- Email: [email protected]
T07-O-06 The benefit of testosterone administration to men not responding to PDE-5 inhibitors: state of the art
Sexologies.book Page 102 Mercredi, 2. avril 2008 4:36 16
S102 Material and Methods: 86 patients with BPH and co-morbidity chronic prostatitis were enrolled in study. Control group (39 patients) received Tamsulosin during 3 months and doxiciclinum for 10 days. Experience group (47 patients) received also laser therapy. Efficiency was assessed using IPSS, uroflowmetry, prostate secretion analysis and bacteriological tests. The first examination was before the treatment, and the final estimation was in 3 months. Results: In control group symptom scores reduced by 38% and flow rates improved by 24%. In experience group improvement in symptom score and flow rates was 54% and 32% accordingly. In control group 58% patients had signs of prostate inflammation, growth of microbial flora and there were only 16% such patients in experience group. No adverse effects were marked. Conclusions: Simultaneous application of laser therapy, doxiciclinum and Tamsulosin in patients with co-morbidity BPH and prostatitis resulted in cumulation of antibacterial in a prostate tissue, removal of spasm, facilitation of outflow of a prostate secret and an inflammatory exudate, cupping of dysuria. All the I-PSS scores decreased significantly during the treatment.
T07-O-04 Sildenafil for erectile dysfunction in Spinal Cord Injury (SCI) patients M. Marzotto Caotorta, D. Molho, C. Martina, A. Tagliabue, S. Sandri. Spinal cord Unit and Urology division - Magenta Hospital Magenta, MI, Italy Objectives: To provide a comprehensive insight into sexuality after spinal cord injury, the patients received a questionnaire to assess their sexual activities, abilities, desires, satisfaction and sexual adjustment before and after injury. Relationship to partner, social life, bladder management and physical well-being had a significant impact on quality of life. Methods: We studied 34 pts. with the following spinal cord lesions: 6 cervical lesions; 6 upper thoracic lesions; 17 thoraco-lumbar (D11-L2), 4 lower thoracic, sacral or cauda equina lesions; 1 transverse myelitis; 1 multiple sclerosis; 23(67%) pts. with complete lesions and 11 (33%) with incomplete lesions. The average is 41 ys. (range: 25-54 ys.) Results: The median f-up was 5 months (range 1-11) in 27 pts. with this results: 13 are very satisfied; 5 with partial response; 9 were unsatisfied unable to have a sexual intercourse. 19 pts. choose the 100 mg dose to have the best response; side effects were reported only in 3 cases: 3 pts. respectively with cephalalgia, severe hypotension and dysreflessia, interrupted the therapy. Conclusions: In the upper motoneuron lesions (LMNS) we had positive and negative response respectively in 77% and 23%. of the cases, but in the lower motoneuron lesions (LMNI) the results were positive and negative respectively in 44% and 56% of the pts.
Topic 7: Pharmacology
T07-O-05 Finasteride 5 mg and sexual side effects. How many of these are related to a nocebo phenomenon? N. Mondaini1, P. Gontero2, E. Sarti1, G. Giubilei1, T. Cai1, A. Gavazzi1, E. Meliani1, M. Pallanti3, V. Boncinelli3, R. Bartoletti1. 1UO Urology, S Maria Annunziata Hospital, University of Florence, Florence, Italy; 2Department of Urology, University of Torino, Torino, Italy; 3Clinical Psicology, University of Siena, Siena, Italy Introduction: Sexual adverse experiences such as erectile dysfunction, loss of libido, and ejaculation disorders have been consistent side effects of Finasteride in a maximum percentage of 15% after one year of therapy as reported in the PLESSStudy.Such data could be seen as far from reality, if compared to a higher percentage that may be found in any common clinical practice.This study wishes to explain the dichotomy between literature's data and clinical practice data. Materials and methods: 120 patients with diagnosis of Benign Prostatic Hyperplasia (prostate volume >40 ml), age ranging between 45 and 65, sexually active (IIEF questionnairie > 25) in a stable relationship for at least 6 months; testosterone level in the normal range; never on previous BPH medication were randomized to receive finasteride 5 mg per day for one year with (group 2) or without (group 1) counselling on the drug sexual side effect.The phrase used to inform group 2 patients was "….it may cause erectile dysfunction, decreased libido, problems of ejaculation but these are uncommon ".The estimation of side effect was conducted at 6 months and 12 months with MSF 4 Questionarie and the information reported by patients diary. Results: Data are referred to 107 patients who completed the study.Group 2 patients (N= 55) reported a significant higher proportion of sexual side effects as compared to group 1 (N °=52) (43.6 vs 15.3%).The incidence of erectile dysfunction; decrease libido.; ejaculation disorders were 9.6%, 7.7%,5.7% for group 1 and 30,9%; 23,6%; 16,3% for group 2 respectively. Conclusions: In the current study Finasteride showed a significantly higher proportion of sexual dysfunction in patients informed on side effects (group 2) as compared to those in which information on side effects was blinded (group 1) (p=0,03). A scenario similar to group 2 of the current study is likely to occur in clinical practice, where the patient has access to the drug information sheet. The burden of this nocebo effect has to be taken into account when managing finasteride sexual side effects.
