Efficacy of trospium chloride in patients with detrusor instability: a placebo‐controlled, randomized, double‐blind, multicentre clinical trial

• DOI: 10.1046/j.1464-410x.2000.00575.x
• Publication Date: 2003-03-11T07:52:27Z
• Authors: L. Cardozo; C.R. Chapple; P. Toozs‐hobson; M. Grosse‐freese; M. Bulitta; W. Lehmacher; W. Strösser; B. Ballering‐brühl; M. Schäfer
• Keywords: Interim analysis; Detrusor instability

Objectives To assess the efficacy and safety of trospium chloride (TCl, 20 mg twice daily) in treatment detrusor instability, compared with placebo. Patients methods In all, 208 patients were allocated at random to either TCl or placebo a double‐blind clinical study; treated for 3 weeks. Urodynamic values measured beginning end period. Adverse events recorded on patient diary cards. A confirmatory adaptive procedure one planned interim analysis was used evaluate efficacy. Results Trospium produced significant improvements maximum cystometric bladder capacity (median effect 22.0 mL, mean 37.3 one‐sided P = 0.0054) urinary volume first unstable contraction 45.0 63.6 0.0015). The patients’ assessment showed significantly greater improvement group than (two‐sided 0.0047). Furthermore, well tolerated, similar frequencies adverse reported both groups (68% 62% group). Conclusion (20 is an effective safe option instability.