Sexual Function in Men Treated for Symptomatic Benign Prostatic Hyperplasia

Abstract and Introduction

Abstract

We evaluated the effects of extended-release alfuzosin HCl 10 mg once daily (q.d.) on sexual function in men with lower urinary tract symptoms associated with benign prostatic hyperplasia (BPH). In a randomized, double-blind, placebo-controlled study of men aged ≥50 years, after a 28-day placebo run-in period, patients were randomized to receive alfuzosin 10 mg q.d. or matching placebo for 28 days. The mean change from baseline (day 1) in sexual function on day 29 was assessed using the Danish Prostate Symptom Score Sex (DAN-PSSsex) questionnaire. A total of 372 patients were randomized to receive alfuzosin (n=186) or placebo (n=186), with 355 completing the study. At baseline, 64% of the patients reported erectile dysfunction (ED) and 63% reported ejaculatory dysfunction (EjD). For the 320 patients who completed the DAN-PSSsex, alfuzosin treatment was associated with a significant improvement in the mean change from baseline in erectile function on day 29 compared with placebo (P=0.02). No significant difference was observed between the two treatment groups in the mean change from baseline in ejaculatory function on day 29. For patients with ED at baseline, a marginal improvement in erectile function was demonstrated with alfuzosin treatment (P=0.09 vs placebo). For patients with EjD at baseline, the mean change from baseline in ejaculatory function with alfuzosin was comparable to that with placebo. Dizziness was the most common adverse event with alfuzosin treatment (5 vs 0% with placebo), with other adverse events reported with comparable frequency in both treatment groups. After 1 month of treatment, alfuzosin 10 mg q.d. significantly improved erectile function in men with lower urinary tract symptoms/ benign prostatic hypertrophy and had no adverse effect on ejaculatory function.Introduction

Recent studies have demonstrated a significant association between lower urinary tract symptoms (LUTS) and sexual dysfunction in aging men.[1-4] In the Multinational Survey of the Aging Male (MSAM-7), which surveyed 12 815 men aged 50–80 years, sexual activity was reported by 83% of the respondents, with 71% reporting at least one episode of sexual activity in the past 4 weeks.[4] Data from the MSAM-7 revealed a high prevalence of both LUTS and sexual dysfunction in older men. Although the frequency of sexual activity decreased with age, sexual function was strongly and independently associated with the severity of LUTS.[4]

It has been proposed that increased α-adrenergic activity may be a common underlying pathophysiological mechanism for benign prostatic hypertrophy (BPH) symptoms (that is, LUTS), erectile dysfunction (ED) and ejaculatory dysfunction (EjD).[5] Thus, blocking α-adrenergic activity in the lower urinary tract may improve both LUTS associated with BPH and sexual dysfunction. In an open-label study of men with LUTS and sexual dysfunction, treatment for 1 year with alfuzosin 10 mg once daily (q.d.) improved both ED and EjD, as assessed with the Danish Prostate Symptom Score sex (DAN-PSSsex) questionnaire.[6]

Alfuzosin, a uroselective α1-adrenergic receptor antagonist (α-blocker) for the treatment of the symptoms of BPH, is distributed preferentially in the lower urinary tract versus vascular tissues.[7] By selectively blocking α1-adrenergic receptors, alfuzosin causes relaxation of smooth muscle in the bladder neck and prostate gland, thereby reducing LUTS and improving urine flow, with minimal effects on blood pressure and a low incidence of sexual side effects.

In 2003, an extended-release formulation of alfuzosin 10 mg q.d. was approved by the US Food and Drug Administration for the treatment of the signs and symptoms of BPH. Alfuzosin 10 mg q.d. was shown to be an effective and well-tolerated treatment for symptomatic BPH in three pivotal, placebo-controlled, clinical trials.[8-11] In these clinical trials, symptom relief during 12 weeks of treatment with alfuzosin 10 mg q.d. or placebo was first assessed at 4 weeks post-treatment using the International Prostate Symptom Score (IPSS) and measurements of peak urinary flow rate (Qmax). In a recent placebo-controlled crossover study, men with symptomatic BPH who were known responders to α-blockers demonstrated a significant improvement in Qmax as rapidly as 8 h after the initial dose of alfuzosin 10 mg q.d. compared with the initial dose of placebo.[12] The onset of this improvement in Qmax correlated with the previously reported peak plasma concentration of alfuzosin.[13]

The present study describes the effects of alfuzosin 10 mg q.d. versus placebo on erectile and ejaculatory function in men with symptomatic BPH. Previously published results of this study indicated that Qmax increased significantly from baseline within 24 h after the first dose of alfuzosin 10 mg q.d. compared with placebo, and this improvement was maintained on days 8 and 29.[14] In addition, significant improvements were observed in the total IPSS on day 8 and maintained on day 29 in patients treated with alfuzosin.  Printer- Friendly Email This

Int J Impot Res.  2007;19(5):480-485.  ©2007 Nature Publishing Group
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