B Jacquetin1, J Wyndaele. 1. Urogynaecology Unit, Hôtel Dieu Maternité, CHU, BP 69-63003 Cedex 1, Clermont-Ferrand, France. bjacquetin@chu-clermont.fr
Abstract
OBJECTIVE: To evaluate the efficacy, safety and tolerability of tolterodine compared to placebo in patients with an overactive bladder. STUDY DESIGN: A double-blind, multi-centre phase III study in France and Belgium 251 patients with overactive bladder symptoms, and urodynamically verified detrusor overactivity, were randomised to receive 4-week treatment with either placebo or tolterodine 1 or 2mg twice daily (bd). Efficacy was evaluated from patient micturition diaries. Safety and tolerability endpoints were also evaluated. RESULTS: After 4-week treatment, the number of incontinence episodes/24h decreased significantly relative to placebo in the tolterodine 1 and 2 mgbd groups (P=0.045 and P=0.0089, respectively). Both dosages of tolterodine increased volume voided per micturition compared with placebo (P=0.055 and P=0.056, respectively), although significant decreases in micturition frequency were not apparent. Tolterodine was safe and well tolerated, few patients were withdrawn due to adverse events. Dry mouth, mainly of mild-to-moderate intensity, was the most common adverse event. No clinically relevant changes in blood pressure or laboratory safety variables were reported. CONCLUSION:Tolterodine is effective, safe and well tolerated for the treatment of symptoms of an overactive bladder, particularly urge incontinence.
RCT Entities:
OBJECTIVE: To evaluate the efficacy, safety and tolerability of tolterodine compared to placebo in patients with an overactive bladder. STUDY DESIGN: A double-blind, multi-centre phase III study in France and Belgium 251 patients with overactive bladder symptoms, and urodynamically verified detrusor overactivity, were randomised to receive 4-week treatment with either placebo or tolterodine 1 or 2mg twice daily (bd). Efficacy was evaluated from patient micturition diaries. Safety and tolerability endpoints were also evaluated. RESULTS: After 4-week treatment, the number of incontinence episodes/24h decreased significantly relative to placebo in the tolterodine 1 and 2 mgbd groups (P=0.045 and P=0.0089, respectively). Both dosages of tolterodine increased volume voided per micturition compared with placebo (P=0.055 and P=0.056, respectively), although significant decreases in micturition frequency were not apparent. Tolterodine was safe and well tolerated, few patients were withdrawn due to adverse events. Dry mouth, mainly of mild-to-moderate intensity, was the most common adverse event. No clinically relevant changes in blood pressure or laboratory safety variables were reported. CONCLUSION:Tolterodine is effective, safe and well tolerated for the treatment of symptoms of an overactive bladder, particularly urge incontinence.
Authors: Patrick D Meek; Samuel D Evang; Mina Tadrous; Dianne Roux-Lirange; Darren M Triller; Bora Gumustop Journal: Dig Dis Sci Date: 2010-07-02 Impact factor: 3.199