 [55%, 77%]), satisfaction with hardness of erection (SEP Q4 [63%, 69%]), satisfaction with the sexual experience (SEPQ5 [61%, 66%]). 89% of the patients who answered GAQ1 reported improved erections post-treatment. The most common treatment emergent adverse events were headache (8%), flushing (4%), dyspepsia (3%), influenza (3%), nasal congestion (3%), and back pain (3%). Conclusion: In the patients with ED and clinical depression studied in this trial, tadalafil 20 mg is an effective and safe treatment for ED.

Paradiso, GG, Italy; Pace, G; Gravina, G; Costa, AM; Vicentini, C

P-023 P-021

The effects of a-LIPOIC ACID on nitric oxide synthase of streptozotocin induced diabetic rat penile tissue Ozkara, H, Turkey; Çitçi, S; Alici, B; Uyaner, I; Akkus, E; Hattat, I Objective: Diabetes mellitus induced erectile dysfunction (DMED) is one of the most prevalent complications of diabetes in males. Alpha lipoic acid and its reduced form, dihydrolipoic acid, are powerful antioxidants. Data strongly suggests that lipoic acid because of its antioxidant properties is particularly suited to the prevention and/or treatment of diabetic complications that arise from an overproduction of reactive oxygen species and nitrogen. The aim of this study is to investigate the localization of NOS in normal and diabetic rat’s cavernous smooth muscle and examine the effects of the alpha-lipoic acid on them. Methods: Four groups of rats were studied: Group 1. control; 2. Group: diabetic; 3. Group diabetic + ALA; 4. Group. control + ALA. After 15 days that we applied ALA to the groups, were radix penis excised, fixed and stained. Results: In the comparison of the control group with diabetic group, we found that in diabetic rat cavernous tissue neurons did lost its structure on MT (Masson trichrome), NOS and immune staining (e NOS). In diabetic rats with ALA administration we observed improvement in MT, NADPH-d and e-NOS immune staining. In control + ALA group there is no difference on MT staining, but increase on NADPH-d and e NOS staining. Conclusion: Alpha lipoic acid has an antioxidant effect, and it decreases i-NOS, and increases e-NOS, n-NOS in this way it may take an important role in treatment of erectile dysfunction.

J Sex Med 2005; Supplement 1

Penile expression of nitric oxide synthase isoforms and vascular endothelial growth factor in the type II diabetic rat Park, NC, Republic of Korea; Park, HJ; Park, Bk; Kim, JM; Nam, JK Objective: Erectile dysfunction is commonly accompanied in men with diabetes mellitus. Nitric oxide synthase (NOS) is essential for regulation of penile erection and vascular endothelial growth factor (VEGF) has been recognized for its significance in different complications of diabetes. However, little is known about the localization and abundance of NOS isoforms and VEGF are changed in diabetes. So we characterized the localization and abundance of NOS isoforms and VEGF and explored how they altered in diabetes and their relationships. Methods: Otsuka Long-Evans Tokushima Fatty (OLETF) rat, a type II diabetes mellitus, and Long-Evans Tokushima Otsuka (LETO) rat, a non-diabetic control group, were used. We analyzed the distribution of endothelin-1 (ET-1), NOS isoforms and VEGF in the isolated corupus cavernosum from both LETO and OLETF rats by immunohistochemical (IHC) stain. mRNA expressions of ET-1, NOS isoforms and VEGF were also analyzed by reverse transcriptase-polymerase chain reaction (RT-PCR). Results: The concentration of nitrite/nitrate in corpus cavernosum was significantly decreased in diabetic rats. The IHC stain revealed that the diabetic corpus cavernosum showed a highly positive staining for inducible NOS (iNOS) although the corpus cavernosum from nondiabetic rats were a negative for iNOS. In contrast, there was a reduction of immunoreactivity for endothelial NOS (eNOS) as well as eNOS mRNA expression in diabetic rat comparing to markedly increased iNOS mRNA expression. IHC stain for VEGF decreased

45

Unmoderated Poster Session Abstracts the both endothelium and vascular smooth muscle in diabetic rats. mRNA expression of VEGF gene was down-regulated in diabetic rats. Conclusion: The activation of VEGF and NOS isoforms may play an important role in diabetic erectile dysfunction.

P-024

(64% mild, 63% mild to moderate, 60% moderate, and 53% severe) attempted intercourse at least once 12–36 hours post dose. Conclusion: ≥79% of patients attempted intercourse 4–36 hours post tadalafil dosing at least once during the study regardless of age. Importantly, over the treatment period the majority attempted intercourse at least once 12–36 hours post tadalafil irrespective of age or ED severity.

Motivational factors of medical treatment among erectile dysfunction patients

P-026

Rusz, A, Hungary; Gyovai, G; Lantos, Z; Jermendy, G; Ágoston, G; Alföldi, S; Romics, I

Peyronie’s disease: Does shock-wave therapy (SWT) delay penile curvature formation?

Objective: The aim of this study was to analyze the positive and negative motivational factors of patients decision about treatment of ED and preference of available PDE5 inhibitor characteristics. Methods: 20 ED patients were interviewed with deep interviews using the story telling technique to explore the typical positive and negative motivational factors, and also the associations of good sexual life as ultimate motivational factor. Using the explored motivational factors about the ED treatment and good sexual life, quantitative survey was conducted interviewing 400 ED patients. In another panel of the interviews the preference of the individual product features of the PDE5 inhibitors were tested. The attitude and preference questions were measured and evaluated with Likert scale (1–5). Results: Good sexual life has the associations of creating harmonic being together, affectionateness, complete fulfillment; I can bring my best shape and ecstasy (between 4.31 and 3.98). These positive motivational factors are describing the sensation of flow as experience of perfect performance. The most pronounced negative motivational factors against any medical treatment were that it is “annoying to visit a doctor with this problem” (3.65), “it may be difficult to carry through the treatment” (2.97). In preference panel highest features were “It is in the organism, just until needed to advance rigid erection” (4.03); “It starts to act within half an hour” (3.74); “It is the cheapest one if calculated for one tablet” (3.65); “Its price is the lowest for one intercourse” (3.58). The long duration of action was less important (p < 0.05) for the patients. Conclusion: The positive communication of the sensation of flow as typical experience of good sexual life can surpass the perceived negative emotional barrier to medical treatment. The most important product characteristics for patients were: the quick onset of action, few side effects and good price.

Sytenko, A, Ukraine Objective: To discover whether medium energy level SWT postpones penile curvature formation in patient with Peyronie’s disease. Methods: 48 patients with early stage of Peyronie’s disease and without angulation were recruited. Patients were subdivided into 2 groups. I—group received shock-wave therapy; II—preferred “watchful waiting.” A mean rising of penile angulation per month was used as an exponent. Angulation was evaluated upon induced erection by means of photography with goniometry after treatment termination. Treatment regimen included 2 sessions of SWT monthly during 6 month. Each session consisted of 500 shocks/mm2 with an emission frequency of 240 shockwaves/min and at an energy density of 0.28 mJ/mm2. A Dornier Epos device was used for application shock waves. Statistic analysis: Wilcoxon two-sample test. Significance level-0.05. Results: As it can be seen from the table a mean penile angulation rising per month is lower in I group compared with II. But this difference is insignificant because estimated criterion We = 344 is sited in the interval between upper (W = 350) and lower (w = 189) points of the Wilcoxon distribution. Conclusion: Preliminary results indicate that medium energy level SWT has probably no preventive effect on processes curvature formation in patients with early stage of Peyronie’s disease.

P-027 P-025

Time of sexual intercourse attempts in men taking tadalafil—An analysis by age of patients and severity of erectile dysfunction Shabsigh, R, USA; Sharlip, I; Ellsworth, P; Natanegara, F; Ahuja, S Objective: Data from 11 studies were pooled to determine the percentage of men with erectile dysfunction (ED) who attempted sexual intercourse during various time intervals after dosing with tadalafil, which has shown clinical efficacy up to 36 hours. Methods: In 11 blinded, placebo-controlled, 12-week studies, patients with ED recorded the time of each dose (tadalafil 10 or 20 mg [N = 1464] or placebo [N = 638]) and each subsequent intercourse attempt. The percentage of patients having at least 1, 4, 8, or 12 attempts (cumulative number) in the time intervals (>0 to £1, >1 to £4, >4 to £36, and >12 to £36 hours) post-dose during the study was determined. Data were also analyzed based on patients’ age and ED severity for ≥1 attempt. Results: Over 12 weeks, 61%, 45%, and 32% of patients attempted intercourse ≥4, ≥8, and ≥12 times, respectively, between 4 and 36 hours post-dosing with tadalafil. 79% and 57% of men >64 years old attempted intercourse at least once in the 4- to 36-hour and 12- to 36hour time intervals, respectively. The percentage of men who attempted sexual intercourse ≥1 time in either of these time intervals was similar in men aged £44 years (82% and 57%), and >44 to £64 years (83% and 61%). Over 50% of patients with any ED severity

La Peyronie’s disease—Treatment by means of local hyperthermia Teodonio, S, Italy Objective: Therapy of La Peyronie’s disease it is not very well established so far and every Author rely on his own experiences concerning the treatment of this pathology by means of oral therapy, local injection with different drugs, laser treatment, ultrasounds or shock waves applications, with the aim to make this patology tollerable from patients until possible surgical therapy is then required. Previous experiences in Orthopaedics in the treatment of plaques or tendinous fibrosis with hypertermia, led the Authors to investigate on the role of this kind of therapy in patients with La Peyronie’s disease. Methods: the study included 28 patients age ranged from 36 to 76 suffering from La Peyronie’s disease with single or multiple penile plaques, variable in size from 1 to 18 mm, with penile bending and pain during intercorses. Results: Twenty patients are evaluable for the study. Seven patients (35%) showed a complete vanishing of the plaques, 5 patients (25%) showed a partial regression of the plaques, in 8 patients (40%) the plaque were stable. All patients tolerated very well the therapy referring a complete disappearance of the pain after few treatments and a surprising improvement of sexual performance of erection as shows by increased IIEF 5 score. Conclusion: the study which has not previous report in the Literature, even if carried out on a limited number of patients, showed encouraging results, and it surely needs further investigation on larger

J Sex Med 2005; Supplement 1

46 series of patients to establish the right number of treatments, the lapse of time between each treatment, and the right temperature. Hyperthermia could have a role even on the treatment of erectile disfunctions.

P-028

Prophilaxis of fibrosis and modification of penile lenght after radical retropubic prostatectomy by means of local hyperthermia Teodonio, S, Italy; Albanesi, L Objective: The aim of the study was to evaluate the efficacy of local hyperthermia in patients undergone radical retropubic prostatectomy (RRP) in order to reduce the post ischaemic fibrosis and the possible shortening of penis which, according to what reported in the literature can occur even in a precocious stage, within three months after surgery. Methods: The study included 20 patients, age ranged from 52 to 74 undergone RRP, without any penile abnormalities or previous penile and urethral surgery. Patients were divided in two groups of 10 patients each; in the first group patients did not perform any treatment in the three months following surgery but a monthly check for post surgical evaluation. In the second group patients underwent local hyperthermia All patients underwent measuring of penile length in the “stretching phase” from pubo-penile junction to the tip of the glans before surgery and three months later. Results: 6 patients of the first group (60%) showed a reduction of penile length ranging from 0.5 to 2.5 cm; more exactly in two patients (20%) the reduction was 0.5 cm, in 3 patients (30%) the reduction ranged from 1 to 2 cm; in 1 patient the reduction was 2.5 cm. 4 patients (40%) of the first group did not show any penile modification. Patients treated by means of hyperthermia did not have any variation of penile length in 8 cases (80%) while in 2 patients (20%) the reduction was 0.5 and 1.5 cm, respectively. Conclusion: The results of this study even if carried out on a limited number of patients showed how hyperthermia, thanks to the action on the microvesels both arterial and venous and the cellular metabolism, could have a role in the rehabilitation of corpora cavernosa of patients underwent RRP improving the trophism and reducing the possible penile shortening.

P-029

Immunohistochemical distribution of cyclic ampphosphodiesterase (PDE) isoenzymes in the human labia minora Ückert, S, Germany; Oelke, M; Hedlund, P; Albrecht, K; Jonas, U; Andersson, K-E Objective: To date, the physiology of female sexual function is receiving increasing awareness. Nevertheless, only little research has focused on those female genital organs contributing to the normal cycle of sexual arousal and orgasm. Some reports indicated that there might be a significance of cyclic nucleotides (cAMP, cGMP) in the control of the normal function of female genital tissues. It was the aim of our study to elucidate by means of immunohistochemistry the distribution of cAMP-degrading PDE isoenzymes (PDE1, 3, 4, 10 and 11) in the human labia minora. Methods: Human labial tissue was obtained from four female cadavers (age at death: 18–42 years). Vibratome sections prepared from formaldehyde-fixated tissue specimens were incubated with primary antibodies (Dilution 1:250) directed against the respective PDE isoenzymes. Then, sections were incubated with fluorochrome (FITC, TR)labeled secondary antibodies. Visualization was commenced by means of a laser fluorescence microscope. Results: Immunostaining indicating the presence of PDE4 was abundantly observed in the epithelium, smooth musculature and small vessels. Staining indicating the expression of PDE3 was recognized in epithelial and subepithelial layers, sebacious glands, and interstitiallike single cells located in the epithelium. Signals specific for PDE10

J Sex Med 2005; Supplement 1

Unmoderated Poster Session Abstracts and 11 (Dual Substrate PDEs) were limited to collagen fibers and glandular-like structures, respectively. In contrast, no immunoreaction indicating PDE1 (Calmodulin-dependent PDE) was detected. Conclusion: Our results, for the first time, demonstrate the presence cAMP-PDEs in the human labia and give hint to a significance of PDE4 in the control of labial vascular and non-vascular tissue function. The findings may give a rationale for the use of selective PDE inhibitors in the pharmacotherapy of FSD/FSAD.

P-030

Impact of neurovascular bundle electrostimulation on the membranous urethra in the male rabbit van der Horst, C, Germany; Böhler, G; Naumann, CM; Stübinger, SH; Seif, C; Bannowsky, A; Braun, PM; Jünemann, K-P Objective: The pathophysiology of post-prostatectomy incontinence is supposed to be multifactorial and the impact of the neurovascular bundles on the urethral sphincter function is still under debate. This study was carried out to clarify the impact of the cavernous nerves on the function of the membranous urethra (MU). Electrophysiological stimulation trials on the neurovascular bundles were compared to pudendal nerve stimulation regarding the MU pressure responses in the male rabbit. Methods: Six male rabbits (chinchilla bastard) were included in this study. In all animals the pudendal nerve as well as the cavernous nerve branches were exposed bilaterally. Randomised electrostimulations of the pudendal nerve fibres and of the cavernous nerves (confirmed by erectile response) were carried out using a biphasic signalform (0.3 mA, 200 ms). The stimulation frequency was changed in a randomized pattern from 10 Hz to 40 Hz. Changes of the MU pressure were measured urodynamically via an transurethral microtip catheter placed in the MU. The stimulation response of both nerve structures were compared to each other. Results: The median baseline pressure of the MU without stimulation was 23 cm H20 (range 20–25 cm H20) in all animals. During unilateral pudendal stimulation, the median pressure response rose highly significantly (p < 0.005) to 33 cm H20 (10 Hz), 43 cm H20 (20 Hz), 59 cm H20 (30 Hz) and 60 cm H20 (40 Hz). Stimulation of the cavernous nerves in contrast did not result in any significant changes of the proximal urethral pressure (median 23 cm H2O; range 20–25 cm H2O) compared to the baseline pressure (p > 0.05). Conclusion: The primacy of the pudendal nerve in the innervation of the urethral sphincter is well known and was confirmed by our results. Stimulation of the cavernous nerves, by contrast, did not produce any pressure changes in the MU. These results confirm that the neurovascular bundles have no functional impact on the function of the MU.

P-031

Intracavernous injection of “methylene blue” in the treatment of prolonged pharmaco-induced erections van der Horst, C, Germany; Martinez Portillo, FJ; Naumann, cm; Seif, C; Böhler, G; Braun, PM; Jünemann, K-P Objective: This pilot in-vivo study was initiated to compare the efficacy and safety of methylen blue (MB) with established sympathomimetic substances like epinephrine (EN) in the treatment of prolonged pharmaco-induced erections. Adrenergic substances are known to provide potential systemic cardiovascular side effects. From in-vitro studies, MB is a well-known inhibitor of cGMP. This effect inhibits the relaxation of the cavernous smooth muscles. Methods: Twelve male rabbits (chinchilla bastard) were included in this study. Anesthesia and artificial ventilation were performed to provide stable cardiovascular, acid-base balance and arterial oxygenation conditions. In all animals prolonged erections were induced by i.c. injection of a mixture of phentolamin and papaverin. Five animals received i.c. injection of MB and five received EN after 1.5 hours erectile response. Two animals remained untreated as a control group. Intracavernous pressure, arterial blood pressure and heart frequency

47

Unmoderated Poster Session Abstracts were measured continuously. Deviations in acid-base balances or arterial oxygenation were corrected immediately. Results: All rabbits revealed basal pressure values of 5–8 cm H2O intracavernously. After i.c. injection of a combination of phentolamin/papaverin, the median intracavernous pressure rose to 54 cm H2O (40–69 cm H2O). In the control animals this pressure could be maintained for at least 2 hours. In the MB group as well as in the EFF group intracavernous pressure dropped back to baseline after i.c. administration. Both substances did not diverge significantly (p > 0.05). No significant cardiovascular changes during i.c. injection of these substances could be measured. Conclusion: To our knowledge this is the first in-vivo study investigating the efficacy and safety of MB in the treatment of prolonged pharmaco-induced erections. Further clinical studies are essential to verify these findings in men. MB can be considered as a potential alternative agent to sympathomimetic substances to achieve immediate detumescence in prolonged pharmaco-induced erections.

P-032

The role of RhoA/Rho kinase pathway in the control of 23-adrenergic receptors in human corpus cavernosum Verze, P, Italy; Cirino, G; Imbimbo, C; Palmieri, A; Longo, N; Fusco, F; Mirone, V Objective: Recently we demonstrated the presence of b3-adrenergic receptors in human corpus cavernosum and studied their mechanism of activation and intracellular signalling transduction. The activation of these receptors leads to a vasodilatation through a NOendothelium-independent but cGMP-dependent pathway. In our study we demonstrate that human corpus cavernosum presents a basal vasorelaxant tone controlled through a complex integration between b3-adrenergic receptors and RhoA/Rho kinase pathways. Methods: Human corpus cavernosum (HCC) strips, obtained with male-to-female transsexual surgical procedures, were precontracted with endothelin 1 (hET1) and then challenged with BRL37344 (selective b3-adrenergic agonist), Ach and SNP. Results: endothelin-1 stimulation causes a 17-fold increase in Rho-A content in HCC. Strips did not relax to BRL 37344 and displayed a reduced relaxant response to Ach, while response to SNP resulted unaffected. Conclusion: our data provide evidence fot the existence of a close functional link between b3-adrenergic receptor-mediated vasorelaxation and RhoA-Rho kinase-mediated vasoconstriction in HCC. Activation of the RhoA-Rho kinase pathway prevents the vasorelaxant effect of b3-adrenergic receptors stimulation and the maximal vasorelaxant response induced by b3-adrenergic receptors requires inactivity of the RhoA-Rho kinase pathway. Therefore, the two pathways may function physiologically to regulate or modulate the state of tumescence of the HCC.

P-033

Prevalence, causes and prevention of erectile dysfunction after transurethral resection of the prostate Vinarov, A, Russia; Alyaev, Y; Chalyi, M; Lokshin, K; Akhvlediani, N Objective: To study the prevalence and etiology of ED after transurethral resection of the prostate (TURP) and to assess the effectiveness of prevention erectile disorders with an early administration of the vardenafil. Methods: Sixty sexually active patients (mean age 61.3 years) with benign prostatic hyperplasia who underwent TURP participated in the study. The patients were randomly assigned to two groups of 30 patients each. Group 1 included the controls, and group 2 was given 10 mg of vardenafil on alternate days for seven weeks, beginning with the first postoperative day. The patients resumed sexual activity three weeks after the intervention. The plan of the preoperative examination and the postoperative follow-up seven weeks after surgery

included testing according to the IIEF, penile Doppler ultrasonography, and corpus cavernosum electromyography (cc-EMG). Results: In group 1, a decrease in the average IIEF score after surgery was noted in six (20%) patients, whereas no ED was revealed in group 2 patients (p < 0.01). The control examination of group 1 patients showed that the peak systolic velocity (PSV) of the blood flow in the cavernous arteries did not differ significantly from the baseline values (PSV before surgery was 27.6 ± 7.6 m/s; after surgery, 27.7 ± 7.9 m/s; p > 0.1). One the contrary, group 2 patients showed an improvement in the PSV values from 26.3 ± 7.7 to 28.9 ± 8.1 m/s (p < 0.01). All the patients with postoperative ED had the signs of an impairment of the autonomous nerve supply to the penis in the cc-EMG. Conclusion: The study showed that ED after TURP is predominantly of neurogenic character and occurs in 20% of operated patients. The early administration of vardenafil at a dose of 10 mg on alternate days for seven weeks, beginning with the first postoperative day, is an efficacious method of prevention of postoperative disorders, which gives evidence of the neuroregeneratory effect of the phosphodiesterase-5 inhibitors.

P-034

Erectile dysfunction after radical prostatectomy may be caused by a decrease of penile NO content: A hypothesis to explain frequent failure of PDE5 inhibitors Virag, R, France; Richard, C Objective: ED after radical prostatectomy (RP) remains a challenging issue. PDE5 inhibitors having poor results, we hypothesized that the NO content of the cavernous bodies (CB) may be decreased after RP. To verify the hypothesis, we used the recently described penile NO release test (PNORT). Methods: 73 patients (fifty-two patients had tried inhibitors of PDE5 with negative responses) were submitted (ICI) to penile NO release test (PNORT) after RP with a postoperative delay ranging from 1 to 36 months. PNORT consisted in the measurement of the diameter of one of the two cavernous arteries localized by echo-Doppler, before and after a five minutes supra-systolic occlusion with a five cms wide cuff. The results were expressed in percentage of increase of the diameter (PID). Statistical comparison using Statistica software were done with an age matched series of 13 patients with non organic ED. 5 patients had a pre and post operative PNORT and 11 one or several measurements under injection therapy. Subsequently,all patients had full erections with intracavernous injections (ICI). Results: Median age was 62, and short IIEF mean value 5.59 ± 3. Ttest for independent values show a significant (p < 0.0001) decrease of PID after RP (21% vs. 52.53%) for the control group). For the 5 patients with pre and post RP measurements the average PID decreased dramatically (52% to 11%). Eight of the eleven patients controlled during ICI therapy showed significant increase of the PID (11% to 32%) and short IIEF score at 25. Conclusion: These results suggest that RP causes a huge decrease in penile NO production explaining the failure of PDE5 inhibitors. ICI seems to be able to enhance this production. Early post operative start of ICI is thus recommended after RP.

P-035

Evaluation of diabetic patients among the total population from the Erectile Dysfunction Observational Study (EDOS): Baseline findings von Keitz, A, Germany; Buettner, H; Haro, JM; Hatzichristou, D; Martin-Morales, A; Mirone, V; Needs, N; Riley, A; Varanese, L Objective: To determine the prevalence of diabetes in a large cohort of male patients seeking treatment for erectile dysfunction (ED) recruited in a 6-month, on-going naturalistic pan-European observational study (EDOS). To describe the baseline findings in diabetic and non-diabetic patients with ED.

J Sex Med 2005; Supplement 1

48 Methods: EDOS aims to describe the effectiveness of, and satisfaction with ED treatments in routine clinical practice. Patients enrolled include those initiating treatment for ED and those changing treatment, the choice of which is at the discretion of the treating physician and the patient. Results: 7949 ED patients were enrolled as of May 2004. 7773 patients responded to the question regarding diabetic status. Of these, 23.2% were diabetic, 76.4% were non-diabetic and 0.4% had unknown diabetic status. The most important baseline characteristics are summarised in the table. Of note, diabetics had ED of greater severity and a higher proportion with organic origin than non-diabetic patients with ED.

Unmoderated Poster Session Abstracts denafil concentration of 1 ¥ ±10–5 M. The concentration-response curves of sildenafil and tadalafil recorded a remaining tension between 25% and 60% at the same concentration. Conclusion: All three PDE5 inhibitors significantly contribute to the relaxation of HCA and underline the importance of the NO/ cyclic GMP pathway in penile vasodilation and erection. Our preliminary results did not reveal functional differences induced by PDE5 inhibitors between the first and second or third branches of HCA in healthy patients. Further investigations including patients with cardiovascular diseases will be necessary to supplement our findings.

P-037

Neurotransmitters modulating the smooth muscle contractility from seminal vesicle and vas deferens Wang, W, United Kingdom; Ralph, D; Minhas, S

Conclusion: Across Europe, the prevalence of diabetes in the general population is increasing [1]. Erectile dysfunction is highly prevalent in men with diabetes and is due to the macro- and microvascular lesions and peripheral neuropathy. The baseline data from EDOS confirm that diabetes is highly prevalent (approximately 25%) in men with ED. This study confirms recent published data, which emphasize the increasing health-related and socio-economic impact of diabetes in Western societies. [1] Lewis R. Nature 2004;430:1064–5.

P-036

Effects of the cyclic GMP-dependent relaxation of human cavernous arteries by the PDE5 inhibitors sildenafil, tadalafil and vardenafil Waldkirch, E, Germany; Hedlund, P; Ückert, S; Andersson, K-E; Jonas, U Objective: Alterations of the blood flow in penile arteries are considered to be one of the most frequent causes of male erectile dysfunction. Besides the cyclic AMP pathway the NO/cyclic GMP signaling cascade plays a pivotal role in penile vasodilatation and erection. PDE5 inhibitors are widely accepted as standard treatment for erectile dysfunction. We therefore investigated the relaxant effects of sildenafil, tadalafil and vardenafil on different branches of human cavernous arteries (HCA). Methods: Human cavernous tissue was obtained from three patients, who underwent male-to-female gender reassignment surgery. First, second and third branches of HCA were microsurgically excised and mounted in organ baths containing Krebs solution. The relaxant effect of sildenafil, tadalafil and vardenafil in 1 ¥ ±10–6 M NA-contracted preparations was recorded. Results: The three PDE5 inhibitors induced concentration-dependent and rapid relaxations in NA-contracted preparations from first, second and third branches of HCA. The PDE5 concentration— response curves did not reveal differences between the first and second or third branches of HCA. Complete relaxation was obtained at a var-

J Sex Med 2005; Supplement 1

Objective: Up to date, the mechanisms of premature ejaculation and male infertility are poorly understood. Abnormal neurotransmission in the smooth muscle from seminal vesicle and vas deferens may underlie them. However, few systematic studies have been carried out on neurotransmitters modulating the smooth muscle contractility in these tissues. The objective of this study was to identify the main neurotransmitters from seminal vesicle and vas deferens and to provide a physiological basis for understanding the mechanisms of premature ejaculation and male infertility. Methods: Small muscle strips were dissected from seminal vesicle and vas deferens from guinea pigs and isometric tension measured with a force transducer. Nerve-mediated contractions were elicited by short trains of electric-field stimulation (EFS) over a frequency range between 10 Hz to 100 Hz and verified with the neurotoxin— tetrodotoxin (TTX). Phentolamine (10 mM), atropine (10 mM) and aa,b-methylene ATP (AMBA, 10 mM) were used to investigate the neurotransmitters involved. Data were expressed as mean ± SD. Results: TTX-sensitive and frequency-dependent contractions were generated in preparations from seminal vesicle and vas deferens. Phentolamine, atropine and AMBA produced differential inhibition on contractility in both tissues over a wide range of stimulation frequencies. The relative inhibition of contraction at 40 Hz in the presence of phentolamine, atropine, and ABMA in seminal vesicle was 50.3 ± 10.1%, 50.6 ± 9.8% and 27.8 ± 8.7%, respectively, whilst in vas deferens 37.8 ± 6.5%; 49.0 ± 12.1% and 70.8 ± 8.1%, respectively. A combination of the three agents largely abolished the contractions; an inhibition of 97.5 ± 3.5% and 95.1 ± 5.7% were observed at 40 Hz for seminal vesicle and vas deferens, respectively. Conclusion: Initiation of smooth muscle contraction in guinea-pig seminal vesicle and vas deferens are mainly mediated by a-adrenergic, cholinergic as well as purinergic neurotransmitters. Whilst both preparations exhibit similar cholinergic neurotransmission, vas deferens tends to express more purinergic and less adrenergic components. Alterations to these transmitters may lead to dysfunction of seminal vesicle and vas deferens and contribute to the mechanisms of premature ejaculation and male infertility.

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Unmoderated Poster Session Abstracts Diagnosis of ED P-038

Prevalence of chronic prostatitis (CP) in patients with unknown origin of erectile dysfunction (ED) Fekete, F, Hungary; Andras, R; Pánovics, J; Romics, I Objective: CP of the ED patients has to be detected and treated not only because of the possible correlations of the CP with ED but because of many other reasons. The purpose of this study was to investigate the prevalence of chronic prostatitis in patients with unknown origin of ED. We also wanted to answer the question if it is enough to examine the patients with prostatic symptoms or it is recommended to screen for CP the asymptomatic ED patients? Physical examination alone or special urine examination is also recommended for this patients as a routine? Methods: From 05 2003 to 08 2004, we examined 352 ED patients/mean age 37.8 years with unknown origin of ED. Patients with diabetes, cardiovascular disease or any other known origin of ED excluded. CP related symptoms evaluated by questionare, prostate physical examination, DRE, and laboratorical examination of the first portion of urine after a prostate massage was performed. CP was defined as more than 25 leucocytes/microliter in the first portion of urine after a prostate massage, independently of the symptoms and prostate physical examination result. Results: From 352 ED patients 116/33% had more than 25 leucocytes/microliter in the first portion of urine after a prostate massage. Only 54/15% had CP related symptoms. The physical examination of the prostate was positive in 57/16%. Conclusion: The prevalence of CP was very high in our ED patients with unknown origin. About half of ED patients with CP had no prostatitis related symptoms and had a normal physical examination findings. Despite of negative symptoms and physical examination result, laboratory examination of urine after a prostate massage is always recommended to detect the CP for the ED patients.

P-039

Pudendal nerve conduction to evaluate organic erectile dysfunction Fishel, B, Israel; Chen, J; Alon, M; Zhukovsky, G; Matzkin, H Objective: This study aimed to evaluate the value of testing pudendal nerve conduction in men with erectile dysfunction. Methods: An open prospective study was conducted at the Souraski Medical Center, Tel Aviv, on 150 men with documented erectile dysfunction of at least 6 months duration, all of whom underwent pudendal nerve conduction testing by the same investigator. Results: Only patients with erectile dysfunction and low back pain (n = 9) showed statistically significant prolonged pathologic pudendal nerve conduction latency of 43.1 msec/div (SD ± 11.3 msec/div, p < 0.05). There were no correlations between the pudendal nerve conduction latency in patients suffering from erectile dysfunction associated with diabetes mellitus, local trauma, pelvic surgery, or antihypertensive drugs. Conclusion: Pudendal nerve conduction may contribute valuable information to the evaluation of patients with erectile dysfunction caused by neurologic deficits as manifested by low back pain.

P-040

Screening for erectile dysfunction as part of periodic examination programs—Concept and implementation Heruti, RJ, Israel; Yossef, M; Shochat, T Objective: Erectile dysfunction (ED) can be an early and first sign of an underlying systemic disease. A screening program is offered by the Israeli Defense Force for career servicemen at the staff periodic examination center (SPEC), aimed to early detection of morbidity. We introduced the Sexual Human Inventory for Males (SHIM) question-

naire, in order to detect examinees with ED, and offer them suitable treatment options. The purpose of this study is to introduce the concept of an ED questionnaire as part of a screening program, and to describe the first months of its implementation. Methods: A computerized questionnaire is used to collect the medical history. The SHIM questionnaire was incorporated into the medical questionnaire. Relevant data including compliance to reply, SHIM scores, age and accompanying diseases of patients was collected from the computerized database of SPEC. Results: 2,182 patients reported to SPEC from 1/5/01–1/11/01, 1980 of whom were males. 881 of the males (44.5%) chose to fill the SHIM questionnaire (mean age 34.5 ± 6.7 years), 244 of them (27.7%) had a score of 21 or less (20.7% had 17–21, 5.7% 11–16, 1.4% 0–10). The prevalence of ED and its severity increases with age. An inverted linear correlation was found between age and SHIM score (r = -0.22, p < 0.0001). Prevalence of hypertension and diabetes mellitus is higher in patients with SHIM score = 16 compared to those with a score ≥22. Conclusion: Only 15% of men with ED refer themselves for medical help. The concept of adding an ED questionnaire to a screening program may encourage more men to seek treatment, not only for their ED, but also for the underlying disease. The platform of a periodic examination offers maximum privacy to the examinees, resulting in better cooperation.

