(P12) silodosin 4 mg on demand in treatment of premature ejaculation: prospective double-blind placebo control study

Abstract Background Premature ejaculation (PE) is a deviation from the normal length of intravaginal ejaculatory latency time (IVELT), which is the time taken from vaginal penetration to ejaculation. PE was classified as lifelong (primary) or acquired (secondary). The prostate and the seminal vesicles play a vital role in the physiology of ejaculation, and the smooth muscle of both of these organs contains alpha-1 receptors. Alpha-1 blockers have been reported to cause ejaculatory dysfunction. Although this ejaculatory dysfunction was originally thought to be caused by retrograde ejaculation, studies have shown that it is caused by the contraction failure of the seminal vesicles, resulting in emission reduction. The study aimed to evaluate the effectiveness and safety of silodosin 4 mg in the treatment of premature ejaculation. Methods One hundred and sixty individuals were recruited from Andrology Outpatient Clinics. An informed written consent was taken from all individuals before enrollment in the study after approval of the Medical Research Ethics Committee. They were divided into Group 1 (80 patients), who were informed to administer 4 mg of silodosin 2 hours before intercourse on demand for 2 months. Group 2 (80 patients) was informed to administer a starch capsule as (a placebo) 2 hours before intercourse on demand for 2 months. All members of the study were subjected to a full history as well as general and local genital examination. Inclusion criteria PE diagnosed by the Diagnostic and Statistical Manual of Mental Disorders, fourth edition, text revision (DSM-IV-TR) criteria, Stable heterosexual, monogamous relationships of more than 3 months, and Age of 30 years or older. Exclusion criteria Age below 30 years, Patients who received any medication for premature ejaculation during the last 4 weeks, Patients on sex hormone supplementation, Erectile dysfunction, and a History of physical or psychological disorder (patient or partner). Antidepressant therapy, local anesthetic spray, intracavernosal injection, or psychotherapy within 4 weeks, History of alcohol or drug abuse. Hypotensive patients. All patients in this study were evaluated according to IVELT in seconds by a calibrated stopwatch, by patients themselves pre- and post-treatment, and the premature ejaculation profile questionnaire (PEPQ). Results There is a statistically significant difference (p-value <0.001) between the patient group (559.3 ± 159.9) and the control group (248.4 ± 83.7) as regards intravaginal ejaculatory latency time (IVELT) post-treatment (p-value <0.001). Also, a statistically significant difference (p-value <0.001) between the premature ejaculation profile questionnaire (PEPQ) pre-and post-treatment in the patients’ group. Silodosin caused improvement in control over ejaculation, satisfaction with sexual intercourse, personal distress related to ejaculation, and interpersonal difficulty. At the end of the study, only 11 (13.75%) patients reported that they had a decreased semen volume as a side effect of silodosin, which disappeared completely after discontinuation of the drug. Conclusion Silodosin 4 mg on demand is effective in the treatment of premature ejaculation, as it is effective, cheap, and safe.