Safety and efficacy of once-daily trospium chloride extended-release in male patients with overactive bladder.

This study used pooled data from 2 large, phase III, double-blind, randomized, placebo-controlled studies for a subgroup analysis of the safety and efficacy of trospium chloride extended-release (XR) in men with overactive bladder (OAB). A subgroup analysis was performed on data from the 176 male patients (trospium XR, 94; placebo, 82) who participated in 1 of the 2 studies. Patients received either trospium XR 60 mg or placebo once daily for 12 weeks. The mean age was 66.2 years for trospium XR and 63.1 years for placebo. A history of benign prostatic hyperplasia was recorded for 29 trospium XR recipients (30.9%) and 23 placebo recipients (28.0%). A total of 19 patients (20.2%) receiving trospium XR and 15 (18.3%) receiving placebo experienced ≥1 treatment-emergent adverse event considered at least possibly related to the study medication. Two trospium XR patients (2.1%) developed urinary retention; both were aged ≥75 years, and 1 had a history of prostate enlargement. Treatment with trospium XR compared with placebo resulted in significantly greater decreases from baseline in the mean number of daily toilet voids (-2.5 vs -1.5; P < .05) and urgency urinary incontinence episodes (-2.3 vs -1.4; P < .05) in men at week 12 (the coprimary efficacy variables). Trospium XR is safe and effective in men with OAB. The risk of urinary retention is low and may be further decreased by careful patient selection.