T07-O-06 The benefit of testosterone administration to men not responding to PDE-5 inhibitors: state of the art A. Yassin1, F. Saad2. 1GUlF Medical College, Ajman/Uae & Segeberger Kliniken, Norderstedt, Germany; 2Gulf Medical
Sexologies.book Page 103 Mercredi, 2. avril 2008 4:36 16
Topic 7: Pharmacology College Ajman/Uae and Bayer Schering Pharma Ag, Berlin, Germany Introduction: Delivery of the phosphodiesterase type 5 inhibitors (PDE 5-inhibitors) has been a step forward in the treatment of erectile dysfunction. The success of the PDE 5-inhibitors rendered androgens as treatment for erectile problems in the average patient as something of the past. Methods: Over the last 15 years the age-related decline of circulating testosterone in men has received serious attention. Moreover, new research has presented convincing evidence that testosterone has profound effects on tissues of the penis involved in the mechanism of erection and that testosterone deficiency impairs the anatomical and physiological substrate of erectile capacity, at least in part reversible upon androgen replacement. Results: There are androgen receptors in the human corpus cavernosum. The expression of nitric oxide (NO) synthesis is regulated by androgens. Several studies show that androgen plays a critical role in restoring and maintaining the penile trabecular smooth muscle structure and function as well as regulating the cell apoptosis. Testosterone deficiency induces both biological and structural/functional changes in the trabecular cavernosal tissues. Adipocyte accumulation in penile subtunical area of the corpus cavernosum emphasized the potential mechanism for veno-occlusive dysfunction in androgen deficiency. Conclusion: So, in androgen-deficient men, testosterone may restore the anatomical/biochemical substrate on which the PDE-5 inhibitors act. The above argues for measurement of testosterone in men with complaints of erectile dysfunction. Several studies, including our own, show that testosterone treatment alone, or in addition to PDE-5 inhibitors, may restore erections in these men.
T07-P-01 Usage of phosphodiesterase-5 inhibitors among physicians without erectile dysfunction D. Justo1, A. Shechter2, A. Gal-oz1, M. Swartzon1, R. Heruti2. 1The Department of Internal Medicine D, Sourasky Medical Center, Tel-Aviv, Israel; 2Sexual Rehabilitation Clinic, Reuth Medical Center, Tel-Aviv, Israel Objectives: Recent medical literature reports recreationl usage of phosphodiesterase-5 inhibitors (PDE5is) in men with no erectile dysfunction (ED), as well as in women. We studied what proportion of male physicians without ED and female physicians, who prescribe PDE5is on a regular basis, use PDE5is. Methods: Male and female physicians who prescribe PDE5is on a regular basis have completed an anonymous questionnaire concerning their use of PDE5is. The control group included male physicians who rarely or never prescribed PDE5is. Results: Overall, 82 physicians mean ages 42.0±10.3 years, completed the questionnaire: 69 male physicians and
S103 13 female physicians. Most of the physicians were family physicians (28/82; 34.1%), Internists (27/82; 32.9%), and urologists (12/82; 14.6%). Ten (12.2%) male physicians reported ED. Among male physicians who prescribed PDE5is on a regular basis and had no ED (n=28), 53.6% used PDE5is once (n=8) or several times (n=7). Among male physicians who rarely or never prescribed PDE5is and had no ED (n=31), 29.0% used PDE5is once (n=7) or several times (n=2). The 13 female physicians in our sample did not use PDE5is or prescribed PDE5i to their partners. Conclusions: The more you prescribe PDE5is, the more you use PDE5is. Many male physicians, who have no ED and prescribe PDE5is on a regular basis, also use PDE5is personally. These physicians probably feel the safety profile of PDE5is is strong enough to allow these agents for personal recreational usage.
