Prospective randomized placebo-controlled study to assess the safety and efficacy of silodosin in the management of acute urinary retention

摘要

Objective: To determine the safety and efficacy of silodosin in the management of acute urinary retention (AUR) related to benign prostatic hyperplasia (BPH). Methods: From January 2011 to May 2012, 60 men over 50 years of age with AUR were equally randomized to either silodosin 8 mg once daily or placebo for 3 days followed by trial without catheter (TWOC). If the patient re-experienced urinary retention or if postvoid residual urine volume was >150 mL, he was re-catheterized and considered to have a failed TWOC. All patients with a successful TWOC on day 3 were started on silodosin regardless of which arm they had belonged initially. Uroflowmetry, postvoid residual volume and International Prostate Symptom Score (IPSS) were noted at TWOC and after 2 weeks. Results: Baseline patient demographics and clinical characteristics were similar in both groups (P >.1). The success rate of TWOC was 76.7% in the silodosin group and 36.7% in the placebo group (P =.002). On multivariate analysis, patients in silodosin group had lesser odds of having a failure (0.13) when compared to those not given treatment (P =.008). Among the clinical parameters, a retention volume more than 800 mL (P =.038) and an IPSS score more than 25 (P =.042) had significantly greater odds of failure. There were no adverse effects related to the use of silodosin. Conclusion: Silodosin significantly increases the chances of successful TWOC after AUR.