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464 ACUPUNCTURE VERSUS PAROXETINE FOR THE TREATMENT OF PREMATURE EJACULATION: A RANDOMIZED PLACEBO CONTROLLED CLINICAL TRIAL
Materials & Methods: EFS was performed on phenylephrine (PhE) pre-contracted penile corpus cavernosum smooth muscle from male New Zealand White rabbits. The intrinsic nerves were field-stimulated electrically (voltage, 30 V; pulse duration, 1 ms; trains of pulses, 10 seconds; train interval, 3-5 min; frequency, 0.5-32 Hz). We also investigated the penile tracing elicited by EFS (voltage, 30 V; pulse duration, 1 ms; frequency, 8 Hz) on guanethidine (Guan), tetrodotoxin (TTX), Nω nitro-L-arginine-methyl ester (L-NAME), atropine or eserine pre-incubated tissues. Results: We obtained consilient results from both models. Phase I was abolished by L-NAME. Phase II was significantly decreased by eserine and Guan but increased by L-NAME. Phase III was abolished by atropine but enhanced by eserine and Guan. TTX diminished all the three phases. Conclusions: The results indicated that EFS stimulated adrenergic, cholinergic, and NANC neuroeffector systems simultaneously. Phase I was related to the NO pathway. Phase II was multiply affected by self-recovery property, adrenergic nerve and cholinergic nerve. Phase III was related to cholinergic nerve.
463
The role of bilateral major pelvic ganglia in the neural pathway of electrical stimulation of lesser splanchnic nerve-induced seminal vesical pressure increase in the rat
Chen K.K., Chang L.S. Taipei Veterans General Hospital, Div. of Urology, Dept. of Surgery, Taipei, Taiwan Introduction & Objectives: Seminal vesicle contraction under sympathetic innervation occurs during emission, which is a part of ejaculatory process. The results of our previous study suggested that electrical stimulation of the lesser splanchnic nerve (LSN) may elicit a simultaneous significant equivalent increase of each side seminal vesical pressures (SVP) in the rat. Electrical stimulation of the major pelvic ganglion (MPG) also induced a significant increase of SVP. Therefore, the objective of this study was to investigate the role of bilateral major pelvic ganglia (MPG) in the neural pathway of electrical stimulation of LSN-induced SVP increase in the rat. Materials & Methods: Male adult Sprague-Dawley rats were used. A PE50 tube was inserted into the left and right side seminal vesicle to simultaneously monitor each side SVP, respectively on the polygraph. The MPG and LSN were identified and was electrically stimulated with stimulus parameters (10 V, 40 Hz, 1 ms, 60 seconds), respectively. Then the right MPG was resected and the LSN was electrically stimulated. Subsequently the left MPG was also resected (bilateral MPG resected) and the LSN was electrically stimulated again. The SVP on left and right side was monitored simultaneously. The amount of SVP increase was calculated by subtracting resting SVP from peak SVP. The amount of SVP increase between left and right side was compared by Mann-Whitney U test. Results: There was a significant similar amount of SVP increase at left and right side (60.3 ± 8.2 mmHg and 61.1 ± 6.3 mmHg), respectively after electrical stimulation of right MPG. A significant amount of SVP increase at left and right side (56.4 ± 9.8 mmHg and 44.7 ± 8.5 mmHg), respectively after electrical stimulation of LSN was also noted. After resection of right MPG followed by electrical stimulation of LSN, again there was a significant amount of SVP increase at left and right side (55.5 ± 7.1 mmHg and 34.7 ± 3.3 mmHg), respectively. However, there was no change of SVP at each side of seminal vesicle (resting SVP 3.3 ± 0.7 mmHg vs. peak SVP 3.3 ± 0.7 mmHg at left side; resting SVP 7.7 ± 2.1 mmHg vs. peak SVP 7.7 ± 2.1 mmHg at right side), respectively after resection of bilateral MPG followed by electrical stimulation of LSN. Conclusions: The results of this study suggest that electrical stimulation of the MPG and LSN may elicit a simultaneous significant increase of SVP on the left and right side seminal vesicle, respectively in the rat. The amount of SVP increase is not significantly different between the left and right side seminal vesicle. This electrical stimulation of LSN-induced bilateral SVP increase is eliminated after resection of bilateral MPG. This implies that the neural pathway of electrical stimulation of LSNinduced SVP increase is through bilateral MPG in the rat.