T07-P-02 Penile color-Doppler ultrasonography after audio-visual sexual stimulation and vardenafil administration. Results of single blind, prospective study F. Menchini-Fabris. Università di Pisa, Pisa, Italy Introduction: Dynamic Penile color-Doppler ultrasonography (CDS) is to be considered a second-level invasive test for the etiological diagnosis of erectile dysfunction. Some scientific evidences underline the possibility of replacing the drug-injection with a PDE-5 Inhibitors. The purpose of the study was to evaluate the possible relationship between the basal and dynamic results of penile Doppler ultrasound, complications and patient's compliance, after intra-cavernosal injection (ICI) or after vardenafil administration and audio visual sexual stimulation (AVSS). Materials and methods: Between January an May 2007, 40 ED patients, median age 52 years (range 45-58), without contra-indications for using PDE-5 inhibitors, were included in the study. Each patient underwent two CDS in basal and dynamic condition using ICI (PGE 10 MCG), or, after 2 weeks, using vardenafil 20 mg and AVSS. The same operator, blinded performed all the tests. A satisfaction questionnaire was administrated to the patients after each study session. The differences were considered statistically significant for values of P < .05 Result: After CDS and ICI there were 30 patients (75%) with nonvasculogenic ED, 2 patients (5%) with arteriogenic ED, 8 patients (20%) with venogenic ED. All the diagnosis were confirmed after 2 weeks with CDS and vardenafil, except in 4 patients (2 with arteriogenic and 2 with venogenic ED) vardenafil non-responders. Most part of patients (35/40) would prefer, in the need of procedure repetition, vardenafil instead of ICI. Conclusions: The results of this study demonstrate that the two techniques are comparable in terms of diagnostic results. Patients'preferences highlight the conclusion that vardenafil can be regarded as an alternative to FIC during CDS evaluation.
S102 Material and Methods: 86 patients with BPH and co-morbidity chronic prostatitis were enrolled in study. Control group (39 patients) received Tamsulosin during 3 months and doxiciclinum for 10 days. Experience group (47 patients) received also laser therapy. Efficiency was assessed using IPSS, uroflowmetry, prostate secretion analysis and bacteriological tests. The first examination was before the treatment, and the final estimation was in 3 months. Results: In control group symptom scores reduced by 38% and flow rates improved by 24%. In experience group improvement in symptom score and flow rates was 54% and 32% accordingly. In control group 58% patients had signs of prostate inflammation, growth of microbial flora and there were only 16% such patients in experience group. No adverse effects were marked. Conclusions: Simultaneous application of laser therapy, doxiciclinum and Tamsulosin in patients with co-morbidity BPH and prostatitis resulted in cumulation of antibacterial in a prostate tissue, removal of spasm, facilitation of outflow of a prostate secret and an inflammatory exudate, cupping of dysuria. All the I-PSS scores decreased significantly during the treatment.
T07-O-04 Sildenafil for erectile dysfunction in Spinal Cord Injury (SCI) patients M. Marzotto Caotorta, D. Molho, C. Martina, A. Tagliabue, S. Sandri. Spinal cord Unit and Urology division - Magenta Hospital Magenta, MI, Italy Objectives: To provide a comprehensive insight into sexuality after spinal cord injury, the patients received a questionnaire to assess their sexual activities, abilities, desires, satisfaction and sexual adjustment before and after injury. Relationship to partner, social life, bladder management and physical well-being had a significant impact on quality of life. Methods: We studied 34 pts. with the following spinal cord lesions: 6 cervical lesions; 6 upper thoracic lesions; 17 thoraco-lumbar (D11-L2), 4 lower thoracic, sacral or cauda equina lesions; 1 transverse myelitis; 1 multiple sclerosis; 23(67%) pts. with complete lesions and 11 (33%) with incomplete lesions. The average is 41 ys. (range: 25-54 ys.) Results: The median f-up was 5 months (range 1-11) in 27 pts. with this results: 13 are very satisfied; 5 with partial response; 9 were unsatisfied unable to have a sexual intercourse. 19 pts. choose the 100 mg dose to have the best response; side effects were reported only in 3 cases: 3 pts. respectively with cephalalgia, severe hypotension and dysreflessia, interrupted the therapy. Conclusions: In the upper motoneuron lesions (LMNS) we had positive and negative response respectively in 77% and 23%. of the cases, but in the lower motoneuron lesions (LMNI) the results were positive and negative respectively in 44% and 56% of the pts.
