Prospective Randomized Placebo-controlled Study to Assess the Safety and Efficacy of Silodosin in the Management of Acute Urinary Retention

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. UROLOGY 82: 171-175, 2013. (C) 2013 Elsevier Inc.