Schäfer M.’s research while affiliated with Universität des Saarlandes and other places

To assess the efficacy and safety of trospium chloride (TCl, 20 mg twice daily) in the treatment of detrusor instability, compared with placebo. In all, 208 patients were allocated at random to either TCl or placebo in a double-blind clinical study; the patients were treated for 3 weeks. Urodynamic values were measured at the beginning and end of the treatment period. Adverse events were recorded on patient diary cards. A confirmatory adaptive procedure with one planned interim analysis was used to evaluate efficacy. Trospium chloride produced significant improvements in maximum cystometric bladder capacity (median treatment effect 22.0 mL, mean 37.3 mL, one-sided P = 0. 0054) and urinary volume at first unstable contraction (median treatment effect 45.0 mL, mean 63.6 mL, one-sided P = 0.0015). The patients' assessment of efficacy showed significantly greater clinical improvement in the TCl group than in the placebo group (two-sided P = 0.0047). Furthermore, TCl was well tolerated, with similar frequencies of adverse events reported in both groups (68% in the TCl and 62% in the placebo group). Trospium chloride (20 mg twice daily) is an effective and safe option for the treatment of detrusor instability.

Trospium chloride (TCl; code MP94) is a parasympatholytic with antispasmodic and ganglion blocking properties. The aim of this study was to evaluate the efficacy and tolerability of TCl in the treatment of motor urge syndrome. TCl (20 mg b.d.) given for three weeks was compared with placebo in a total of 309 patients (TCl: n = 210; placebo: n = 99; allocation ratio 2:1). Primary efficacy variables were urodynamically measured maximum cystometric bladder capacity (BC) and the volume at first unstable contraction (VC). In the per-protocol analysis BC increased markedly more in the patients receiving TCl (n = 99) than in those receiving placebo (n = 48); treatment effect: +73.9 ml, 95% CI 38.4 to 109.0 ml, p = 0.0001. The increase in VC was more pronounced in the TCl group compared to the placebo group (treatment effect: +55.0 ml, 95% CI 15.4 to 94.6 ml, p = 0.0027). Intention-to-treat analysis yielded almost identical results. In patients with motor urge syndrome, trospium chloride increased maximum bladder capacity and volume at first unstable contraction and was well tolerated (TCl: 19.0%, placeb: 15.2% of the patients reported adverse events).