464
Acupuncture versus paroxetine for the treatment of premature ejaculation: A randomized placebo controlled clinical trial
Sunay D.1, Sunay M.2, Aydogmus Y.2, Bagbanci S.2, Arslan H.3, Karabulut A.2, Emir L.2 1 Ministry of Health Ankara Training and Research Hospital, Dept. of Family Medicine, Ankara, Turkey, 2Ministry of Health Ankara Training and Research Hospital, 1st Clinic of Urology, Ankara, Turkey, 3Ministry of Health Ankara Training and Research Hospital, Acupuncture Clinic, Ankara, Turkey Introduction & Objectives: To determine whether acupuncture is effective on premature ejaculation (PE) treatment by comparing with paroxetine and placebo. Materials & Methods: Ninety patients referred to clinic of urology at a tertiary training and research hospital with PE were included into this randomized controlled trial and randomly assigned into paroxetine, acupuncture and placebo groups. Intravaginal ejaculation latency times (IELTs) and Premature Ejaculation Diagnostic Tool (PEDT) were used to assess PE before and after treatment. IELTs were calculated by using partner held stopwatch. Groups were received paroxetine 20mg/day, acupuncture or sham acupuncture twice a week for 4 weeks,
Eur Urol Suppl 2011;10(2):158
respectively. Data obtained were analyzed statistically. Results: Mean IELTs of paroxetine, acupuncture and placebo groups were 28.8, 41.0 and 30.9 seconds before treatment, 137.0, 84.2 and 34.6 seconds after treatment, respectively. IELTs were significantly increased both with acupuncture and with paroxetine therapies (p=0.001 and p=0.002, respectively) but not with placebo (p=0.325). Total PEDT scores of paroxetine, acupuncture and placebo groups were 15.6, 16.3 and 16.0 before treatment, and 9.7, 11.5 and 15.4 after treatment, respectively. The total scores and sub scores after treatment were significantly lower than the sub scores before treatment in paroxetine and acupuncture groups, but same in placebo group. The most important limitation of the study was the lack of follow-up. Conclusions: Acupuncture shows sufficient activity relative to paroxetine, however further investigations with longer follow-up are needed to obtain more reliable results.
465
Drop out from dapoxetine treatment in patients with lifelong premature ejaculation
Mondaini N.1, Cai T.1, Gavazzi A.1, Meliani E.1, Bongini A.1, Sarti E.1, Selli C.2, Bartoletti R.1 1 S Maria Annunziata Hospital, Dept. of Urology, Florence, Italy, 2University of Pisa, Dept. of Urology, Pisa, Italy Introduction & Objectives: Dapoxetine, a selective serotonin reuptake inhibitor, is the first oral pharmacological agent indicated for the treatment of men aged 18-64 years with premature ejaculation. The aim of this study was to assess the acceptance of and the discontinuation rate from dapoxetine treatment in patients with lifelong PE. Materials & Methods: We analyzed the acceptance of and discontinuation rates of 120 consecutive potent patients (mean age, 40,3 range 18-63 years ) seeking medical treatment for lifelong PE. The patients were assessed with detailed medical and sexual history, self-reported intravaginal ejaculatory latency time, self-administered International Index of Erectile Function, complete physical examination. The patients received dapoxetine prescription (30 mg on demand ; 60 mg if 30 were not efficacious after 3 months) .Thereafter, the patients could either stay with the same on-demand treatment for the next 9 months. The patients were evaluated at 1, 3 ,6 and 12 months, and requested to complete multiple-choice global assessment questions regarding specific reasons for eventual therapy discontinuation. MAIN OUTCOME MEASURES: The primary end point was acceptance and discontinuation rates for dapoxetine treatment in patients seeking medical treatment for lifelong PE. The secondary end point was the reasons for nonacceptance of treatment or discontinuation. Results: Twenty-four (20%) patients decided not to start dapoxetine. Fear of using a " drug" was the main reason (50%) for treatment nonacceptance; the cost was the reason for 25%.Ninety-six (80%) started therapy. Twenty-five (26%) dropped out at 1 month, the main reasons were side effects (52%) and no efficacy (48%). Forty-one (42,7%) dropped out at 3 months: treatment effect below expectations (51,2%) was the main reason of treatment dropout ,followed by temporary loss of interest in sex (14,6%) because of relationship issues, costs (24,3%) , side effects (9,7%). Eighteen (18,75) dropped out at 6 months, the main reason was loss of interest 50% and costs 50%.Two patients (2,08%) dropped out at 12 months. Ten patients (10,4%) are still caring the therapy after one year. Conclusions: Twenty percent of lifelong PE patients seeking medical treatment for complaints of early ejaculation freely decided not to start any dapoxetine treatment, and roughly 90 percent of patients who started therapy discontinued it after one year.