P-041

Who initiates the discussion on erectile dysfunction— The patient or physician? Martin-Morales, A, Spain; Cassinello, J; Haro, JM; Hatzichristou, D; Kielhorn, A; Kontodimas, S; Mirone, V; Riley, A; von Keitz, A Objective: Erectile dysfunction (ED) remains an under-diagnosed and under-treated condition, which is often perceived to reflect reluctance among patients to discuss their symptoms. As part of the Erectile Dysfunction Observational Study (EDOS) we sought to explore this issue and identify who in fact initiates the discussion on ED in real-life medical practice. Methods: EDOS is an ongoing 6-month, pan-European, observational study designed to evaluate the effectiveness of, and level of patient satisfaction with, ED treatments in routine clinical practice. This study also captures socio-demographic data of patients seeking such treatment, and records who initiated the discussion of ED at the study’s primary consultation. Patients enrolled (n = 7,949) include those initiating treatment for ED and those requesting a change in treatment, the choice of which is at the discretion of the treating physician and the patient. Results: Baseline data of 7824 patients eligible for analysis to date were considered. In the vast majority of consultations it was the patient who initiated the discussion on ED (n = 5,830, 76%), and this was largely independent of aetiology and profile of concomitant disease. Treatmentnaïve patients were more likely to initiate the discussion (80%) than patients previously exposed to ED therapy (71%). Patients were also more likely to initiate the discussion when consulting a urology specialist than general practitioners (81% and 73%, respectively). Conclusion: Patients with ED appear to be prepared to discuss their symptoms in the medical setting. In fact, 76% of the EDOS patients have initiated the discussion during their baseline consultation. In order to optimise treatment and diagnosis of this highly prevalent condition, physicians should be aware of this and, in turn, be more proactive in considering that ED often reflects the overall health status of the patient.

P-042

New approach in diagnostic of erectile dysfunction by penile color duplex doppler ultrasound with vardenafil hydrochloride (Levitra-Test) versus alprostadil intracavernous injection Ovchinnikov, R, Russia; Mazo, E; Gamidov, S; Andranovich, S; Iramashvili, V

J Sex Med 2005; Supplement 1

50

Unmoderated Poster Session Abstracts

Objective: To evaluate vardenafil (V) versus intracavernous injections of alprostadil (A) for assessment of penile haemodynamics during color Doppler duplex ultrasound (CDDU) of penis in patients with erectile dysfunction (ED). Methods: 48 patients with ED 35–73 years ago (at mean 51.4 ± 7.2) were examined, including complaints, sexual anamnesis, medical history, physical examination and routine laboratory and hormone tests. All patients were tested with CDDU (“Technos”, ESAOTE, Italy), transducer LA-523 (5.5–10 MHz). First, peak systolic velocity (PSV) and end diastolic velocity (EDV) of cavernous artery were assessed 30 and 60 min after V with manual and audio-visual sexual stimulation (AVSS). Three days later CDDU was repeated 5 and 10 min after intracavernous injection 20 mcg A with manual and AVSS. Erection was assessed visually and with palpation. Results: Duration of ED 0.5–7 years (mean 17 months). Arteriogenic ED has 31 (64.6%) patients, venoocclusive—5 (10.4%) and psychogenic—12 (25%). The values of PSV and EDV summarized in table. The most common adverse events of V were headache and flushing, which were mild and transient. Conclusion: V versus intracavernous injections of A during CDDU of penis (Levitra-test) in patients with ED is highly effective, noninvasive method for examination of penile haemodynamics. Correlation rank was 0.84–0.87 for PSV and 0.69–0.87 for EDV. There were no adverse events comparing with A, such as priapism or penile pain. Moreover, quick action (15–20 min), reliable efficacy and more biochemical potent of V comparing with sildenafil make Levitra-test more appropriate than Viagra-test.

A

Parameter PSV

5 min 26.04 ± 7.22

EDV

3.42 ± 2.19

V 10 min 29.10 ± 9.32 2.25 ± 2.83

30 min 25.67 ± 7.90 3.63 ± 2.33

r (Correlation rank) 0.843 28.71 ± 9.60 0.865 0.867 2.69 ± 3.12 0.685 60 min

Hormones in Male and Female Sexuality P-043

Female sexuality with hyperprolactinaemia Onem, K, Turkey; Musaoglu, A; Tezer, M; Kadioglu, A; Kadioglu, P Objective: The purpose of this study is to investigate sexual function in hyperprolactinemic women with an emphasis on the domains of FSFI. Methods: Twenty five women with primary hyperprolactinaemia and 16 age matched healthy women as control group were evaluated with a detailed medical and sexual history including female sexual function index (FSFI) questionnaire and Beck’s Depression Inventory (BDI). Serum levels of prolactin (PRL), dehydroepiandrosterone sulphatase (DHEA-SO4), free testosterone (free T), androstenedione (A), 17-m hydroxyprogesterone (17OH P), estradiol (E2), free thyroxin (fT4) and thyrotropin (TSH) were measured. Results: In our study group serum hormon levels, except PRL levels and BDI scores were not different from control group. Mean total FSFI score was 22.43 ± 6.19 in hyperprolactinemic group, whereas healthy women had a mean FSFI score as 30.26 ± 3.09 (p < 0.0001). Female sexual dysfunction (FSD) was diagnosed in 22 of 25 patients (88%), on the other hand only 4 of 16 healthy women (25%) had reported FSD (p = 0.03). Arousal (p = 0.05), lubrication (p = 0.01), satisfaction (p = 0.01) and pain domain scores (p = 0.01) were also significantly lower in hyperprolactinemic women. However, desire and orgasm scores were not different from control group. Total FSFI (p = 0.009, r = -0.405), desire (p = 0.001, r = -0.512), arousal (p = 0.002, r = -0.466), orgasm (p = 0.026, r = -0.348) and satisfaction (p = 0.041, r = -0.320) scores were negatively correlated to mean PRL levels, but not with other hormones measured. Conclusion: In conclusion, high frequency of sexual dysfunction is encountered (%88) in hyperprolactinaemia. The most effected domains are lubrication, satisfaction and pain.

P-044

The effect of long-term testosterone (testosteroneundecanoate) replacement therapy on prostate specific antigen and prostate volume in hypogonadal men Sommer, F, Germany; Engelmann, U; Schwarzer, U; Schubert, M; Jockenhoevel, F Objective: Androgen replacement therapy in hypogonadal men is required to prevent or reverse the symptoms of androgen deficiency. Despite its frequent use, the effect of testosterone on prostate specific antigen (PSA) and prostate size in these patients is controversial and therefore an object of further investigation. Methods: In this prospective trial we investigated the use of intramuscular (i.m.) testosterone supplementation in 40 hypogonadal men (serum testosterone concentration <5 nmol/l, mean age 40.3 years, range 18.5 to 65.7 years). Patients were randomly assigned to receive either 250 mg testosterone-enanthate (TE) i.m./21 days (n = 20) or 1000 mg testosterone-undecanoate (TU) i.m/twice every six six weeks and every nine weeks thereafter (n = 20), after 30 weeks all men received 1000 mg TU every twelve weeks for two years. After 30, 54, 90, 114 and 138 weeks the serum levels of PSA were assessed and prostate volume was measured by transrectal ultrasound (TRUS). Results: In this prospective trial we investigated the use of intramuscular (i.m.) testosterone supplementation in 40 hypogonadal men (serum testosterone concentration <5 nmol/l, mean age 40.3 years, range 18.5 to 65.7 years). Patients were randomly assigned to receive either 250 mg testosterone-enanthate (TE) i.m./21 days (n = 20) or 1000 mg testosterone-undecanoate (TU) i.m./twice every six six weeks and every nine weeks thereafter (n = 20), after 30 weeks all men received 1000 mg TU every twelve weeks for two years. After 30, 54, 90, 114 and 138 weeks the serum levels of PSA were

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Unmoderated Poster Session Abstracts assessed and prostate volume was measured by transrectal ultrasound (TRUS). Conclusion: Under intramuscular testosterone supplementation prostate volume enlarges and PSA levels in hypogonadal patients rise. Independent of a significant increase of both mean levels testosterone treatment does not enlarge prostate volume over the normal range, likewise PSA values remain unsuspicious.

Epidemiology and Risk Factors P-045

Prevalence of sexual dysfunction in male patients referred for urodynamics Belal, M, United Kingdom; Sivalingam, S; Al-Hayek, S; Abrams, P Objective: Recent studies have suggested a strong association between lower urinary symptoms (LUTS) and erectile dysfunction (ED) based on postal questionnaires. MSAM-7 study has suggested a greater prevalence of ED with increasing severity of LUTS [1]. The aim of this study is to examine if such a relationship exists in patients referred for urodynamics, with and without bladder outlet obstruction (BOO). Methods: Male patients were identified on databases, who were referred to our urodynamic unit, from 1994 to 2004. The presence of sexual dysfunction (SD) was asked on direct questioning and the diagnosis of bladder outlet obstruction was based on pressure flow studies. Results: A total of 1239 patients were identified (age range 19–91 years, median 68). The table below show the prevalence of SD in this population. A total of 492 patients were identified with SD (age range 40–89 years, median 70) with an overall prevalence of 40%. Number of patients SD prevalence (%) Obstructed 243 39 Nonobstructed 249 40 There are a significant proportion of patients referred for urodynamics with sexual dysfunction. However, there is no statistical difference in the prevalence between the obstructed and non-obstructed groups. The overall prevalence is also less than previously stated. This may be explained by the direct method of questioning compared to postal questionnaires in other studies. The majority of sexual dysfunction was erectile dysfunction (70%). Conclusion: There is a high prevalence of sexual dysfunction (40%) in male patients referred for urodynamics. However the presence of urodynamic obstruction does not increase the prevalence of sexual dysfunction. [1] Rosen R, Altwein J, Boyle P et al. Eur Urol 2003;44:637–49.

P-046

Cardinal points of sexuality—A French 2004 survey Colson, MH, France; Lemaire, A; Hamidi, K Objective: To geographically analyze sexual habits in France. Methods: 1,002 men (483) and women (519) from 5 geographic areas: South (S), North (N), East (E), West (W) and Ile-de-France (IDF) aged >35 years were selected to constitute a representative sample of the French population. Data were collected by phone with a dedicated questionnaire. Results: Sexuality is mainly associated with pleasure and sensuality (44%) and with love (42%). For S, N and E people, sexuality is mainly associated with love (respectively, 48%, 44%, 42%) rather than with sensuality. In IDF, sexuality is more associated with pleasure (21%) and sex (13%) while it is considered as a need (8%) in the W. S people are more tender (34%) while E people privilege faithful (9%). In the E, they are less defending them to admit having more desire for others partners (66%), well more than what acknowledged at W (51%). Sexuality is a frequent matter of thought for 47% of all but more often in the E (50%) than in the W (45%). Sexuality is considered as important by 72% of all but more often in the E (76%) than in IDF (68%) where they spoke about it more easily (82%) than in the E (75%). W people are less concerned by their sexuality (14%). While Intercourse is preferred in IDF (12%) and preliminaries in the N (16%), emotions and feelings are essential to all (37%). 42% of the French men report suffering from Erectile Dysfunction (ED) with 54% in IDF and 35% in the S. In comparison, their partners declare a lower national frequency (37%) and more men suffering from ED in the S (45%) than in IDF (36%).

P-047

Assesment of cavernous arteries in the doppler velocimetry Dachille, G, Italy; Ludovico, G; Vitarelli, A

J Sex Med 2005; Supplement 1

52 Objective: To evaluate the possible correlation between the diameters of the cavernous artery at a basal and dynamic level in patients who underwent a doppler velocimetry evaluation in the erectile dysfunction (ED). Methods: 124 patients with a mean age of 54 years (range 23–76) who came to andrologyst’s surgery of ED from October 2003 till July 2004, and 20 patients were included in the control group. All the patients have been evaluated by basal and dynamic penile ecocolordoppler and NPT test by Rigiscan. In the velocimetric Doppler diagnostics we measured the diameters of cavernous arteries at crural level under basal and dynamic conditions. Results: In 20 patients of the control group we have reported a basal level mean diameters of cavernous artery right 0.82 mm (range 0.6–1.3 mm) left 0.8 mm 7 range 0.5–1.25) in dynamic after 10 mgr PGE1 to right (range 0.9–1.6 mm), and 1.25 mm to left (range 0.9–1.60). In 66 patients with organic DE have reported in basal level mean diameters in basal level of cavernous artery right 0.70 mm (range 0.3–1.3 mm) and 0.76 mm left (range 0.3–1.24), in dynamic after 10 mgr PGE1 1.21 (range 0.8–1.93) and 1.24 mm left (range 0.9–1.66). Velocimetric doppler dysfunctions (low systolic peak, cavernous-venous dysfunction) have shown correlation with level basal (70% 9 and dynamic (30%) of cavernous artery. In this group is clear the correlation with power doppler. 58 patients with psychological DE to NPT test, we have reported basal level of cavernous artery right 0.9 mm8 range 0.8–1.399 left 0.75 (range 0.8–1.39) dynamic level 1.4 mm right (range 1–2 mm), 1.43 mm left (range 1.33–2 mm). Conclusion: Evalutation of cavernous arteries under basal and dynamic conditions in the doppler velocimetry is a significant parameter because it shows a clear correlation with the organic cause for the velocimetric alterations. Alterated measurements can predict an altered diastolic or systolic peak velocity.

Unmoderated Poster Session Abstracts P-049

Asthenia as cause of sexual dysfunction in married men Kulchavenya, E, Russia Objective: Physical and psychical asthenia leads to violation of patient’s relationship with their family. Methods: 80 married men in age 35–45 years, suffered from asthenia also erectile dysfunction (ED) were enrolled in study. 58 were treated with sulbutiamin for a month and 22 received placebo. Efficiency was estimated with spermograms, night monitoring of erections (RigiScan) and analysis of 3 questionnaires. Results: Significant increasing of both quantity and quality of spermies was found in sulbutiamin group, while in placebo group there was not any changes. Improvement of ejaculate was secondary—due to increasing of level testosterone in blood. Also the number and duration of night erections in sulbutiamin group was increased. On the contrary in placebo group situation remained stable. Initially all patients had asthenia; reception of sulbutiamin during 1 month allowed improving this sign in 97%. Subjective estimation of the patients their sexual potency has increased from 31.8 scores up to 47.2 in sulbutiamin group and from 32.3 up to 34.1 in placebo group. Also the marital partners were interrogated concerning quality of sexual life (on 5-scores scale). Before the treatment 85.7% wives estimated their relations as “very bad.” After treatment significant improving was in sulbutiamin group in 89,5% and in placebo group—in 22.2% only. As whole, results of the therapy like “Successful” were in sulbutiamin group in 78.6% and 22.2%—in placebo group. Conclusion: Sulbutiamin is safe and well-tolerated; it regulates metabolism, decreases asthenia, increases psychological condition of patients. sulbutiamin promotes for couple to enjoy a satisfactory sexual experience that have a positive impact on QoL and partner relationship.

P-048

Aging male symptoms (AMS) scale scoring in a randomly screened male population of North Italy Gontero, P, Italy; Carboni, F; Longoni, C; Galzerano, M; Parola, A; Buffa, B; Alberti, E; Fontana, F; Frea, B; Heinemann, LAJ Objective: The AMS scale is a validated questionnaire to assess symptoms of aging independent from those that are disease-related. In spite of being validated in several languages, up to now norm values have been published only in Germany. Moderate to severe scores for all 3 subscales (psychological, somatic and sexual) have been found to have a high correlation (80%) with a clinical diagnosis of “male climateric.” Aim of the present study was to assess the AMS scores in different age intervals in a randomly selected group and to compare the severity of complaints with a population norm values. Methods: Four hundred “presumably” healthy subjects in the age range 40–60 were randomly selected out of a comprensory population of 125,000 in North Italy. Selected participants were posted a letter announcing a telephone survey. The AMS 17 items questionnaire as well as some questions on demographics and comorbidities were administered by 2 expert psychologists. Computerized data were analysed with conventional statistics using the SPSS package. Results: Three hundred and eighty one out of 400 completed the telephone interview giving a 95.5% response rate. Median age of the group was 51 (38–61). AMS total scores and subscales scores were slightly more elevated in the age group >50, particularly for the sexual subscale but without statistical significancy. The distribution of the severity of complaints was similar to the norm values for the total scale score. For the sexual subscale there was a four fold higher percentage of severe complaints in our population than in the standard norm population. Conclusion: Our study did not detect significant AMS scores differences across the 2 age subgroups considered. Overall, 20% of subjects scored moderate to severe complaints. These were particularly marked and significantly higher than the reference norm population for the sexual subscale (50% of moderate + severe complaints).

J Sex Med 2005; Supplement 1

P-050

Sexual quality of life in men with erectile dysfunction—A French 2004 survey Lemaire, A, France; Colson, MH; Hamidi, K; Pinton, P; Klein, P Objective: To analyze sexual dysfunction among men and women in France. Methods: 483 men and 519 women aged >35 years selected to constitute a representative sample of the French population. Data were collected by phone with a dedicated questionnaire by professional interviewers. Results: Only results in males (mean age 51 years) are presented. Erectile Dysfunction (ED) is reported by 42% of men; 41% of them are worried about this trouble. ED is more frequent in celibates (51%) than in men living in couple (40%). ED increases with age (36% for the 35–44 years old up to 50% for the 60–69 years old). Among men with ED, 42% report having a sexual partner and 40% are living in couple. Among men worried by ED, only 20% report having a sexual partner and 17% living in couple. Men who report ED have 2 sexual intercourses per week on average: a frequency similar to the overall male population. Spontaneity appears as a critical factor in the sexual life of men with ED: 51% would like to have more freedom to choose the moment for intimacy and 78% of them decide to have sex a few seconds/minutes before attempt. ED alter their mood (39%), sexual desire (37%), self-esteem (36%), sexual quality of life (33%), feelings towards their partners (23%), partner’s feelings toward themselves (22%) and couple harmony (22%) While 77% of men with ED are ready to be treated, only 8% of them did previously take any ED treatment (3% of the whole male population). Conclusion: This survey confirms the high prevalence of ED among French men and underlines the importance of spontaneity in their sexual life. This high prevalence contrasts strikingly with the very low proportion of males treated although effective drugs are now available.

53

Unmoderated Poster Session Abstracts P-051

Screening for erectile dysfunction in an at-risk population Levy, L, France; Giuliano, F; Allaert, F-A; Girerd, X; Pouchain, D; Schaetz, D; Slama, A; El Hasnaoui, A Objective: To describe the characteristics of patients with erectile dysfunction (ED) in an at-risk population. Methods: A national, multicenter, descriptive as well as prospective study was conducted among general practitioners and urologists. Male patients over 18 years of age with at least one of the following risk factors for ED: cardiovascular disease, dyslipidemia, diabetes, depression, or prostatic disease were asked to fill out the IIEF5 questionnaire (score 0–25), in order to diagnose ED (score <21). Results: 8026 patients (mean ± SD age 59 ± 10 years) with ED risk factors were included into the study. Among them, 64.1% had a cardiovascular disease (55.4% hypertension and 21.4% others), 54.8% a dyslipidemia, 34.2% a diabetes, 31.6% a prostatic disease, 15.6% a depression and 24.4% were smokers. Out of the 8026 patients, 7723 filled out the IIEF5 questionnaire and 73.3% (n = 5662) had an ED and 31.7% had previously received treatment for ED; According to the IIEF5, 30.5% had mild ED (score 16–20), 26.8% had moderate ED (score 11–15) and 16.0% had severe ED (score 5–10). The existence of ED varied according to the number of risk factors, ranging from 66.3% for 1 risk factor, 69.3% for 2, 73.5% for 3 to 83% for 4 or more risk factors. The percentage of ED patients varied with age (p < 0.001), 57.1% (<45 yrs), 71.5% (45–65 yrs), 82.1% (>65 yrs). Conclusion: The risk factors for ED are well established. The number of previously undiagnosed and untreated patients suggests the difficulty of establishing a doctor/patient dialogue on the subject of ED. Implementation of a questionnaire such as the IIEF5 allowed optimal management of ED.

P-052

Observational study of erectile dysfunction management by specialists—Results of ONIRIS 1— Parameters impacting treatment efficacy and management Pinton, P, France; Costa, P; Leriche, A; Buvat, J Objective: To characterize how specialists treat erectile dysfunction (ED), and to identify commonly used treatment (TX) options in reference to ED etiology, we explored and compared ED treatment strategies, evaluated the role of specialists in ED treatment and examined which factors influence treatment. Methods: A cohort with more than 1000 ED patients consecutively recruited by French specialists was longitudinally monitored over a 4month period. Adult men seeking initial ED TX or modification of current ED TX were included. Demographic characteristics, patient and ED histories, treatment, physician, and patient appraisals were recorded at baseline. At 4 months, recourse to other care since baseline, change in ED, patient medical management, and physician appraisal were recorded. Patients were also issued a “Sexual-FunctionIndex” self-questionnaire at inclusion and once over the 4-month follow-up period. The main analysis was performed on the overall population with predefined patients subgroups: Responders(R) and NonResponders(NR) defined as R: satisfied or improved at follow-up, NR: unsatisfied or not improved. Satisfaction and improvement refer to Erectile Function. Results: From Feb.03 to Feb.04, 283 specialists followed 1246 patients including 514 R and 153 NR. NR were older (medians: 59.0, 56.0, years), more frequently widowed (9.2%, 3.5%), with a more frequent history of prostate cancer (15.7%, 4.9%). NR were less anxious (49.7%, 61.2%) but more had a total absence of erection (30.9%, 16.8%) and fewer had spontaneous good quality morning erections (36.8%, 48.4%). Their ED etiology was organic or mixed (75.0%, 65.9%), more severe (severe/very severe) (58.9%, 45.1%) and with a lower chance to fully recover (low/moderate) (55.3%, 37.1%). NR patients were less demanding after TX (low/moderate) (33.1%,

21.1%). A logistic regression evaluated the relationship between response and covariates assessed at inclusion. No spontaneous good quality morning erection, ED etiology and TX demand are significant predictive factors. Conclusion: This unique observational study illustrates the complexity of ED and suggests new attitudes in its management.

P-053

Observational study of erectile dysfunction management by specialists—Results of ONIRIS 1— Therapeutic strategies according to erectile dysfunction etiology Pinton, P, France; Leriche, A; Buvat, J; Costa, P Objective: To characterize how specialists treat erectile dysfunction (ED), and to identify commonly used treatment (TX) options in reference to ED etiology, we explored and compared ED treatment strategies, evaluated the role of specialists in ED treatment and examined which factors influence treatment. Methods: A cohort with more than 1000 ED patients consecutively recruited by French specialists was longitudinally monitored over a 4-month period. Adult men seeking initial ED treatment or modification of current ED treatment were included. Demographic characteristics, patient and ED histories, treatment, physician, and patient appraisals were recorded at baseline. At 4 months, recourse to other care since baseline, change in ED, patient medical management, and physician appraisal were recorded. Patients were also issued a “SexualFunction-Index” self-questionnaire at inclusion and once over the 4month follow-up period. ED etiology was defined as organic (O), psychogenic (P) and mixed (M). Results: From Feb.03 to Feb.04, 283 specialists followed 1246 patients. Etiology was determined in 1230 patients as O (202, 16.4%), P (386, 31.4%) and M (642, 52.2%). O patients were older on average (O: 61.7, P: 48.3, M: 58.2, years) and had more ED risks factors on average (1.7, 0.5, 1.5, respectively) and less spontaneous good quality morning erection (19.9%, 74.9%, 34.1%, respectively). ED was very severe in, respectively, 18.9%, 3.1%, 4.5%. Patients were initially treated by PDE5 inhibitors in, respectively, 76.6%, 92.7%, 90.7%. At 4 months, there were few TX modifications with PDE5 inhibitors in, respectively, 60.6%, 89.6%, 84.2%. In case of TX modifications, intra-cavernous injections were mainly prescribed in O (33.3%) and M (15.8%) while equivocally to apomorphins in P (2.1% each). At endpoint, patients declared their ED improved in, respectively, 55.4%, 82.9%, 77.5% and they were satisfied by their sexual life (rather or totally, SFI) in, respectively, 30.2%, 52.2%, 36.6%. Conclusion: This observational study demonstrates the need to consider ED etiology in its therapeutic management.

P-054

The effect of therapy for BPH upon male sexual function Sak, SC, United Kingdom; Baldo, O; Tirukonda, P; Eardley, I Objective: Sexual dysfunction and lower urinary tract symptoms (LUTS) and are common in the elderly. In elderly men, LUTS are commonly secondary to benign prostatic hyperplasia (BPH). We have previously reported the relationship between LUTS and sexual function in 696 men who had presented to a LUTS assessment clinic [1]. This is a study to assess the effect of therapy for BPH on sexual function in these men. Methods: All men had undergone therapy for BPH. 66 men had died or had become lost to follow-up. Questionnaires included a global assessment question (GAQ) and the Brief Sexual Function Inventory (SFI) of O’Leary were mailed to the remaining 630 patients to assess their sexual function after BPH therapy. Results: 315 (50%) men replied and data was incomplete in 24 cases. The median follow-up for the remaining 291 men was 35 months (range 20 to 75 months). 59 had undergone surgery, 117 had been treated by medical therapy, and 115 had been treated by observation

J Sex Med 2005; Supplement 1

54 alone. As assessed by the GAQ, more men in the surgical group had a significant worsening of sexual function than in the observation group (p = 0.002). There were no significant differences between the observation and medical groups (p = 0.13). As assessed by the SFI, all 3 groups had significant deterioration of erectile function. Both medical and surgical groups also had significant deterioration of ejaculatory domain score over time (p = 0.01 and 0.005, respectively), but the observation group did not (p = 0.12). Conclusion: Patients treated for LUTS had reduced erectile function over time regardless of the type of therapy. For ejaculatory function, both surgical and medical therapy groups had significant deterioration over time. [1] What is the relationship between male sexual function and lower urinary tract symptoms (LUTS)? Eur Urol 2004;46:482–7.

P-055

An automated electronic reminder to improve erectile dysfunction diagnosis in at risk patients Sessa, A, Italy; Michieli, R; Cricelli, C Objective: Barriers to sexual health care can be removed by convincing primary care physicians to proactively and routinely address sexual health. Only 35 percent of primary care physicians report that they often (75 percent of time) or always take a sexual hystory. Physicians are often reluctant to address sexual health issues for embarrassment, feeling ill-prepared, bilief that the sexual history is not relevant to the chief complaint and time constraints. When physicians increase their sexual history-taking, the rate of sexual problems reported by patients increases sixfold. Methods: To improve the performance of physicians and patient outcomes, the use of patient-specific prompts at the time of the consultation has been suggested. This approach can be achieved with a computerized support system already successfully checked for other clinical issues. Among Italian general practitioners (GPs) that use a standard software system for patient data management (Millewin®), an electronic reminder allow to ask about erectile dysfunction (ED) in at risk patients. Everytime a patient attending GP’s surgery belongs to at risk class for ED (hypertension, smoke, diabetes or obesity) an electronic reminder (a window) remembers GP that patient may have an ED. At the same time IIEF-5 appears and clicking on it questions can be asked and score given. Results: Eight GPs preliminary tested this procedure on 250 consecutive patients at-risk for ED attended their surgeries. 34.4% of smoker, 40.7% of obese, 49.3% of hypertensive and 56.6% of diabetic patients reported to have ED. 52 of them (46%) had minimal, 48 (42%) moderate and 14 (12%) complete ED according to IIEF score. Conclusion: This procedure shows that GPs can improve the underdetected diagnosis in the daily clinical practice.

P-056

Evaluation of the activity of the sildenafil molecules on erectile disfunction at patient with whom diabetes mellitus diagnosed

Unmoderated Poster Session Abstracts Results: There is no difference between diabetic patients and nondiabetic patients in respect of age (p > 0.05). In DM-identified group (n = 44), the number of patients with whom EDF-diagnosed as symptom was established as 16 (36.4%). These diagnoses was confirmed by consultation. Ten patients couldn’t be confirmed. A significant relation established between EDF presence and diabetes term (p < 0.01), fasting blood glucose (FBG) level (p < 0.01) and diabetic neuropathy presence (r = 0.124, p < 0.05), but no relation was ascertained between oral antidiabetics use and insulin use. In the group (n = 50), with no DM-diagnosed and randomly selected and examined, symptomaticEDF was ascertained with 8 (16%) patients. In this group, somatisation disorder was existing. At patients to whom SildM applied while a prominent falling in symptoms of the patients with no DM-diagnosed was achieved at the end of 4th month. An significant relation between FBG-regulation and SildM acticity was existent with DM-group (r = 0.104, p < 0.05), it was established that as the age increase activity of SildM lessens at EDF symptoms regardless of DM (r = 0.204, p < 0.06). Conclusion: It was agreed that the more important thing is to ensure FBG-regulation at DM-patients and prevent EDF development by interference before complications.

P-057

What factors affect the severity of ED as assessed by the EF domain score? Tirukonda, P, United Kingdom; Sak, SC; Baldo, O; Wong, L; Walker, R; Eardley, I Objective: Erectile function can be assessed objectively by use of the Erectile Function domain of the International Index of Erectile Function (IIEF) with decreasing values being associated with increasing severity of erectile function. We prospectively recorded the IIEF in men attending a community based ED clinic, and this study explores the relationship between ED severity and patient age, duration of symptoms and risk factors. Methods: All men presented with ED and underwent full assessment. Patient age and the duration of the ED history were recorded. All men were also assessed for the presence of risk factors for ED. If present these were divided into vascular risk factors (smoking, diabetes, hypertension, obesity, hyperlipidaemia) and non-vascular risk factors. Results: Complete data was available on 157 men. The mean age was 55.1 ± 13.1 years and the median EF domain score fell with increasing age (13 for men under 50 yrs, 11 for men aged 50–60 yrs, 9 for men aged 60–70 yrs and 8.5 for men more than 70 yrs) (Kruskal Wallis, p = 0.008). The median duration of symptoms was 24–30 months (range 2 to 300 months). The EF domain score was significantly lower in patients with duration of symptoms exceeding 24 months when compared to patients with duration of symptoms less than 12 months (p = 0.012, Mann Whitney U test). Eighty-seven men had vascular risk factors, 39 had non-vascular risk factors and 31 had no obvious risk factors. Those men with vascular risk factors had a lower mean EF domain score (11.4) than those men with no risk factors (14.7) (Mann Whitney U, p = 0.011) while the mean EF domain score for those with non-vascular risk factors was 12.9 (NS). Conclusion: As assessed by the EF domain score severity of ED deteriorated with increasing age, and duration of symptoms, and was more severe in those with vascular risk factors.

Tanriverdi, O, Turkey Objective: At patients with whom diabetes mellitus (DM) diagnosed, erectile disfunction (EDF) is a frequently encountered case. At DMdiagnosed male patients, in which macrovascular-microvascular complications are nested, the objective is to investigate the activity of Sildenafil molecules (SildM) on the patients with whom no ischemic heartdisease (IHD). Methods: EDF was investigated on 44 DM-diagnosed patients with the same age average. The psychosomatic conditions of the patients was also examined, investigating prostatism symptoms and the system. Urology consultations of those who require advanced careful examination was done at relevant deparments. SildM was started on 6 diabeticEDF patients, with whom no IHD was diagnosed and 4 nonDM-EDF patients, and at the end of 4th month it was evaluated clinically.

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P-058

Is there a relationship among age, international index of erectile function, international prostate symptom score and Heinemann score? Tuncel, A, Turkey; Atan, A; Basar, M; Mert, C; Aslan, Y; Agras, K Objective: To compare International Index of Erectile Function (IIEF), International Prostate Symptom Score (IPSS) and Heinemann score in various age groups of males. Methods: Three hundred-seven male were involved in the study. Mean age was 52.3 ± 12.4 (21–77) years. IIEF, IPSS and Heinemann scores were obtained. Three group were consisted according to age

55

Unmoderated Poster Session Abstracts Scatterplot of Nitric Oxide concentrations vs IEEF scores

800 Spearman’s rho: 0.844; p<0.0001 Nitric Oxide (nmol/ml)

(Group 1: £39 years, Group 2: 40–59 years and Group 3: ≥60 years). Results: While significant differences were found for IIEF and IPSS among the groups (pIIEF = 0.00, pIPSS = 0.00), no significant difference was found for Heinemann scores (p = 0.32). Although IIEF scores showed significantly difference among the groups (p = 0.00), IPSS scores did not show significant difference in patients with >40 age (p = 0.76). In correlation analysis, age showed negative and significant relationship with IIEF (r = -0.561, p = 0.00), positive and significant relationship with IPSS (r = 0.199, p = 0.00). However, positive but insignificant relationship was found between age and Heinemann score (r = 0.086, p = 0.135). In Heinemann score, no significant differences were found between somatic and psychogenic subscores (p = 0.62, p = 0.06). However, sexuel subscores were observed significant difference (p = 0.00). Conclusion: While IIEF significantly decreased with aging, Heinemann score and IPSS increased. No significant elevation in Heinemann score is related to increased sexual subscore only.

600

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P-059

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IIEF score

Radical prostectomy and sexual function: Is NO a prognostic index?

