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EARLY REHABILITATION AND NERVE-SPARING CYSTECTOMY. IS THERE ANY VALUE?
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EARLY REHABILITATION AND NERVE-SPARING CYSTECTOMY. IS THERE ANY VALUE? Hekal E., El-Bahnasawy M., Mesbah A., Shaaban A. Urology and Nephrology Centre, Urology, Mansoura, Egypt INTRODUCTION & OBJECTIVES: To assess the value of early rehabilitation in post- nerve sparing radical cystectomy patients, evaluating by IIEF (International Index of Erectile Function) questionnaire & penile Doppler ultrasound. MATERIAL & METHODS: A prospective study between March 2003 and March 2005 was carried out, the study included 21 potent males with organ confined bladder cancer who were managed by radical cystectomy& diversion with nerve sparing technique (as by Walsh 1982), in Mansoura urology and nephrology centre. All patients were encouraged to resume sexual activity as early as the first two post-operative months. On follow-up the patients were classified according to their compliant to our instructions into: the first group (early rehabilitation): those who retained spontaneous postoperative erectile function successfully or who used an erectogenic aid to resume their sexual activity early. The second group (late rehabilitation): non compliant patients, who missed follow up and came reporting no sexual activity in the first postoperative 6 months. After the first month the erectile function state of the patients was assessed provisionally as: Complete regain of spontaneous erectile function, mild tumescence unsatisfactory to intercourse or complete loss of erectile function. The latter two groups were given (PDE-5 Inhibitor; 50 mg) on demand basis, to be increased to 100 mg after failed 50 mg response. Total 8 doses were tried before considering its failure and shift to intracorporeal prostaglandin E 1 injection. 12 cases of them were early rehabilitated & 9 cases with late rehabilitation. The pre-operative IIEF domains and penile duplex ultrasound were assessed; the patients were followed up 2, 6, 12 months regularly regarding the same parameters. RESULTS: The pre-operative IIEF domains (erectile function, orgasm, desire, intercourse satisfaction and overall satisfaction) were assessed and compared with postoperative scoring. The erectile function and overall domains had improving figures with a significant value than other parameters regarding the follow-up period. Corresponding penile Doppler findings were comparable in peak systolic velocity along the course of follow up, while the end diastolic velocity was significantly improving along the time of follow up, which was more evident at 12 months of the surgery in early rehabilitation group. CONCLUSIONS: Early rehabilitation provides good, rapid recovery of erectile function in patients were managed by nerve sparing radical cystectomy.
SILDENAFIL IN THE TREATMENT OF POST-RADICAL CYSTECTOMY ERECTILE DYSFUNCTION IN 100 PATIENTS Syed Ahmed T.1, El-bahnasawy M.2, Ibrahiem E.h.2, El-sobky E.2, El-tabeiy N.2, Bazeed M.2 Urology and Nephrology Center, Urology, Sharjah, United Arab Emirates, 2Urology and Nephrology Center, Urology, Mansoura, Egypt
1
INTRODUCTION & OBJECTIVES: To assess the efficacy and safety of sildenafil citrate in management of erectile dysfunction (ED) following radical cystoprostatectomy (RC). MATERIAL & METHODS: One hundred patients with ED following (RC) participated in an open labeled non randomised prospective dose-escalation study. The median age was 53 years and mean period after (RC) was 80.7 ± 54.8 months. The study duration was 12 weeks, 4 weeks run-in period followed by two active treatment periods of 50mg and 100mg sildenafil, 4 weeks each. Patients were assessed by the international index of erectile function (IIEF) questionnaire at basal evaluation and after each treatment period. At the end of the study the Global Efficacy Assessment Question (GAQ) was used to evaluate treatment satisfaction. Factors affecting the patient’s response to sildenafil were assessed by univariate and multivariate analysis. RESULTS: The entire study group was suffering sever ED at basal evaluation with mean erectile function (EF) domain score of (6.5 ± 0.93). EF scores improved to (12.2 ± 7.76) and (18 ± 10.3) with 50mg and 100mg sildenafil respectively. Sildenafil therapy improved the ability of many patients to achieve and maintain erection significantly. The mean ± SD of question 3 were (1±0.14, 2.1±1.4, and 3±1.8), while of question 4 were (1±0.10, 1.9±1.35 and 3±1.85) at basal, 50mg and 100mg respectively. Satisfaction rate was 54%. Erectile function (EF) domain score improved in 48% after 50mg and 58% after 100mg sildenafil therapy. According to the severity of ED as measured by the EF domain score, 9%, 10%, 11% and 8% of patients were assessed as having moderate, mild-moderate, mild, and no ED respectively on 50mg sildenafil therapy; While after 100mg sildenafil, the aforementioned degrees becomes 5%, 4%, 8% and 41% respectively. The response was dose dependent but adverse effects increased from (6%) with 50mg to (34%) with 100mg. Tumour histology, grade, and post-operative spontaneous partial tumescence significantly affected the patient’s response to sildenafil. On multivariate analysis, postoperative spontaneous partial tumescence was the only independent predictive variable. CONCLUSIONS: Sildenafil was safe and satisfactory treatment for post radical cystectomy ED. 41% of patients were considered as having normal erections on 100mg sildenafil. The effect was dose related. Patients with spontaneous postoperative partial tumescence were the best responders.