Topic 7: Pharmacology
T07-O-05 Finasteride 5 mg and sexual side effects. How many of these are related to a nocebo phenomenon? N. Mondaini1, P. Gontero2, E. Sarti1, G. Giubilei1, T. Cai1, A. Gavazzi1, E. Meliani1, M. Pallanti3, V. Boncinelli3, R. Bartoletti1. 1UO Urology, S Maria Annunziata Hospital, University of Florence, Florence, Italy; 2Department of Urology, University of Torino, Torino, Italy; 3Clinical Psicology, University of Siena, Siena, Italy Introduction: Sexual adverse experiences such as erectile dysfunction, loss of libido, and ejaculation disorders have been consistent side effects of Finasteride in a maximum percentage of 15% after one year of therapy as reported in the PLESSStudy.Such data could be seen as far from reality, if compared to a higher percentage that may be found in any common clinical practice.This study wishes to explain the dichotomy between literature's data and clinical practice data. Materials and methods: 120 patients with diagnosis of Benign Prostatic Hyperplasia (prostate volume >40 ml), age ranging between 45 and 65, sexually active (IIEF questionnairie > 25) in a stable relationship for at least 6 months; testosterone level in the normal range; never on previous BPH medication were randomized to receive finasteride 5 mg per day for one year with (group 2) or without (group 1) counselling on the drug sexual side effect.The phrase used to inform group 2 patients was "….it may cause erectile dysfunction, decreased libido, problems of ejaculation but these are uncommon ".The estimation of side effect was conducted at 6 months and 12 months with MSF 4 Questionarie and the information reported by patients diary. Results: Data are referred to 107 patients who completed the study.Group 2 patients (N= 55) reported a significant higher proportion of sexual side effects as compared to group 1 (N °=52) (43.6 vs 15.3%).The incidence of erectile dysfunction; decrease libido.; ejaculation disorders were 9.6%, 7.7%,5.7% for group 1 and 30,9%; 23,6%; 16,3% for group 2 respectively. Conclusions: In the current study Finasteride showed a significantly higher proportion of sexual dysfunction in patients informed on side effects (group 2) as compared to those in which information on side effects was blinded (group 1) (p=0,03). A scenario similar to group 2 of the current study is likely to occur in clinical practice, where the patient has access to the drug information sheet. The burden of this nocebo effect has to be taken into account when managing finasteride sexual side effects.
T07-O-06 The benefit of testosterone administration to men not responding to PDE-5 inhibitors: state of the art A. Yassin1, F. Saad2. 1GUlF Medical College, Ajman/Uae & Segeberger Kliniken, Norderstedt, Germany; 2Gulf Medical
Sexologies.book Page 103 Mercredi, 2. avril 2008 4:36 16
Topic 7: Pharmacology College Ajman/Uae and Bayer Schering Pharma Ag, Berlin, Germany Introduction: Delivery of the phosphodiesterase type 5 inhibitors (PDE 5-inhibitors) has been a step forward in the treatment of erectile dysfunction. The success of the PDE 5-inhibitors rendered androgens as treatment for erectile problems in the average patient as something of the past. Methods: Over the last 15 years the age-related decline of circulating testosterone in men has received serious attention. Moreover, new research has presented convincing evidence that testosterone has profound effects on tissues of the penis involved in the mechanism of erection and that testosterone deficiency impairs the anatomical and physiological substrate of erectile capacity, at least in part reversible upon androgen replacement. Results: There are androgen receptors in the human corpus cavernosum. The expression of nitric oxide (NO) synthesis is regulated by androgens. Several studies show that androgen plays a critical role in restoring and maintaining the penile trabecular smooth muscle structure and function as well as regulating the cell apoptosis. Testosterone deficiency induces both biological and structural/functional changes in the trabecular cavernosal tissues. Adipocyte accumulation in penile subtunical area of the corpus cavernosum emphasized the potential mechanism for veno-occlusive dysfunction in androgen deficiency. Conclusion: So, in androgen-deficient men, testosterone may restore the anatomical/biochemical substrate on which the PDE-5 inhibitors act. The above argues for measurement of testosterone in men with complaints of erectile dysfunction. Several studies, including our own, show that testosterone treatment alone, or in addition to PDE-5 inhibitors, may restore erections in these men.
