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

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. (C) 2005 Elsevier Inc.