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TADALAFIL IN MEN WITH ERECTILE DYSFUNCTION AND SPINAL CORD INJURY
EFFICACY OF SILDENAFIL 100 MG ON DEMAND IN PATIENTS UNDERGOING BILATERAL NERVE-SPARING RADICAL PROSTATECTOMY IS BASED ON PRECISE PREDICTING FACTORS
Giuliano F.1, Sanchez Ramos A.2, Loechner Ernst D.3, Del Popolo G.4, Zhao Y.5, Casariego J.6 Academic Hospital of Bicetre, Urology, Le Kremlin Bicetre Cedex, France, 2Hospital Nacional de Paraplejicos, Sexuality and Reproduction, Toledo, Spain, 3Berufsgenossenschaftl iche Unfall Klinik, Urologische Abteilung, Murnau, Germany, 4Azienda Ospedaliera Careggi, Urology, Florence, Italy, 5Eli Lilly, Lilly Research Laboratories, Indianapolis, United States, 6 Eli Lilly, Clinical Research, Madrid, Spain
1
INTRODUCTION & OBJECTIVES: Erectile dysfunction (ED) is a common problem in men with traumatic spinal cord injury (SCI). This study was conducted to determine the efficacy and safety of tadalafil when taken as needed by men with ED due to SCI. MATERIAL & METHODS: This multicentre, randomised, double-blind, placebo-controlled, flexible-dose, parallel group study was conducted in 4 countries in Western Europe. Enrolled patients had ED secondary to traumatic SCI (all spinal levels) sustained ≥6 months before visit 1. After a 4-week run-in period, patients were randomly assigned to treatment with tadalafil 10 mg (T10) or placebo for a 12-week treatment period. Assessment visits were made at the end of each 4-week interval. After the first treatment interval, the dose of tadalafil was increased to 20 mg (T20) or unchanged, depending on the patient’s response to T10. Similarly, after the second treatment interval, the dose was increased (T10 to T20), decreased (T20 to T10), or unchanged. At baseline (BL), residual erectile function (REF) was assessed and severity of SCI was determined with the American Spinal Injury Association (ASIA) scale. Efficacy was measured using International Index of Erectile Function (IIEF), Sexual Encounter Profile (SEP), and Global Assessment Question (GAQ). Safety was evaluated using treatmentemergent adverse events (TEAEs) and vital signs collected at each visit.
Montorsi F., Zanni G., Salonia A., Gallina A., Briganti A., Barbieri L., Dehò F., Suardi N., Fabbri F., Farina E., Rigatti P. University Vita-Salute San Raffaele, Urology, Milan, Italy INTRODUCTION & OBJECTIVES: To identify predicting factors for efficacy of sildenafil 100 mg on demand in patients with clinically localised prostate cancer (PCa) who underwent bilateral nerve sparing radical retropubic prostatectomy (BNSRRP). MATERIAL & METHODS: Fifty-one pts (group 1) younger than 65 years old (mean +/- SE : 57.2+/-0.9), a IIEF-EF domain >= 26, no preoperative use of a PDE5-I and with organ confined PCa (
RESULTS: There were 186 patients enrolled (n=142 tadalafil; n=44 placebo) with mean age of 38 years. At BL, 38% of patients had severe ED and 25% had no rigidity (REF Grade 0 or 1). Tadalafil significantly improved all key efficacy parameters, compared to placebo (P<.001), including change in IIEF EF domain score (BL 13.5, endpoint 22.6), percentage of patients with normal IIEF EF score (≥26) at endpoint (54.0%), SEP 2 (penetration - BL 43.6%, endpoint 75.4%), SEP 3 (successful intercourse - BL 10.8%, endpoint 47.6%), and GAQ1 (improved erections - 85%). Tadalafil also improved ejaculation frequency (P=.028). The most common TEAEs (≥5% incidence) were headache (8.5% tadalafil, 4.5% placebo) and urinary tract infection (7.7% tadalafil, 6.8% placebo).