466
Efficacy and safety of clomipramine hydrochloride containing nasal spray for the pharmacotherapy of premature ejaculation
Akilov A.1, Shavakhabov Sh.2, Fozilov A.2, Rustamov R.2 1 Republic Specialized Center of Urology, Dept. of Urology, Tashkent, Uzbekistan, 2 Republic Specialized Center of Urology, Dept. of Andrology, Tashkent, Uzbekistan Introduction & Objectives: The aim of the study is to evaluate the efficacy and safety of nasal spray, containing clomipramine hydrochloride (CL) at the treatment of men with premature ejaculation (PE). Materials & Methods: The single blinded, randomized, placebo controlled, parallel trial included 34 heterosexual men (mean age 34 years), who had stable monogamous sexual relations and self-reported intravaginal ejaculation latency time (IELT) of less than 2 minutes during the period at least 6 last months. The clinical study has been approved by institutional ethical committee. They underwent assessment in accordance with International Society for Sexual Medicine guidelines. After two week washout period men were randomized to receive either single dose 4 mg nasal CL spray (n-19), or nasal placebo spray (n-15), in daily regimen at 5 hours before usual time of intercourse. Patients were prospectively followed for 8 weeks. Every 4th week of treatment patient condition was assessed by self-reported IELT, fill in questionnaire Chinese Index of Premature Ejaculation (CIPE) and International Index of Erectile Function-5 (IIEF5). The primary endpoints were the self-reported IELT and CIPE score; secondary endpoints include IIEF-5 score and adverse effects of the drug.
463
The role of bilateral major pelvic ganglia in the neural pathway of electrical stimulation of lesser splanchnic nerve-induced seminal vesical pressure increase in the rat
Chen K.K., Chang L.S. Taipei Veterans General Hospital, Div. of Urology, Dept. of Surgery, Taipei, Taiwan Introduction & Objectives: Seminal vesicle contraction under sympathetic innervation occurs during emission, which is a part of ejaculatory process. The results of our previous study suggested that electrical stimulation of the lesser splanchnic nerve (LSN) may elicit a simultaneous significant equivalent increase of each side seminal vesical pressures (SVP) in the rat. Electrical stimulation of the major pelvic ganglion (MPG) also induced a significant increase of SVP. Therefore, the objective of this study was to investigate the role of bilateral major pelvic ganglia (MPG) in the neural pathway of electrical stimulation of LSN-induced SVP increase in the rat. Materials & Methods: Male adult Sprague-Dawley rats were used. A PE50 tube was inserted into the left and right side seminal vesicle to simultaneously monitor each side SVP, respectively on the polygraph. The MPG and LSN were identified and was electrically stimulated with stimulus parameters (10 V, 40 Hz, 1 ms, 60 seconds), respectively. Then the right MPG was resected and the LSN was electrically stimulated. Subsequently the left MPG was also resected (bilateral MPG resected) and the LSN was electrically stimulated again. The SVP on left and right side was monitored simultaneously. The amount of SVP increase was calculated by subtracting resting SVP from peak SVP. The amount of SVP increase between left and right side was compared by Mann-Whitney U test. Results: There was a significant similar amount of SVP increase at left and right side (60.3 ± 8.2 mmHg and 61.1 ± 6.3 mmHg), respectively