Sustained-release alfuzosin and trial without catheter after acute urinaryretention: a prospective, placebo-controlled trial

Objective To establish whether the administration of sustained-release (SR) alfuzosin improves the outcome of a trial without catheter (TWOC) after an episode of acute urinary retention. Patients and methods In a prospective, randomized, placebo-controlled trial , 81 patients with acute urinary retention related to benign prostatic obst ruction received either SR alfuzosin (n = 40), an alpha 1-selective blocker , given at a dose of 5 mg twice daily, or placebo (n = 41) for 48 h. The ca theter was removed after 24 h of treatment. The main outcome measurement wa s success or failure of the TWOC. At the end of this double-blind phase the patients were followed up on an open basis. Results After removal of the catheter, 42% of patients voided successfully, 22 of 40 (55%) with SR alfuzosin and 12 of 41 (29%) with placebo (P = 0.03 ). The mean age of patients voiding successfully, regardless of treatment g roup, was 68.4 years, whilst the mean age of those who Were not successful was 72.9 years (P = 0.015). In an intention-to-treat analysis of outcome ad justed for this age difference, the benefit in favour of those receiving SR alfuzosin was not significant, but at P = 0.052 there was a strong suggest ion of a positive treatment effect. The observed benefit remained significa nt in a per-protocol analysis adjusted for age. Taken together, these resul ts indicate that treatment with SR alfuzosin was effective and that the obs erved benefit was not simply the effect of age difference between the group s. Of the 34 patients who voided successfully 23 (68%) required no further intervention within a mean follow-up of 7 months. Conclusions Treatment with SR alfuzosin is effective in improving the succe ss rate of a TWOC after an episode of acute urinary retention, although old er patients are less likely to void successfully. By reducing the numbers o f men sent home with urinary catheters, such treatment may result in a redu ction in the associated perioperative morbidity in those undergoing prostat ic surgery, and is clearly desirable for the patients' comfort and convenie nce.