RESULTS: Pre-operative PSA level, clinical stage and grade, BMI and co-morbidities were similar in both groups. In group 2, 27 patients (49.1%) had an abnormal preoperative IIEF and 15 (27.3%) had been sporadically using PDE5-Is. Forty-nine (96.1%) and 45 (81.8%) patients in group 1 and 2 started postoperative treatment with sildenafil (95% CI = 3.1 to 26.3; Chi-square = 4.26; p = 0.04). Forty-four (89.8%) and 35 (77.8%) completed the 3 phases of sildenafil treatment at the 12-month FU in group 1 and 2, respectively (95% CI = -2.8 to 26.8; Chi-square = 1.71; p = 0.19). Number of sexual attempts and IIEF-EF domain was significantly (p<0.01) higher in group 1 than group 2 patients at all follow-up dates. No correlation was found between IIEF-EF and CES-D or IPSS scores.
CONCLUSIONS: In this study, tadalafil (10 mg and 20 mg) was an efficacious and well tolerated treatment for men with ED secondary to traumatic SCI. Treatment with tadalafil also improved erections leading to a normal IIEF EF domain score in > 50% of patients.
CONCLUSIONS: The surgeon, preoperative patient age, IIEF-EF domain score and use of PDE5-inhibitors, the adequate postoperative counselling have a significant impact on the use of and the response to sildenafil 100 mg after surgery.
Eur Urol Suppl 2006;5(2):179
626
EARLY REHABILITATION AND NERVE-SPARING CYSTECTOMY. IS THERE ANY VALUE? Hekal E., El-Bahnasawy M., Mesbah A., Shaaban A. Urology and Nephrology Centre, Urology, Mansoura, Egypt INTRODUCTION & OBJECTIVES: To assess the value of early rehabilitation in post- nerve sparing radical cystectomy patients, evaluating by IIEF (International Index of Erectile Function) questionnaire & penile Doppler ultrasound. MATERIAL & METHODS: A prospective study between March 2003 and March 2005 was carried out, the study included 21 potent males with organ confined bladder cancer who were managed by radical cystectomy& diversion with nerve sparing technique (as by Walsh 1982), in Mansoura urology and nephrology centre. All patients were encouraged to resume sexual activity as early as the first two post-operative months. On follow-up the patients were classified according to their compliant to our instructions into: the first group (early rehabilitation): those who retained spontaneous postoperative erectile function successfully or who used an erectogenic aid to resume their sexual activity early. The second group (late rehabilitation): non compliant patients, who missed follow up and came reporting no sexual activity in the first postoperative 6 months. After the first month the erectile function state of the patients was assessed provisionally as: Complete regain of spontaneous erectile function, mild tumescence unsatisfactory to intercourse or complete loss of erectile function. The latter two groups were given (PDE-5 Inhibitor; 50 mg) on demand basis, to be increased to 100 mg after failed 50 mg response. Total 8 doses were tried before considering its failure and shift to intracorporeal prostaglandin E 1 injection. 12 cases of them were early rehabilitated & 9 cases with late rehabilitation. The pre-operative IIEF domains and penile duplex ultrasound were assessed; the patients were followed up 2, 6, 12 months regularly regarding the same parameters. RESULTS: The pre-operative IIEF domains (erectile function, orgasm, desire, intercourse satisfaction and overall satisfaction) were assessed and compared with postoperative scoring. The erectile function and overall domains had improving figures with a significant value than other parameters regarding the follow-up period. Corresponding penile Doppler findings were comparable in peak systolic velocity along the course of follow up, while the end diastolic velocity was significantly improving along the time of follow up, which was more evident at 12 months of the surgery in early rehabilitation group. CONCLUSIONS: Early rehabilitation provides good, rapid recovery of erectile function in patients were managed by nerve sparing radical cystectomy.
