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

Urology. 2011 Jan;77(1):24-9. doi: 10.1016/j.urology.2010.07.469. Epub 2010 Oct 23.

Abstract

Objectives: 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).

Methods: 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.

Results: 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).

Conclusions: 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.

Publication types

  • Clinical Trial, Phase III
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Benzilates
  • Delayed-Action Preparations
  • Double-Blind Method
  • Drug Administration Schedule
  • Humans
  • Male
  • Middle Aged
  • Nortropanes / administration & dosage*
  • Nortropanes / adverse effects
  • Parasympatholytics / administration & dosage*
  • Parasympatholytics / adverse effects
  • Safety
  • Urinary Bladder, Overactive / drug therapy*

Substances

  • Benzilates
  • Delayed-Action Preparations
  • Nortropanes
  • Parasympatholytics
  • trospium chloride