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 obstruction received eitherSR alfuzosin (n=40), an alpha1-selective blocker, given at a dose of 5 mg twice daily, or placebo (n=41) for 48 h. The catheter was removed after 24 h of treatment. The main outcome measurement was 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 group, 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 adjusted 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 suggestion of a positive treatment effect. The observed benefit remained significant in a per-protocol analysis adjusted for age. Taken together, these results indicate that treatment with SR alfuzosin was effective and that the observed benefit was not simply the effect of age difference between the groups. 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 success rate of a TWOC after an episode of acute urinary retention, although older patients are less likely to void successfully. By reducing the numbers of men sent home with urinary catheters, such treatment may result in a reduction in the associated perioperative morbidity in those undergoing prostatic surgery, and is clearly desirable for the patients' comfort and convenience.
RCT Entities:
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 obstruction received either SR alfuzosin (n=40), an alpha1-selective blocker, given at a dose of 5 mg twice daily, or placebo (n=41) for 48 h. The catheter was removed after 24 h of treatment. The main outcome measurement was 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 group, 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 adjusted 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 suggestion of a positive treatment effect. The observed benefit remained significant in a per-protocol analysis adjusted for age. Taken together, these results indicate that treatment with SR alfuzosin was effective and that the observed benefit was not simply the effect of age difference between the groups. 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 success rate of a TWOC after an episode of acute urinary retention, although older patients are less likely to void successfully. By reducing the numbers of men sent home with urinary catheters, such treatment may result in a reduction in the associated perioperative morbidity in those undergoing prostatic surgery, and is clearly desirable for the patients' comfort and convenience.
Authors: K Höfner; T Bach; R Berges; K Dreikorn; C Gratzke; S Madersbacher; M-S Michel; R Muschter; M Oelke; O Reich; C Tschuschke; T Bschleipfer Journal: Urologe A Date: 2016-02 Impact factor: 0.639
Authors: R Berges; K Dreikorn; K Höfner; S Madersbacher; M C Michel; R Muschter; M Oelke; O Reich; W Rulf; C Tschuschke; U Tunn Journal: Urologe A Date: 2009-12 Impact factor: 0.639