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Multicenter phase III trial studying trospium chloride in patients with overactive bladder
Delbert Rudy1, Kevin Cline, Richard Harris
1North Texas Clinical Research, Urology Associates of North Texas, Arlington, Texas 76017, USA. drudy@uant.com
Urology
|February 8, 2006
Summary
Trospium chloride effectively reduced overactive bladder symptoms, including voids and incontinence episodes, within one week. This anticholinergic medication demonstrated sustained efficacy and safety over 12 weeks.
Area of Science:
- Pharmacology
- Urology
- Clinical Trials
Background:
- Overactive bladder (OAB) significantly impacts quality of life.
- Trospium chloride, a peripheral antimuscarinic agent, is a potential OAB treatment.
Purpose of the Study:
- To evaluate the efficacy and safety of trospium chloride in OAB patients.
- To assess trospium chloride's impact on voiding frequency, urgency, and incontinence.
Main Methods:
- A 12-week, double-blind, placebo-controlled study randomized 658 OAB patients.
- Participants received either trospium chloride (20 mg twice daily) or placebo.
- Primary endpoint: change in daily toilet voids; secondary endpoints included urgency and incontinence episodes.
Main Results:
- Trospium chloride significantly reduced daily voids, urgency severity, and incontinence episodes.
- Increased voided volume and sustained improvements were observed from week 1 through week 12.
- Common adverse events were dry mouth and constipation.
Conclusions:
- Trospium chloride demonstrated significant and sustained effectiveness for OAB symptoms.
- Treatment benefits were evident by week 1 and maintained throughout the 12-week study period.
- Trospium chloride was found to be safe and well-tolerated in OAB patients.
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