Silodosin Relieves Urinary Symptoms in Men With Benign Prostatic Hypertension, Induces Retrograde Ejaculation: Presented at AUA
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Silodosin Relieves Urinary Symptoms in Men With Benign Prostatic Hypertension, Induces Retrograde Ejaculation: Presented at AUA

By Em Brown

CHICAGO -- April 30, 2009 -- Silodosin, recently approved for the treatment of benign prostatic hypertrophy (BPH), has been found to induce retrograde ejaculation while reducing urinary outlet obstruction, according to results of a phase 3 study reported here at the 2009 American Urological Association (AUA) Annual Meeting.

Lead investigator Claus G. Roehrborn, MD, University of Texas, Southwestern Medical Center, Dallas, Texas, announced findings here on April 29 from a study of nearly 1,000 men with BPH and lower urinary tract symptoms (BPH-LUTS) who were randomised to silodosin 8 mg daily or placebo.

Subjects were at least 50 years of age, had International Prostate Symptom Scores (IPSS) of at least 13, a peak flow rate (Qmax) between 4 and 15 mL/sec, a voided volume greater than 125 mL and a postvoid residual volume of less than 250 mL. The subjects were stratified by whether they did or did not report retrograde ejaculation as an adverse event during the study.

At 12 weeks, baseline IPSS and Qmax were comparable between the treatment and placebo groups. Of the 466 patients on active treatment, 131 subjects reported retrograde ejaculation, while 335 did not. Improvements in IPSS and Qmax were significantly greater for patients who did not report retrograde ejaculation.

The improvements in symptoms and peak flow rate were greater in the silodosin-treated patients with retrograde ejaculation than those on active treatment without retrograde ejaculation. "There was a trend toward significance for Qmax," Dr. Roehrborn noted.

"Silodosin appears to relax the smooth muscles of the lower urinary tract and the genital tract enough to induce retrograde ejaculation," he explained.

Coinvestigator Steven A. Kaplan, MD, Weill Cornell Medical College, New York, New York, concurred, stating: "Our observation suggests that retrograde ejaculation is actually an indirect indicator of the relaxation of the smooth musculature that silodosin induces. For the older BPH patient who experiences retrograde ejaculation, it may be a small trade-off for the rapid and significant relief of urinary symptoms that treatment with silodosin offers."

Funding for this study was provided by Watson Pharmaceuticals.

[Presentation title: Retrograde Ejaculation Induced by Silodosin Is the Result of Relaxation of Smooth Musculature in the Male Uro-Genital Tracts and Is Associated With Greater Urodynamic and Symptomatic Improvements in Men LUTS Secondary to BPH. Abstract 1922]

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