after electrical stimulation of right MPG. A significant amount of SVP increase at left and right side (56.4 ± 9.8 mmHg and 44.7 ± 8.5 mmHg), respectively after electrical stimulation of LSN was also noted. After resection of right MPG followed by electrical stimulation of LSN, again there was a significant amount of SVP increase at left and right side (55.5 ± 7.1 mmHg and 34.7 ± 3.3 mmHg), respectively. However, there was no change of SVP at each side of seminal vesicle (resting SVP 3.3 ± 0.7 mmHg vs. peak SVP 3.3 ± 0.7 mmHg at left side; resting SVP 7.7 ± 2.1 mmHg vs. peak SVP 7.7 ± 2.1 mmHg at right side), respectively after resection of bilateral MPG followed by electrical stimulation of LSN. Conclusions: The results of this study suggest that electrical stimulation of the MPG and LSN may elicit a simultaneous significant increase of SVP on the left and right side seminal vesicle, respectively in the rat. The amount of SVP increase is not significantly different between the left and right side seminal vesicle. This electrical stimulation of LSN-induced bilateral SVP increase is eliminated after resection of bilateral MPG. This implies that the neural pathway of electrical stimulation of LSNinduced SVP increase is through bilateral MPG in the rat.
464
Acupuncture versus paroxetine for the treatment of premature ejaculation: A randomized placebo controlled clinical trial
Sunay D.1, Sunay M.2, Aydogmus Y.2, Bagbanci S.2, Arslan H.3, Karabulut A.2, Emir L.2 1 Ministry of Health Ankara Training and Research Hospital, Dept. of Family Medicine, Ankara, Turkey, 2Ministry of Health Ankara Training and Research Hospital, 1st Clinic of Urology, Ankara, Turkey, 3Ministry of Health Ankara Training and Research Hospital, Acupuncture Clinic, Ankara, Turkey Introduction & Objectives: To determine whether acupuncture is effective on premature ejaculation (PE) treatment by comparing with paroxetine and placebo. Materials & Methods: Ninety patients referred to clinic of urology at a tertiary training and research hospital with PE were included into this randomized controlled trial and randomly assigned into paroxetine, acupuncture and placebo groups. Intravaginal ejaculation latency times (IELTs) and Premature Ejaculation Diagnostic Tool (PEDT) were used to assess PE before and after treatment. IELTs were calculated by using partner held stopwatch. Groups were received paroxetine 20mg/day, acupuncture or sham acupuncture twice a week for 4 weeks,
Eur Urol Suppl 2011;10(2):158
respectively. Data obtained were analyzed statistically. Results: Mean IELTs of paroxetine, acupuncture and placebo groups were 28.8, 41.0 and 30.9 seconds before treatment, 137.0, 84.2 and 34.6 seconds after treatment, respectively. IELTs were significantly increased both with acupuncture and with paroxetine therapies (p=0.001 and p=0.002, respectively) but not with placebo (p=0.325). Total PEDT scores of paroxetine, acupuncture and placebo groups were 15.6, 16.3 and 16.0 before treatment, and 9.7, 11.5 and 15.4 after treatment, respectively. The total scores and sub scores after treatment were significantly lower than the sub scores before treatment in paroxetine and acupuncture groups, but same in placebo group. The most important limitation of the study was the lack of follow-up. Conclusions: Acupuncture shows sufficient activity relative to paroxetine, however further investigations with longer follow-up are needed to obtain more reliable results.