Nitric Oxide concentrations (mean±SD) subdivided according to IIEF score In the box were reported Nitric Oxide values of every subject

Zucchi, A, Italy; Mearini L; Fioretti, F; Arienti, G; Palmerini, Ca; Bini, V; Porena, M 800

Nitric Oxide (nmol/ml)

Objective: Radical prostectomy often results in erectile dysfunction; if neurovascular bundle is preserved, a recovery of erectile function may be expected in 41–60% of cases at a mean time of 6–18 months. Previous work on guinea-pigs has shown that the recovery of erectile function is connected to the regeneration of nervous fibres, especially of those that produce NO. We investigated the possible prognostic value of the determination of NO (as nitrite) in the cavernous blood after surgery related to the recovery of the erectile function. Methods: Radical prostatectomy (mono- or bilateral nerve-sparing) was performed on 15 pts suffering from localized prostate cancer. Before surgery, all pts were sexually potent (IIEF 15 items). Two months after surgery, patients were evaluated with IIEF and penile colordoppler. Cavernous blood samples were taken after pharmacological erection, and employed to determine NO as nitrite, through an electrochemical assay (Palmerini 1998). Pts were evaluated again by IIEF 18 months later. Results: No pts showed spontaneous erections two months after surgery. Only 12 patients could be evaluated 18 months later, since 3 of them had a cancer recurrence. In 8 cases, erectile function was compromised (mean IIEF score 5.3), while in 6 cases sexual potency was restored (mean IIEF score 24.8). Statistical analysis showed a close relationship between NO levels in cavernous blood and erectile function (p < 0.001). Conclusion: NO is one of the main factors involved in penile erection. NOS (nitric oxide synthetase) mainly occurs in NANC fibres whose destruction following radical prostectomy causes erectile dysfunction. If at least one of the two neurovascular bundles is preserved, a nervous regeneration can occur, and spontaneous erections may be present 6–18 months after surgery. In most cases, it is not possible to establish whether a patients will or not recover erectile function. We propose that the determination of NO (nitrites) in cavernous blood after surgery can be used as a prognostic index, with low values indicating scant probability of erection recovery.

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absent/mild

IIEF score

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56 Pharmacotherapy P-060

Fluctuations of sex hormones in men with ED during long-term tadalafil administration Aversa, A, Italy; Isidori, AM; Corona, G; Maggi, M; Fabbri, A; Spera, G Objective: Lack of sexual activity due to erectile dysfunction (ED) decreases testosterone levels through a central effect on the hypothalamic–pituitary axis. Aim of the present study was to investigate whether the known changes in sex hormones associated with resumption of sexual activity are sustained in the long-term. Methods: In a open-label fashion, 20 patients (mean age 51.8 ± 11.4) received tadalafil 20 mg on-demand for 12 months. Exclusion criteria were those reported for phosphodiesterase type-5 inhibitors, including hypogonadism and hyperprolactinemia. Primary endpoint were variation from baseline of steroid hormones: total-(T) and free-testosterone (FT) and estradiol (E). Results: A net increase in the IIEF-5 scores were observed (13.7 ± 5.9 vs. 25.7 ± 2.9, P < 0.0001). TAD assumption was safe and well tolerated (overall AEs in 12% of patients) and none discontinued medication. A significant decrease in E levels occurred at the end of the study (from 73.4 ± 35.2 to 61.0 ± 29.6 pmol/L, P < 0.05 vs. baseline), whereas no changes in T and FT serum levels were observed, respectively (14.4 ± 4.6 to 15.2 ± 6.2 nmol/L and 47.7 ± 15.3 to 49.9 ± 19.1 pmol/L, NS). Interestingly, non-parametric subgroup analysis for related samples revealed that E decrease was detectable only in lean (N = 14) but not in obese (N = 6, BMI >27.5) subjects (65.5 ± 37.1 vs. 49.6 ± 25.1, P < 0.05). Conclusion: Sustained improvement in sexual function due to prolonged tadalafil administration results in a decrease in estradiol levels without major changes in other sex steroids. Whether higher estradiol levels were involved in the pathogenesis of ED in our series of patients has not been investigated. We hypothesize that estrogen-androgen cross-talk and fluctuations due to resumption of sexual activity may have a role in the regulation of erectile function.

P-061

What proportion of men continue to use oral therapy for ED when it is reimbursed? Baldo, O, United Kingdom; Sak, SC; Mustafa, A; Cross, W; Cartledge, J; Lloyd, Sn; Eardley, I Objective: All forms of ED therapy are associated with a gradual dropout of men from treatment. There are a number of causes for this, including inability to pay for therapy. In the UK, for political reasons, specific groups of men are able to receive reimbursed ED therapy under prescription. One such group are able to receive reimbursed therapy from a hospital specialist, providing that they are seen to suffer from “severe distress.” We have been treating such men since 2000, and have the opportunity to assess whether men discontinue therapy despite “free” therapy. Methods: 319 patients were registered to receive reimbursed ED therapy between November 2000 and September 2003 (providing at least 12 months follow-up on all men). Each patient was assessed and cared for by their hospital specialist and the urology pharmacist. We reviewed all patients’ records and contacted patients via telephone to determine frequency of tablets usage, patient’s satisfaction and reasons of stopping treatment. Results: Telephone contact was achieved with 202 (63%) patients. The other men (n = 117) patients were not contactable despite three separate attempts. Sixty eight per cent (80/117) of those men who we could not contact were still regularly receiving their medications while 32% (37/117) were not. Among the patients whom we did contact, 90% (182/202) were still using use their treatment regularly and 10% (20/202) had stopped therapy. Reasons of stopping included side effects (n = 6), cured of ED (n = 4), lack of efficacy (n = 4), lost interest (n = 3), loss of partner (n = 2) and penile implant inserted (n = 1). In short, combining the two groups, 262 (80%) patients were still

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Unmoderated Poster Session Abstracts receiving therapy while 57 (20%) were not. The overall satisfaction rate among contactable patients was 90%. Conclusion: Despite the provision of reimbursed therapy, 20% of men had discontinued ED treatment. The scheme is however well utilised by 80% of patients with most of them being satisfied/pleased with their treatment.

P-062

Covariates of treatment effect in trials with oral sildenafil in the treatment of erectile dysfunction— A meta-analytic regression analysis Berner, M, Germany; Kriston, L; Harms, A Objective: Sildenafil provides the largest study database on a single PDE-V-inhibitor. This meta-analytic regression-analysis investigates possible covariates of treatment effect. Methods: Electronical databases were searched for efficacy trials of Sildenafil. The drug manufacturer was asked to provide unpublished or missing data. Randomised, double-blind, placebo controlled, parallel group, maximum fixed- or flexible-dose, broad spectrum efficacy trials, in which IIEF was administered, were included in the analysis. Data were independently extracted by two reviewers. Weighted regression models were used to test the effect of the following covariates on treatment effect: dose (flexible vs. highest fixed), baseline IIEF-score, age, aetiology (proportion of “psychogen”), ethnicity (proportion of “white”) and year of publication. Each model included one covariate; an intercorrelation table of all covariates was generated. Data were analysed using Microsoft Excel (v8.0) and SPSS (v11.5). Results: 28 RCTs of sildenafil efficacy administering IIEF were detected. 13 were conducted in broad spectrum samples. The trials were of good methodological quality. Trials with fixed-dose Sildenafil showed bigger effects as flexible-dose trials (R2 = 0.18, p < 0.01), higher baseline IIEF-scores lead to smaller effects (R2 = 0.53, p < 0.001), trials with higher “psychogen” proportion of patients showed larger effects (R2 = 0.23, p < 0.01), earlier publicised studies produced larger effects (R2 = 0.52, p < 0.001) and trials with higher proportion of “white” ethnicity resulted in larger effects (R2 = 0.34 p < 0.001). The correlation coefficients between the covariates varied between -0.53 and 0.62 suggesting strong and multiple correlations. Conclusion: The multiple intercorrelations between covariates of efficacy and their effect on outcome measures must be considered in the planning, execution and evaluation of further especially comparative efficacy trials. Known covariates must be kept in mind when interpreting study results. CONFLICT OF INTEREST: No external funding. MB previously sponsored by GSK, Lilly and Pfizer.

P-063

Dosage decisions in patients receiving tadalafil in clinical practice—Results from the German CIDRE observational study Büttner, H, Germany; Manning, M; Hahn, H; Wagner, T; Bermes, U; Kessler, FH Objective: Inhibitors of PDE5 are currently the treatment of choice for patients with ED. As for other inhibitors of PDE5, it is recommended to start treatment with tadalafil with the lower available dose (10 mg vs. 20 mg) and to reassess the prescribed dose according to effectiveness and tolerability. In a prospective observational study, it was assessed if this dosing schedule is used in common clinical practice and how dosing affects treatment success. Methods: 13,510 patients were observed by 1285 office-based urologists throughout Germany at initial prescription of tadalafil, after 4 weeks and 4 months of treatment. Results: Patients’ mean age was 57.2 years (18–99 years), 23.6% were newly diagnosed, and for all other patients the mean time since diagnosis was 17.6 months. Prior ED therapy was reported by 48.5% of all patients. The majority of patients had the 20 mg tablet initially prescribed: 70.9% (9,502) of all patients at baseline, decreasing to 68.6% after 4 weeks and to 64.7% after 4 months. The 10 mg dose was

57

Unmoderated Poster Session Abstracts initially given to 28.4% (3,825). Dose reduction after 4 weeks was reported for 7.4%, and an increase for 6.7% of the patients. Improved erections after 4 months were reported by 92.1% and 84.4% of the patients for 10 mg and 20 mg, respectively. Patients on 20 mg tadalafil were perceived as having more severe or limiting ED (ED history, rate of nocturnal/morning erections, concomitant diseases/risk factors, concomitant medication). Conclusion: Although a minority of physicians initiated tadalafil treatment with the recommended starting dose of 10 mg, tadalafil was effective after 4 months, regardless of dosage. Dose adjustments after 4 weeks were necessary in less than 15% of the patients. Assessed severity of ED accounts in part for physicians’ initial dosing decision. Factors not assessed—as e.g. patient’s wish—may also play a role in initial dosing decisions.

Results: Improvement in ED was seen in 81.8% of the patients in Group 1 and 84.6% of the patients in group 2 (p > 0.05); improvement in both ED and EP was seen in 54.5% of the patients in Group 1 and 69.2% of the patients in group 2 (p < 0.05). None of the patients in Group 1 was reported an improvement in EP only, while 76.9% of the patients were reported in Group 2. Mild or moderate side effects were reported in 2 patients (%18.2) in group 1 and in 4 patients (30.8%) in group 2. None of the serious side effect was seen in any patient that leading to discontinue the treatment. Conclusion: It seems that combination therapy with Vardenafil and clomipramine has a superior effect than Vardenafil treatment only in patients with PE and ED. However, combined treatment is associated with a higher incidence of side effects.

P-064

P-066

Trial of tadalafil in 166 ED patients with previous experience of sildenafil prescribed appropriately

Real world experience with tadalafil in 300 ED patients: Apparent cure in 12%

Buvat, J, France; Colson, MH; Lemaire, A; Bou-Jaqude, G; Alexandre, B

Colson, MH, France; Buvat, J; Lemaire, A; Bou-Jaqude, G; Alexandre, B

Objective: Study of Tadalafil (TAD) in patients with previous experience of Sildenafil (SILD). Methods: Prospective evaluation of TAD efficacy in 226 consecutive ED patients, mean age 55 + 9, with previous experience of SILD taken on demand. TAD was prescribed at the dose of 20 mg, on demand in 159 patients, and initially according to a fixed schedule (thrice a week) in the other 67. Results: 166 patients used both SILD and TAD appropriately: either complete efficacy or use of maximum dosage (100 mg SILD or 20 mg TAD) at least 5 times. Among these the rates of complete, partial or absent improvement of erections were of, respectively, 46, 36, and 16% on SILD, and 62, 29 and 5% on TAD. 20% considered their erections stronger on SILD and 31% on TAD. 19% expressed preference for SILD and 67% for TAD. The corresponding proportions were of, respectively, 7% and 77% in their partners. The main reason for TAD preference was its longer duration of action which allowed more spontaneity in sexual activity (79%, + in 71% better efficacy and in 11% better tolerance). 11% of these couples elected to continue with SILD and 67% with TAD. 7% alternated the 2 drugs. Conclusion: In this uncontrolled study the seeming TAD superiority may have been magnified by selecting patients little satisfied with SILD, dreading risks from it (103/226), and by using the fixed schedule of TAD in 30% of cases. The study also showed that some patients may prefer TAD though they feel SILD more potent, the partner’ preference may affect the choice of the drug, and each drug may salvage failures of the other. The most often cited reasons for preferring TAD were linked to its longer duration of action.

Objective: In this study independent of the industry, we aimed at verifying in a real world setting the good results reported with Tadalafil (TAD) in preregistration studies. Methods: Prospective evaluation of efficacy and tolerance of TAD proposed to 300 consecutive patients (mean age 55 + 5 years) visiting our private practices for ED of at least 6 months duration. Results: 10 patients refused the trial. 256/290 patients (88%) judged their erections had been improved with TAD but only 176 (61%) were fully satisfied with their rigidity and duration, including 41 (14%) who reported a partial return of their spontaneous erections (occasional possibility of satisfying intercourse >7 days after the last TAD dosing) and 36 (12%) a total return (satisfying intercourses following each attempt more than 8 weeks after the last TAD dosing). Adverse events (AE) were observed in 70 patients (24%), including headache in 5%, vasodilation in 10%, gastralgia in 5%, back and muscle pain in 10%, and visual symptoms in 1 patient. No severe AE was observed, and AE were mostly mild or moderate and transient in nature. Overall, 69% of the patients who tried TAD decided to continue it (56%), or were able to stop any treatment because of the return of spontaneous erections (12%). When it was effective TAD was so in <30 mn in 47% of the patients and in <60 mn in 97%. 87% felt it was effective >24 h including >48 h for 47% of them. Conclusion: In this real world study, the efficacy and safety of TAD were close to those reported in the preregistration studies. However the proportion of the patients with return of spontaneous erections and capability for intercourse seemed unusually high: 26%, including 12% apparently cured since they had stopped any dosing with TAD since at least 8 weeks.

P-065

Treatment of premature ejeculation and erectile dysfunction Cakan, M, Turkey Objective: To evaluate the efficacy and safety of Vardenafil alone and combined with in patients complaining of premature ejaculation (PE) and erectile dysfunction (ED) concomitantly. Methods: This prospective randomized study involving 24 consecutive patients suffering from mild or moderate primary PE complicated by ED. The mean age was 47.4 (22 to 68 y). The patients were divided in two groups. The patients had used no medication in the last 6 months prior to the study. All had been engaged in a stable relationship for at least 3 months. Group 1 (n = 11) was treated with flexible doses of Vardenafil from 10 to 20 mg per day, 15 minutes before intercourse and Group 2 (n = 13) was treated with flexible doses of Vardenafil from 10 to 20 mg and clomipramine (25 mg per day) for 1 month. Clomipramine was administered 3 to 5 hours before anticipated coitus. Intravaginal ejaculatory latency time (IVELT) and IIEF-5 were compared before and after treatment.

P-067

Influence of ED severity on the efficacy and tolerability of vardenafil in men with erectile dysfunction consequent to traumatic spinal cord injury Giuliano, F, France; Rubio-Aurioles, E; Kennelly, M; Montorsi, F; Kim, E; Finkbeiner, A; Shahan, B; Wilkins, J; Wachs, B Objective: To determine the influence of ED severity on the efficacy and tolerabilty of vardenafil in men with ED due to a traumatic spinal cord injury (SCI). Methods: In this multicenter, double-blind, parallel group 12-week study, 418 patients >18 years of age with ED >6 months consequent to SCI (65% of whom were sildenafil—naïve) were randomized to vardenafil 10 mg (n = 207) or placebo (n = 211) for 4 weeks, with option to remain on vardenafil 10 mg or titrate to 5 mg/20 mg at weeks 4 and 8. Efficacy variables included the IIEF-EF domain score, mean per patient positive responses to diary questions regarding vaginal penetration (SEP-2), maintenance of erection to completion of intercourse

J Sex Med 2005; Supplement 1

58 (SEP-3), and the Global Assessment Question (GAQ) regarding erection improvement over the past four weeks. Efficacy parameters were stratified by baseline EF domain scores. Results: Mean baseline EF domain scores were 11.6/12.1 (moderate ED) in the vardenafil /placebo groups, respectively. Overall, 6%, 15%, 29%, and 43% had mild, mild-moderate, moderate and severe ED at baseline. Vardenafil clinically improved all key efficacy parameters vs placebo irrespective of baseline ED severity (Table). The most frequently reported adverse events (AEs) included headache (16%/5%), UTI (11%/10%), flushing (6%/0%), nasal congestion (5%/0%), diarrhea (3%/4%), and dyspepsia (4%/0%) in patients receiving vardenafil/placebo, respectively. Serious AEs occurred in 2%/3% of patients receiving vardenafil/placebo, respectively; none were considered to be treatment-related.

Conclusion: In men with ED due to traumatic SCI, flexible dose vardenafil was generally well tolerated, and improved key efficacy parameters of erectile function irrespective of ED severity.

P-068

Clinical efficacy of apomorphine SL in erectile dysfunction of diabetic men Gontero, P, Italy; D’anatonio, R; Pretti, G; Allochis, G; Frea, B Objective: Although subgroup analyses form large randomised premarketing studies have shown that Apomorphine SL enhances the percentage of erections firm enough for sexual intercourse in diabetic men, the clinical role of the drug in this patients’ population remains to be elucidated. The aim of the present study was to assess the efficacy of Apomorphine SL in diabetic males with erectile dysfunction (ED) and to identify factors predicting those who may benefit from the treatment. Methods: On hundred and thirty diabetic patients were randomised to receive either 4 tablets of 3 mg Apomorphine or a matching placebo. Assessments of efficacy comprised the Erectile Function (EF) domain of the IIEF and the 1 item global efficacy question (GEQ). Patients with both a positive response to the GEQ and an improvement of at least 5 points in the EF domain of the IIEF were considered responders and subanalysed by several parameters indicative of the severity of both the erectile dysfunction and the diabetes. Results: Response rate was 17% after placebo and 22% after Apomorphine SL. The EF domain of the IIEF and both question 3 and question 4 scores did not significantly improve in either of the two arms over the baseline. A younger age and a lower Hb1Ac were significantly linked to the status of responder in the Apomorphine arm. Conclusion: Apomorphine SL failed to show a statistically significant benefit over a placebo but 22% of patients had a clinically significant erectile response. This observation combined with the good safety profile makes it worth considering the drug for ED diabetic patients, particularly those who are younger and with a better diabetic control.

Unmoderated Poster Session Abstracts Methods: Following the launch of Tadalaful in the UK in February 2003, 129 consecutive patients with ED associated with a broad range of aetiologies were prescribed the drug according to government regulations. Review was conducted by face to face interview in the clinic at 3 months and postal questionnaire sent out in June and July 2004. Results: 129 consecutive patients treated with tadalafil were evaluated, with 109 (84%) completing data at 3 months and 92 (71%) at 12 months. Fifty five per cent were new patients and 45% were previous sildenafil users. Seventy eight patients (71%) were still taking tadalafil at 12 months, with 14 (13%) discontinuing therapy. In 8 cases this was due to lack of efficacy, and 3 cases due to side effects. Ninety one per cent of 57 patients on NHS prescription were satisfied or very satisfied compared with 81% of 21 patients receiving the drug privately. NHS patients used an average of 5.1 tablets per month compared with 3.1 per month privately. Forty per cent of patients felt that Tadalafil was effective beyond 24 hours and 26% beyond 36 hours. Thirty six per cent reported improved erections when they did not use the medication. Headache (4%) and dyspepsia (4%) were the commonest side effects with 1 case of back pain. 20 (22%) reported improved self confidence, 7 complained about the cost of drugs (all receiving private prescriptions) and 2 complained of reduced satisfaction because their GP had stopped their wife’s HRT resulting in reduced intercourse. Conclusion: Tadalafil provided a highly effective response in both new and previously treated patients attending a UK hospital ED clinic.

P-070

Efficacy, safety and patients’ preference of tadalafil (CIALIS) in men with erectile dysfunction Hammadeh, M, United Kingdom; Kwong, Y; Araya, M; Dadswell, R; Fowlis, G; McDonald, J Objective: We performed a prospective study to evaluate the efficacy and safety of oral Tadalafil in a busy general district hospital. Also we assessed the patient’s preference for Tadalafil or Sildenafil in patients who tried both drugs. Methods: 124 consecutive patients with ED (mean age 56 years ± 13) underwent baseline IIEF questionnaire (questions 3, 4 and 14), physical examination, Blood tests (testosterone, glucose) and the cause of their ED was identified. The patients were initially given 10 mg Tadalafil (4 tablets), to use at home with the instructions to increase the dose to 20 mg depending on the response. All reviewed at 4 and 8 weeks and assesses by IIEF (Q3, 4, 14), global efficacy question (GEQ), and treatment Preference Questionnaire (TPQ). Results: The mean duration of ED was 46 months ± 43. The most common aetiology of ED in these patients was organic in 77 patients (62%), unknown 39 patients (31%) and psychogenic in 8 patients (6%). Following the treatment, 94 patients (76%) had good erections sufficient for penetration, which was maintained over the follow up period. The mean Tadalafil efficacy duration was 27 hours ± 10. 71 patients (57%) who had tried Sildenafil previously, took the option of trying Tadalafil. 29 patients had good response to both drugs, 25 (86%) of them preferred to continue on Tadalafil. 14 patients (42%) out of 33 patients who failed Viagra had good response to Tadalafil. Side effects occurred in 10 patients (10.6%). Conclusion: Oral Tadalafil significantly improved the quality of erection and sexual satisfaction in most of our patients with ED. Patients who fail one PDE5 inhibitor drug may have good response to other PDE5 inhibitors.

P-071 P-069

Tadalafil shows efficacy, tolerability and safety in a UK clinic population followed up at 12 months Hackett, G, United Kingdom; Milledge, D Objective: To assess the efficacy, tolerability and safety of Tadalafil in 129 consective patients 12 months after referral to a UK hospital erectile dysfunction clinic.

J Sex Med 2005; Supplement 1

The first experience of treatment of erectile dysfunction with tadalafil Khomyakov, V, Russia; Kulchavenya, E; Shkuratov, S; Lazarev, M Objective: Inhibitors of phosphodiesterase type 5 are playing a large role in the treatment of erectile dysfunction (ED). The first drug, sildenafil, opened new possibilities for treatment ED. While the efficacy of sildenafil has been striking, the drug is not effective and agree-

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Unmoderated Poster Session Abstracts able for all patients. So new medicines were created—more selective, potent and tolerable; one of them—tadalafil (sialis). Methods: 127 men (age 25–59 years) were enrolled in study. The sexual function was reduced during 3–14 years; 109 received earlier various conservative treatments, but were not satisfied with results completely. 87 had accompanying diseases: 24—cardiovascular and hypertension, 18—gastric ulcer, 19—chronic bronchitis, 16—diabetes, and 10—tuberculosis of lymphatic nodes. All patients received tadalafil in a doze 20 mg. Effect of treatment was evaluated using IIEF scores. As 32 patients planned in a near future pregnancy, at them the influence of short-term application of sialis on qualitative and quantitative parameters of ejaculate was estimated also. Results: 98 men (77.2%) have noted significant improvement of the sexual function on a background of reception sialis: concerning the ability to penetrate, the ability to complete intercourse, erectile function, intercourse satisfaction, orgasmic function, sexual desire and overall satisfaction. 14 have found, that sexual function was improved, but the achieved results satisfy them not quite. Thus, as a whole sialis has appeared effective in 88.2%. Only in 7 patients (5.5%) were moderate side effects (transient headache or nausea). The parameters of spermograms were stable. Conclusion: Tadalafil has been found to possess all of the characteristics desired of a PDE5 inhibitor intended to treat sexual dysfunction: selectivity, potency, efficacy and tolerability. Patients with comorbidities such as hypertension, diabetes etc have all seen significant improvements in their sexual function with sialis treatment.

P-072

Influence of viagra on sexual function of healthy men Koroleva, S, Russia; Kovalev, V; Danovich, V Objective: Lately, episodes of use of inhibitors PDE-5 by men not suffering from erectile dysfunction have become frequent. The aim of the study was studying the changes of coitus under influence of inhibitors PDE-5. Methods: 15 healthy volunteers (age from 28 till 32 years). NPT was executed with Rigiscan without use of Viagra and on a background of reception of 50 mg in all cases. 7/15 pts. the Doppler sonography was made on a background of visual erotic stimulation without Viagra and on a background of reception of 50 mg. All 15 healthy volunteers used Viagra in a doze of 50 mg not less than 5 times at home. Results were estimated on the basis of data Rigiscan software, the data of Doppler sonography and results of questioning (total point IIEF). Results: Parameters NPT Amount/Gradient of growth RAU on the tip 13/15 2 RAU on the basis 13/15 2,3 TAU on the tip 13/15 2,4 TAU on the basis 13/15 2,6 Duration of episodes spontaneous erection 10/15 1,8 Number of episodes spontaneous erection 10/15 1,8 Rigidity duration >50% on the tip 10/15 3 Doppler sonography: On a background of reception of Viagra high-grade erection was developed at 5 patients in 1–2 minutes, at 6 patients duration was 38 min. ± 9. Authentic changes in Doppler parameters of penile arteries has not been revealed. Sexological testing: 12/15 pts.-reduction of refractory period, 10/15 pts.—lot of repeated sexual acts, 9/15 pts.-lengthening of the sexual act (on the average for 12 minutes), 3/15 pts.-anejaculation, 2/15 pts.-increase of sensitivity of penile skin, 11/15 pts.-minimal stimulation for development high-grade erection. Changes of total point of IIEF was not revealed. Conclusion: Research opens prospects of use the PDE-5 inhibitors at patients with premature ejaculation.

P-073

Erectile function is associated with sexual and relationship satisfaction: A pooled analysis of 26 randomized, double-blind, placebo-controlled trials Levinson, I, USA Objective: Erectile dysfunction (ED) impacts attitudes and behaviors regarding sexual relationships. We investigated the association between erectile function and sexual relationship satisfaction with the

percentage of successful sexual intercourse attempts in men treated with Viagra® (sildenafil citrate). Methods: This was a pooled analysis of data from 26 randomized double-blind, placebo-controlled trials conducted from 1996–2003. Erectile function and sexual relationship satisfaction were assessed at baseline and end of treatment (EOT) using the International Index of Erectile Function (IIEF). ED severity was determined by scores on the Erectile Function domain of the IIEF: No ED >25, Mild = 17–25, Moderate = 11–16, Severe <11. Results for percentage of successful attempts were based on 18 of these studies. Differences between groups were determined using ANCOVA with terms defined for study, baseline score, and treatment group. Results: Data from 6126 men (3251 and 2875 randomized to Viagra or placebo, respectively) were analyzed, stratified by disease severity. Patients randomized to Viagra (vs placebo), who had mild, moderate, or severe ED, reported greater increased scores from baseline to EOT on the Erectile Function domain (5.04–11.93 vs 0.05–3.70, P < 0.0001) and the Overall Satisfaction domain (2.26–3.29 vs 0.63–0.97, P < 0.0001) of the IIEF. Change scores from baseline were significant (P < 0.0001) for individual questions regarding erection hardness, frequency of achieving and maintaining an erection satisfactory for sexual intercourse, satisfaction with sexual intercourse, sex life, and sexual relationship. Patients randomized to Viagra (vs placebo), who had mild, moderate, or severe ED, reported 50% vs 14%, 61% vs 17%, and 49% vs 12% (P < 0.001) more successful sexual intercourse attempts, respectively. Conclusion: The results of this pooled analysis reveal that in men with ED, Viagra treatment is associated with significant improvements in erectile function and satisfaction with sexual relationships. Further, the results suggest that Viagra significantly improves the percentage of successful sexual intercourse attempts and sexual relationships in men with mild, moderate, or severe ED.

P-074

Viagra® (sildenafil citrate) improves erectile function and quality in men with erectile dysfunction Levinson, I, USA Objective: Erection hardness is a primary component of erection quality, which can impact sexual relationships. We sought to determine if improvement in erection hardness after treatment with Viagra® (sildenafil citrate) correlates with improved sexual intercourse success. Methods: Hardness was graded at baseline and at the end of treatment (EOT) in a double-blind, fixed dose, placebo-controlled trial: Grade 1—poor: increase in size, but not hard; Grade 2—good: hard, but not hard enough for penetration; Grade 3—very good: hard enough for penetration, but not completely hard; Grade 4—excellent: completely hard. The percentage of men who improved from Grade 1 erections at baseline to Grade 4 and Grade 3 or 4 erections at EOT was determined and was correlated with the percentage of successful sexual intercourse attempts. Results: For men taking Viagra (25 mg, 50 mg, 100 mg, vs placebo), Grade 4 erections increased from 4% to 21%, 6% to 30%, and 4% to 34%, respectively (vs 3% to 5% for placebo); Grade 3 or 4 erections increased from 33% to 55%, 34% to 57%, and 29% to 65%, respectively (vs 33% to 32% for placebo). The percentage of men taking Viagra (25 mg, 50 mg, 100 mg, vs placebo), who reported poor erections, Grade 1, at baseline, and reported excellent erections, Grade 4, at EOT was 25%, 47%, and 62%, vs 12%, respectively; the percentages were 57%, 64%, and 84%, vs 40%, respectively, for very good or excellent erections at EOT. The percentage of men taking Viagra (25 mg, 50 mg, 100 mg) or placebo who reported Grade 4 erections at EOT was well correlated (r = 0.45, 0.53, 0.55, and 0.29, respectively) with the percentage of successful sexual intercourse attempts; the correlations for men who reported Grade 3 or 4 erections at EOT were r = 0.76, 0.75, 0.66, and 0.65, respectively. Conclusion: Men taking Viagra reported 2 to 5-fold greater improvement in erection quality from poor to excellent erections than men taking placebo. Viagra increased erection hardness and quality, which was well correlated with sexual intercourse success.

J Sex Med 2005; Supplement 1

60 P-075

Predictors of remission in depression intensity (HAMD17) and erectile function in men with mild major depressive disorder and erectile dysfunction treated with vardenafil: The depression related improvement with vardenafil for erectile response (DRIVER) Montorsi, F, Italy; Bakish, D; Berber, M; Assalian, P; Bangerter, K; Seger, M; Rosen, R Objective: To explore which variables predicted a return to normal erectile function (International Index of Erectile FunctionErectile Function domain [IIEF-EF] score >26) or remission in depression (Hamilton Rating Scale for Depression [HAM-D17] score = 7). Methods: In this multi-center, flexible-dose, randomized, parallelgroup, double-blind study, 280 men = 18 years of age with erectile dysfunction (ED) >6 months and diagnosed untreated mild MDD (296.22 by DSM IV and Hamilton Depression Scale [HAM-D17] score 11–17) received placebo or vardenafil 10 mg for 4 weeks, with the option to titrate to 5 mg/20 mg after two consecutive 4-week intervals. In a retrospective analysis, logistic regression was used to determine which variables predicted remission in EF and depression scores. Variables entered into logistic regression models included treatment, IIEF-EF baseline, IIEF-EF change, IIEF-EF return-to-normal, HAM-D17 baseline, HAM-D17 change, and HAM-D17 return-to-normal, age, and ED-duration. Results: Treatment with vardenafil was most predictive of a return to normal EF (p < 0.0001). Greater changes in HAM-D17 score, higher IIEF-EF baseline, shorter ED duration, or younger age also predicted a return to normal EF. The most important predictor of depression remission was improvement in IIEF-EF domain score (p < 0.0001), followed by IIEF-EF or HAM-D17 baseline scores. Conclusion: Treatment with vardenafil was the most predictive for EF return to normal, and IIEF-EF improvement was most predictive of depression remission, reinforcing the concept that improvement of ED symptoms may be important for achieving depression remission.

P-076

Therapy combined with 5 phosphodiesterasis inhibitors and antagonists of alfa 1 adrenergic receptors in the treatment of erectile dysfunction in patients with benign prostatic hyperplasia Paradiso, GG, Italy; Ronchi, P; Pace, G; Gravina, G; Vicentini, C Objective: To value the effectiveness and pressure variation in patients in therapy with inhibitors of 5-phosphodiesterasis (tadalafil) and antagonists of alfa1 adrenergic receptors (alfuzosina). Methods: 42 patients aged 56 to 71 years, affected by erectile dysfunction (ED) and benign prostatic hyperplasia (BPH). All after one month of treatment with antagonist of alfa 1 receptors, has been submitted for 3 months to a therapy with inhibitors of 5 phosphodiesterasis (5-PDF), the administration of the first happened daily while 5-PDF inhibitor was assumed to demand. Pressure values have been performed to one month by the insertion in the study, 15 days from the 5-PDF inhibitors assumption and subsequently monthly for 3 months. To every patient a diary has been furnished to annotate the effectiveness of the therapy and the presence of collateral effects. Results: Of the 42 patients, in 8 ED has disappeared with the only treatment with the antagonists of alfa1 adrenergic receptors, the 34 patients who initially refer only urinary symptoms and who subsequently reported problems related to the sexual sphere too, have been treated first with antagonists of alfa1 adrenergic receptors and then also with the 5-PDF inhibitors; in those patients the reduction or disappearance of the urinary symptoms has coincided with the resolution of ED. The analysis of the pressure values has underlined that the 5PDF inhibitors assumption in association with the antagonists of alfa1

J Sex Med 2005; Supplement 1

Unmoderated Poster Session Abstracts adrenergic receptors didn’t provoke substantial pressure variations, if not of ± 4 mmhgs. Conclusion: ED in subjects with urinary symptoms due to BPH finds benefit from the therapy combined with antagonists of alfa1 adrenergic receptors and 5-PDF inhibitors, the improvement of the obstructive symptoms coincides with the resolution of the ED. The association of antagonists of alfa1 adrenergic receptors and 5-PDF doesn’t clinically alter in meaningful way the pressure values.