SILDENAFIL IN THE TREATMENT OF POST-RADICAL CYSTECTOMY ERECTILE DYSFUNCTION IN 100 PATIENTS Syed Ahmed T.1, El-bahnasawy M.2, Ibrahiem E.h.2, El-sobky E.2, El-tabeiy N.2, Bazeed M.2 Urology and Nephrology Center, Urology, Sharjah, United Arab Emirates, 2Urology and Nephrology Center, Urology, Mansoura, Egypt
1
INTRODUCTION & OBJECTIVES: To assess the efficacy and safety of sildenafil citrate in management of erectile dysfunction (ED) following radical cystoprostatectomy (RC). MATERIAL & METHODS: One hundred patients with ED following (RC) participated in an open labeled non randomised prospective dose-escalation study. The median age was 53 years and mean period after (RC) was 80.7 ± 54.8 months. The study duration was 12 weeks, 4 weeks run-in period followed by two active treatment periods of 50mg and 100mg sildenafil, 4 weeks each. Patients were assessed by the international index of erectile function (IIEF) questionnaire at basal evaluation and after each treatment period. At the end of the study the Global Efficacy Assessment Question (GAQ) was used to evaluate treatment satisfaction. Factors affecting the patient’s response to sildenafil were assessed by univariate and multivariate analysis. RESULTS: The entire study group was suffering sever ED at basal evaluation with mean erectile function (EF) domain score of (6.5 ± 0.93). EF scores improved to (12.2 ± 7.76) and (18 ± 10.3) with 50mg and 100mg sildenafil respectively. Sildenafil therapy improved the ability of many patients to achieve and maintain erection significantly. The mean ± SD of question 3 were (1±0.14, 2.1±1.4, and 3±1.8), while of question 4 were (1±0.10, 1.9±1.35 and 3±1.85) at basal, 50mg and 100mg respectively. Satisfaction rate was 54%. Erectile function (EF) domain score improved in 48% after 50mg and 58% after 100mg sildenafil therapy. According to the severity of ED as measured by the EF domain score, 9%, 10%, 11% and 8% of patients were assessed as having moderate, mild-moderate, mild, and no ED respectively on 50mg sildenafil therapy; While after 100mg sildenafil, the aforementioned degrees becomes 5%, 4%, 8% and 41% respectively. The response was dose dependent but adverse effects increased from (6%) with 50mg to (34%) with 100mg. Tumour histology, grade, and post-operative spontaneous partial tumescence significantly affected the patient’s response to sildenafil. On multivariate analysis, postoperative spontaneous partial tumescence was the only independent predictive variable. CONCLUSIONS: Sildenafil was safe and satisfactory treatment for post radical cystectomy ED. 41% of patients were considered as having normal erections on 100mg sildenafil. The effect was dose related. Patients with spontaneous postoperative partial tumescence were the best responders.
