TROSPIUM CHLORIDE IMPROVES OVERACTIVE BLADDER SYMPTOMS: A MULTICENTER PHASE III TRIAL

Abstract

Trospium chloride is an anticholinergic agent with predominantly peripheral nonselective antimuscarinic activity lacking central nervous system effects. It has no known drug-drug interactions, an advantage for patients taking many medications. Because these qualities may provide added benefit when treating patients with symptoms associated with overactive bladder (OAB) and urge incontinence, we studied the effectiveness of trospium in treating these conditions.Patients with OAB with urge incontinence were randomized 1:1 to 20 mg trospium twice daily or placebo in this 12-week, multicenter, parallel, double-blind, placebo controlled trial. Dual primary end points were change in average number of toilet voids and change in urge incontinent episodes per 24 hours. Secondary efficacy variables were change in average of volume per void, voiding urge severity, urinations during day and night, time to onset of action and change in Incontinence Impact Questionnaire.A total of 523 patients were entered at 51 sites. Trospium significantly decreased average frequency of toilet voids and urge incontinent episodes compared to placebo. It significantly increased average volume per void, and decreased average urge severity and daytime frequency. All effects occurred by week 1 and all were sustained throughout the study. Nocturnal frequency decreased significantly by week 4 and Incontinence Impact Questionnaire scores improved at week 12. Trospium was well tolerated.Trospium was found to have sustained effectiveness beginning at the end of week 1 in decreasing the number of voids, urge incontinent episodes, total daily micturitions and urge severity, and in increasing volume per void. It also improved symptoms of OAB and quality of life.