P-077

An open-label, multicenter, flexible dose study to evaluate the efficacy and safety of Viagra® (sildenafil citrate) in males with erectile dysfunction and arterial hypertension who are taking antihypertensive treatment Park, NC, Republic of Korea; Shim, HB; Lee, SW; Kim SW; Moon, KH; Lee, DH; Park, Ks; Park, JK; Yoon, SJ; Cho, SJ; Park, HJ Objective: We evaluated the safety and efficacy of sildenafil citrate in men with erectile dysfunction who had been taking one or more antihypertensive agents in order to provide the supportive scientific data which can be used as a reference when describing sildenafil citrate in patients with hypertension. Methods: 198 male subjects, aged 20 years and older were enrolled from September 2002 to June 2003. Subjects were those with arterial hypertension taking one or more antihypertensive agents, and who had been diagnosed with erectile dysfunction of more than 3 months duration. This study was conducted for 10 weeks as an open-label, multicenter and flexible dose clinical study with 2-week screening period and 8-week treatment phase. At all visits, the heart pressure and heart rate were measured and concomitant medications and adverse events were recorded for each subject. Subjects were asked to complete the Event Log Worksheets and questionnaires of the IIEF and the GEAQ during the study period. Results: 167 subjects have completed this study. The average of age was 55.3 (31 to 77) years old and that of duration time of erectile dysfunction was 3.3 years. Each score of question 3 and 4 of IIEF has improved from 2.35 and 1.76 at baseline to 3.67 and 3.41 at week 4 and 3.88 and 3.51 at week 8. 88.3% and 89.9% of patients have answered “Yes” to the questionnaire “Has the medication improved your erections?” at week 4 and 8, and 87.7% and 91.6% of patients have answered “Yes” to the questionnaire “Has the medication improved your ability to have sexual intercourse” at week 4 and 8. There were no significant differences in responses of question 3 and 4 of IIEF and GEAQ by the number of antihypertensive agents taken. Conclusion: According to the results of this study, we can conclude that sildenafil citrate is effective in improving erection and well tolerated and safe in treating men with erectile dysfunction taking antihypertensive agents for arterial hypertension.

P-078

Comparison of the efficacy and safety of continuous positive airway pressure (CPAP) and the combination of sildenafil and CPAP in the treatment of erectile dysfunction (ED) in men with obstructive sleep apnea syndrome (OSAS) Perimenis, P, Greece; Gyftopoulos, K; Karkoulias, K; Markou, S; Perimeni, P; Kartsanis, G; Athanasopoulos, A; Barbalias, G; Spyropoulos, K Objective: To compare the efficacy and safety of CPAP and the combination of sildenafil and CPAP in the treatment of ED in men with OSAS. Methods: Forty men with OSAS and ED (EF domain—IIEF score <26) started on CPAP treatment after a thorough investigation. After 4 weeks, 20 of them were allocated to receive additionally sildenafil 100 mg on demand for 6 weeks while 20 did not receive. After a 1week wash-out, they switched to the other treatment mode for an additional 6-week period. Study outcomes were the efficacy, determined as

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Unmoderated Poster Session Abstracts the percentage of successful attempts for intercourse based on event log, and the satisfaction with sildenafil in the treatment of ED. The significance of adverse events (AEs) was evaluated regarding to the need for treatment or withdrawal from study. Results: Mean values of the studied men were for age 56.2 years, ED duration 18.2 months, apnea index 15 and EF domain score 15.4. Of the patients, 75% suffered one or more comorbidities, 87.5% were heavy smokers and 80% were overweight. The patients recorded 424 attempts for intercourse with sildenafil and 343 without sildenafil, of which 259 (61.1%) vs 85 (24.8%), respectively were successful (p < 0.001). Of the studied men, 28 (70%) were satisfied with sildenafil in the treatment of ED. Five men reported insignificant AEs under sildenafil and 3 men under CPAP. Conclusion: The combination of sildenafil and CPAP is safe and more effective than CPAP alone in the treatment of ED in men with OSAS. Based on results of analogous studies, the therapeutic impact of this combination is superior compared to sildenafil alone. Due to the high proportion of men who are not satisfied from this ED treatment, it is likely that additional therapeutic options must be studied further.

Methods: One hundred and forty patients who consulted because of erectile dysfunction at daily clinical practice in Fundació Puigvert between February and June 2003 were assessed. The sample was randomly selected. Drug efficacy was assessed by comparing changes from baseline of the scores obtained from questions 1 to 5 and 15 of IIEF and by evaluating the penetration and erection manteinance abilities (questions number 3 and 4 of IIEF) and occurrence of adverse effects and their severity. We used the Wilcoxon signed rank test to compare the paired data of scores pre and post-treatment, and the results were statistically significant (p < 0.0001). Results: Response to tadalafil was assessed in 140 patients who complaint of erectile dysfunction, randomly selected at the daily clinical practice. Positive response was obtained in 52.85% of the cases. Obtaining an erection with enough rigidity and duration to enable coitus satisfactory for the patient was accepted as a positive response. The overall incidence of adverse effects was 53.57%, and myalgia is the most frequently reported (50.66%). The adverse effects were mild and were not a frequent cause of quitting treatment. Conclusion: Tadalafil is an effective treatment for patients with erectile dysfunction. In spite of the incidence of adverse effects, they are not disturbing enough for patients to quit treatment.

P-079 P-081

Reliability and safety of vardenafil 10 mg for the treatment of erectile dysfunction: The reliabilityvardenafiL for erectile dysfunction (RELY I) trial Porst, H, Germany; Valiquette, L; Young, J; Moncada, I; Vezina, J-G; Shahan, B; Edmunds, K; Montorsi, F Objective: Reliability is an important factor for men choosing and continuing oral therapy for erectile dysfunction (ED). This study evaluated the reliability of vardenafil (Levitra) 10 mg in a broad population of men with ED. Methods: In this double-blind, international (10-country) multicenter study, 600 patients (vardenafil, but not necessarily PDE5 inhibitor naive), with ED were first given a single dose of vardenafil 10 mg. Patients achieving successful penetration with this single dose were randomized to treatment wtih vardenafil 10 mg or placebo for 12 weeks. Subsequent penetration (SEP-2) reliability was calculated as percentage of successful doses by total valid doses (dosing with sexual activity initiated with the intent of intercourse within 0–12 hours postdose). Subsequent completion of intercourse (SEP-3) reliability was also calculated as percentage of successful doses over valid doses. Analyses were performed on the intent-to-treat (ITT) population. Results: The mean baseline IIEF-EF domain score of the ITT population (vardenafil, n = 255, placebo, n = 254) was 14.6 (moderate ED). A total of 520/600 patients (87%) who received the first dose achieved SEP-2 success. Subsequent mean per-patient SEP-2 reliability rates were 83% and 56% (p < 0.001) for patients receiving vardenafil (n = 254) and placebo (n = 246), respectively. A total of 443 patients (74%) who responded to the initial dose achieved SEP-3 success rates wth vardenafil 10 mg. Subsequent mean per-patient SEP-3 success rates were 77%/42% (p < 0.001) for those receiving vardenafil 10 mg (n = 216) and placebo (n = 205), respectively. Vardenafil was generally welltolerated; most commonly reported treatment-emergent adverse events (vardenafil/placebo%) were flushing (5.4/08), headache (5.0/1.9) and dyspepsia (2.3/0.4). Conclusion: In this study, vardenafil provided for high initial/subsequent attempts in successful penetration (87%/83%), and intercourse completion (74%/77%) up to week 12. These results demonstrate that the 10 mg dose of vardenafil provides high reliability in key efficacy parameters important to patients for selecting and continuing oral treatment for ED.

P-080

Our clinical experience with tadalafil Rodríguez-Villalba, R, Spain; Pomerol, J Objective: To assess the efficacy and safety of tadalafil as treatment for patients with erectile dysfunction.

Impact of diabetes mellitus on the severity of erectile dysfunction and response to treatment: An integrated analysis of data from tadalafil clinical trials Seftel, A, USA; Fonseca, V; Denne, J; Fredlund, P Objective: Diabetes mellitus (DM) and erectile dysfunction (ED) share similar risk factors. We evaluated the efficacy and safety of tadalafil for the treatment of ED in men with and without DM. Methods: We conducted a retrospective analysis of data from 12 placebo-controlled trials. Patients were randomized to tadalafil 10 or 20 mg, or placebo, taken as needed (up to once daily) for 12 weeks (637 men with DM [mean 57 years] and 1681 men without DM [mean 56 years]). Glycemic control was assessed by baseline hemoglobin A1c (HbA1c) levels. Efficacy measures included the International Index of Erectile Function Erectile Function (IIEF EF) domain score and Sexual Encounter Profile Diary Question 3 (SEP3, Did your erection last long enough for successful intercourse?). Results: At baseline, men with DM had more severe ED than men without DM; mean IIEF EF scores were 12.6 and 15.0, respectively (p < 0.001). Tadalafil significantly improved erectile function compared with placebo in men with ED both with and without DM (p < 0.001, IIEF EF & SEP3). The mean improvement in IIEF EF for men with DM was 6.2 and 7.4 for tadalafil 10 and 20 mg versus 0.9 for placebo (p < 0.001); and for men without DM, the mean change in IIEF EF was 6.7 and 8.9 for tadalafil 10 and 20 mg versus 0.8 for placebo (p < 0.001). The effect of tadalafil relative to placebo was not significantly influenced by baseline HbA1c or by diabetic medication (insulin, oral agents or none). The most common adverse events were headache, dyspepsia, back pain, myalgia, and nasopharyngitis. Conclusion: Men with DM had more severe ED than those without DM. Despite this, tadalafil was efficacious and well tolerated. The effect of tadalafil to improve erectile function was not significantly influenced by HbA1c levels.

P-082

Curing erectile dysfunction—long term effects (12 months) of taking PDE-5-inhibitors on a daily basis Sommer, F, Germany; Engelmann, U; a. t. German Men’s Health Study Group Objective: Nocturnal erections contribute to the maintenance of the morphodynamic integrity of smooth muscle cells within the corpora cavernosa. This study was aimed at evaluating the effect of sildenafil taken at bedtime on erectile function. Methods: In a prospective, randomised, controlled trial to determine whether sildenafil taken at bedtime affected erectile function after one

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Unmoderated Poster Session Abstracts

year, 77 patients were randomly assigned to two groups (1st group: 50 mg sildenafil taken every night at bedtime, 2nd group [control group]: 50–100 mg sildenafil on demand). Additionally, a 3rd group was also followed up, consisting of patients who did not undergo any medical therapy. Sildenafil was taken by groups 1 and 2 for a period of 12 months, followed by a wash-out phase of one and six months respectively. The primary efficacy measures were IIEF domain score and peak systolic velocity (PSV) of penile arteries. Results: After the one-month “wash-out” phase, 58.8% of Group 1, and 9.7% of Group 2 had an IIEF domain score >26. PSV of the cavernous arteries improved in Group 1 from 29.4 + 9.8 cm/s to 38.9 + 10.3 cm/s (p < 0.05). In Group 2 a small, not statistically significant average improvement in PSV (+3.0 cm/s) was seen. In Group 3 PSV declined slightly. 20 of the 34 patients in Group 1 had an IIEF domain score >26. These 20 patients with normal erectile function were followed up for a further 12 months (IIEF-questionnaire and PSV of penile arteries) without taking any medication. 80% (16/20) of these patients still had normal erectile function at the end of 12 months. Conclusion: After only one year, sildenafil taken regularly at bedtime may be able to bring about regression of ED or can be a useful tool for curing ED.

Methods: In one open randomized study was investigated the fertile and erectile function in 40 infertile couples with artificial insemination. Males received 50 mg Sildenafil citrate 1 hour before sexual intercourse. Pre-treatment workup: history + physical + examination, International Index of Erectile Function (IIEF), semen analysis and sperm-cervical mucus interaction tests (post-coital tests and Kremer tests). The control group was 20 couples without treatment. Results: In the study group of men taking Sildenafil citrate, sperm parameters were significantly improved. Spermatozoa penetration ability in the cervical mucus showed acceleration of all studies parameters. Surpassing finding was the improvement of the all ovulatory cervical mucus parameters. Baseline IIEF score was lower in infertile population and the control group without Sildenafil citrate treatment confirming the stress status in the infertile patients. After the treatment we observed advance in per cent maximum response in all the five domains of sexual function. Conclusion: Our data confirms the efficacy of Sildenafil citrate in the treatment of infertile couples and improvement of fertility ability of spermatozoa and ovulatory cervical mucus parameters. We explain the increased pregnancy rate with better quality of life in the infertile group of patients.

P-083

P-085

The Real-Life Safety and Efficacy of vardenafil (REALISE)—An international post-marketing surveillance study—Results from Germany

Treatment satisfaction with Viagra® (sildenafil citrate) in men with erectile dysfunction: Combined analysis of 6 trials

Sprenger, K, USA; van Ahlen, H; Zumbé, J; Stauch, K; Landen, H

Stecher, VJ, USA; Wang, H

Objective: To determine the safety, efficacy and patient acceptance of vardenafil 5, 10 and 20 mg in real-life use. Methods: Data from a prospective, non-interventional study collected between March-December 2003 from 5032 sites in Germany were available. These results are the first part of an ongoing multinational post-marketing surveillance study program. Subjects with ED where vardenafil was prescribed in routine practice were followed for a period of 2 months. Efficacy was measured under daily life conditions. Data were acquired by interviews and diaries. Safety was determined by reporting of adverse events (AE). Subjects who took at least one tablet and had follow-up data were valid for analyses. Results: Data from 29,358 subjects with a mean age of 57.9 ± 10.0 years were analyzed. Currently, follow-up information is available from 99.55% of subjects. 10 mg vardenafil was the most frequently used dose (72.1%). In 93.9% of all subjects erections improved, and improvement occurred after the first/second tablet in 73.6%/88.5%, respectively. In 92.7% of all subjects overall efficacy was rated satisfying/very satisfying. Additional data were available from patient diaries from the majority of subjects. In these subjects penetration was possible for 94.9% of all attempts, and in 86.7% of all attempts erections were maintained long enough to complete intercourse. Erections were considered to be satisfying/very satisfying in 88.7% of attempts. Finally, 86.4% of all subjects stated that they would like to continue vardenafil treatment. The overall incidence of AEs was 1.42%; the incidence of drug-related AEs was 1.29%. The most frequently reported AEs were headache (0.64%) and flushing (0.16%). There were 21 (0.07%) serious AEs. Overall one death was reported, which was not drug-related. Conclusion: In this large, post-marketing surveillance trial of 29,358 subjects, vardenafil was generally safe and well tolerated with high efficacy consistent with data reported from other open-label studies.

Objective: To evaluate patient satisfaction with Viagra treatment for erectile dysfunction (ED) using the 11-item Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS). EDITS assesses attitudes about treatment effectiveness, side effects, ease of use, naturalness, and impact on partners. Methods: Included were men with ED treated with Viagra (8–12 wk) in 6 open-label, country-based studies (United States, Belgium, Czech Republic, Germany, the Netherlands, and Russia). Items were scored from 0 (lowest satisfaction) to 4 (highest satisfaction). The EDITS index was derived by multiplying the mean score by 25. Patients with an index greater than 50 were considered satisfied with treatment. Satisfaction was assessed across categories of age and ED duration, etiology, and severity. ED severity was defined by Erectile Function domain scores from the International Index of Erectile Function (minimal, 26–30; mild, 22–25; moderate, 11–21; severe, 10 or more) or response to an erection problem question. Results: 2,640 men (mean age, 54 y, range, 18–96) received Viagra (25–100 mg). Overall, 86% (2,265/2,625) who completed the EDITS were satisfied with Viagra treatment. By age, this included 89% 60 y or younger and 78% older than 60 y. By ED duration, this included 88% with 2 y or less, 83% with 2 to 5 y, and 83% with more than 5 y duration. By ED etiology, this included 79% with organic, 90% with mixed, and 96% with psychogenic ED. And by severity, this included 88% with minimal, 93% with mild, 96% with moderate, and 76% with severe ED. Conclusion: More than 75% of men in any given category, and 86% overall, were satisfied with Viagra treatment. The highest rates of satisfaction were in men aged 60 y or younger, those with ED of 2 y duration or less, those with ED of psychogenic or mixed etiology, and those with mild or moderate ED.

P-086 P-084

Positive influence of sildenafil citrate on fertility ability in patients with sexual disturbanses Stanislavov, R, Bulgaria; Nikolova, V Objective: The aim of the present study was to determine the effects of Sildenafil citrate on sperm parameters before and after treatment in a group of infertile couples and the penetration ability of the spermatozoa in ovulatory cervical mucus.

J Sex Med 2005; Supplement 1

VIAGRA® (sildenafil citrate) 50-mg starting dose is well tolerated in elderly patients Stecher, VJ, USA Objective: Although the incidence of adverse events (AEs) with Viagra® (sildenafil citrate) was similar across all age groups at the time of marketing authorization application, free Viagra plasma concentrations approximately 40% greater in elderly (age 65 or older) compared with young (18–45 years) volunteers prompted a conservative recom-

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Unmoderated Poster Session Abstracts mendation of a 25-mg Viagra starting dose in elderly patients. However, the elderly typically have more severe erectile dysfunction (ED) and many may require 100 mg Viagra for optimal efficacy and thus may endure 2 dose escalations before achieving a successful response. We examined data from double-blind, placebo-controlled studies of Viagra in men with ED to assess if the safety and tolerability of a 50-mg Viagra starting dose differs from that of a 25-mg or less starting dose in elderly patients. Methods: Findings from 38 double-blind, placebo-controlled studies of Viagra (5–200 mg) in 9197 men with ED were pooled in this analysis. Most studies were 12 weeks in duration and most patients received 25 mg to 100 mg Viagra; 367 patients were randomized to 5, 10, or 200 mg Viagra. Results: A similar profile of AEs was observed for elderly patients receiving either a 25-mg or less or 50-mg Viagra starting dose (table). There were no differences in the rate of serious AEs between Viagra and placebo for either dose group. The rates of severe AEs and discontinuations due to AEs were similar for the Viagra 50-mg dose group and placebo and were not higher than that reported for patients in the 25mg or less dose groups. The profile and occurrence of AEs in elderly patients was also similar to that of younger patients for all doses.

Conclusion: Compared with a starting dose of 25 mg or less, a 50-mg Viagra starting dose does not substantially increase the rate of AEs, serious AEs, or severe AEs in elderly patients and may allow elderly patients to more rapidly achieve successful treatment of their ED.

P-087

Comparison the efficacies of re-sildenafile only and sildenafile plus testosterone treatments in sildenafilefailed patients Tuncel, A, Turkey; Atan, A; Basar, M; Ferhat, M; Agras, K; Tekdogan, U Objective: To compare the efficacy of re-sildenafile only and sildenafile + testosterone in patients who did not benefit from previous sildenafile treatment. Methods: Nighty-three male patients who have previously used various doses and times of sildenafile for ED but have not succeded adequate erection for coitus were included. Mean age was 52.3 ± 9.6 (33–69) years. The patients were evaluated with the International Index of Erectile Function-5 (IIEF-EFA) and serum PSA levels. The patients were informed in detail about sildenafile use. Sildenafile 100 mg (at least 6 times) or Sildenafile 100 mg (at least 6 times) + testosterone (Sustanon® depot, IM injection in each 2 weeks) were randomly given. After two months, the patients were re-evaluated with IIEF-EFA and serum PSA levels. Results: Sildenafile only and Sildenafile + testosterone was given to 42 and 51 patients. There wasn’t significant difference between pretreatment scores in both groups (IIEF-EFA-1) (p = 0.17). Although significant difference was observed in both groups with regard to IIEFEFA-scores after the treatment (IIEF-EFA-2) (psild = 0.00, psild + test = 0.03), IIEF-EFA-2 score increased more significant in the combination group (p = 0.00). No significant difference was observed in two groups with regard to serum PSA levels before and after the treatment (psild = 0.08, psild + test = 0.38). Eighty-four (90.3%) patients had 0–20 IIEF-EFA score and 9 (9.7%) patients had ≥21 IIEF-EFA score. After the treatment, IIEF-EFA score was ≥21 in one patient (2.4%) in

the sildenafile group and eight (15.7%) patient in the combination group. Conclusion: IIEF-EFA scores significantly increased after both treatments. However, increase of IIEF-EFA-2 score in combination group were more significant.

P-088

Comparison the sildenafil treatment only to sildenafil plus testosterone combination in patients with erectile dysfunction Tuncel, A, Turkey; Atan, A; Basar, M; Tuglu, D; Agras, K; Tekdogan, U Objective: To compare the efficacy of sildenafil citrate only treatment to sildenafil citrate and testosterone combination in erectile dysfunction (ED). Methods: Ninety-five male patients with ED were involved in the study. The patients with taking nitrate group medicine, abnormal liver function tests, urologic cancer, any condition to avoid for coitus and previously usage of sildenafil were excluded. Group 1 was consisted of 58 patients who took 100 mg sildenafile only (minimum 6 times). Group 2 was consisted of 37 patients who took 100 mg sildenafile (minimum 6 times) and depot androgen (Sustanon®) IM twice a month. The treatment protocols were used for 2 months. The patients replied first 5 questions of the International Index of Erectile Dysfunction (IIEF-EFA) before and after the treatments. The scores were compared for assessment of the treatments efficacy. Results: In Group 1 and Group 2, mean age were 49.9 ± 8.6 and 48.3 ± 12.2 years, respectively (p = 0.49), ED time were 29.3 ± 11.4 and 30.7 ± 10.7 months, respectively (p = 0.72). IIEF-EFA scores in both groups significantly increased after the treatment (pGroup1 = 0.00, pGroup2 = 0.00). However, combination treatment provided no additional contribution. Serum PSA levels in both groups after treatment did not change significantly (pGroup1 = 0.33, pGroup2 = 0.55). Conclusion: Sildenafile and androgen combination is not found superior to sildenafile only in ED treatment.

P-089

Sexual attempts and efficacy of two dosing regimens of tadalafil: SURE study in 14 European countries van Ahlen, H, Germany; Damber, J-E; Costa, P; Moncada, I; Mirone, V; Wespes, E; Chan, M; Varanese, L Objective: Tadalafil, a phosphodiesterase 5 inhibitor, improves erectile function up to 36 hours post-dosing in men with erectile dysfunction (ED). SURE data were analyzed to determine the effect of two treatment regimens of tadalafil 20 mg, on demand or 3 times/week, on the sexual attempt patterns and efficacy of the drug at several time intervals after dosing. Methods: SURE is a 14 European country, multicenter, crossover, and open-label study. 4262 men were randomized to tadalafil 20 mg treatment 3 times/week or on demand for 5–6 weeks, followed with 1-week washout period, then crossed over to the alternate regimen for 5–6 weeks. Results: Approximately 75% of sexual attempts during the 3 times/week regimen and around 47% of attempts during the ondemand regimen occurred >4 hours after dosing with tadalafil 20 mg. The mean per-patient percentage of successful attempts (SEP3) was similar between regimens (>70%) at each time interval. The primary efficacy variable in this study was the patient response to the Treatment Preference Question (Which treatment regimen did you prefer?). Most men chose the on demand regimen (57.8%) and a substantial number chose the 3 times/week treatment (42.2%). Conclusion: The efficacy of tadalafil 20 mg can last up to 36 hours. In this analysis, patients engaged in sexual activity over a wide distribution of time after dosing, regardless of the treatment regimen (on demand or 3 times/week). Patients also experienced a high rate of successful intercourse that lasted up to 36 hours post dosing on both regimens. With efficacy up to 36 hours, tadalafil gives men with ED the flexibility to choose the time for having sexual intercourse.

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P-090

The fate of patients consulting for ED: A retrospective study of 539 cases Virag, R, France; Floresco, J; Richard, C Objective: Very few studies focus on the evolution of patients consulting for ED. We present the preliminary results of a huge retrospective survey (12,000 cases) carried on to evaluate treatments and their follow-up. Methods: We evaluate a preliminary sample of 539 patients attended for ED for the first time between October 97 and December 98. Regardless to age and aetiology we quoted the issue of the first consultation and the evolution after the proposal and/or the installation of a treatment. Inclusion criteria for phase 2 were a minimum followup latency of 1 y. Results: We eliminated 12 patients attended for stuttering priapism during sickle cell disease. Of the remaining 527, 139 (26.4%) were not proposed any treatment, 38 (7.2%) refused further evaluation; 317 patients (60.1%) were proposed a treatment: oral including PDE5 inhibitors for 58 (18.2%), self intracavernous injections (SICI) for 248 (78.2%) and surgery for 11 (3.5% consisting in 7 implants and 4 vascular procedures). Follow-up for 1 y. and more (up to 7 y.) is available in 253 (80%); 30 on oral treatment, 10 after surgery and 213 under SICI. 90% of the patients on oral treatment were satisfied, the remaining shifted to SICI. In the SICI group, 74% continue their treatment eventually with hormone replacement; 31% (n = 58) tried PDE5 inhibitors: 46.5% stopped SICI and elect oral therapy; 27.5% use it as an adjuvant therapy and 27% were unsatisfied. Surgery (8 implants and 1 vascular) was indicated in 9 cases (3.55%) Conclusion: Only 48% of this sample of ED patients started a treatment; 30% use PDE5 inhibitors, 62.2% use SICI and 7.8% were operated on. The study is continuing to understand why so many patients are reluctant to accept any treatment and to evaluate how those who are treated behave with what is mainly on demand treatments.

P-091

A prospective clinical study of sildenafil in alleviating premature ejaculation Wang, W, United Kingdom; Ralph, D; Minhas, S Objective: Up to date, premature ejaculation (PE), the most common sexual diseases, has not a universally approved therapy. Sildenafil has been demonstrated to have effect on PE by a few studies recently. The objective of this study is to further evaluate the efficacy and safety of sildenafil in the treatment of premature ejaculation (PE). Methods: 180 potent men with PE were divided into three groups randomly and followed 6 months: Group A treated with 50 mg sildenafil daily, Group B with 20 mg paroxetine daily and Group C with squeeze technique. Patients and/or their sexual partners were required

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Unmoderated Poster Session Abstracts

to record their PE grade, intravaginal ejaculatory latency time (IELT), intercourse satisfactory scores (ISS) and reaching orgasm scores (ROS) and side effect of drugs before treatment and 6 months. Results: Pretreatment PE grade, IELT, ISS of patients and ISS and ROS of sexual partners in Group A, B, C were 5.58 ± 0.35, 5.66 ± 0.48, 5.62 ± 0.56; 1.09 ± 0.32, 1.11 ± 0.45, 1.06 ± 0.36; 1.21 ± 0.45, 1.30 ± 0.51, 1.28 ± 0.38; 0.65 ± 0.45, 0.68 ± 0.50, 0.70 ± 0.49; 0.00, 0.00, 0.00, respectively, and there was no significant difference among three groups (P > 0.05). After 6 months treatment, they were 1.53 ± 0.49, 2.89 ± 0.47, 3.19 ± 0.72; 13.21 ± 4.86, 3.93 ± 1.36, 3.12 ± 0.69; 3.30 ± 0.58, 2.50 ± 0.68, 2.00 ± 0.65; 3.23 ± 0.75, 2.02 ± 0.49, 1.52 ± 0.65; 3.09 ± 0.65, 1.72 ± 0.55, 1.02 ± 0.76, respectively, and there was a significant difference (P < 0.05, <0.01 or <0.001). Compared with pretreatment, all the groups after 6 month follow up had a significant difference in all parameters (P < 0.05 0.01 or 0.001). Sildenafil was much better than paroxetine and squeeze technique in the efficacy. After 6 month study, 1.67%, 26.67% and 38.33% patients in Group A, B, C, respectively withdrew from the study because of no efficacy or side effect and 57 (95.00%), 36 (60.00%) and 26 (43.33%) patients wanted to be treated further with original administration, and there was a significant difference (P < 0.01 or 0.001). Conclusion: Sildenafil is very effective and safe to treat PE. But, its mechanism is not clear and well designed experimental trials are needed to elucidate it.

P-092

Patient satisfaction with Viagra® (sildenafil citrate) for erectile dysfunction (ED) after switching from other treatment options Wetterauer, U, Germany; Grohmann, W; Albrecht, S Objective: To examine the safety, efficacy, and treatment satisfaction of Viagra® (sildenafil citrate) in patients with ED who were switched to Viagra by their physician after unsuccessful treatment with other ED therapies. Methods: This was a 12-week, prospective, multicenter, open-label, observational, noninterventional study. Treatment satisfaction was assessed at baseline and after treatment with Viagra. Patients were asked if their ability to engage in sexual activity was improved, if sexual activities felt natural, if they would continue using Viagra, and if they preferred Viagra to their previous treatment. Results: 2849 men were observed and included in the safety analysis; 1972 were included in the intent-to-treat group: 818 (41%) were taking either tadalafil or vardenafil, and 1154 (59%) were using a different ED therapy. Patients were switched to Viagra by their physician because of treatment ineffectiveness (83%) and poor tolerability (13%) of their previous treatment. 92% of men reported that they preferred Viagra because of increased efficacy; 95% were satisfied or very satisfied with the onset of action, 94% were pleased with the duration of erection hardness, and 73% had erections that were

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Unmoderated Poster Session Abstracts “harder” (32%) or “a lot harder” (41%) than before taking Viagra. 94% of patients reported that sexual activities felt more natural and that spontaneous sexual activities were improved. Viagra was well tolerated: 26 (0.9%) patients reported adverse events, most frequently headache and rhinitis (5 patients, each), followed by flushing (4 patients). 87% reported that they “definitely preferred Viagra to their previous treatment,” and nearly all patients (96%) were willing to continue using Viagra. Conclusion: Patients who were switched by their physician from other ED treatments to Viagra reported greater success with Viagra and better erection hardness. Nearly all men preferred Viagra to their previous treatment and described their sexual activities as improved, natural, and spontaneous.

P-093

Switching from sildenafil (viagra) to tadalafil (cialis) in men with erectile dysfunction in Central/Eastern Europe and Eastern Mediterranean regions: Assessment of sexual attempt behavior and psychological and interpersonal relationship scales Yaman, O, Turkey; Chlosta, P; Kovalev, V; Shenfeld, O; Pacík, D; Breza, J; Clarke, P; Kopernicky, V Objective: Tadalafil, a phosphodiesterase type 5 inhibitor, has an extended period of effectiveness for the treatment of erectile dysfunction (ED) up to 36 hours. This study evaluated patients’ sexual attempts relative to dosing, and psychosocial factors associated with ED treatment. Methods: Subset analysis of an open-label, multi-national study was conducted for Czech Republic, Israel, Poland, Russia, Slovakia and Turkey. Patients with ED, who had been taking sildenafil for ≥6 weeks, continued sildenafil for another 4-weeks, then switched to tadalafil (20 mg) for 8 weeks. During the final 4 weeks of each treatment, sexual attempt patterns were assessed from patient diaries, and time concerns, spontaneity and sexual self-confidence were evaluated using the Psychological and Interpersonal Relationship Scales (PAIRS, scale range: 1–4). Patients continued their treatment of choice in an extension phase. Results: A total of 544 patients were enrolled. The median time from dose to sexual attempt increased from 1.08 hour for sildenafil to 3.00 hours for tadalafil. 38.8% of patients attempted intercourse >4 hours post dosing when treated with sildenafil; this increased to 79.0% with tadalafil. Patients attempting intercourse ≥12 hours after dosing increased from 26.6% during sildenafil to 50.6% during tadalafil treatments. After switching from sildenafil to tadalafil, mean PAIRS time concern scores decreased from 2.55 to 2.33 whereas sexual spontaneity and self-confidence increased from 2.94 to 3.03 and from 2.61 to 2.80, respectively (all p < 0.0005). The majority of patients preferred tadalafil (83.5%) over sildenafil (16.5%) (p < 0.0001). Proportions of patients reporting ≥1 treatment-emergent adverse events during sildenafil and tadalafil assessment periods were 8.9% and 5.7%, respectively. Conclusion: Previous sildenafil users prolonged their dose-attempt timing and reported improvements in sexual time concerns, spontaneity and self-confidence after switching to tadalafil. These changes may reflect an appreciation of tadalafil’s extended effectiveness and contribute to tadalafil preference in men with ED.