627
628
TADALAFIL IN MEN WITH ERECTILE DYSFUNCTION AND SPINAL CORD INJURY
EFFICACY OF SILDENAFIL 100 MG ON DEMAND IN PATIENTS UNDERGOING BILATERAL NERVE-SPARING RADICAL PROSTATECTOMY IS BASED ON PRECISE PREDICTING FACTORS
Giuliano F.1, Sanchez Ramos A.2, Loechner Ernst D.3, Del Popolo G.4, Zhao Y.5, Casariego J.6 Academic Hospital of Bicetre, Urology, Le Kremlin Bicetre Cedex, France, 2Hospital Nacional de Paraplejicos, Sexuality and Reproduction, Toledo, Spain, 3Berufsgenossenschaftl iche Unfall Klinik, Urologische Abteilung, Murnau, Germany, 4Azienda Ospedaliera Careggi, Urology, Florence, Italy, 5Eli Lilly, Lilly Research Laboratories, Indianapolis, United States, 6 Eli Lilly, Clinical Research, Madrid, Spain
1
INTRODUCTION & OBJECTIVES: Erectile dysfunction (ED) is a common problem in men with traumatic spinal cord injury (SCI). This study was conducted to determine the efficacy and safety of tadalafil when taken as needed by men with ED due to SCI. MATERIAL & METHODS: This multicentre, randomised, double-blind, placebo-controlled, flexible-dose, parallel group study was conducted in 4 countries in Western Europe. Enrolled patients had ED secondary to traumatic SCI (all spinal levels) sustained ≥6 months before visit 1. After a 4-week run-in period, patients were randomly assigned to treatment with tadalafil 10 mg (T10) or placebo for a 12-week treatment period. Assessment visits were made at the end of each 4-week interval. After the first treatment interval, the dose of tadalafil was increased to 20 mg (T20) or unchanged, depending on the patient’s response to T10. Similarly, after the second treatment interval, the dose was increased (T10 to T20), decreased (T20 to T10), or unchanged. At baseline (BL), residual erectile function (REF) was assessed and severity of SCI was determined with the American Spinal Injury Association (ASIA) scale. Efficacy was measured using International Index of Erectile Function (IIEF), Sexual Encounter Profile (SEP), and Global Assessment Question (GAQ). Safety was evaluated using treatmentemergent adverse events (TEAEs) and vital signs collected at each visit.
Montorsi F., Zanni G., Salonia A., Gallina A., Briganti A., Barbieri L., Dehò F., Suardi N., Fabbri F., Farina E., Rigatti P. University Vita-Salute San Raffaele, Urology, Milan, Italy INTRODUCTION & OBJECTIVES: To identify predicting factors for efficacy of sildenafil 100 mg on demand in patients with clinically localised prostate cancer (PCa) who underwent bilateral nerve sparing radical retropubic prostatectomy (BNSRRP). MATERIAL & METHODS: Fifty-one pts (group 1) younger than 65 years old (mean +/- SE : 57.2+/-0.9), a IIEF-EF domain >= 26, no preoperative use of a PDE5-I and with organ confined PCa (
RESULTS: There were 186 patients enrolled (n=142 tadalafil; n=44 placebo) with mean age of 38 years. At BL, 38% of patients had severe ED and 25% had no rigidity (REF Grade 0 or 1). Tadalafil significantly improved all key efficacy parameters, compared to placebo (P<.001), including change in IIEF EF domain score (BL 13.5, endpoint 22.6), percentage of patients with normal IIEF EF score (≥26) at endpoint (54.0%), SEP 2 (penetration - BL 43.6%, endpoint 75.4%), SEP 3 (successful intercourse - BL 10.8%, endpoint 47.6%), and GAQ1 (improved erections - 85%). Tadalafil also improved ejaculation frequency (P=.028). The most common TEAEs (≥5% incidence) were headache (8.5% tadalafil, 4.5% placebo) and urinary tract infection (7.7% tadalafil, 6.8% placebo).
RESULTS: Pre-operative PSA level, clinical stage and grade, BMI and co-morbidities were similar in both groups. In group 2, 27 patients (49.1%) had an abnormal preoperative IIEF and 15 (27.3%) had been sporadically using PDE5-Is. Forty-nine (96.1%) and 45 (81.8%) patients in group 1 and 2 started postoperative treatment with sildenafil (95% CI = 3.1 to 26.3; Chi-square = 4.26; p = 0.04). Forty-four (89.8%) and 35 (77.8%) completed the 3 phases of sildenafil treatment at the 12-month FU in group 1 and 2, respectively (95% CI = -2.8 to 26.8; Chi-square = 1.71; p = 0.19). Number of sexual attempts and IIEF-EF domain was significantly (p<0.01) higher in group 1 than group 2 patients at all follow-up dates. No correlation was found between IIEF-EF and CES-D or IPSS scores.
CONCLUSIONS: In this study, tadalafil (10 mg and 20 mg) was an efficacious and well tolerated treatment for men with ED secondary to traumatic SCI. Treatment with tadalafil also improved erections leading to a normal IIEF EF domain score in > 50% of patients.
CONCLUSIONS: The surgeon, preoperative patient age, IIEF-EF domain score and use of PDE5-inhibitors, the adequate postoperative counselling have a significant impact on the use of and the response to sildenafil 100 mg after surgery.
Eur Urol Suppl 2006;5(2):179