T07-P-01 Usage of phosphodiesterase-5 inhibitors among physicians without erectile dysfunction D. Justo1, A. Shechter2, A. Gal-oz1, M. Swartzon1, R. Heruti2. 1The Department of Internal Medicine D, Sourasky Medical Center, Tel-Aviv, Israel; 2Sexual Rehabilitation Clinic, Reuth Medical Center, Tel-Aviv, Israel Objectives: Recent medical literature reports recreationl usage of phosphodiesterase-5 inhibitors (PDE5is) in men with no erectile dysfunction (ED), as well as in women. We studied what proportion of male physicians without ED and female physicians, who prescribe PDE5is on a regular basis, use PDE5is. Methods: Male and female physicians who prescribe PDE5is on a regular basis have completed an anonymous questionnaire concerning their use of PDE5is. The control group included male physicians who rarely or never prescribed PDE5is. Results: Overall, 82 physicians mean ages 42.0±10.3 years, completed the questionnaire: 69 male physicians and
S103 13 female physicians. Most of the physicians were family physicians (28/82; 34.1%), Internists (27/82; 32.9%), and urologists (12/82; 14.6%). Ten (12.2%) male physicians reported ED. Among male physicians who prescribed PDE5is on a regular basis and had no ED (n=28), 53.6% used PDE5is once (n=8) or several times (n=7). Among male physicians who rarely or never prescribed PDE5is and had no ED (n=31), 29.0% used PDE5is once (n=7) or several times (n=2). The 13 female physicians in our sample did not use PDE5is or prescribed PDE5i to their partners. Conclusions: The more you prescribe PDE5is, the more you use PDE5is. Many male physicians, who have no ED and prescribe PDE5is on a regular basis, also use PDE5is personally. These physicians probably feel the safety profile of PDE5is is strong enough to allow these agents for personal recreational usage.
T07-P-02 Penile color-Doppler ultrasonography after audio-visual sexual stimulation and vardenafil administration. Results of single blind, prospective study F. Menchini-Fabris. Università di Pisa, Pisa, Italy Introduction: Dynamic Penile color-Doppler ultrasonography (CDS) is to be considered a second-level invasive test for the etiological diagnosis of erectile dysfunction. Some scientific evidences underline the possibility of replacing the drug-injection with a PDE-5 Inhibitors. The purpose of the study was to evaluate the possible relationship between the basal and dynamic results of penile Doppler ultrasound, complications and patient's compliance, after intra-cavernosal injection (ICI) or after vardenafil administration and audio visual sexual stimulation (AVSS). Materials and methods: Between January an May 2007, 40 ED patients, median age 52 years (range 45-58), without contra-indications for using PDE-5 inhibitors, were included in the study. Each patient underwent two CDS in basal and dynamic condition using ICI (PGE 10 MCG), or, after 2 weeks, using vardenafil 20 mg and AVSS. The same operator, blinded performed all the tests. A satisfaction questionnaire was administrated to the patients after each study session. The differences were considered statistically significant for values of P < .05 Result: After CDS and ICI there were 30 patients (75%) with nonvasculogenic ED, 2 patients (5%) with arteriogenic ED, 8 patients (20%) with venogenic ED. All the diagnosis were confirmed after 2 weeks with CDS and vardenafil, except in 4 patients (2 with arteriogenic and 2 with venogenic ED) vardenafil non-responders. Most part of patients (35/40) would prefer, in the need of procedure repetition, vardenafil instead of ICI. Conclusions: The results of this study demonstrate that the two techniques are comparable in terms of diagnostic results. Patients'preferences highlight the conclusion that vardenafil can be regarded as an alternative to FIC during CDS evaluation.