P-094

Efficacy of sildenafil 100 mg on demand in selected young patients after bilateral nerve sparing radical prostatectomy Zanni, G, Italy; Salonia, A; Briganti, A; Gallina, A; Barbieri, L; Suardi, N; Fabbri, A; Deho’, F; Rigatti, P; Montorsi, F Objective: Aim of this study was to evaluate efficacy and safety of sildenafil 100 mg in a selected population of young patients

affected by clinically localized prostate cancer (pCa) who underwent bilateral nerve sparing radical retropubic prostatectomy (BNSRRP). Methods: We enrolled 51 patients younger than 65 years old (mean age ± SD: 57.23 ± 4.33) affected by organ confined pCa who underwent BNSRRP. Patients were instructed to use a maximum dosing consisting of 8 tablets of sildenafil 100 mg at least 1 hour prior to sexual intercourse after surgery. No one of these patients has been treated with either neoadjuvant hormonal therapy or adjuvant therapy (hormonal/radiotherapy) after surgery. Patients filled in the IIEF both before surgery, after surgery prior to sildenafil administration and after Sildenafil 100 mg consumption. Results: Pre-operative patients data: median PSA: 5.94; BMI (mean ± SD): 25.28 ± 2.54. Seven out of 51 (13.7%) patients were affected by hypertension, 1/51 (2%) suffered from type II diabetes mellitus. Mean ± SD time between surgery and Sildenafil consumption was: 4.53 ± 2.19 months. IIEF-Erectile Function (EF) domain before surgery: 21.64 ± 9.67. IIEF-EF domain after surgery prior to sildenafil administration: 12.91 ± 9.7 (p < 0.001). IIEF-EF domain after sildenafil consumption: 18.9 ± 9 (p = 0.0054). No significant differences in terms of erectile function has been found between the pre-operative and post-operative period in patients treated with Sildenafil 100 mg (p = 0.057). Adverse events (AEs): flushing (5/51), headache (4/51), nausea (3/51), rhinitis (1/51). Three out of 51 patients (6%) prematurely discontinued sildenafil because of the AEs severity. Conclusion: Our data seem to show how in a selected population of young patients affected by clinically localized pCa undergoing BNSRRP, sildenafil 100 mg is associated with a significant improvement of erectile function after surgery. Furthermore if we compare pre-operative and post-operative data, no significant differences are reported in terms of erectile function among patients treated with sildenafil 100 mg.

P-095

Recovery of sexual function after nerve-sparing radical prostatectomy by early use of alprostadil or vacuum device, in combination with sildenafil Zucchi, A, Italy; Mearini, L; Fioretti, F; Vianello, A; Costantini, E; Porena, M Objective: Purpose of this perspective randomized study is evaluation of the effectiveness of early sexual “rehabilitation” in patients after nerve-sparing radical prostatectomy (PRR-NS), using PGE1 and Sildenafil vs Vacuum Device and Sildenafil. Methods: 26 patients (mean age 60 yrs) who had PRR-NS between April 2002 and November 2003, with normal sexual function before surgery (evaluated with IIEF and colordoppler) and localized prostate cancer were unrolled. A month after surgery patients have been randomized into two groups: A (13 pts, mean age 59 yrs, mean IIEF score 27.1) and B (13 pts, mean age 62 yrs, mean IIEF score 27). Group A has been treated with PGE1 10 mcg three times a week for four weeks, group B with Vacuum Device 15 minutes three times a day for four weeks. Both groups received Sildenafil, 50–100 mg every other day, for eigth weeks. All patients re-evaluated by sexual interview and IIEF at the end of the treatment. Results: 9 pts (69.2%) of group A and 8 (61.5%) of group B reported spontaneus sexual activity, 3 patients of group A and 3 of group B needed Sildenafil 50 or 100 mg. One pt needed PgE1 and 2 pts needed Vacuum Device. Mean IIEF score was 24.6 for group A and 23.8 in group B (p = NS). Conclusion: The use of PGE1 is unanimously accepted in sexual rehabilitation after RP, inducing oxigenation of erectile texture, while Vacuum permits erection with low O2 concentration. However, it determines elastic stretching of the cavernous structures contrasting the fibrotic process. Our analysis shows the same results with PGE1 or Vacuum (p = ns). Vacuum Device may be an alternative to PGE1 in rehabilitation therapy: it has been well accepted, easy to perform and with low morbidity.

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66 Surgery in Male and Female Sexual Dysfunction P-096

Penile prosthesis surgery in Peyronie’s disease: Long-term results Agrawal, V, United Kingdom; Minervini, A; Kumar, P; Minhas, S; Ralph, D Objective: To evaluate the long-term results of penile prosthesis surgery in Peyronie’s disease (PD). We also analyzed the complications arising from inserting penile prosthesis in PD, and their management. Methods: A retrospective case-notes review was conducted of men who underwent implantation of penile prosthesis over a 24-year period (1975–2004) at our institution. Patients included 82 men aged 32– 70 yrs (mean 54), all of who had a significant penile curvature secondary to PD. A total of 92 prostheses were implanted in these 82 men. The mean follow-up period was 36 months (range 1–204). 4 patients (5%) were lost to follow-up. A malleable prosthesis was implanted in 53 (58%) men and inflatable in 39 (42%). 22 (24%) patients required additional procedures to straighten the penis including penile moulding (13), plaque excision (4), suspensory ligament repair/division (4) and glanspexy (1). Results: The penis was straight in 88 (95%)men. 74 (90%) men were able to have satisfactory intercourse. The reasons for inability to have intercourse in the remaining 8 patients included removed prosthesis owing to infection (3), persistent bend (2), pain (2), and mechanical failure (1). 81 (92%) prostheses were in satisfactory position. 67 (82%) patients were satisfied with the results of the surgery. Reasons for dissatisfaction included post-operative complications requiring revision surgery (7), infection requiring prosthesis removal (3), unrealistic expectation (3), and cosmetic (2). Complications of penile prosthesis implantation in PD were Auto-inflation (9), infection (8), lack of glans sensation (5), pain (5), urinary retention (4), pump erosion (3), reservoir migration (3), scrotal haematoma (3), distal cross-over of cylinders (1), and superficial wound dehiscence (1). Management of complications included prosthesis replacement (10), pump revision surgery (8), use of MUSE (5), prosthesis removal (4), reservoir replacement (3), tubing repositioning (3), capsulotomy (2), glans tilt correction (2), and repositioning of malleable rods (1). 14 (17%) patients required revision surgery. Conclusion: Most patients (82%) who undergo penile prosthesis surgery for Peyronie’s disease are satisfied with the results. Surgery for penile prosthesis insertion for Peyronie’s disease is safe and associated with a low morbidity and good long-term outcome.

P-097

Neovaginoplasty with perineal approach in complicated transsexual surgery—A new technique Colombo, F, Italy; Guarneri, A; Kartalas-Goumas, I; Romanò, AL; Piedra Aguilera, J; Austoni, E Objective: Neovaginoplasty in male-to-female transsexuals, in case of failed surgery, is usually reconstructed using rectosigmoid colon. The authors present a new technique with perineal mini-invasive approach. Methods: We used this new technique in a 32 y patient who underwent a genital reassignment surgery, male-to-female transsexual, in 1998. For vaginal reconstruction a skin flap fashioned from the penile skin was used, according to the modified Edgerton procedure. The first post-operative period was complicated from a severe local infection, which resulted in important inflammatory tissues reaction and consequent scarring of the neovagina. After 5 years, the cavity measured 3 cm in depth and 1.5 cm in width, without possibility of penetration. We chose a perineal approach “U” inverted, 1 cm above the anus, and we proceeded as in radical perineal prostatectomy, creating a deep and width neocavity. Then a longitudinal incision of the floor of the scarred neovagina resulted in a unique big space. Split-thickness skin grafts, mobilized from posterior thighs

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Unmoderated Poster Session Abstracts surface, were used to cover vaginal cavity. A vaginal inflatable dilator (like Heyer & Schulte type) was left inside for the first 3 months post-operately. Then it was possible to begin with progressive dilations. Results: After 5 months from the neovagina reconstruction, the size and the elesticity of the neocavity allow the introduction of a 20 cm vaginal dilator. The skin grafts appeared perfectly taken root. The patient reported complete satisfaction from both the functional and aesthetical point of view. Up to now the patient refers no sexual activity yet. Conclusion: Vaginal atresia after transsexual surgery represents a severe complication. Traditional rescue surgical options foresee the use of colon for vaginoplasty, but this tends to elevate morbidity and important aesthetic and psychological complications. The technique we propose seems to offer a mini-invasive option to repair this kind of complication in male-to-female transsexual surgery.

P-098

Comparison of colony counts of staphylococcus epidermidis between coated and uncoated bioflex in a rat model Dhabuwala, C, USA; Rajpurkar, A; Sumit, F Objective: Polyvinylpyrrolodine (PVP)-coated bioflex was introduced in clinical practice to reduce the incidence of infection following penile prosthesis implantation. We have studied the colony counts of Staphylococcus epidermidis (SE) after implanting coated and uncoated bioflex in rats. Additionally, we determined the effect of antibiotic treatment of these strips prior to implantation on bacterial counts. Methods: We utilized 60 animals for the experiment. Half the animals (n = 30) had uncoated bioflex implanted subcutaneously, while the other half were implanted with coated bioflex strips. Fifteen animals in each group were implanted with the strips after dipping them in saline solution whereas in the rest, strips were implanted after dipping them in an antibiotic solution consisting of 1 g/l vancomycin and 160 mg/l gentamicin. Half ml of bacterial solution containing SE was then directly introduced into the wound of all the animals prior to closure. Strips were explanted along with 0.5 ¥ 0.5 cm of surrounding tissue after 7 days after sacrificing the animals and a colony count was performed on the strips and surrounding tissue. The data were analyzed using Student’s t test. A p-value less than or equal to 0.05 was considered to be statistically significant. Results: Antibiotic treatment of the coated Bioflex strips led to a significant reduction (55%) in colony count of SE compared to the uncoated Bioflex strips (13 versus 29 CFU, respectively, p-value <0.05). A trend towards significance was noted with a 41% reduction in bacterial count in the coated bioflex group compared to uncoated bioflex. Conclusion: Antibiotic treatment of coated bioflex produces a 55 percent decrease in bacterial count compared to uncoated bioflex. Also, a trend is noted towards a beneficial effect of coating bioflex with a hydrophilic material.

P-099

Polyvinylpyrrolidone-coated bioflex reduces infection rates compared to uncoated bioflex Dhabuwala, C, USA; Rajpurkar, A; Fogla, S Objective: Polyvinylpyrrolidone-coated (PVP) three-piece penile prosthesis, TitanTM (Mentor Corp., Santa Barbara, CA) was introduced in August 2002 for clinical use to decrease the rate of infection following penile implant surgery. PVP is a hydrophilic material that decreases bacterial attachment that is a critical early step in the development of implant-related infections. The aim of the present study is to compare the infection rates between uncoated Mentor Alpha I® (Mentor Corp., Santa Barbara, CA) penile prosthesis and coated Titan prosthesis. Methods: We compared the data between 3668 patients that underwent Titan implant placement and 500 Mentor Alpha I penile pros-

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Unmoderated Poster Session Abstracts thesis placement in the United States. During surgery for placement of Titan prosthesis, the 3-piece device was soaked in antibiotic solution prior to implantation. Postoperatively, patients were evaluated for signs of infection such as redness of wound, purulent discharge from the wound, etc. In the presence of infection, cultures were obtained from the wound and the bacteriology of the infection was studied. The infection rates in the 2 groups were determined and a Chi-Square statistical analysis was performed to assess for significance between the 2 groups. A p-value of <0.05 was considered to be statistically significant. Results: Of the 3668 patients that underwent Titan prosthesis placement, 51 (1.39%) developed infection compared to 10 (2.0%) of 500 patients in whom Mentor Alpha I prosthesis was utilized. Staphylococci were the commonest causative organisms in both groups. Conclusion: Preliminary data 18 months after the introduction of Titan prosthesis in clinical practice seem to indicate an advantage of the PVP coating in reducing infection following the insertion of 3penile prosthesis. Further follow-up will determine long-term efficacy of the Titan implant in reducing infection.

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Evaluation of post-operative residual function of corpora cavernosa after soft penile prosthesis implant for Peyronies’s disease Grasso, M, Italy; Caterina, L; Flavio, F; Salvatore, B; Marco, B Objective: The objective of this retrospective study is to evaluate the results of surgical implant with a new soft penile prosthesis, called SSDA, without plaque surgery in the treatment of impotence associated with Peyronie’s disease. Methods: This study included 48 men with Peyronie’s disease who underwent placement of a penile prosthesis. All the patients were followed for at least one year with clinical evaluation and interview. Ten patients underwent a further examination with basal and dynamic duplex color-doppler ultrasound to establish the residual function of the corpora cavernosa. Results: The implant of this kind of prosthesis straightened the penile shaft in all cases, restoring sexual satisfaction to the couple. Corpora cavernosa preserves the ability to enhance the tumescence and penile girth. No operative or postoperative complications occurred and no reoperations were needed. Conclusion: SSDA penile prosthesis are safe and effective in the treatment of Peyronie’s disease associated with impotence.

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SurgisisTM and PelvicolTM grafting for penile curvature: An analysis of outcome Koupparis, A, United Kingdom; Jones, R; Persad, R; Wright, M; Gingell, C Objective: To assess the use of SurgisisTM (porcine small intestinal submucosal tissue), and PelvicolTM (non-allergenic acellular porcine collagen matrix) in the surgical correction of dorsal and lateral penile curvature. Methods: 32 patients (mean age 54 years, range 28–69) underwent a modified Lue procedure using SurgisisTM or PelvicolTM grafts between 2000 and 2004. Curvature was secondary to Peyronie’s disease in 29 patients (mean angle 46°) and congenital in 3 (mean angle 58°). At a mean of 28.7 months postoperatively, a detailed postal questionnaire was sent to these patients. Results: 87% of patients were mostly or highly satisfied with their outcome. 82% of patients reported very mild or no residual curvature. 78% of patients reported very mild or no shortening. 12% reported an adverse effect on their preoperative erectile function. Conclusion: These long-term follow-up data indicate that the uses of SurgisisTM and PelvicolTM as tunical grafts are effective management

options in the surgical correction of penile curvature. However, residual curvature and shortening remain a risk.

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Complications of penile revascularization Kovalev, V, Russia; Koroleva, S; Danovich, V; Lesheva, N; Shein, V; Nephedova, G Objective: The aim of the study was to analyze the early and late complications influencing on penile revascularization outcome. Special value was gave to hemodynamic significant complications (penile hypervascularization, thrombosis, priapism, bleeding). Methods: 63 patients (middle age of 38 years) with executed penile revascularization have been divided into two groups depending on character of the transferred intervention. 1 group (35 person)—deep dorsal vein (DDV) arterialization in various updating, 2 group (28 person)—arterio-arterial anastomosis. Results: Totally early and late hemodynamic significant complications in 1 group are marked in 26%, and in the second -39%. Hemodynamic significant complications in early terms in 1 and 2 groups are marked in 11.4% and 14.3% accordingly, and repeated operative interventions are executed in 5.7% (1 group) and 7.2% (2 group). Late hemodynamic significant complications (15–90 days after operation) in 1 and 2 groups are marked in 14.3% and 25% accordingly, and repeated operative interventions are executed in 8.5% (1 gr.) and 10.7% (2 gr.). At the remote terms of supervision (5–10 years) efficiency of DDV arterialization was 74%, arterio-arterial techniques—50%. At use of various techniques of penile revascularization we have defined a ratio of efficiency and quantity of complications as factor of expediency (k), calculated as follows: K = % of the remote positive results/% of complications. The given parameter has made 74/26 = 2.8 for the first group 50/39 = 1.9 for the second group. Conclusion: DDV arterialization, in our opinion, is the most expedient correction method as arterial and venous insufficiency of penis.

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Surgical repair of the penile suspensory ligament Li, C-Y, United Kingdom; Christopher, N; Minhas, S; Ralph, D Objective: The penile suspensory ligament serves to support and maintain the erect penis in an upright position during sexual intercourse. This paper assesses the management of patients who presented with an abnormality of the suspensory ligament and subsequently had it repaired. Methods: The diagnosis was made clinically, often by a palpable gap between the pubis and penis being present, and/or following a pharmacologically induced erection. The repair of the ligament was performed using 4 Ethibond sutures inserted into the midline tunica and the symphysis pubis. A total of 62 patients were included with a mean age of 28 years (range 14–51 yrs). The underlying aetiologies included congenital penile curvature or torsion (n = 31), following sexual trauma (n = 17), iatrogenic (n = 6), venogenic erectile dysfunction (n = 5), Peyronie’s disease (n = 2) and following a pelvic fracture (n = 1). The most common presenting complaints were penile curvature or torsion (n = 47), penile instability (n = 15) or erectile dysfunction (n = 16). The surgical outcome was assessed using cosmetic and functional status of the penis together with patient satisfaction rate. Results: A good surgical result (correction of penile deformity/instability with normal sexual function) was obtained in 55 patients (89%). No improvement or persistent erectile dysfunction was present in 7 patients (11%). Overall 76% of patients were happy with the end result. Conclusion: Abnormalities of the penile suspensory ligament usually present with complex and unusual penile deformities associated with a variable degree of sexual dysfunction. The diagnosis is made clinically and surgical repair is a simple technique with successful cosmetic and functional outcome.

J Sex Med 2005; Supplement 1

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Unmoderated Poster Session Abstracts

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P-106

Diagnosis and repair of fractured penis

Inflatable penile prosthesis (IPP) and Peyronie’s disease: Functional results and satisfaction index using IIEF on a series of 43 consecutives patients in the same institution

Ravindranathan, G, Saudi Arabia Objective: This study is to highlight the importance of clinical diagnosis of fracture of the penis and managing it with urgent surgical correction. Methods: Fiftyfive patients with fractured penis during the past 13 years were studied with an age group ranging from 17 to 70 years. All the patients reported within 24 hours except one patient. Accurate diagnosis was made on clinical basis alone. Fifty two patients were operated as emergency procedure. The patient was placed in cystoscopy position and a 14 Fr. silicone catheter was placed per urethra. The fracture site was exposed through subcoronal circumferential incision. The bulging haematoma was evacuated and hidden clots were flushed out with heparinised saline injected through the opposite cavernosum. The tear in the tunica albugenia was sutured with 3–0 polyglactin stitches. Artificial crection was induced to see any leakage and the degree of tumescence. Results: Patients were followed up from 3 months to 3 years. All the patients reported with in twenty four hours and had emergency repair recovered fully with their penile function. The patient who came five days after the injury developed impotence and curvature inspite of surgery. Two cases refused operation and became impotent, developed curvature and plaque formation. Conclusion: Fracture of the penis can be diagnosed accurately on clinical basis alone. Cystoscopy position facilitates easy access to the whole of the shaft of penis. Subcoronal circumferential incision helps easy localization of the fracture site and better cosmetic result. Flushing with heparinised saline through opposite cavernoisum brings out the hidden clots from inside. Artificial erection done after the repair helps to find out any leakage, degree of tumescence and to diagnose any suspensory ligament tear by seeing the erect penis falling forward. Emergency repair of the fracture is essential to restore the functional and anatomical integrity of the penis.

Tremeaux, J-C, France Objective: Peyronie’s disease is an alteration of the connective tissue that result in the formation of plaques in the tunica albuginea of the penis. This pathology is responsable of curvature, stricture deformities, penile shortening and at last impotence. The ame of this study is to analyse the functionnal results of inflatable penile prosthesis (IPP) on an homogeneus series in the same institution. Methods: Between January 1996 to June 2004, 180 patients were treated for organic impotence using IPP. Among theses, 43 had Peyronies’ (24%) ranging from 36 to 73 years old (mean: 58.02). Associed pathology were vascular disease in 7 patients (16%), Diabetus Melitus in 7 Patients (16%) and 2 had previous radical Prostatectomy (4.6%). Pre-operative treatment were Oral medication for 19 patients (44%), Intacavernosal injections for 13 patients (30%) and 11 had previous penile implants (25.6%). All the implants were placed through a penoscrotal approach and we used the following devices : 21 AMS 700 CX® (48.8%), 6 Ultrex (14%), 3 AMS 700 CXM®, 2 Ambicor (4.6%) and 1 DYNAFLEX®. Functionnal results were analysed using the 15 questions of IIEF score by ROSEN. Results: The succes rate of the procedure is 86% (37/43). We deplore 5 malfunctions (11.6%) of the implant due to problems with the connection or the pump or cylinders in 3 pieces (2 Ultrex, 2 CXM and 1 CX). We had 1 sepsis due to an haematoma in a patients wich major lesions necessiting a cavernoplasty. Pre-operative IIEF was 22.5 and Post-operative 71.5 with a very good overall satisfaction (the details are analysed). Conclusion: Implantation of a penile prosthesis in man with Peyronies’ disease suffering from impotence is a very nice option safe and giving excellent functionnal results. A special care is necessary in diabetes patients and men with very severe plaques necessiting cavernoplasty.

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The 10 years experience in grafting corporoplasty know-how and quality-factors

Treatment of erectile dysfunction secondary to priapism in sickle cell disease with penile implants— A report of 12 cases

Sedigh, O, Italy; Paradiso, M; Milan, GL; Graziano, ME; Ferrando, U Objective: The therapeutic treatment of IPP is still uncertain under many aspects. Even surgical therapy is characterized by a few steady points and different personal interpretations. The purpose of this work is to outline—that the disease has reached surgical solution—such an algorithm of behaviour and strategic choices as to achieve widespread success. Methods: 150 patchworks were performed in the last 10 years with different biomaterials. Fifty men with a mean-age of 49, were assessed after 2-years of plaque incision/excision and grafting with different biomaterials. Results: The experience acquired have been worked out in a therapeutic module consisting of the 5 following major strategic factors: 1. The presence of E.D. anyway found or documented (patient’s opinion or instrumental result) is an indication to prosthetic-implant. 2. IPP is an retracting disease. Within corrective-surgery it is unlikely that a correctly informed patient, can give his consent to such an reducing intervention like Nesbit. 3. The so-called patchwork surgery pursues a corrective aim, sometimes an elongation on the retracted-organ. The surgeon who performs it, pursues the cure of the disease as well as a tissue replacement, process induced by a biomaterial in accordance with the principle of inductive surgery (regenerative-medicine, tissuebioengineering). 4. The quality of the patch is not, the primary factor in terms of surgical results. All biomaterials act as a scaffold colonized by the host tissue and involved in a tissue replacement process. Time and manner of hystotransformation may vary. Best results obtained with saphenous, S.I.S. and Intexen. 5. The most important quality factors were surgical technique and early postoperative rehabilitation (daily stretching with vacuum device). Conclusion: Penile grafting is not associated with a significant patient dissatisfaction rate and orgasmic morbility.

J Sex Med 2005; Supplement 1

Virag, R, France Objective: Priapism is a common complication in sickle cell disease (SCD). Severe fibrosis of the cavernous bodies occurs, leading to impotence. In such cases surgical insertion of penile implants is the only solution. We report our experience of 12 cases. Methods: Three patients were failures of the preventive treatment consisting in the oral and local use of the alpha adrenergic agent etilefrine, and nine presented with fibrotic lesions after untreated priapism or previous vascular derivations. Mean age is 34.6 y (23 to 49) All but 2 were SS type. 11 hydraulic penile implants and 1 semi-rigid one were inserted, all by one single surgeon (RV). In 8 instances the surgeon reports difficulties to insert the device and in 2 cases, the corporae had to be enlarged with a patch. Pre, per and post operative antibiotherapy was given. Recently, a specially coated device (Resist® Mentor corp.) able to absorbe antibiotics prior to insertion is in use (7 cases). The end-point criteria for success is the patient’s satisfaction. The mean follow up is 45.5 months (1 to 96). Results: For six patients (50%), follow up was uneventful, three patients suffered infection, one in the scrotum was solved by simple cleaning and the two others lead to the removal of the implants after several operations. Two patients had to be reoperated for perforation of the tip of one cavernous body and successfully repaired. Nine patients (81% of 11 with a sufficient follow up) are satisfied, experiencing satisfactory sexual life. The best results were achieved in patients operated early, free of other surgical procedures (derivations). Conclusion: When prevention of priapism fails, implantation of penile implants is an efficacious alternative. We reached an 80% rate of satisfaction but with a 50% rate of reoperation. The latter will be reduced by operating sooner before heavy fibrosis is established.

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Unmoderated Poster Session Abstracts Penile Trauma, Priapism, Genital Surgery, Penile Cancer P-108

Some distinctive features and the remote outcomes of priapism

Conclusion: Selective embolisation for high flow priapism is a safe well tolerated procedure that preserves premorbid erectile function. Patients should be told that multiple procedures may be required and that subsequent erectile dysfunction is possible. Shunt surgery increases the risk of subsequent erectile failure.

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Kovalev, V, Russia; Koroleva, S; Danovich, V; Shein, V; Lesheva, N; Nephedova, G

Prognostic criteria for positive inguinal lymph nodes in penile carcinoma

Objective: On our data, in difference of data other researchers, there are some differences in etiology and clinical current of priapism. Methods: 210 patients in the age of from 11 till 49 years have been surveyed. In structure of cases observable by us the pharmacological priapism was prevailed—59%. Other reasons of priapism included: chronic intoxication—11%, hematological and neoformation factors— 4%, trauma—2%. Primary ideopathic priapism has been marked in 23% of supervision. In 75% of cases duration of priapism exceeded 36 hours. In one case duration of disease has made 28 day! Results: Only in 16% of ideopathic priapism the puncture and conservative actions were effective. In 84% of cases operative treatment was required. The complicated current with development of cavernitis, penile gangrenes and a sepsis has been marked. in most cases. Depending on severe of priapism sapheno-cavernous shunt, cavernous drainage and penile amputation have been made. One patient has died, in 69% an outcome was cavernous fibrosis. Only in 28% of cases erectile function has remained safe. In case of pharmacological priapism the puncture was effective in 54%. In 46% operative intervention was required. Cavernous fibrosis has been marked in 20%. In 80% erectile function has not suffered significantly. Conclusion: Secondary, first of all pharmacological priapism, is characterized by more favorable current, than primary idiopathic priapism. The outcome of priapism depends not only and not so much on prescription of disease, how many depends on it etiology and accompanying complicating factors.

Naumann, CM, Germany; Seif, C; van der Host, C; Jünemann, K-P; Martinez Portillo, FJ

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High flow priapism: Treatment and long term follow up Kumar, P, United Kingdom; Agrawal, V; Kayes, O; Hegarty, P; Ralph, D; Minhas, S Objective: High flow priapism follows unregulated arterial flow into the lacunar spaces of the corpora cavernosae. This occurs most commonly following penile or perineal trauma producing a cavernosal artery laceration. Embolisation of the arterial-lacunar fistula is the management of choice. This study aims to ascertain the long term results of this therapeutic intervention. Methods: The study included fifteen patients with high flow priapism confirmed using cavernosal blood gas analysis and colour Doppler ultrasonography managed at our institution from January 1995 to December 2002. In all cases pudendal angiography was carried out and super-selective embolisation of the vascular anomaly performed. Data consisted of a retrospective case note review and a questionnaire administered in either outpatients or over the telephone for long-term follow up. Results: Mean patient age at the time of the priapism was 29 (range 12–52 years). Aetiology was trauma (10/15), sickle cell (2) self injection (1), unknown (2). Prior to referral, nine patients had undergone aspiration and injection with sympathomimetic agents and three of these had shunt surgery due to difficulties in diagnosis. All but three patients reported normal erectile function prior to their priapism (IIEF-5 score 20+). Mean interval between onset of priapism and embolisation was 9 days. Although eight patients required a repeat embolisation, detumescence was achieved in all patients with no immediate complications. No patients required opioid analgesia. Mean follow up was 42 ± 8 months. Of the 15 patients, 11 reported a return to normal erectile function (IIEF-5 20+). 3 patients had undergone insertion of a penile prosthesis (2 of these had shunt surgery prior to embolisation) and 1 patient required oral pharmacotherapy.

Objective: The most significant predictors of survival in men with penile carcinoma are presence and extent of inguinal lymph node metastases. The most reliable procedure for determination of the inguinal nodal status is the inguinal lymph node dissection (ILND). Additionally, early removal of positive groin nodes offers a potential option of curability in some patients. Unfortunately, ILND is associated with a high morbidity. While the risk of groin metastases increases with tumor grading and T-stadium of the primary lesion, controversies persist with regard to inguinal lymph node dissection in patients with low T-stadium, moderately differentiated tumors and clinical N0status. In the present study we determined the patient population who takes benefit from INLD by correlation of T-stadium and grading with inguinal lymph node status. Methods: We retrospectively analysed the records of 24 patients with penile squamous cell carcinoma who were treated between 1992 and 2003. Histopathological classification was correlated with the developement of inguinal lymph nodes metastases. Mean follow up was 31 months. Results: Tumor stage was pT1 in 15 cases, pT2 in 8 and pT4 in 1 case. Tumor grade was I, II and III in 7, 13 and 4 cases, respectively. 6 patients with pT1 tumors showed inguinal metastastes in ILND or developed metastases during surveillance. 4 pT2 tumors and the pT4 tumor developed positive groin nodes. None of the patients with a G2 tumor has shown inguinal metastases whereas all poorly differentiated tumors developed metastases. 7 of the 13 G2 carcinoma were positive for inguinal lymph nodes. Interestingly, 4 of 7 pT1G2 penile carcinoma suffered from inguinal metastases. Conclusion: Tumor grade of penile carcinoma was the most significant predictor of inguinal metastases in our patient population. We recommend early ILND in pT2 tumors or moderate grading since morbidity after ILND has markedly decreased by modifications of surgical techniques.

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Erectile function and sexual satisfaction after contralateral corporoplasty for congenitale and aquaired penile curvatures (Peyronie’s disease)— Long term patients’ view Nyirády, P, Hungary; Rusz, A; Szász, A; Sulya, B; Kelemen, Z; Romics, I Objective: We assessed erectile and sexual function in long-term follow-up after contralateral corporoplasty operation for congenital curvature of the penis and Peyronie’s disease using postal questionnaire method. Methods: Twenty-three (17 ventral, 4 lateral and 2 dorsal) of 31 with congenital curvature (73%) and 45 (39 dorsal, 6 lateral) of 55 patients with Peyronie’s disease (82%) operated between 1993 and 2002 were included in our study. In 2003 a standardised IIEF-5 and an own questionnaire were completed about erectile function and sexual satisfaction by operated patients and their partners, after operation. Mean follow-up was 68 months, ranges between 12 to 120 months. In all patients, correction was performed by contralateral corporoplasty as performing multiple longitudinal incisions and transversal suturing. Results: Mean age was 60 ± 9.5 years for patients with Peyronie’s disease and 29.2 ± 7.9 years for those with congenital penile deviation. All patients with Peyronie’s disease were treated conservatively before operation. Twenty-two of 23 patients had good (IIEF-5 > 21) and 1

J Sex Med 2005; Supplement 1

70 acceptable (IIEF-5 = 21) erectile function. However, in Peyronie’s group, only 10 of 45 men scored erectile function over 21 (standardised IIEF-5) and 78% (35 of 45) were not satisfied with the results of their erectile function. In 13 of 23 (56.5%) patients with congenital and 36 of 45 (80%) penetration was impossible or very difficult during sexual intercourse with congenital curvature before the surgery. After corporoplasty none of the congenital and 7 of 45 (15.5%) patients found penetration difficult but not impossible after surgery. Conclusion: Contralateral corporoplasty for patients with curvature of the penis did not disturb sexual and erectile function in patients in congenital group. However, the erectile function after penile straightening with the same technique was found poor (78%) in patients with Peyronie’s disease, even in the age of 60 years. This might suggest contrary to other publications, that induratio penis plastica (IPP) as multifactorial disease should harm erectile function. Same preoperative assessment is needed to justify our conclusion.

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Anastomosis of testicular with external pudendal vessels in traumatic testicular avulsion Papatsoris, A, Greece; Gekas, A; Tsiliboti, D; Palaiodimos, H; Antonopoulos, D; Kalogeropoulos, N Objective: We present a unique case of complete traumatic testicular avulsion, which we tried to manage with anastomosis of testicular with external pudendal vessels. Methods: A 31 year old male, after alcohol consumption, fell along a 6 meter flagpole and underwent complete traumatic avulsion of his right testicle. On physical examination, there was only a 5 cm traumatic incision at the right hemiscrotum, while the stump of testicular vessels was 2–3 cm in length. Within 60 minutes after the injury, we tried to anastomose the testicular vessels in order to reposition the testicle. Results: Under epidural anesthesia and right inguinoscrotal incision, we unsuccessfully tried to identify the proximal stump of the testicular cord. The distal stump of the spermatic duct was ligated. We performed anastomosis of the distal stump of the testicular artery and vein with the external pudendal artery and vein, respectively. The testicle regained its natural color, and was fixated into the hemisrotum. Unfortunately, the second postoperative day, the patient experienced expanding hematoma at his hemiscrotum. During surgical exploration we diagnosed thrombosis and disruption of the anastomosis, and we performed orchidectomy. Conclusion: In the present case of complete testicular avulsion, anastomosis of the spermatic with external pudendal vessels was unsuccessful. If the proximal stump of the testicular cord was identified and anastomosed the case progression might be better.

