Effects of terodiline on urinary incontinence among older non-institutionalized women. Terodiline in the Elderly American Multicenter Study Group

Abstract

Objective: To determine the effectiveness of terodiline, a drug with calcium antagonist and anticholinergic properties, on the frequency of incontinence in older non-institutionalized women.

Design: Randomized, placebo-controlled, parallel-group, double-blind trial.

Setting: Twelve outpatient clinics across the United States affiliated with programs in either geriatrics, gynecology, or urology.

Participants: Ninety-eight women, age 60 or older, with symptoms of urge incontinence and self-reported frequency of incontinence four or more times per week and involuntary bladder contractions on dual-channel water cystometry.

Main outcome measures: Self-reported urinary frequency, urgency, number of incontinence episodes, and number of heavily soaked pads.

Results: Eighty-one women, average age 71, completed the trial, 40 in the active drug group, 41 in the placebo group. Incontinence frequency and the number of heavily soaked pads were reduced in the active drug group by 64% and 55%, respectively, and by 21% (P = 0.002) and 9% (P = 0.04) in the placebo group. No patients dropped out due to adverse effects. An intention-to-treat analysis of all 98 patients yielded the same conclusion.

Conclusion: Terodiline is highly effective in reducing incontinence in older, noninstitutionalized women with urge incontinence. Because of its potential association with polymorphic ventricular tachycardia (torsades de pointes), terodiline must undergo further testing to define its safety before it can be recommended for clinical use in the incontinent geriatric population.