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Erschienen in:
01.08.2001 | Clinical Use
Randomised, Double-Blind, Placebo-Controlled Study on the Efficacy and Tolerance of Trospium Chloride in Patients with Motor Urge Incontinence
Erschienen in: Clinical Drug Investigation | Ausgabe 8/2001
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Objective
Trospium chloride is an antimuscarinic drug with a quaternary ammonium structure for the treatment of detrusor instability and hyper-reflexia. It is generally considered to be well tolerated, but exhibits poor gastrointestinal absorption after oral administration. This study was conducted to assess the efficacy and safety of trospium chloride 15mg three times daily for 28 days in patients with motor urge incontinence.
Design
Multicentre, double-blind, randomised, placebo-controlled study.
Patients and Participants
46 patients with motor urge incontinence.
Methods
Patients were treated either with trospium chloride-coated tablets 15mg or placebo, administered three times daily for 28 days. The main parameter was the change in maximum bladder capacity as determined by cystometry before and after treatment. The occurrence and frequency of adverse events during treatment were assessed as secondary parameters.
Results
Pretreatment values for maximum bladder capacity were comparable in the two groups (trospium chloride: 174.7ml, placebo: 206.2ml; p = 0.21). In patients assessed by per-protocol analysis, the mean maximum bladder capacity increased by 82.3ml in patients receiving trospium chloride therapy, but decreased slightly (−4. 1ml; p ≤ 0.01) in the placebo group. Dry mouth was reported as an adverse event 11 times in the trospium chloride group and 7 times in the placebo group (p = 0.41). Other adverse events were rarely observed in the two treatment groups (0 to 3 times).
Conclusion
In this controlled clinical study in patients with urodynamically verified motor urge incontinence, treatment with trospium chloride 15mg three times daily for 28 days led to a significant increase in maximum bladder capacity compared with placebo treatment. There were no differences in the frequency of adverse events in the treatment group compared with the placebo group.