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Repair of complicated perineal hypospadias Papatsoris, A, Greece; Gekas, A; Papoutsakis, M; Djordjevic, M; Perovic, S; Palaiodimos, H; Kalogeropoulos, N Objective: Hypospadiology remains a real challenge for urologic surgeons interested in genital surgery. We present the surgical repair of a case of complicated perineal hypospadias in two operations. Methods: Recently, a two year old boy was admitted in our Department with a diagnosis of perineal hypospadias which was associated with severe ventral penile curvature (120°), penoscrotal transposition, bifid scrotum, cryptorchidism, and left solitary kidney. Investigation revealed a normal male karyotype. Intraoperatively, cystoscopy revealed a small (<0.5 cm) Mullerian duct remnant. Initially, we performed a dorsal albuginoplication, an urethroplasty with the use of a tubularized skin flap, a scrotal urethrostomy, a right orchidopexy, a subcutaneous fixation of the left testicle at the inguinal region, a reconstruction of the penile skin and a penile fixation. After three months, a silicone testicle prothesis was fixated at the left hemiscrotum followed by a scrotoplasty. In addition, in the same time we performed a meatoplasty by a tubularized skin flap as well as a fistuloraphy and a reconstruction of the penile basis. In both operations urinary diversion by cystostomy took place for fifteen days.

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Unmoderated Poster Session Abstracts Results: During the follow up, eight months after the second operation, a forward urinary stream, a straight penis in erection, and an excellent penile appearance were achieved without any early or late complications. Conclusion: The final decision on which repair method should be used in cases of complicated perineal hypospadias can only be taken intraoperatively. Such a repair depends on the quality and length of the urethral plate, the amount of available foreskin and the degree of penile curvature.

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Corporoplasthy in penile fractures our experience and review of 36 patients Sedigh, O, Italy; Paradiso, M; Milan, GL; Graziano, ME; Ferrando, U Objective: Objectives Penile fracture is defined as, traumatic rupture of cavernous body during erection. Immediate surgical treatment is recommended in order to prevent possible complications associated with delayed manegment. The aim of this study is to evaluate the clinical presentations, diagnostic-methods, outcome of the treatments and the effect of sexual-function in this patients. Methods: We reviewed the records penile fracture patients seen in our institution in the last 10 years. The patients were recalled for assessment of current sexual function. Results: Records of 36-patients are included in this riview. Cause of injury: 18 had been injured during sexual intercourse (50%), 12 had been injured during masturbation (33.3%) and 5 during sleep and 1 had a domestic accident with hoover. Three over-60 patients were treated conservatively after refusing the surgery, demonstrated angulation in follow-up. 33 patients were treated by immediate surgery, degloving and scrotal access, when neccessery. The scrotal access must be remembered, in hard and large haematoma (good vision of all alubuginea). In the hoover-suction case we had glans-sub-total disassembly, fortunately without bundles dissection. Urethral injury in 2 cases was reported. The tunica was repaired with absorbable-Vickryl4/0, after evacuating the haematoma in 70% of the patients. Nesbit procedure was performed for final straitening, in 30% of these patients. In 4 patients we grafted the alubuginea-missing with biomaterials (SIS, Intexen), for delayed diagnosis (covered rupture) and the alumina missing was large, maybe for the necrosis and retration of the borders (1-euro-coin). 83% answered and reported no erectile/voiding disfunctions and mentioned adequate erection for intercourse, while 3 reported mild curvature. Conclusion: Early surgical exploration is successful and associated with low incidence of complications. The penile fracture has very typical clinical signs and the diagnostic is sample (Investigation, Sonography, Cavernosography and RMN). Scrotal access and grafting could be useful in some cases. The 2 minute Final Video emphasizes the scrotal access and the technique.

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Unmoderated Poster Session Abstracts Genital Anomalies and Diseases, Peyronie P-115

An alternative, non-invasive treatment for Peyronie’s disease Claro, J, Brazil; Ortiz, V; Srougi, M Objective: We evaluated prospectively the efficacy and safety of the association of high dose vitamin E and ESWT as a non-invasive treatment for the disease. Methods: Twenty-five patients 42 to 68 years old (mean of 54 years) presenting penile deviation and sexual distress caused by Peyronie’s disease were treated in a non-invasive manner. The time of penile deviation ranged from 16 to 52 months (mean of 30 months). All patients had previous unsuccessful treatment for Peyronie’s disease. The patients received vitamin E l,200 mg daily during 3 months and underwent 3 to 6 sessions (mean of 3) of ESWT (3,000 to 4,000 shock waves) at a power level of l to 2 at 1-week intervals. The results were analysed using two tailed t test with bonferroni correction for statistical comparison. P value <0.01 was admitted as significance criterion. Results: Of the 25 patients treated, 16 (64%) reported an improvement in penile angulation, with a mean reduction of 21° (10°–40°). Eight patients reported an improvement in this spontaneous erections. Patients presented before treatment with a mean diameter of 1.08 cm (0.60–1.50) in the control group and 1.32 cm (0.60 cm–2.80 cm) in the study group (p = 0.089). The mean of angulation was 51.33° (40°–60°) in the control group and 54.23° (40–70) in the study group (p = 0.25). There was no statistical difference between both groups. After treatment the mean of diameter was 1.03 cm (0.70 cm–1.40 cm) in the control group and inside the study group the mean was 0.63 cm (0 cm–1.80 cm). Additionally, the mean of angulation after treatment in the control group was 48.67° (30°–70°) and the mean of study group was 24.42° (0°–70°). There were statistical difference between groups in the meaning of diameter (p = 0.0001) and in the meaning of angulation (p = 0.0001). Conclusion: Considering the common complications and the unsatisfactory outcome of the surgical correction for Peyronie’s disease, the association of high dose vitamin E and ESWT represents a good option for a non-invasive, effective and safe treatment of the penile deformity.

Conclusion: ESWT is a safe and effective method in the symptomatic treatment of the Peyronie’s disease. These findings are promising in the treatment of a disease with many unknown features. The need for larger series with long term results is obvious.

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Treatment options for hydiopathic short penis: What is the evidence? Gontero, P, Italy; Mondaini, N; Frea, B Objective: Penile size is becoming a healthcare problem given the increasing number of patients seeking urological advice for a so-called short penis. Aim of the present study was to review the level of evidence in literature for any treatment option to elongate the penis. Methods: The study was conducted through a medline search for the last 20 years on surgical and non surgical treatment modalities for penile lenghtening. Peered reviewed abstracts were also included. We focused on the term lengthening phalloplasty, that summarises a small group of surgical procedures aimed to elongate the shaft mainly in the flaccid state. Other search terms included non invasive methods like penile stretchers. Results: Based on the currently available literature it appears that the most common techniques to lengthen the penis (section of the penile suspensory legament, the infrapubic liposuction and a V-Y or Z plasty) provide only rudimentary results and a high patient dissatisfaction rate. On the other hand, literature reports mainly the disastrous results of pericavernosal apposition of autographs. In a recent technique of augmentation phalloplasty bilateral saphena grafts have been employed to increase the corpora cavernosa girth thus providing a true penile enlargement during erection. Interestingly, a number of peered reviewed abstracts agree that the penile stretchers may significantly improve penile length with an extremely low complication rate. Conclusion: Penile additive surgery remains a real controversial issue, dominated more by opinions than a scientific background. In our opinion, a more open view should be directed in the field of conservative methods of penile lengthening. Theoretically, there is no reason to believe that a penile stretcher may be less successful than surgery in elongating the suspensory ligament. Additionally, the use of noninvasive options gives the opportunity of widening considerably the indications for a treatment that, in the majority of cases, is merely cosmetic.

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The role of extracorporeal shockwave therapy in the treatment of Peyronie’s disease Deveci, S, Turkey; Peskircioglu, L; Turunc, T; Tekin, MO; Özkardes, H Objective: To show the effectiveness and safety of the extracorporeal shockwave therapy (ESWT) in the treatment of Peyronie’s disease. Methods: Twenty-seven patients with Peyronie’s disease with a mean age of 54.9 ± 6.8 years (45–75) were included in the study. The mean duration of the disease was 9.7 ± 7.8 (2–36) months. The patients received 3–6 session of ESWT. The effectiveness of ESWT was assessed before and after the treatment using visual analog scale (VAS) for the pain during erection, 5-item version of International Index of Erectile Function (IIEF-5) for erectile function, goniometry for angulation and ultrasonography for plaque size. Results: The mean angulation which was 45.30 ± 22.58 degrees before ESWT decreased to 22.26 ± 21.77 after the treatment (p < 0.0001). In 11 patients out of 23 (47.8%)who experienced coital problems due to an angulation of 30 degrees or more, ESWT decreased the angulation below 30 degrees. The mean IIEF-5 score which was 17.48 ± 4.55 before the treatment increased up to 20.64 ± 4.36 (p < 0.0001). The mean pain during the erection which was 6.4 ± 2.7 according to VAS before the treatment decreased to 1.2 ± 1.8 (p < 0.001).The mean plaque size which was 2.1 ± 0.97 cm before ESWT was reduced to 1.16 ± 0.81 cm (p = 0.007). The minimal penile petechiae observed in ten patients, minor urethral bleeding in two patients and a localized hematoma in one patient disappeared within 48 hours with conservative management.

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Relationship of penile curvature type and penile hemodynamics in men with Peyronie’s disease Kendirci, M, USA; Nowfar, S; Gur, S; Myers, L; Sikka, SC; Hellstrom, WJG Objective: To evaluate penile vascular status using penile duplex Doppler ultrasound (PDDU) according to the type of deformity in patients with Peyronie’s disease. Methods: Five hundred twenty-three Peyronie’s patients were evaluated retrospectively, in terms of the relationship between the type of curvature and penile hemodynamics. Each patient underwent a PDDU by injecting IC 10–15 microgr of PGE1 with accompanying visual sexual stimulation to evaluate penile blood flow at baseline. The type of curvature was divided into 7 different groups. Objective evaluation of penile curvature was done by using a protractor during maximum erection. The mean PSV, EDV and RI were calculated for each group. The number of arterial insufficiency (AI), veno-occlusive dysfunction (VOD), mixed arterio-venous disease (MAVD) and non-vascular etiology (NV) were determined according to the groups. The results were compared statistically among groups. The values were expressed as the mean plus and minus SEM. Results: The mean age of the patients was 54.2 years. The most frequently encountered type of deformity was dorsal (43.5%) followed by lateral (24.8%) and ventral (11.0%). Indentation and hourglass deformities were 6.5% and 5.3%, respectively. The mean penile curvature was 12.8 and 12.5 degree in the indentation and hourglass deformity

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72 groups, respectively, while between 38.0 and 47.7 degree in the dorsal, lateral, ventral, dorsolateral, and ventrolateral groups. The mean PSV values in the ventrolateral group were greater than all other groups. However, the lowest values were noted in the hourglass deformity group. The hourglass group had the highest rates of AI, while VOD was seen most commonly in the ventral curvature group. The ventrolateral group recorded the best vascular status. Conclusion: Although the hourglass deformity demonstrated the lowest degree of angulation in Peyronie’s patients, it was associated with the poorest penile vascular status. Patients with ventrolateral curvature patients had the best penile hemodynamics in our series.

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Single-blind, multi-center, placebo-controlled, parallel study to assess the safety and efficacy of intralesional interferon ALPHA-2b in the non-surgical treatment of Peyronie’s disease Kendirci, M, USA; Matern, R; Nowfar, S; Gur, S; Myers, L; Sikka, SC Objective: The objective of this study was to investigate the efficacy and safety of intralesional interferon alpha-2b (IFN-alpha-2b) for the treatment of Peyronie’s disease (PD). Methods: Between 2000 and 2003, 117 PD patients with an average age of 55.1 years were enrolled in a single-blind, multi-center, placebo-controlled, parallel study to determine the efficacy and safety of intralesional IFN-alpha-2b therapy (62 in placebo, 55 in IFN-alpha-2b group). Saline 10 mL for control and INF-alpha-2b 5 ¥ 106 units for study group were administered with 6 injections for a total of 12 weeks. Each patient was evaluated for penile curvature, plaque size, plaque density, penile pain, erectile function, and penile hemodynamics before and after study completion. The improvement in these parameters was statistically compared between the groups. Results: A total of 53 patients in control and 50 patients in IFN-alpha2b arm completed the study. Penile curvature, plaque size, plaque density, and pain resolution improved statistically in both control and IFN-alpha-2b patients. However, the improvement of these parameters was significantly greater in IFN-alpha-2b treated patients than placebo. The mean IIEF scores were improved in both placebo and IFN-alpha-2b treated patients, but no statistically difference was found between groups. Mean peak systolic velocity improvement was observed in IFN-alpha-2b treated patients but not in placebo. In addition, the decrease in the number of patients with penile vascular pathology was significantly higher in IFN-alpha-2b patients than in placebo. Side effects, which were frequently encountered in IFNalpha-2b patients, were mild flu-like symptoms that lasted <24 hours and effectively responded to NSAIDs. Conclusion: This single-blind, multi-center, placebo-controlled, parallel study demonstrates that intralesional IFN-alpha-2b with 5 ¥ 106 units for a total of 12 weeks and 6 injections is effective and safe minimally-invasive therapy for men with PD.

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The use of extracorporeal shock wave therapy in Peyronie’s disease Muneer, A, United Kingdom; Hanna, S; Bell, R; Kunkler, R; Miller, M Objective: The use of extracorporeal shock wave therapy (ESWT) as a non invasive treatment option in Peyronie’s disease is still controversial. The aim of this study was to analyse the effects of ESWT on penile angulation, penile pain and sexual function in patients diagnosed with Peyronie’s disease. Methods: Over a 36 month period 28 patients (mean age 53, range 29 to 69)with symptomatic Peyronie’s disease were treated with ESWT. The duration of symptoms varied from 6 months to 10 years. Preoperative penile angulation was assessed using digital photography and the erectile function assessed using an IIEF-5 questionnaire. Pain related to the plaque was recorded according to a visual analogue scale prior to commencing ESWT. A Storz SLK lithotriptor was used for 3

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Unmoderated Poster Session Abstracts separate treatment sessions consisting of 3000–4000 shockwaves, frequency 4 Hz, energy 0.26–0.4 mJ/mm2. Results: In all, 24 patients have been followed up. Of these 6 (25%) reported an improvement in penile curvature. Before treatment 6 patients reported significant pain related to their plaque. Follow up showed that 4 of these patients reported an improvement in their pain score. Penetration improved in 4 out of 10 patients (40%) and erectile dysfunction improved in 2 out 10 patients (20%). Complications were infrequent and limited to small haematomas which occurred in 50% of patients during at least one treatment session. Conclusion: ESWT is associated with minimal complications. We have found no significant improvement in penile angulation or sexual function following treatment with ESWT. Patients reporting significant penile pain before undergoing ESWT did however report an improvement in the pain following treatment.

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Technique for the foreskin preservation during nesbit operation for congential penile curvature Perdzynski, W, Poland; Kidawa, A; Lewicki, A Objective: Assessment of results of operative treatment of congenital penile curvature (CPC) by Nesbit method with direct incision over curvature for foreskin preservation. Methods: From 1998 to 2003 authors operated on 54 men with isolated CPC. Ventral curvature was detected in 27 patients, lateral curvature in 16 men, ventrolateral curvature in 7 men, dorsal curvature in 2 patients, dorsolateral curvature in 2 patients. Before operation glans was covered by foreskin. Longitudinal skin incision was done directly over convex surface of penis which allowed to leave the foreskin intact. After approaching tunica albuginea angle of curvature was assessed by injection of saline into cavernous body, after compressing of penile base with a tourniquet. In men with ventral curvature after separating of neurovascular bundle eliptic fragment of tunica albuginea was excised transversally to long penile axis. Edges of tunica were sutured with a single, invaginating vicryl 3/0 sutures. In patients with dorsal curvature corporoplasty was performed on ventral penile surface after separating of fragment of urethra. In all patients straightening of penis was confirmed by “artificial erection.” Results: In all patients mild to moderate foreskin oedema appeared but it diminished gradually during 3 to 7 days. Postoperative wounds healed by primary intention in all patients. During follow-up examinations done 3 and 6 months after operation and then once a year all patients well assessed the shape of penis in state of erection as well as its function during sexual intercourse.

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Clinical characteristics of pure notching group in Peyronie’s disease Sanli, O, Turkey; Akman, T; Onem, K; Acar, O; Gokce, O; Kadioglu, A Objective: To determine the clinical characteristics of patients with pure notching deformity in Peyronie’s disease. Methods: Clinical features, risk factors, erectile status and suggested treatment alternatives of patients with isolated notching deformity as a special group in Peyronie’s disease, detected with combined injection and stimulation (CIS) test were evaluated. Results: Retrospective evaluation of 663 Peyronie’s patients revealed that 8.5% (57) of the patients had pure notching deformity and 9.9% (66) of them had notching deformity with curvature. Mean patient age and mean duration of disease in patients with pure notching deformity was 51.9 ± 10 years and 29.4 months, respectively. The leading presenting symptom was ED encountered in (31.5%). Other presenting symptoms were ED with notching (28%), only notching (24.5%) and pain (8.7%). Notching was detected distally in 49.1%, proximally in 40% and mid penile in 10.5% of the patients. Most leading systemic vascular risk factor in this subgroup of patients with Peyronie’s disease was diabetes 26.3% (15). Other systemic risk factors were hyperten-

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Unmoderated Poster Session Abstracts sion 21%, hypercholesterolemia 15.7%, ischemic heart disease 14% and hypertriglyceridemia 10.5%. 23 (40%) patients had no risk factor. CIS test revealed diminished erectile capacity in 50.9% of the patients. Eventually, surgical and medical treatment was recommended to 26.3% and 63% of the patients, respectively, while follow-up was suggested to 10.5% of the patients. Conclusion: Pure notching is observed in 8.5% of patients with Peyronie’s disease, which is more common distally followed by the proximal location. The most common presenting symptom is ED and 26.3% of them were the candidates for surgical treatment.

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Single institution experience on 663 patients with Peyronie’s disease Sanli, O, Turkey; Akman, T; Acar, O; Tezer, M; Celtik, M; Kadioglu, A Objective: To discuss the clinical parameters and outcome of Peyronie’s disease. Methods: A total of 663 patients with a diagnosis of Peyronie’s disease were evaluated retrospectively in terms of risk factors, penile deformity, erectile status and recommended treatment alternatives. Results: The mean age of the patients with Peyronie’s disease was 53.01 ± 10.53 years. and 83.4% of the patients had at least one of the classical symptoms of the disease (penile deformity, pain on erection and palpable nodule). 50.6% and 49.4% of the patients were in acute and chronic phases, respectively. Penile deformities were found to be dorsal (32.1%), left (21.1%), ventral (11.9%), dorsolateral (11%), right (9.5%), pure notching and hourglass deformities (8.5%), ventrolateral (3.6%) and swan neck deformity (2.1%) with CIS test. 31.3% of the patients had concomitant ED, whereas 16.4% of the patients presented solely with ED. Angle of deformity was <30° in 38.9%, 30–60° in 34.8% and >60° in 16.1% of the patients. 56.7% of the patients had at least one of the vascular risk factors. The most common risk factors were diabetes (26.8%), hypercholesterolemia (26.3%), hypertension (17.1%), hypertriglyceridemia (16.1%), ischemic heart disease (8.4%). 43.2% of the patients had no risk factors. Probability of having a severe deformity is 19.7% in patients with at least one risk factor. CIS test revealed diminished erectile capacity in 36.2% of the patients. 41.3% of the patients received medical treatment, whereas surgical treatment was suggested to 30.7%. Conclusion: Peyronie’s disease is most commonly seen in men in their fifties and nearly half of them present in the chronic phase of the disease. The most common presenting symptoms are penile curvature and erectile dysfunction. Penile deformity is commonly mild to moderate and dorsal. Over half of the patients have at least one systemic vascular risk factor and one thirds of the patients receive medical treatment.

Results: Results are avaluated on disparition of pain, discreasing the size of the plaque and the deformity and the ability to have intercourse satisfaction. Pain during erection disapped in all patient afer one session for 14 (63.6%), two for 5 (22.7%) and three for 3 patients (13.6%). Intralesional injection of corticoid was necessary for 1 patient. Modification of the plaque’s size or consistence occur in all patients. A discreasing size more than 25% appear in 20 (87%). Result on penile deformity (more than 25%) is more unpredictable and only 16 patients had a significant result (70%). 4 potent patients needed a NESBIT procedure. On The 13 patients with ED 9 (69%) had good results with spontaneous erection and intercourse without treatment in 6 (46%). Conclusion: Radial shockwave therapy using Swiss Dolorclast seems to be a well-tolerated new method to treat Peyronie’s disease. Theses first results are encouraging and it is probably possible to propose this non-agressive therapy very effective on localized plaque in a first intention treatment.

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Effect of penile size on nocturnal erections: Evaluation with NPTR testing with men having micropenis Yaman, O, Turkey; Soygur, T; Akand, M; Tokatli, Z; Anafarta, K Objective: There has been conflicting opinions in the literature regarding sexual function in hypogonadal men with micropenis. In this study we aimed to evaluate erectile function in hypogonadal men with micropenis by nocturnal penile tumescence and rigidity testing (NPTR) and compared the results with young potent normal penile sized men. Methods: A total of 15 men (ages 17–30 years) defined having a micropenis with a stretched penile length of less than 9.3 cm were constituted the study group. Mean stretched penile length was 6.8 ± 1.6 cm (range 3.6 to 7.8 cm). Karyotype analysis showed 46 XY in all cases. Control group included 22 potent and normal penile sized men (23–29 years). All subjects completed three sessions of consecutive nights using the RigiScan Plus device. Results: Comparison of the results of NPTR of control group with study group revealed that; number and duration of erectile episodes (p < 0.001), duration of tip rigidity >60% (p < 0.01), TAU tip and TAU base (p = 0.001), and RAU base (p = 0.01) were found to be significantly lower in men with micropenis. Conclusion: Our study showed that men with micropenis are associated with decreased nocturnal erectile activity.

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A non-invasive treatment for Peyronie’s disease using swiss dolorclast®: Long term results on 23 consecutive symptomatic patients Tremeaux J-C, France Objective: Peyronie’s disease due to a fibroblast proliferation causes pain, curvature of the penis and erectile dysfunction (ED). The aim of this study is to present our experience of a non-invasive treatment for symptomatic patients using radial shockwave therapy with Swiss Dolorclast®. Methods: From June 2002 to September 2003, 23 consecutive patients ranged from 44 to 69 year-old (mean: 57.9) were treated with Swiss Dolorclast. Symptoms were pain for 22 (96%), penile deformity ranging from 30 to 90° for 22 (96%) and ED for 13 (59%). The plaque’s size was range from 12 to 60 mm (mean: 28 mm). These patients received 6 months of oral vitamin E 500 mg/day. The treatment consisted in 4 sessions of radial shockwave emitted through an applicator of 15 mm size by the Swiss Dolorclast®. 2000 impulsions at frequency of 15 Hz and a pressure of 2.5 bar were done at each session. The mean follow-up is 13.6 months ranges from 12 to 16 months.

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74 Ejaculatory and Orgasmic Disorders P-126

Assessment of treatment outcome with SSRI drugs by means of IIEF in patients with primary premature ejaculation Aslan, G, Turkey; Cihan, A; Ozdemir, I; Esen, AA Objective: In this study we aimed to evaluate the treatment outcome of SSRI drugs by means of Overall Satisfaction and Intercourse Satisfaction domain scores of IIEF in patients with primary premature ejaculation. Methods: The data of 18 patients who underwent SSRI treatment because of primary premature ejaculation were retrospectively analyzed. In all patients, premature ejaculation was defined as the intravaginal ejaculation latency time of less than 2 minutes. As the routine application of our clinic, ELT was determined after it was recorded by the patient using stopwatch technique. Patients with a SHIM score of 21 or less were excluded from the study. All patients were given fixed dose SSRI agent not less than 2 weeks. IIEF Intercourse satisfaction domain (IIEF item 6,7,8) and Overall satisfaction domain (IIEF item 13,14) scores and ELT were determined before and after treatment. Correlation tests were performed between the change in ELT, Overall satisfaction score and Intercourse satisfaction scores after the treatment. Results: Mean age was 48 ± 10.9 years. Pretreatment and after treatment ELT were 56.2 ± 48.1 and 171.4 ± 198.4 seconds, respectively. SSRI treatment significantly improved ELT (p = 0.001). IIEF intercourse domain and overall satisfaction domain scores before and after treatment showed significant difference. There was significant correlation between the change in ELT and overall satisfaction scores after treatment (p = 0.05, Pearson correlation coefficient: 0.468) (Figure 1). Conclusion: IIEF overall satisfaction scores are in accordance with ELT in the treatment of premature ejaculation. IIEF overall satisfaction domain may have role as an efficacy measure in the treatment with SSRI drugs.

Unmoderated Poster Session Abstracts Methods: Forty-three men with DM and ED, successfully treated with Sildenafil (EF score of >26) for their ED, were also questioned about RE using a global assessment question (GAQ), International index of ejaculatory control (IIEC), Intravaginal latency time (IELT) assessed by visual analog scale, and the C-MASH questionnaire before and three months after Sildenafil treatment. The IIEC domains of control over ejaculation, sexual satisfaction and distress were calculated. The correlation between the GAQ and the other RE evaluation tools was analyzed. Results: Satisfied and unsatisfied patients who reported improvement of ejaculatory function were of similar age (61.9 versus 63.5 years) and EF domain (13.9 versus 15.2). Satisfied patients suffered from RE longer (26.7 versus 17.4 months, (p < 0.02). The changes in ejaculatory parameters are shown in table. Conclusion: Sildenafil may improve RE in patients with ED and DM who reported EF >26 following treatment.

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Paroxetine treatment of premature ejaculation: An open clinical trial Claes, HIM, Belgium; van Poppel, H Objective: We study the efficacy and side effects of 20 mg paroxetine once daily during 12 weeks as single oral therapy for patients complaining of premature ejaculation without evident organic causes. Methods: The study comprised 124 patients with a mean age of 34 years with premature ejaculation who presented at the urology clinic of 2 hospitals in Belgium. Pre-treatment evaluation included history and physical examination, International Index of Erectile Function (IIEF) and ejaculatory latency time evaluation. The 12-week followup included: ejaculatory latency time measurement, IIEF and partner sexual satisfaction. Results: Mean intravaginal ejaculatory latency time measurement increased from 0.48 minute (range 0 to 2.10) to 8.4 minutes (range 1.1 to 26.7). Partner sexual satisfaction and IIEF rate improved significantly. Nausea, insomnia and headache were reported side effects but only 12 men did not continue their treatment. Conclusion: In men with premature ejaculation 20 mg paroxetine weekly may be regarded as an effective and safe treatment.

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Does sildenafil affect rapid ejaculation in diabetic patients with erectile dysfunction Chen, J, Israel; Mabjeesh, JN; Matzkin, H; Greenstein, A Objective: Some men with diabetes mellitus (DM) and erectile dysfunction (ED) also complain of rapid ejaculation (RE). Sildenafil alleviates ED in many men with DM but its effect on RE is less defined. The aim of this prospective open label study was to evaluate whether improvement of erectile function (EF) in diabetic men is associated with corresponding improvement of their RE.

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Clinical and demographic evaluation of patients with primary and acquired premature ejaculation Demir, O, Turkey; Cihan, A; Kefi, A; Esen, AA Objective: Patients with premature ejaculation (PE) were subdivided into primary (PPE), individuals who had suffered from PE since the beginning of their sexual lives, and acquired (APE), those who developed the condition after years of satisfactory sexual functioning. Examination of the demographic data and comparation of IPSS, IIEF, and NIH-prostatitis scores of the patients admitting with PPE and APE were aimed. Methods: Fifty three patients whom admitted to our clinic in the last 6-month period with PE were recruited in the study. The patient data were taken from the Microsoft Access database consisted for sexual

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Unmoderated Poster Session Abstracts function disorders. Patient age, partners age, marriage duration, circumcision age, first coitus partner, ejaculation latency time (ELT), foreplay duration, systemic diseases, IPSS, IIEF subgroups and NIH-prostatitis scores were compared. Results: Mean age of 27 PPE and 26 APE patients was determined as 50.6 (12.3) and 53.5 (10.4) years, respectively. Mean circumcision age of the total 53 patients was 5.7 (2.6) years. First coitus age was 19.0 (2.7) years. Significant difference was not determined when two groups were compaired in terms of age, marriage duration, circumcision age, nocturnal continance age, first coitus age, first coitus partner, ELT, foreplay duration, IPSS, IIEF subgroups and NIH-prostatitis scores. While there was at least one systemic disease story in 9 patients (32%) in the PPE group, patients number was 19 (68%) in the APE group (p < 0.05). Diabetes mellitus and the cardiovascular diseases have major role in the APE group. Conclusion: Existence of systemic diseases in APE patients consists major purpose of patients in admission to medical doctor.

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Premature ejaculation: Familial incidence Fernandez Lozano, A, Spain; Ruiz Castañe, E Objective: There is no clear scientific agreement on what constitutes premature or rapid ejaculation. Significant advances are ongoing in understanding the pathophysiology of PE and the hypothesis that biological factors may play an important role in the pathogenesis of primary premature ejaculation seems very credible. We report an observation from patients who undergo pharmachological treatment for PE, and are asked if they have any first degree relative who have suffered also PE. Methods: 129 heterosexual men, aged 19–60 years, were asked routinely in the frame of a study comparing different treatments for PE to the question: Do you have a father, brother or son, who has suffered also PE? All of them had an intravaginal ejaculatory latency time inferior to 2 minutes, more than the 50% of sexual intercourses, measured by stopwatch. Results: 78/129 patients fulfilled the criteria for PPE (lifelong), and 32/78 did not accept to ask their relatives for different reasons. From the others 46/78 who consented to ask, 21/46 had no first degree relative affected of PPE; 9/46 had one or two brothers affected; 5/46 had a brother and father; 1/46 had a son, and 10/46 answer they had their father affected. None of the relatives affected were interviewed by us. Some of the patients didn’t get the information directly from their father but trough their mother. Conclusion: For educational or cultural reasons it is very difficult to investigate the family involucration on sexual disorders. A big majority of patients, are not aware about the occurrence of sexual disorders among other members of the family. Nevertheless, in our observation from the responders, a high percentage of them have a close relative affected of PPE which make us beleive there is a relation between genetic factors and the development of PE.

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Emotional impact of erectile dysfunction (ED) management Levy, L, France; Giuliano, F; Allert, FA; Girerd, X; Pouchain, D; Schaetz, D; Slama, A; El Hasnaoui, A Objective: To describe the effect of ED on patients’ daily life in a treated at-risk population. Methods: This survey was conducted among general practitioners and urologists. Enrolled patients were men over 18 years of age, presenting at their first visit with ED diagnosed with the IIEF5 questionnaire and with at least one of the following risk factors: cardiovascular risk, authenticated cardiovascular disease, prostate disease or depression. Patients filled out IIEF5 at enrollment and after 3 month, as well as visual analogue scales (VAS) (0–10 scores) evaluating the effect of ED on several dimensions of their daily life.

Results: Out of 2,235 enrolled patients 59 ± 10 years of age, only 40.9% of them have previously been treated for ED and 42.4% have previously taken medical advice for ED. At enrollment, a treatment for ED has been prescribed in 96.8% of patients. At 3 month, there was an improvement in IIEF5, D = 5.52 ± 4.99; p < 0.0001), a decrease in the impact of ED on i) patient’s work activity (D = 0.36 ± 1.67; p < 0.0001), ii) family life (D = 0.86 ± 1.92; p < 0.0001), iii) sex life (D = 2.65 ± 2.20; p < 0.0001), iv) depressive mood (D = 0.99 ± 1.97; p < 0.0001), v) nervousness (D = 0.71 ± 2.15; p < 0.0001) and vi) fatigue (D = 1.2 ± 2.08; p < 0.0001) according to VAS. The impact of ED on overall daily life was decreased after 3 months of management (p < 0.0001). In addition the impact of ED was more important in younger patients (p < 0.0001): distress was intolerable or completely intolerable for 54.6% of patients under 45 years of age. Conclusion: ED management has a considerable positive impact on patient’s daily life, by reducing work, family, sexual and psychological disconfort. The management of youngest ED patients appears to be especially important because this subgroup of patients suffers the most.