465
Drop out from dapoxetine treatment in patients with lifelong premature ejaculation
Mondaini N.1, Cai T.1, Gavazzi A.1, Meliani E.1, Bongini A.1, Sarti E.1, Selli C.2, Bartoletti R.1 1 S Maria Annunziata Hospital, Dept. of Urology, Florence, Italy, 2University of Pisa, Dept. of Urology, Pisa, Italy Introduction & Objectives: Dapoxetine, a selective serotonin reuptake inhibitor, is the first oral pharmacological agent indicated for the treatment of men aged 18-64 years with premature ejaculation. The aim of this study was to assess the acceptance of and the discontinuation rate from dapoxetine treatment in patients with lifelong PE. Materials & Methods: We analyzed the acceptance of and discontinuation rates of 120 consecutive potent patients (mean age, 40,3 range 18-63 years ) seeking medical treatment for lifelong PE. The patients were assessed with detailed medical and sexual history, self-reported intravaginal ejaculatory latency time, self-administered International Index of Erectile Function, complete physical examination. The patients received dapoxetine prescription (30 mg on demand ; 60 mg if 30 were not efficacious after 3 months) .Thereafter, the patients could either stay with the same on-demand treatment for the next 9 months. The patients were evaluated at 1, 3 ,6 and 12 months, and requested to complete multiple-choice global assessment questions regarding specific reasons for eventual therapy discontinuation. MAIN OUTCOME MEASURES: The primary end point was acceptance and discontinuation rates for dapoxetine treatment in patients seeking medical treatment for lifelong PE. The secondary end point was the reasons for nonacceptance of treatment or discontinuation. Results: Twenty-four (20%) patients decided not to start dapoxetine. Fear of using a " drug" was the main reason (50%) for treatment nonacceptance; the cost was the reason for 25%.Ninety-six (80%) started therapy. Twenty-five (26%) dropped out at 1 month, the main reasons were side effects (52%) and no efficacy (48%). Forty-one (42,7%) dropped out at 3 months: treatment effect below expectations (51,2%) was the main reason of treatment dropout ,followed by temporary loss of interest in sex (14,6%) because of relationship issues, costs (24,3%) , side effects (9,7%). Eighteen (18,75) dropped out at 6 months, the main reason was loss of interest 50% and costs 50%.Two patients (2,08%) dropped out at 12 months. Ten patients (10,4%) are still caring the therapy after one year. Conclusions: Twenty percent of lifelong PE patients seeking medical treatment for complaints of early ejaculation freely decided not to start any dapoxetine treatment, and roughly 90 percent of patients who started therapy discontinued it after one year.
466
Efficacy and safety of clomipramine hydrochloride containing nasal spray for the pharmacotherapy of premature ejaculation
Akilov A.1, Shavakhabov Sh.2, Fozilov A.2, Rustamov R.2 1 Republic Specialized Center of Urology, Dept. of Urology, Tashkent, Uzbekistan, 2 Republic Specialized Center of Urology, Dept. of Andrology, Tashkent, Uzbekistan Introduction & Objectives: The aim of the study is to evaluate the efficacy and safety of nasal spray, containing clomipramine hydrochloride (CL) at the treatment of men with premature ejaculation (PE). Materials & Methods: The single blinded, randomized, placebo controlled, parallel trial included 34 heterosexual men (mean age 34 years), who had stable monogamous sexual relations and self-reported intravaginal ejaculation latency time (IELT) of less than 2 minutes during the period at least 6 last months. The clinical study has been approved by institutional ethical committee. They underwent assessment in accordance with International Society for Sexual Medicine guidelines. After two week washout period men were randomized to receive either single dose 4 mg nasal CL spray (n-19), or nasal placebo spray (n-15), in daily regimen at 5 hours before usual time of intercourse. Patients were prospectively followed for 8 weeks. Every 4th week of treatment patient condition was assessed by self-reported IELT, fill in questionnaire Chinese Index of Premature Ejaculation (CIPE) and International Index of Erectile Function-5 (IIEF5). The primary endpoints were the self-reported IELT and CIPE score; secondary endpoints include IIEF-5 score and adverse effects of the drug.