Alfuzosin 10 mg once daily in the management of acute urinary retention: results of a double-blind placebo-controlled study

Abstract

Objectives: To study the impact of alfuzosin 10 mg once daily (OD) on the outcome of a trial without catheter (TWOC) after a first episode of acute urinary retention (AUR) related to benign prostatic hyperplasia (BPH) and the subsequent management of BPH in these patients.

Methods: A total of 360 patients underwent emergency catheterization and were blindly randomized to alfuzosin 10 mg OD or placebo for 3 days (first phase). All patients with successful TWOC, regardless of treatment, were then again blindly randomized to alfuzosin 10 mg OD or placebo for 6 months (second phase). The need for BPH surgery (primary endpoint) was assessed after 1, 3, and 6 months of treatment.

Results: Alfuzosin significantly increased the successful TWOC rate (146 of 236, 61.9%) compared with placebo (58 of 121, 47.9%; P = 0.012). In the second phase, 14 (17.1%) of the 82 alfuzosin-treated patients versus 20 (24.1%) of the 83 placebo-treated patients required BPH surgery, 5 (36%) of 14 versus 13 (65%) of 20 within 1 month, and 8 (57%) of 14 versus 17 (85%) of 20 within 3 months of treatment. Emergency surgery because of AUR relapse was the main cause of failure in both groups (11 [78.6%] of 14 in the alfuzosin group and 16 [80.0%] of 20 in the placebo group). Compared with placebo, alfuzosin improved the Kaplan-Meier survival rates by 9.6% (P = 0.04), 11.4% (P = 0.04), and 8.3% (P = 0.20), with surgical risk reductions of 61%, 52%, and 29% at 1, 3, and 6 months of treatment, respectively. High prostate-specific antigen values and the post-TWOC residual urine volume significantly increased the risk of AUR relapse and BPH surgery. Alfuzosin 10 mg OD was well tolerated.

Conclusions: Alfuzosin 10 mg OD increased the likelihood of successful TWOC in men with a first episode of spontaneous AUR and should be continued beyond the acute phase, as it reduced the need for BPH surgery during a 6-month treatment period.