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Semen evaluation and influential factors in spinal cord injury patients Lombardi, G, Italy; Filimberti, E; Degl’Innocenti, S; Macchiarella, A; Natali, A; Rizzo, M; Del Popolo, G Objective: To present seminal characteristics and factors influencing the semen of 72 men with spinal cord injury (SCI). Methods: Each patient underwent penile vibratory stimulation or electroejaculation for semen retrieval at least 3 times. Results: Vibratory stimulation was successful in 30 patients, mean age 34.3, all with lesions above dorsal T10, while electroejaculation was used on 42 patients, mean age 35.7, all except 9 with lesions below T10. With vibratory stimulation median values: sperm count/ml was 127 million, rapid motility of 20.3%, morphology 16%, leukocytospermia exclusively granulocytes were present in 17 out of 30 (56.6%), while in 10 patients leukocites were never detected. These patients had better seminal parameters compared to other patients in relation to the level of lesion; in fact this factor is also correlated to the seminal parameters: the higher the lesion the better the seminal parameters are. With electroejaculation sperm count/ml was 85 million, motility 8.9%, morphology 13.6%, leukocytospermia in 25 out of 42 patients (59.5%), while in 9 patients leukocites were never present. They did not present better semen parameters compared to other patients. The induction of anterograde ejaculation represented a favorable factor over semen parameters. In 4 out of 72 patients we detected azoospermia and FSH greater than 25 mg/ml. Conclusion: Although semen is obtained with conservative methods from over 90% of SCI men, poor semen quality, especially sperm motility, is documented particularly with electroejaculation. Moreover, leucocitospermia is highly present in all patients, explaining in part why patients with good seminal parameters and whose partners had no fertility problems achieved pregnancy only through in-vitro fertilization. Experiments are required to provide better understanding of cellular or biochemical mechanisms responsible for the SCI-induced spermatogenic lesions including prostatic and seminal vesicle factors in order to use strategies to reduce oxidative stress and improve sperm quality.

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Use of conservative treatments for semen retrieval and assisted reproductive techniques for couples with male spinal cord injury: Semen parameters and pregnancy rates Lombardi, G, Italy; Filimberti, E; Degl’Innocenti, S; Macchiarella, A; Panariello, G; Del Popolo, G Objective: To present the results of fertility treatment in 25 men with spinal cord injury (SCI) and their partners from 2001 to 2004.

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76 Methods: Penile vibratory stimulation and electroejaculation as semen retrieval methods. Assisted reproductive techniques used: vaginal and intrauterine insemination (“low technology”) and in vitro fertilization (FIVET) including intracytoplasmic sperm injection (ICSI). Results: Vibratory stimulation was successful in 11 patients, all with lesions above dorsal T10. 14 patients underwent electroejaculation. With vibratory stimulation median values: sperm count/ml was 114.4 million, rapid motility of 19.2%, morphology 17%, while with electroejaculation sperm count/ml was 88.5 million, motility 8.6%, and morphology 13.4%. One couple was excluded because of a new-born genetic risk, 2 women were ruled out for irreversible infertility diseases. 8 women with no infertility disorders and their partners with valid sperm parameters all except one with vibrostimulation were submitted to 22 cycles of “low technology” inseminations resulting in 2 full-term pregnancies. The other 6 were given a FIVET, resulting in no pregnancies. 4 of these underwent ICSI, with 1 resulting in fullterm pregnancy. Of a total of 24 ICSI attempts, 14 patients had no other option due to low sperm parameters, and of these, 6 cases indicated additional female infertility disorders. 1 healthy live birth was achieved in the second round of ICSI, and 1 miscarriage occurred. Conclusion: It is difficult for male patients with spinal cord injury to have children even though in recent years the rate of success is improving thanks to the ICSI technique. Couples with no infertility disorders often rely on ICSI as spermatozoa ultrastructural defects reduce fertilizing capacity. The mean age of the women who became pregnant was slightly lower than that of those who did not and their absence of infertility disorders are fundamental to increasing the percentage of a full-term pregnancy.

Unmoderated Poster Session Abstracts Women Sexual Health and Dysfunction P-134

Relationship between vaginismus and honeymoon impotence Ghazy, S, Saudi Arabia Objective: to investigate the possible causal relationship between vaginismus and honeymoon impotence in a conservative society. Methods: In a prospective study, 40 female partners of patients who are complaining of honeymoon impotence underwent medical consultation and gynecological examination for diagnosis of vaginismus. All couples were in stable marital relation. The selection criteria were the presence of any of the following: clinical history suggestive for vaginismus, longer duration of complaint, and/or failure of medical treatment to overcome the impotence problem. Female partners who were diagnosed to have vaginismus received treatment in the form of behavioral therapy, self use of vaginal dilators and anxieolytic drugs. Results: 25 female partners were diagnosed for vaginismus. Mean vaginismus grade was 3, mean duration 2 years (range: 2 weeks–12 years). All patients had no sexual activities prior to marriage and had no history of sexual abuse. Seven patients were able to reach orgasm through non coital activities. All but 3 patients (dropouts) responded favorably to the therapy and were able to resume normal sexual relation. Mean number of treatment sessions was 8 (range: 5–14). At the stage when sexual intercourse was allowed 10 (43%) of the male partners were still complaining of ED and needed to use oral therapy (Tadalfil) for short duration before they resumed normal erectile function. Conclusion: Vaginismus is a common etiology for honey moon impotence. Therapy is effective in resuming normal sexual function in female partners. However male partners might still needed medical treatment before resuming their normal potency.

P-135

Is evaluation and treatment of hyperoxaluria in women with vulvar vestibulitis syndrome justified? Greenstein, A, Israel; Militscher, I; Chen, J; Matzkin, H; Lessing, JB; Abramov, L Objective: Hyperoxaluria was reported to be associated with vulvar vestibulitis syndrome (VVS). Thus, treatment with a low oxalate diet and oral calcium citrate was recommended. Results however were inconsistent. The aim of the study was to determine whether evaluation and treatment of hyperoxaluria in VVS is justified. Methods: Forty women (mean age 26.5 years, range 18–35) diagnosed with severe VVS at the Sex Therapy Clinic participated. Diagnosis of VVS relied upon Friedrich’s criteria: 1) severe vulvar vestibular pain upon touch or attempted vaginal penetration without any forceful entry into the vagina, 2) tenderness to pressure localized within the vulvar vestibule, and 3) physical findings confined to vulvar erythema of various degrees. Oxalate was measured in a 24-hour urine sample. Women with hyperoxaluria (urine oxalate >75 mg/ 24 hour) were treated with low oxalate diet and oral calcium citrate as their singular therapy. After three months of treatment women were reevaluated. Results: Hyperoxaluria was found in seven women (17.5%). Only one of these seven women demonstrated an objective improvement and was able to have pain free vaginal intercourse following treatment. Thus, only one woman (2.5%) of all women with VVS benefited from the evaluation and treatment of hyperoxaluria. Conclusion: In women with VVS there is no justification for evaluation and treatment of hyperoxaluria due to its low yield, economic burden, and poor outcome.

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Unmoderated Poster Session Abstracts P-136

Initial female sexual function following spinal cord cord injury

Conclusion: Preliminary results of our ongoing study indicates that, TENS is an effective treatment alternative for arousal and orgasmic disorders. Studies with larger number of patients are needed to confirm our data.

Lombardi, G, Italy; Celso, M; Natali, A; Macchiarella, A; Durvall, AM; Del Popolo, G Objective: To investigate in women with spinal cord injuries (SCI) the presence of sexual dysfunction and which factors may affect their sexual functioning. Methods: We selected 28 SCI women in a partnership, median age 34 (3 menopausal before lesion). No patients had any sexual dysfunctions before injury and the time elapsed since patient injury was a maximum of 2 years. 19 patients had complete lesions and 9 incomplete. We assessed the presence of sexual dysfunction by anamnesis, physical examination, and in accordance with the Female Sexual Function Index (FSFI). Moreover, bladder and bowel incontinence, dysreflexia, altered body-shape image and relationship quality were considered in rating sexual intercourse. A self-rating scale was used to evaluate each factor: (0 no problem, 1 slight, 2 important, and 3 determinant problem). Results: All 25 non-menopausal patients recovered menstruation. 11 presented sexual dysfunctions: 5 showed hypoactive sexual desire and arousal disorders, 5 lubrication and orgasmic deficiency and 1 hypoactive sexual desire and sexual pain. The level and degree of injury is not related to a specific sexual impairment. Regarding determinant problems interfering in sexual intercourse, 5 patients reported no sexual activity post-lesion due to unacceptableness of their body. 3 presented increased spasticity, and 2 bladder incontinence. All women not suffering from sexual dysfunction reported no problems with their partners. Conclusion: Sexual dysfunction is common in female SCI patients. As both medical and psychological problems interfere with sexual function, it is important to provide the patient with information about how injury can affect their sexual response and functioning, and for healthcare professionals to know where to refer patients in need of further information. Sexual rehabilitation should also involve partners to help the women overcome earlier psychological problems. The quality of the relationship significantly influences the women’s capacity to accept their disability and adjust their sexuality.

P-138

Vaginal pH in female sexual dysfunction Onem, K, Turkey; Tolga, A; Unal, Z; Kadioglu, A Objective: One of the features of arousal state is increase in vaginal pH. In this study, we aimed to evaluate the relationship between the primary complaints of women with female sexual dysfunction and vaginal pH. Methods: A total of 43 women with FSD were subjected to the study. After obtaining a informed concent to measure vaginal pH before and after sexual stimulation, vaginal pH was measured before sexual stimulation. The patients were then left alone and they were asked to stimulate their genitalia themselves while watching an erotic film. At the time when patients report sufficient stimulation, vaginal pH was measured again. FSFI score was obtained for each patient and patients were classified as having desire, arousal, orgasm and pain disorder. Groups were compared statistically in terms of the increase in vaginal pH. Results: The mean age of the patients was 34.4 ± 8.9 years. Overall, the mean pre and post stimulation vaginal pHs’ were 4.9 ± 0.7 and 5.9 ± 0.7. The mean pre and poststimulation vaginal pH of patients with desire, arousal and orgasmic disorders were 4.9 ± 0.3, 5.9 ± 0.2, 4.6 ± 0.3, 5.2 ± 0.3 and 4.7 ± 0.2, 5.7 ± 0.2. In the group with arousal disorder, the increase in vaginal pH was statistically lower than the other groups. No patient had pain disorder. Conclusion: This study revealed that increase in vaginal pH chances according to the complaints of women with FSD. Lower levels of increase in vaginal pH. was detected in patinets with arousal disorders. For adocating this opinion, futher studies are needed.

P-137

Transcutaneus Nerve Stimulation (TENS): An effective treatment alternative for arousal and orgasmic disorders

P-139

Female sexual dysfunction and PDE5 inhibitors in the UK

Onem, K, Turkey; Ahmet, M; Murat, A; Ates, K

Richardson, D, United Kingdom; Goldmeier, D

Objective: To evaluate the efficacy of TENS as a new treatment alternative for the treatment of female sexual aurosal and orgasmic disorders. Methods: Nine women with primary sexual arousal or orgasmic disorder were subjected to the study. All patients were asked to complete FSFI (Female Sexual Function Index) and Beck deppression questionnaries. Technically, a negative electrode was placed on posterior of the left medial malleolus and the positive electrod was placed 15 cm up to left medial melleolus. Everyday TENS (10 Hz, mean 30 mA) was applied for one hour for a duration of 3 months by patients themselves. FSFI was used to determine the sexual status after the treatment. Results: Totaly, 5 (55.5%) patients complated the treatment (two patients withdrew and two patients are still on the treatment). The mean age of 5 patients were 34 ± 10 (22–48) years. Risk factors, one patient had hypertension and diabetes mellitus for 5 years, one patient was in post-menapausal period. Beck depression scores were within normal limits in all of the patients. A statistically siginificant increase in terms of desire, arousal, lubrication and orgasm scores was evident between pretreatment and posttreatment periods. Pain score was not effected by TENS. No side effects were detected. the increase in desire score was attributed to the increase in arousal and orgasm scores despite the fact no patient complained diminished sexual desire.

Objective: It has been argued that women’s sexual dysfunctions, in particular low sexual desire and arousal, are in many situations; understandable and logical responses for women faced with stress, tiredness, or threatening patterns of behaviour from their sexual partners. Many experts believe that pharmacological research risks oversimplifying sexual problems in men and women because it promotes genital function as the centrepiece of sexuality and ignore other important components of sexual relationships. Although evidence for the use of phosphodiesterase-5 (PDE5) inhibitors in women with sexual dysfunction remains inconclusive; there are some data to suggest that women with female sexual arousal disorder benefit from increased sexual genital arousal, improved orgasm and sexual enjoyment with sildenafil citrate. The aim of this study was to review our experiences of using PDE5 inhibitors in women with female sexual arousal disorder. We parallel this with a questionnaire of psychosexual physicians and therapists in the UK to determine general use in the UK. Methods: Three of our patients with female sexual dysfunction experienced a marked response to PDE5 inhibitors. A questionnaire of 132 UK experts regarding their opinion and experience of PDE5 inhibitor use in women with female sexual dysfunction. Results: Three women with symptoms suggesting female sexual arousal disorder were prescribed sildenafil citrate (off licence). All

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78 three women subsequently reported increased sexual arousal and enjoyment. In the UK, 59% of prescribing sexual dysfunction physicians prescribe PDE5 inhibitors to women with arousal disorder or low sexual desire. 29% of non-prescribing psychosexual therapists advocate PDE5 inhibitors for female sexual arousal disorder, low sexual desire, diabetes associated female sexual dysfunction, spinal cord problems and lack of lubrication. Conclusion: Sildenafil citrate may well increase genital arousal and sexual enjoyment in women with female genital arousal disorder. In the UK, only a minority of psychosexual therapists, but 59% of physicians advocate this use.

Unmoderated Poster Session Abstracts validity and reliability. All domains discriminated between the low libido and normal groups (p < 0.001). Conclusion: The complexity of female sexual function requires use of instruments based on patient experience and point of view. Item generation and cognitive interviews done among target patient populations ensure content validity of the PFSF. The PFSF is a multi-national, validated, highly reliable instrument for the measurement of hypoactive sexual desire in menopausal women.

P-142

P-140

Sexual dysfunction in women with coronary artery disease

The sexual health of women in Ukraine

Salonia, A, Italy; Briganti, A; Montorsi, P; Margonato, A; Nappi, R; Buzzetti, F; Fantini, GV; Rigatti, P; Montorsi, F

Romashchenko, O, Ukraine; Melnikov, S Objective: The study of the frequency and the structure of the sexual dysfunction among women of different ages and social groups in Ukraine. Methods: These sexological, gynaecological and psychological researches have been carried out on 1197 patients aged from 18 to 62. We worked out a special form, which consists of 4 parts: a mark of the social status, a mark of the somatic health, a mark of the gynaecological health and a mark of the sexual health. Results: The frequency of the sexual dysfunctions among women aged from 18 to 25 was 28.9%, among women aged from 26 to 35–34.8%, among women aged from 36 to 49–41.4%, among women aged 50 and older—58.5%. The frequency of sexual dysfunctions correlated with the factor of stress, with the ecological troubles, with the economical instability, with the violations of the somatic and gynaecological status. We also found out that the range of sexual dysfunctions predominated mostly among women occupied with the intellectual work. In 87.5% cases women with the sexual dysfunctions didn’t come for the specialized sexological and psychological medical help. Conclusion: Creation of the system of the special service of Woman Sexology in Ukraine is important for the improving the quality of life and for the harmony relations between man and woman.

P-141

The profile of female sexual function: A patientgenerated, multinational inventory to measure hypoactive sexual desire Rust, J, United Kingdom; Golombok, S; Murray, C; Derogatis, L; Rodenberg, C; McHorney, C Objective: The Profile of Female Sexual Function (PFSF) is a new, patient-generated, multinational instrument to measure hypoactive sexual desire and associated symptoms in surgically and naturally menopausal women. Methods: Multinational interviews among 232 menopausal women with low libido were conducted to generate items for a patient-based questionnaire. The items were reviewed in cognitive interviews with patients to develop the preliminary PFSF and confirm content validity. Conceptual translation and harmonization of the items among 6 languages was carried out. The inventory was tested among surgically menopausal women with low libido (N = 325) and age-matched women with normal libido (N = 255) in 8 countries. Data quality, validity, and reliability were assessed and a final PFSF was generated. The final version was validated among independent samples of surgically and naturally menopausal women with low libido. Results: Over 400 descriptions of symptoms and attitudes were generated and considered as PFSF items. Cognitive interviews revealed ambiguities within languages and altered meanings after translation due to linguistic differences. These difficulties were resolved and an inventory of 65 items (6 domains) was developed. Item reduction yielded a final PFSF of 37 items (7 domains: desire, arousal, orgasm, pleasure, responsiveness, satisfaction, self-image). Results were consistent across the major regions studied. The final PFSF had excellent

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Objective: Aims of this study were 1) To evaluate any correlations between female sexual dysfunction (FSD) and coronary artery occlusive disease (CAD), 2) to compare pts sexual function with that of general female population. Methods: 39 consecutive pts presenting with angina pectoris [age: 57.87 ± 10.91 yrs (mean ± SD)] underwent a morphological and functional evaluation of the coronary arteries with a coronary angiography and entered the present multicenter ongoing study. All pts completed: a general and sexual history; Female Sexual Function Index (FSFI); Female Sexual Distress Scale (SDS); Beck’s Inventory for depression (BDI). 102 consecutive women [age: 54 ± 0.58 yrs (mean ± SE)] assessed for a routine check-up at the Ob/Gyn clinic completed the FSFI and were compared with the CAD patients. Results: FSD in CAD pts: 30.7% (12/39). FSD became evident prior to symptoms of ischemic heart disease in 10/39 (25.6%) pts. Therefore, 10/12 (83.3%) pts in this series developed the sexual disorders prior to angina or a myocardial infarction. Pts reported significantly lower total-FSFI (p = 0.02); FSFI-arousal (p = 0.002) than controls. BDI: mild depression: 13/39 (33%); severe depression: 4/39 (10%). Combination of 2 risk factors: CAD + hypertension: 7/12 (58.3%); CAD + hyper-cholesterolemia: 5/12 (41.6%); CAD + dyslipidemia (Hyper-cholesterol + hyper-try): 6/12 (50%); CAD + Diabetes Mellitus (DM): 5/12 (41.6%); combination of 3 risk factors: (CAD ± hypertension ± dyslipidemia ± DM): 4/12 (33%). BMI: CAD vs controls (mean ± SD): 26.45 ± 4.79 vs 23.37 ± 4.45 (p < 0.0001). Conclusion: This preliminary report suggests that SD is an important health issue in women with CAD. Although these findings need to be confirmed in a larger patient population it seems reasonable to recommend the evaluation of sexual function in women with coronary artery occlusive disease. A significant rate of pts developed FSD a median of 62.6 months (range: 12–108 months) prior to ischemic heart disease.

P-143

Sexual function and endocrine profile in fertile women with diabetes mellitus type 1: Results of a case-control study Salonia, A, Italy; Lanzi, R; Licata, G; Pontillo, M; Fabbri, F; Petrella, G; Briganti, A; Bosi, E; Rigatti, P; Bonini, P; Montorsi, F Objective: To investigate both sexual function and endocrine profile in women suffering from diabetes mellitus (DM) type 1 as compared to a population of age-matched healthy women with a normal sexual function. Methods: 50 DM type I fertile women (mean ± SEM age: 33.5 ± 1.1 years; BMI: 22.8 ± 0.7 kg/h2; length of disease 14.1 ± 1.5 years) (25 pts in follicular phase and 25 in luteal phase) were evaluated with: a semistructured history interview; Beck’s Inventory for depression (BDI); Female Sexual Function Index (FSFI); Female Sexual Distress Scale (FSDS); lab test evaluation.. Patients were directly compared to a group of 47 healthy fertile women (age: 34.1 ± 1.1 years, p = 0.92; BMI: 21.7 ± 0.5 kg/h2, p = 0.17) with a fully normal sexual function. Results: BDI scores were not significantly different between pts and controls. Overall, total-FSFI (p < 0.001), as well as arousal, lubrica-

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Unmoderated Poster Session Abstracts tion, orgasm, satisfaction and pain scores were significantly lower in patients than in controls. When the FSFI was filled-in according to the phase, a statistically significant difference was found only during the luteal phase regarding the arousal, lubrication, orgasm, satisfaction and pain domains. FSDS scores were always significantly lower in DM type 1 pts than in controls. An overall reduction of the estrogenic tone and a “low T3/T4 syndrome” was found in the patients group, as well as an overall reduction of the adrenocortical androgens production. In DM type 1 patients, follicular total-testosterone was positively correlated to total-FSFI, FSFI-arousal, orgasm and satisfaction. The strongest correlation has been found between fT3 and each one of the FSFI domains. Conclusion: These results confirm that FSD have a significant prevalence in fertile DM type I patients, independently from age, BMI, menopausal status, glycemic control, presence of major diabetic complications and depression. Endocrine profile seems to have a significant impact on the overall sexual function in these patients.

P-144

Related factors of dyspareunia Sobhgol, S, Iran; Mohamad Alizadeh Charandabee, S Objective: To determine related factors of dyspareunia. Methods: An analytical and cross-sectional study was carried out on 319 women aged 15–49, nonpregnant, nonbreastfeeding, referred to two gynecologic clinics of Tabriz University of Medical Sciences. A questionnaire was developed to identify dyspareunia and possible related factors. Pelvic organ prolapse was determined by using pelvic organ prolapse quantification system. Pelvic muscle strength, Connective tissue disorder, blood pressure, BMI of women studied were determined too. Data were analyzed using student t and c2. Results: At whole 54.5% had dysparuenia. The means of gravidity, parity, delivery without episiotomy, vaginal length, cesarean, weight of largest infant delivered vaginally, were more in women with dysparuenia. But the means of age, delivery with episiotomy, BMI, prineal length, hiatus diameter showed no significant differences between two groups. The history of macrosomic infant delivered vaginally, heavy liftening, chronic pulmonary obstructive disease, arthritis, constipation, pelvic organ prolapse, pelvic inflammatory disease and pelvic muscle strength had significant relation to dysparuenia. Prevalence of urinary infection, stress incontinence, urgency, positional changes to start or complete voiding, fecal straining, low back pain, digital manipulation of vagina or perineum or anus to complete defecation, feeling genital pain or pressure, sensation of a mass in vagina were more significantly in women with dyspareunia. Conclusion: According to the results of this study and high prevalence of dyspareunia, it is necessary to inform women about the related factors of this disorder. This study’s findings can be helpful in the evaluation of dysparuenia. From the results, it seems pelvic floor exercises, treatment of chronic diseases, prevention of high pregnancy and cesarean can probably reduce the risk of dyspareunia. Further studies are necessary to confirm these findings. Key words: related factors, sexual dysfunction, dysparuenia.

Veneral and Sexually Transmitted Diseases P-145

The management of chronic prostatitis Brizhatyuk, E, Russia; Kulchavenya, E; Lazarev, M Objective: To compare the efficiency of treatment for a chronic prostatitis. Methods: 51 patients were enrolled in this study. For 28 (experience group) the treatment started with Ceftriaxone; in some cases—indirect lymphotropic therapy. Pathogenetic therapy was with Aspirinum, Escuzanum, microclysters with Dimexidum, Pipolphenum, and Halidorum; also—selective a1—adrenoblocker. 23 patients (control group) were treated with antibacterials only. Estimation of efficiency: complaints, inflammatory in a prostate secret, uroflowmetry. The main clinical symptoms (pain, dysuria, erectile dysfunction) allowed on a 3mark scale. We studied quantity of leucocytes in prostate secret, and quantity of lecithin grains. Results: Before treatment a pain syndrome, dysuria and sexual dysfunction on the average were from 1.2 up to 2 balls. After treatment the intensity of the two first parameters has gone down accordingly to 0.3–0.5 in experience group, but only to 0.7–1.3 in control. Mean violation of an erectile function remained high in control group—1.5, though has decreased to initial in 2 times in experience group. Initially there were on average 72.5 leucocytes in a prostate secret; quantity of lecithin grains was on the average 0.9 balls. After treatment in experience group the number of leucocytes was reduced almost in 9 times (on the average 8.2 cells), saturation of smear by lecithin grains, viceversa, has increased in 2 times (on the average 1.8). Uroflowmetry: initially maximum flow rate (Qmax) was 20.0 ml/s, average flow rate (Qave)—9.1 ml/s. After treatment these parameters were increased accordingly up to 26.9 and 11.5 ml/s. In control group all parameters were statistically worse. Conclusion: The aetiotropic therapy alone is insufficient for chronic prostatitis. Complex pathogenetic therapy is necessary.

P-146

Tuberculous inflammation of prostate Khomyakov, V, Russia; Kulchavenya, E Objective: Genitourinary tuberculosis is great problem for Siberia: up to 5% prostatitis tuberculous. Combination nephrotuberculosis with tuberculosis of a prostate is much more often. 52.2% of the men with kidney tuberculosis has genital tuberculosis also. Unfortunately, as rule, inspection of patient with prostatitis doesn’t include investigation on tuberculosis that results in late diagnosis and incorrect treatment. Methods: 84 patients with tuberculosis of prostate were involved in our study. The diagnosis was verificated by bacteriological or pathomorphological methods. The age of patients was from 20 till 68 years. Infiltrative tuberculosis of prostate was in 52 patients, and cavernous tuberculosis—in 32. All patients received polychemotherapy (Isoniazidum 0.6 + Streptomycinum 1.0 + Rifampicinum 0.6) in intermittent regime. In additional 41 patients from them (experience group) were treated with low intensity laser. We used infrared laser with wavelength 0.89 mkm, for 10 min daily No 10 on perineum transcutaneously. 43 patients were as control. The results of treatment estimated by following criteria: sanation of prostate secretion, the termination of growth of Mycobacteria Tuberculosis, local immunological tests, and functional tests. Results: Laser Therapy in combination with polychemotherapy promotes to increase of Isoniazidum concentration in lesion twice and Rifampicinum concentration—in 6.5 time. Complex treatment allows to save functional possibilities of genital system and to increase efficiency of therapy on 42.1%. In 80% patients receiving only polychemotherapy (control group) tuberculous prostatitis became chronic disease, with constant latent inflammation in prostate, and only 20% were cured. Whereas the efficiency of the complex aetiotropic treatment included laser therapy was 62.1%. Essentially, tuberculous caverns of prostate were saved, because of whole healing it’s unlike

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Unmoderated Poster Session Abstracts

pulmonary caverns is impossible. However inflammatory signs were absent. Conclusion: Patients with prostatitis exactly need special examination on tuberculosis. The treatment of tuberculous prostatitis has to include laser therapy.

General Issues in Sexuality

P-147

Astbury-Ward, E, United Kingdom

Sexually transmitted infections in pregnant adolescents and pregnancy outcome

Objective: To identify schools of nursing in the UK that include human sexuality in the pre-registration curriculum. To establish percentage of time devoted to this and what this includes. Methods: Data collection by postal questionnaire (anonymous). The setting and study subjects were all schools of nursing and midwifery in the United Kingdom (England, Northern Ireland, Scotland and Wales) that offer pre-registration nurse training leading to professional registration with the Nursing and Midwifery Council. Subjects were chosen by Purposive/judgement sampling (the subjects had knowledge that was valuable to the research process). Subjects were identified by a system of cross referencing using information from five different sampling frames. A total of sixty eight eligible study subjects were identified as suitable for inclusion. Data was interpreted mainly from a phenomenological perspective and grounded theory. Results: Sixty percent response rate. 93% included human sexuality in pre-registration training. 97% considered human sexuality to be important. 89% taught sexual anatomy and physiology 84% taught STI’s and gynaecology Out of a potential 2,300 hours of theoretical learning in the curriculum only 8% of schools of nursing and midwifery provided more than twenty one hours of instruction on the subject. The average amount of instruction on the subject of human sexuality was a mere 6.8 hours. Formal marking of the subject only occurred if human sexuality was chosen as a special topic. Conclusion: The current pre-registration provision of training in human sexuality in schools of nursing in the United Kingdom is inadequate to meet the diverse needs of patients and the training needs of nurses. The schools of nursing themselves acknowledged their lack of ability to tackle the subject because of low skills and discomfort surrounding the issue. Improvement on implementation has to happen for positive change to occur.

Sakharkar, V, Bahamas; Brown, M Objective: Sexually transmitted infections (STI) in adolescents are a growing problem. STI during pregnancy are found associated with preterm labour, premature rupture of membranes (PROM), low gestational age and birth weight. Present study was undertaken to assess the frequency of STI in pregnant adolescents registered at Adolescent Health Center, Nassau, Bahamas and its impact on pregnancy outcome. Methods: 146 pregnant adolescents registered in the year 2003 (Jan.–Dec.), were subjected to STI screening at their first visit for cervical chlamydial and gonorrhoeal infection and Pap smear. Cervical chlamydial and gonorrhoeal infection were tested by TranscriptionMediated Amplification (TMA) technology (Gen-Probe). Patients infected with C. trachomatis and N gonorrhoae were treated with Erythromycin or Azithromycin and Ceftriaxone while T. vaginalis infection was treated with Metronidazole Gel. Patients were subjected for repeat tests after treatment. Patients were followed till childbirth for pregnancy outcome and complications. Results: Average age and gestation at first visit was 16.07 (±1.04 SD) years and 18.66 (±6.63 SD) weeks, respectively. STI recorded in 37 (25.34%) cases. C. trachomatis infection accounts for 25 (17.12%) cases, followed by N. gonorrhoae 7 (4.79%) and T. vaginalis 6 (4.1%). Genital warts and HPV were detected in 2 cases each (1.36%). 3 (2.05%) patients had repeat positive testing for C. Trachomatis and received treatment. Pregnancy outcome and complications were compared with Non-STI patients for gestational age, birth weight, preterm labour, and PROM. The mean gestation at childbirth found similar in STI and Non-STI patients (38.4 and 38.3 weeks, respectively). STI patients delivered low birth weight babies than Non-STI (mean birth weight 2890 gm. and 3142 gm., respectively). However the difference was not found statistically significant (P = 0.08). In the present study antenatal STI were not found associated with preterm labour and PROM. Conclusion: Chlamydial infection is the commonest amongst STI in pregnant adolescents. Aggressive screening for STI as a part of routine prenatal care and adequate treatment is warranted to lower adverse pregnancy outcome.

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P-148

The provision of training in human sexuality in schools of nursing in the United Kingdom

P-149

Web-based patient record system for our country in sexual function disorders Demir, O, Turkey; Ozturk, U; Acikgun, A; Aslan, G; Asci, R; Esen, AA Objective: A common database which includes the data of the patients whom admitted with sexual dysfunction of our country has not been made yet. In our study, the web based patient database made by Dokuz Eylul (DEU) and Ondokuz Mayy´s University (OMU) Urology Departments is presented. Methods: In September 2003, a decision of making a common database was given by DEU and OMU Urology Departments. In November 2003 DEU and in May 2004, after the technical problems have been solved, OMU has begun to enter data. The records of total 936 cases since the date July 2004 have been recorded to the web based database. The data of the patients are summarized in the Table 1. The data are entered from the address web2.deu.edu.tr/urology. Each center willing to enter the empty database can reach the patient database in the internet after taking a username and password and can enter their own data under the titles summarized in the Table 1. Program prevents mistaken data entries by giving directories to the user. The program is continued to be improved and is open to the membership admissions of other centers. The technical support about the data entry can be given by us. Results: A total of 116 new patients’ data have been recorded to the database since November 2003 by DEU and OMU urology departments. Some demographic data of the whole group is given in Table 2. Conclusion: In today’s science age, making such a database pool will supply data representing the whole population of the country in the sexual function disorders. And also it will help the centers in reaching their own data safely and rapidly.

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Unmoderated Poster Session Abstracts P-151

Help-seeking behaviour in men calling a help-line Papaharitou, S, Greece; Athanasiades, L; Kirana, P; Nakopoulou, E; Hatzichristou, D

P-150

Effect of VIAGRA® (sildenafil citrate) on diseasespecific psychosocial parameters in men with erectile dysfunction Levinson, I, USA Objective: The impact of erectile dysfunction (ED) frequently extends beyond the initial erectile problem. Consequently, an important aspect of successful and long-term continuation of therapy for ED is an improvement in other psychosocial factors of the patient’s life affected by ED. The objective of this current subanalysis was to assess changes in psychosocial factors using a disease-specific instrument in men with ED receiving Viagra or placebo. Methods: Combined data from 5 randomized, double-blind, placebocontrolled, multicenter, flexible-dose, 12-week studies were analyzed in men with ED of broad-spectrum etiology. Patients started with a 50-mg dose of sildenafil, adjustable to 25 or 100 mg, based on efficacy and tolerability. A 5-item disease-specific questionnaire, the Erection Distress Scale (EDS), was used to assess the patient’s concern with his erection problem (“Were you frustrated about your erection problems?”; “Did you feel weighed down by your erection problems?”; “Were you discouraged by your erection problems?”; “Did you feel despair over your erection problems?”; “Were your erection problems a worry in your life?”) at baseline and end of treatment. Responses were graded on a scale from 1 to 6, with higher scores indicative of fewer concerns. Results: At the end of treatment, men receiving Viagra showed significant improvement in each of the 5 EDS questions, compared with men receiving placebo (table). Increases in scores with Viagra ranged from 33% to 64% compared with 7% to 12% with placebo. EDS scores at baseline were lowest and improvements with Viagra highest in men with baseline scores on the Erectile Function domain of the International Index of Erectile Function indicative of moderate (26%–85% improvement) or severe ED (19%–67% improvement). Conclusion: Viagra treatment resulted in significant improvements in disease-specific psychosocial parameters in this group of men with ED of broad-spectrum etiology. Men with more severe ED had the greatest improvements in psychosocial parameters with Viagra treatment.

