Tolterodine reduces the number of urge incontinence episodes in patients with an overactive bladder

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 pati ents with overactive bladder symptoms, and urodynamically verified detrusor overactivity, were randomised to receive 4-week treatment with either plac ebo or tolterodine 1 or 2 mg twice daily (bd). Efficacy was evaluated from patient micturition diaries. Safety and tolerability endpoints were also ev aluated. Results: After 4-week treatment, the number of incontinence episod es/24 h decreased significantly relative to placebo in the tolterodine I an d 2 mg; bd 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 Tolterodine was safe and well tole rated, few patients were withdrawn due to adverse events. Dry mouth, mainly of mild-to-moderate intensity, was the most common adverse event. No clini cally relevant changes in blood pressure or laboratory safety variables wer e reported. Conclusion: Tolterodine is effective, safe and well tolerated f or the treatment of symptoms of an overactive bladder, particularly urge in continence. (C) 2001 Elsevier Science Ireland Ltd. All rights reserved.