Premature Ejaculation Clinical Trial
Official title:
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
The objectives of the present study aims to evaluate the safety and efficacy of Silodosin in a population of patients wih Premature Ejaculation (PE). Coupled with efficient diagnosis, it is hoped that the newer agent will improve the quality of life for patients who suffer from Premature Ejaculation (PE).
Premature Ejaculation (PE) is characterized as the most common sexual dysfunction in men
with a prevalence of 21-33%. Based on the main theories about the pathophysiology of
Premature Ejaculation (PE), the most commonly prescribed medications are topical anesthetics
and serotonin-specific reuptake inhibitors (SSRIs). It has been reported that the abnormal
ejaculation of semen is a typical but rather infrequent side effect of some α1-adrenoceptor
antagonists. Silodosin had the highest selectivity for the vas deferens compared with other
α1-adrenoceptor antagonists.
Patients suitable for inclusion in the baseline period were those who (as part of the
Premature Ejaculation Diagnostic Tool (PEDT) questionnaire) rated their perceived control
over ejaculation as 'moderately difficult', 'very difficult' or 'extremely difficult', and
the other four items as 'about half the time', 'more than half the time' or 'almost always
or always'. Patients completed the Index of Premature Ejaculation (IPE) and Premature
Ejaculation Profile (PEP) questionnaires, and rated the quality of their orgasm in response
to the question: 'In general, how do you rate the orgasm you experience during sexual
intercourse?' on a 5-point scale ('very poor', 'poor', 'satisfactory', 'good', 'very good').
Patients with a baseline Intravaginal Ejaculation Latency Time (IELT) of 2 minutes or less,
as measured by a partner-held stopwatch, for at least two of the first three sexual
encounters were eligible for randomization into the double-blind phase. In total of 40
eligible patients were randomized to receive double-blind treatment with 4 mg Silodosin or
matched placebo for 3 months. One dose was to be taken 2 hours before anticipated sexual
intercourse, and only one dose was allowed per 24-h period. Ejaculation-delaying techniques
and behavioural therapy were to be avoided. Couples were instructed to attempt sexual
intercourse four or more times per month during the 12-week treatment period (minimum of 24
h between doses of medication). During each sexual encounter, the Intravaginal Ejaculation
Latency Time (IELT) was measured and recorded, together with efficacy and tolerability data.
Ejaculation occurring before penetration was assigned an Intravaginal Ejaculation Latency
Time (IELT) of 0 minute. The time noted on the stopwatch at this point was recorded as the
duration of sexual intercourse until ejaculation or withdrawal. Patients returned to the
clinic at 14-21 days intervals (visits 1, 2, 3, 4, 5 and 6) at which the Index of Premature
Ejaculation (IPE) and Premature Ejaculation Profile (PEP) questionnaires were completed.
Also, at visit 3 and 6 patients had a safety evaluation and rated the quality of their
orgasms. Patients' satisfaction for the treatment was evaluated by Clinical Global
Impression of Change (CGIC) in Premature Ejaculation (PE).
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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