Objective: To describe male help-seeking behaviour regarding sexual dysfunction (SD) as reported in a help-line. Design and Methods: The data included the calls between 1/9/2003 and 1/9/2004 made to the help-line of the Greek Centre for Sexual and Reproductive Health by males. During the call, the counsellor addresses demographic characteristics of the caller, the sexual problem reported, any previous doctor contacts and other selected factors (coexisting physical and mental health problems, quality of the couple’s relationships, etc.). Descriptive statistics, Chi-Square test of Association and Independent Samples t-test were used for data processing. Results: Analysis was based on 1.363 calls made by males calling mainly for their own sexual problems (92.3%). Thirty per cent of them had consulted a doctor, 59.1% of whom visited a physician at the private sector. Men having consulted a doctor had significantly (p < 0.005) higher mean age and problem duration as compared to those not seeking medical advice (48.16, +15.61 vs 41.66, +15.61 and 37.23, +50.00 vs 23.51, +31.44, respectively). Men with ED and those discussing their sexual problem with their partner were more likely to seek medical help as compared to men having premature ejaculation and those avoiding discussion over their sexual concerns (odds ratio 2.4 and 2.0, respectively). Private employees had a 2.2 times higher chance of not seeking medical consultation compared to pensioners. Those having consulted a physician, 52.2% were satisfied with the way the physician handled the situation and 11.3% were satisfied with end result of the treatment. Regarding not seeking medical consultation, lack of appropriate information was the most frequent reason (52.9%). Conclusion: Age, occupation, SD’s type and duration, and negative attitudes towards sharing their sexual concern, influence men’s willingness to seek medical help. The above findings should be taken into account when planning sexual health awareness programs for the society.

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Sexuality in the elderly: An exploratory study in the Greek population Papaharitou, S, Greece; Nakopoulou, E; Kirana, P; Giaglis, G; Hatzichristou, D; Moraitou, M Objective: To explore and identify factors affecting sexuality in later life. Methods: A total of 729 participants (M: 404, F: 325) were recruited from Open Protection Centres for the Elderly. A questionnaire was constructed comprising demographics, personal history questions (e.g. reasons for getting married, frequency of sexual intercourse, etc.) and a 14-item scale assessing intimacy and sexuality. For the purposes of the present study, the 5-item sexuality subscale was used (Cronbach a = 0.80). Descriptive statistics, Pearson’s Correlation Coefficient and Multifactorial Analysis of Variance were used for data processing. Results: Participants’ mean age was 69.94 years (SD = 7.09, range: 60–94 years old); most of them were married (62%), primary school graduates (66%) with a monthly income of up to 600 Euro (76%). Sexuality related negatively to age and years of marriage (r = -0.240, p = 0.000 and r = -0.280, p = 0.000, respectively) and positively to income and frequency of sexual intercourse (r = 0.161, p = 0.001 and r = 0.221, p = 0.000, respectively). No significant gender differences were found (p > 0.005). Participants being married out of love and those living in urban areas had significantly (p < 0.05) higher scores on sexuality (mean = 6.65, +2.09 and mean = 6.45, +2.22, respectively) as compared with those in arranged marriages and living in rural areas (mean = 5.66, +2.74 and mean = 6.02, +2.52, respectively). Lower educational levels interacted significantly with reasons for getting married to produce an effect on sexuality [F(2,339) = 3.18, p = 0.043]. Conclusion: The present study indicates the impact of social and interpersonal factors on sexuality. These include quality of the couple’s

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82 relationship as well as educational level and place of residence that might reflect conservative attitudes towards sexuality. The information provided can be useful for health professionals in order to guide discussions with older adults seeking information for sexual health issues.

P-153

The relationship between sexual behaviors and sexual attitudes among paramedical students Papaharitou, S, Greece; Tsimtsiou, Z; Nakopoulou, E; Paralikas, T; Kotrotsiou, E; Hatzichristou, D Objective: To investigate the existence of a relationship between sexual attitudes and sexual behaviours in a group of paramedical students. Methods: The study was conducted at a School of Health Professions. A battery of questionnaires was used comprising demographics, questions for sexual behaviors, the Patient-Practitioner Orientation Scale (PPOS) and the 30-item Derogatis Sexual Functioning Inventory (DSFI) -Attitude subscale. Results: In the study participated 146 students (59.6% nurses; 40.4% medical laboratory technicians). 84.8% of them were females, while the sample’s mean age was 22.98 + 4.10 years. Students coming from urban areas, who had their 1st sexual experience before the age of 18 years and with a sexual partner at the time of the study, expressed significantly (p = 0.003, p = 0.022 and p = 0.019, respectively) more liberal sexual attitudes. Married students had a more conservative orientation (7.67 + 8.00 vs 17.97 + 14.08). Significant predictors of liberal sexual attitudes were the consideration of sex as being important, as well as the poor relationship with religion that explain 13.1% of the variance (b = 0.314 and b = -0.211, respectively). Correlation between patient-centeredness and liberality in sexual beliefs among nurses was also found (Pearson correlation DSFI and PPOS: r = 0.21, p = 0.05, especially with the PPOS-Caring subscale: r = 0.29, p = 0.007). Conclusion: The adoption of a tolerant attitude might help health professionals to address and effectively manage patients’ sexual health problems. The present study indicated that socioeconomic factors and personal experiences significantly influence attitudes towards sexuality. Educational programs should include all health professionals to enable them overcome any personal barriers, while supporting people with sexual health problems.

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The role of interactive learning on ED Papaharitou, S, Greece; Athanasiades, L; Salpiggidis, G; Nakopoulou, E; Hatzichristou, D Objective: To assess the role of interactive techniques when training physicians on ED management. Design and Methods: The study included all the physicians who attended 8 different 2-day workshops that were run by the Greek Centre for Sexual and Reproductive Health between 6/2001 and 10/2004. They included six tutorial and three interactive sessions— role-playing, small-groups workshops (scripted role-play and group discussion) and video-based dramatization—addressing doctor-patient communication skills. Participants used a ten sections questionnaire to evaluate each session and the overall workshop along three dimensions: new knowledge acquisition, quality of presentation and usefulness of the workshop in their clinical practice. Quantitative (descriptive statistics and one-way repeated measures ANOVA) and qualitative (content analysis) methods were employed for data processing. Results: Workshops were attended by 374 physicians (mainly males: 84.7%, GPs: 66.4%, self-employed: 40.4%). The overall assessment of the workshop ranged, on average, from 3.98/5 (+0.78) for new knowledge acquisition to 4.38/5 (+0.57) for quality of presentation. The three interactive sessions differed significantly in their mean overall evaluation scores [F(2, 472) = 9.246, p = 0.000] with role-playing and small-groups workshops having the highest scores on all three dimen-

J Sex Med 2005; Supplement 1

Unmoderated Poster Session Abstracts sions as compared to the video-based dramatization (mean: 4.01/5, SD: 0.69 and mean: 4.04/5, SD: 0.67, respectively vs mean: 3.83/5, SD: 0.80). In support to the above are free-text comments providing positive remarks on the effectiveness of role-play in raising awareness and acquiring new knowledge on ED management (38.4%). Comments (~25%) of attendees referred to the need for increased frequency of similar training activities. Conclusion: The use of interactive methodology in workshops on ED management proved to be highly acceptable to physicians. Roleplaying and small-group workshops constitute a constructive learning approach that appears to enhance awareness raising to physicians dealing with ED patients.

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State of the art communication skills training for medical students in an outpatient clinic for erectile dysfunction—Away from embarassing emotions Riedasch, G, Germany; Holler, S Objective: Erectile dysfunction is becoming an often mentioned complain of many patients, especially after surgical pelvic interventions. Also many elderly patients still enjoy sexuality and do not accept impotence. In an aging society erectile dysfunction could become the same medical significance as hypertension. But most doctors are not educated in sexual history taking regarding this major concern because communication skills training is neglected in medical education. Methods: In a pilot study we developed a new communication skills training session in a newly implemented curriculum for “rehabilitation and physical therapy.” First the learning objectives were formulated and in a next step transformed into adequate teaching strategies. The successful implementations was evaluated by students. Results: We designed a case report of a 40 year old patient who underwent anterior rectum excision. A group of students had to write a role play in which the patient consulted the doctor because of erectile dysfunction after surgery. The role-play was videotaped, watched and feedback was given. Evaluation results reflect student’s appreciation of this method. Conclusion: Role-plays seem to be an adequate tool for students to learn who to optimize sexual history taking and talk about intimate subjects. The videotaping helps to give appropriate feedback. This tool could be also used for residents to improve their communication skills in this important area.

P-156

Sexual satisfaction in infertile couples: A multivariate correlation analysis Salonia, A, Italy; Fabbri, F; Zanni, G; Briganti, A; Gallina, A; Longhi, E; Brigante, C; Fusi, F; Rigatti, P; Montorsi, F Objective: Aim of this study was to define any potential predictors of sexual satisfaction within infertile couples, according to several internationally validated questionnaires. Methods: 19 couples (female mean age ± SEM: 32.9 ± 1.1 years; male: 35.9 ± 1.1 years; p = 0.2) were evaluated for infertility and entered this still ongoing study aimed at assessing both sexual function and predictors of sexual satisfaction among infertile partners. Both partners anonymously filled in a brief semi-structured sexual history and a set of questionnaires [namely, women: the Female Sexual Function Index (FSFI), the Female Sexual Distress Scale (FSDS), the Beck’s Inventory for depression (BDI), the ZUNG questionnaire for anxiety, the Dyadic Adjustment Scale (DAS) and the Coping Scale for Infertile Couple. Men: International Index of Erectile Function (IIEF); BDI, DAS, Coping and Zung questionnaire]. Results: BDI: partners were not differently depressed (female vs male partner: 6.8 ± 1.5 vs 5.6 ± 1.4, p = 0.38). ZUNG anxiety questionnaire: female vs male: 36.2 ± 2.0 vs 33.1 ± 2.8, p = 0.23). DAS-tot: female vs male: 113.5 ± 3.0 vs 115.8 ± 3.1, p = 0.40). Coping questionnaire: female vs male: 38.1 ± 3.1 vs 36.7 ± 2.5, p = 0.60).

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Unmoderated Poster Session Abstracts FSFI-total: 30.2 ± 0.9. FSDS: 8.8 ± 2.6. IIEF-total: 64.1 ± 2.4. IIEFerectile function domain: 26.8 ± 1.1. Multivariate correlation analysis. FSFI-satisfaction domain was significantly correlated with ZUNG-anxiety for female (r = -0.04, p = 0.032) but also with the IIEF-Total (r = -2.20, p = 0.02), the IIEF-EF (r = 0.26, p = 0.04) and the IIEF-satisfaction domain (r = 0.92, p = 0.002). Interestingly, IIEFoverall satisfaction domain was significantly correlated with FSFIsatisfaction (r = 1.80, p = 0.01) and FSFI-pain domain (r = 0.71, p = 0.03). Moreover, the IIEF-total was significantly correlated with FSFI-sexual pain domain (r = 7.28, p = 0.0002). Interestingly, FSFI-arousal domain was significantly correlated with both female (r = -0.09, p = 0.0004) and male BDI (r = 0.05, p = 0.03) and female Coping questionnaire (r = 0.03, p = 0.007). Conclusion: Although these findings need to be confirmed in a larger patient population, these results seem to suggest that woman’s sexual satisfaction significantly depends on the partner’s sexual satisfaction and viceversa within partners of infertile couples.

P-157

Increased rate of successful intercourse correlates with improved self-esteem in men with erectile dysfunction treated with Viagra® (sildenafil citrate)

using the same protocol determined the degree of improvement in erectile function (EF) and in psychosocial quality-of-life parameters measured with the ED-specific Self-Esteem And Relationship (SEAR) questionnaire. Methods: The 12-week, double-blind, placebo-controlled, flexibledose (25, 50, or 100 mg) trial was conducted in men aged 18 years or older with ED. Severity of ED was categorized by scores on the EF domain of the International Index of Erectile Function (IIEF EF), as minimal (26–30), mild (22–25), mild-to-moderate (17–21), moderate (11–16), or severe (10 or less). Scores for the SEAR questionnaire components were transformed onto a 0 to 100 scale, with higher scores more favorable. Results: At baseline, 5% or less of men in the Viagra (9/256) and placebo (13/254) groups had minimal or mild ED. Viagra treatment improved ED by 1 or more IIEF EF severity category in 85% (217/256) of men, versus 46% (118/254) for placebo. At end of treatment, 72% (184/256) of the Viagra group had minimal or mild ED versus 36% (91/254) of the placebo group. Improvement in EF with Viagra treatment was associated with substantial improvement in transformed SEAR component scores (Figure). Conclusion: Viagra treatment results in a near-normalization of EF in most men with ED, accompanied by substantial improvements in self-esteem, confidence, and relationship.

Stecher, VJ, USA

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Near-normalization of erectile function and improvement of psychosocial quality-of-life in men with erectile dysfunction treated with Viagra® (sildenafil citrate) Stecher, VJ, USA Objective: In men with erectile dysfunction (ED) treated with Viagra, this pooled analysis of a United States and an international trial

Change in SEAR Score by Viagra Effect on IIEF EF Domain Mean (SE) Change in Score (0–100)

Objective: Low confidence and poor self-esteem are often associated with erectile dysfunction (ED), but there is little research on the interaction between these parameters and efficacy of ED treatment. This open-label, multicenter study evaluated the relationship between successful intercourse and self-esteem using the Self-Esteem And Relationship (SEAR) questionnaire, a validated, patient-administered, 14-item, ED-specific instrument with domains of Sexual Relationship and Confidence. Methods: 382 men (mean age 55 years) with clinically documented ED and in a stable sexual relationship began the 10-week treatment period with Viagra 50 mg (prn, adjustable 25–100 mg). Primary efficacy measures were the 4-item Self-Esteem subscale of the SEAR Confidence domain, the percentage of occasions at which intercourse was successful recorded from Event Logs, and their correlation. The Self-Esteem subscale addresses self-esteem and confidence, with items scored on 5-point scale (maximum score 20, transformed to a 100-point scale). The Event Log is used by patients to record sexual attempts and outcomes in the home setting. The change scores from baseline to endpoint were analyzed with paired t-tests. Results: The intent-to-treat analysis using last observation carried forward for dropouts included 368 men. Compared with baseline, treatment with Viagra improved the mean ± SD Self-Esteem subscale score from 55 ± 25 to 79 ± 22 (P < 0.0001) and the percentage of occasions during which intercourse was successful from 21% ± 30% to 70% ± 36% (P = 0.0001). The overall correlation was low (r = 0.32) but significant (P = 0.0001). The correlation was greater in men >65 (r = 0.35, P = 0.0013) and in men 50–65 (r = 0.37, P = 0.0001) than in those <50 (r = 0.18, P = 0.0614). Conclusion: In men with ED, Viagra treatment significantly improved Self-Esteem subscale scores and the rate of successful intercourse recorded in Event Logs. The correlation between these measures suggests that as the percentage of occasions during which intercourse is successful increases, self-esteem improves.

EF Did not improve (N=39)

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EF Improved by 1 IIEF EF severity category (N=47) EF Improved by 1 or more IIEF EF severity categories (N=217)

40

20

0 Sexual

–20 Relationship domain

Confidence Self-Esteem Overall Overall score domain subscale Relationship subscale

SEAR Components

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The professional practice and opinions of UK clinicians: A comparison by initial training and gender—II. What do clinicians feel they need to know more about? Wylie, K, United Kingdom; Giami, A Objective: To identify clinicians working within the field of sexual and psychosexual medicine and to gain insight into the varied practices of these physicians, psychologists, nurses and therapists, a European survey was carried out with the collaboration of 7 countries. This presentation will explore the opinions of UK clinicians and the areas of sexology that they feel they need to know more about. Methods: In the UK a prospective questionnaire was sent to 2352 practitioners of which eight hundred and fourteen responded detailing their training, professional practice and opinions about sexology. Clinicians were categorised by their initial training, either as physician or non-physician. Chi Square tests were carried out to analyse differences between physicians (male and female) and non-physicians responses. Results: The majority of clinicians believed that male and female sexual problems originate both organically and psychologically (89%, 78%). There were significant differences (p < 0.01) in the areas of sexology that physicians and non-physicians felt they needed to know more about. Physicians felt they needed to know more about psychol-

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84 ogy, psychotherapy and social science whereas non-physicians felt they needed to know more about medical specialities such as endocrinology, pharmacology and neurology. There were also gender differences in the opinions of physicians. Male physicians felt they needed to know more about sex education and sex therapy, whereas female physicians felt they needed to know more about research methodology. Conclusion: The results of the survey provide an important insight into areas of sexology that clinicians feel they need to know more about. The current opinion of clinicians is that sexual problems have an equal biological and psychological origin. This would explain some of the needs of different clinicians practising in the field.

Unmoderated Poster Session Abstracts Sexual Counseling and Therapy P-160

Pre-morbid and present sexual dysfunction in patients with Parkinson’s disease Bronner, G, Israel; Royter, V; Korczyn, AD; Giladi, N Objective: To investigate present and pre-morbid sexual function of patients with Parkinson’s Disease (PD). Methods: Subjects: Seventy five (32 women and 43 men) non demented non depressed consecutive PD patients, age 31–83, in Movement Disorders Unit. Questionnaires: Present and pre-morbid sexual function was assessed by the Israeli sexual behavior inventory (ISBI) (Kravetz 1999), including eight scales: sexual satisfaction, intimacy, sexual drive, health perception, anorgasmia, dyspareunia, erectile dysfunction, premature ejaculation (PE). Stage of PD, duration of the disease, present pharmacological treatment, associated illnesses obtained by clinical examination and medical records. Statistical Analysis: Pearson correlation coefficients and student t-test, paired or unpaired assessed associations between variables. Best subset regression identified explanatory variables for changes in each sexual scale. Stepwise regression was performed with combined variables and explaining model was constructed. SPSS was used with 0.05 level significance. Results: PD patients report sexual dysfunction in all scales: 68% ED, 41% PE, dificulties to reach orgasm- 75% women, 40% men, sexual dissatisfaction- 37% women, 65% men. Pre-morbid low desire, intimacy and sexual satisfaction, orgasmic difficulties and dyspareunia contribute to cessation of sexual activity along PD. Stepwise regression demonstrated that medical factors explained sexual deterioration: associated diseases, use of medications, stage of PD among men and use of L-dopa among women. Treatment with L-dopa and dopamine agonists had independent negative effect on erectile function and desire. ED may be an autonomic disturbance, additional to other autonomic disturbances in PD, which can be worsened by chronic dopaminergic treatments (slower gastric emptying time, ortostatic hypotension). Decrease in desire can be explained by lack of motivation and self initiation, following abnormalities at the prefrontal cortex and its subcortical connections, frequently associated with abulic syndrome in PD patients. Additional psychological facotrs may contibute to low desire. Conclusion: Prevention of multi sexual dysfunction in PD patients demands early evaluation and treatment adjacent to diagnosis of disease.

P-161

Randomised controlled trial of pelvic floor exercises for erectile dysfunction Dorey, G, United Kingdom; Speakman, M; Feneley, R; Dunn, C; Swinkels, A; Ewings, P Objective: To compare the efficacy of pelvic floor muscle exercises and manometric biofeedback with lifestyle changes for men with erectile dysfunction. Methods: Fifty-five men with a history of erectile dysfunction of 6 months to 30 years (median age 59.2 years: range 22–78) were enrolled from a local urology clinic. Twenty-eight subjects were randomised to an intervention group and received pelvic floor muscle exercises, biofeedback and suggestions for lifestyle changes, such as reducing, smoking, reducing alcohol consumption, getting fit, losing weight and avoiding saddle pressure. Twenty-seven controls were solely advised on lifestyle changes. Baseline, 3 and 6 months assessments were: Erectile Function domain of the International Index of Erectile Function (IIEF), Partner’s International Index of Erectile Function, Erectile Dysfunction-Effect on Quality of Life, anal manometry, digital anal measurements, and assessment by an assessor who was unaware of the subject grouping. After 3 months the control group were transferred into the active arm.

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Unmoderated Poster Session Abstracts Results: At 3 months, compared to the controls, men in the intervention group showed significant mean increases in the Erectile Function domain of the IIEF (6.74 points, p = 0.001); anal pressure (44.16 cm H2O, p < 0.001); digital anal (1.5 grades, p < 0.001). All showed further improvement in these outcomes at 6 months. Similar benefits were seen in the control arm after transfer to active treatment. At 6 months, the increase in IIEF grades was 8 points which was similar to a large trial using sildenafil for men with similar aetiology where the increase in IIEF grades was 10 points. Also, 65.5% of men experienced post-micturition dribble at baseline. Pelvic floor muscle exercises also improved this condition in the active group when compared to the controls (P < 0.001). Conclusion: Pelvic floor muscle exercises are an effective treatment for men with erectile dysfunction. They should be used as a first-line treatment. They may be used in conjunction with oral and other therapies for erectile dysfunction.

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Unconsumed marriages and sexuality Longhi, E, Italy; Salonia, A; Montorsi, F Objective: The present study has tried to investigate the aspects of the relationship and sexuality in couples in unconsumed marriages using validated questionnaires and specific counselling. Methods: 32 couples between the ages of 28 and 40 were recruited. They must have been married for at least 7 years and have known each other or have been engaged beforehand for one to two years on average. Each partner was administered the following: MMS-3G, CTS, SSS, CPQ, QER. After there was an individual check-up interview and then in couple. Results: The couples were homogenous never having had other sexual experiences other than the one with the partner. They exclude passionate erotic throbbing and sensations as they are associated with violent acts and sexual teachings in the couple is undertaken by one partner as well as the creative aspect of sexual games. The disagreement on times and ways of spending time together is also due to the times and ways intimacy is desired, sought after and lived. Very often it is romantic and affectionate in the couple and erotically transgressive when speaking of autoeroticism. Both partners, without following up on it, pursue fantasies and desires of betrayal. Very often the desire to have a child pushes the couple to face the sexual problem but not always to live intimacy as an experience in itself. Conclusion: The individual sexological exercises and the ones in couple, together with interviews in two have been a valid support in order to redefine in the couple the emotive needs, the sexual times as well as to express fantasies and desires. 11 couples out of 32 have had a child.

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Male and female sexual dysfunctions—A clinicaldiagnostic, integrated, multi-disciplinary approach to treatment tailored to the needs of the individual patient

on its own or combined with other treatments) and follow up. In a few months of being active, our “Centre for Psychosexology” has been approached by 103 people presenting sexual disorders, 85 males (79 heterosexual, 1 transsexual, 1 exhibitionist, 1 fetishist and 3 homosexual) with an average age of 42.6; and 18 females (17 heterosexual e 1 homosexual) (average age of 43). Results: 42 males with more than one concurrent SD; 51 ED; 40 PE; 6 with orgasm disorder; 34 with hypoactive sexual desire; 4 with depression; 6 without SD. 3 females with more than one concurrent SD; 4 anorgasmia; 3 dyspareunia; 1 vaginismus; 1 with post-coital pelvic pain; 8 with hypoactive sexual desire; 2 with depression; 3 without SD. Conclusion: This approach treats sexual dysfunction not as an expression of a single pathological factor but as the result of a complex series of factors working in concert on the whole organism and the connections which inevitably surround it. Moreover, we would maintain that this approach reduces not only the incidence of pharmacological dropouts but also the improper use of pharmacology: i.e. when it becomes associated with certain stimulants.

P-164

Satisfaction with the hardness of erection and with the overall sexual experience in patients treated with tadalafil Porst, H, Germany; Tomlin, M; Wylie, K; Colpi, G; Krajka, K; Denne, J; Denes, B Objective: To assess Sexual Encounter Profile (SEP) diary question 4 (SEP-Q4, satisfaction with hardness of erection) and SEP-Q5 (satisfaction with overall sexual experience) responses in men with Erectile Dysfunction when they achieved successful sexual intercourse (SEPQ3) with tadalafil. Methods: Data were integrated from 11 randomized, double-blind, placebo-controlled 12-week trials. Men (N = 2102; mean age, 56 yrs) with mild-to-severe ED of various causes were randomly allocated to fixed doses of placebo (N = 638), tadalafil- 10 mg (N = 321), or 20 mg (N = 1143). After each sexual intercourse attempt, patients completed SEP diaries with 5 yes/no questions. For analysis, a “yes” response to SEP-Q4 and SEP-Q5 was only possible with a “yes” response to SEP Q3. The mean per-patient percentages of “yes” responses to SEP-Q4 and Q5 for all intercourse attempts and for all successful intercourse attempts were evaluated. Results: For all intercourse attempts, the mean SEP Q3, Q4, and Q5 percentages at baseline were 23%, 7% and 6%, respectively. For placebo, 10 mg, and 20 mg, the respective change from baseline was 11%, 37%, and 50% for SEP-Q4 (P < 0.001, both doses) and 10%, 35%, and 48% for SEP-Q5 (P < 0.001, both doses). The post-baseline mean SEP scores for successful sexual intercourse attempts are summarized in the table. The most frequent adverse events were headache, dyspepsia, back pain, and myalgia. Conclusion: In this analysis, men who reported successful intercourse with tadalafil were significantly more satisfied with the hardness of their erection and with the sexual experience than men who reported successful intercourse with placebo.

Optale, G, Italy; De Riva, C; Longo, A; Marin, S; Nasta, A; Vianello, F; Zanella, C; Pianon, C Objective: Today, the therapy of sexual dysfunction (SD) (in particular ED) has become more and more centred on pathological symptoms. This has tended to devalue/exclude not only the constituent psychological aspects of sexuality (which can have profound and related personal meanings) but also co-morbidity. Methods: A clinical-diagnostic screening is carried out by a multidisciplinary team (urologist/andrologist, gynaecologist, psychotherapist). After this, an etiopathologic and differential diagnosis of the SD is made (with contributions from other specialists as required). Following investigation of the presence of any biological and/or psychological contributory factors, we design an integrated and personalised therapeutic programme (pharmacotherapy coupled with psychosexual counselling, surgical intervention, psychotherapy either

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Unmoderated Poster Session Abstracts

Miscellaneous

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P-165

Might heart rate variability biofeedback (“coherence training”) be useful in sexual medicine?

Assessments of sexual functions (libido, potency and fertility) in renal transplants Darabi, MR, Iran Objective: Chronic renal failure and hemodialysis may culminate into sexually disability, oligospermia, germinal cells dysphasia, and delayed sexual maturity. After a renal transplants, improvement in these patients libido, potency and orgasms are observed. Methods: 100 male patients at Imam Reza Hospital in the Renal Transplant Unit, who have or were going to under go kidney transplants, were selected. The minimum age was 18 and the maximum was 61. Of these, 98% had been under going hemodialysis before the renal transplant and 2% peritoneal dialysis. 90 cases had received kidneys from related living donors and 10 cases received kidneys from related living donors. 92 cases had their first kidney transplant and 8 cases had their second due to transplant rejection. After the transplant 36 cases received double drug therapy and 64 had triple durg therapy. Results: Out of 100 patients: 16 were single, 84 were married (12 were renal failure before marriage). Before the transplant the libido was good in 22 cases. 52 cases were moderate and 26 poor (no libido) potency was good in 31 cases, moderately good in 48 and poor in 21 cases (impotent). 22 cases did not have children during their marriage (infertile). After the transplant the libido improved, 76 cases were good, moderately good in 18 cases and poor in 6 cases. potency was good in 80 cases, moderate in 16 and poor in 4 cases. Fertility improved and in 27 cases conception culminated into a live birth. prior to the transplant 15 patients had no children. Conclusion: Kidney transplants not only improve and increase the quality of life and health of patients with CRF which compromises the libido, potency and fertility, but also improve libido, potency and fertility and in this may bring more satisfaction to couples.

Mueck-Weymann, M, Germany; Mösler, T Objective: Biofeedback is an established behavioral technique that can be used to treat various psychiatric, somatic and psychosomatic diseases. Treatment effects can be characterized by measures of physiological functions such as skin conductance, peripheral blood flow and skin temperature. The presentation deals with psychophysiological background, possible clinical applications in sexual medicine as well as with limitations and some major pitfalls of HRVbiofeedback. Methods: Heart rate shows a complex pattern of beat-to-beat variability in healthy subjects which is named heart rate variability (HRV). HRV is based on autonomic reflexes and humoral processes due to homeostatic regulation. A novel biofeedback technique employing assessment of HRV—called HRV biofeedback as well as coherence training—has been promoted as a tool for treatment of asthma, hypertension and anxiety disorder. Results: During the last two decades the bimillenary ken of HRV was packed into computer aided systems for medical diagnostics and promoted as a wide spread biofeedback tool for improvement of vitality and wellbeing. Therefore and while training with HRV-biofeedback can induce a vagaly dominated trophotropic state due to its relaxational effects, coherence training might be a supportive tool in sexual medicine as well. Conclusion: Further studies should prove the clinical effectiveness of this new technique.

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Clinical experience in an integrated ambulatorial study uroandrologist and diabetologist following diabetes affected patients with ED Mauro, S, Italy; Minocci, D Objective: Erectile disfunction is a complication frequently related to diabetes mellitus. Cooperation within two different specialist on the same field could be rich in developing a good control on patients as regards counselling and therapy. Our service started on March 2003 to integrate uroandrology and diabetology to inform, control and treat diabetic patients with ED. Methods: In our first year we evaluated 80 diabetic patients affected by moderated to severe ED. A QoL questionnaire, whit special interest regarding sexual life, was administered to all pts (afe 44–66) were clinically evaluated with IIEF5, Test. F/T, TSH, PRL, glicoprofile, gHb, lipids; then pts had a dynamic penile ECD, rigiscan-test, biotesmetry, 4O pts were insulin-dependent, 40 were treated with different oral drugs. All pts presented ED; no-one was vere treated iPDE5. We divided pts in two groups A (hypoglicemic drugs, B insulinic treated).Group A: 10 pts were submitted to 100 mg Sildenafil max twice a week, 10 pts with 20 mgr Vardenafil, 10 with 20 mgr Tadalafil (tuesday/saturday), 10 had a placebo. Same procedure to goup B. Therapy was prolonged for six months. Results: All pts were controlled with clinical examination, IIEF 5, rigiscan test, glicemic control at 45.90 and 180 days. We observed a better glicemic control, an increasing of serum testosterone, better scoring in IIEF5, an increased number of erectile episodes in treated groups. No variations in placebo groups was observed. Conclusion: Synergy between different specialist in different fields can be considered an important assumption to diagnosis and treatment of such a socially relevant pathology as diabetes, to avoid sexually correlated sequelae, to integrate therapy.

J Sex Med 2005; Supplement 1

Attitudes towards sexual education during adolescence Papaharitou, S, Greece; Kirana, P; Akrita, I; Nakopoulou, E; Hatzichristou, D Objective: To examine opinions expressed by parents and coordinators of school health promotion divisions, concerning the provision of sexual education to adolescents. Methods: The Greek Centre for Sexual and Reproductive Health constructed and administered a questionnaire containing 20 items to adolescents’ parents participating in Parents’ School Associations. Another 10-item questionnaire was telephone -administered to the coordinators of all the School Health Promotion divisions in Greece. 49 out of 51 coordinators agreed to participate to the study. For the analysis of the data, descriptive statistics, independent samples t-test and one-way ANOVA were conducted. Results: Ninety three parents participated in the study. Although 91.3% of them reported that they discuss sexual health issues with their children, half of them (51.5%) reported that they only have moderate resources for that, irrespective of their demographic characteristics (p > 0.005). Although the majority of parents (65.5%) believe that sexual education should start before adolescence, no sexual education programs were implemented in primary schools. In addition 80% states that school lacks the necessary resources to provide it. Regarding the coordinators of all the School Health Promotion divisions, 83% have attended seminars on sexual education and 83.3% have implemented sexual education programs in schools. They believe that although parents, teachers and the local society are slightly sensitised in sexual health issues (30.6, 30.6 and 51%, respectively), adolescents are highly interested (51%) in them. Conclusion: At this first attempt to explore the above target groups, a discrepancy was revealed between the views of parents and the coordinators concerning their adequacy for the provision of sexual education. Awareness raising programs should encourage the cooperation of institutes and individuals in order for sexual health to be promoted.

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Erectile dysfunction after radiation therapy (RT) and radical prostatectomy (RRP) for localized prostate cancer Vlachiotis, J, Greece; Petsis, D; Zozas, N; Spiliopoulos, K; Tsintavis, A Objective: Erectile dysfunction (ED) is a standard complication of treatment for localized prostate cancer. The objectives of this study were: 1) to determine the prevalence and outcomes of various ED therapies and 2) to elucidate further the potency statistics with radiation therapy vs radical prostatectomy.

87 Methods: From December 1999 to November 2003, 13 patients with ED after RT were tested with color duplex doppler scans. All patiens were potent before RT. Peak systolic velocities (PSV) were examined. The scans of 13 patients underwent RRP for the same period of time were compared with scans of ED patients after RT. All patients had failed therapy with sildenafil or tadanafil. Results: The ED after RT was a combination of both venoocclusive and arteriogenic aetiology. All patients had external beam radiation. Conclusion: Patients with ED after RT have more severe ED than the patients with ED after RRP. Our data suggest that many of these patients have vasculogenic causes for impotency.

J Sex Med 2005; Supplement 1