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drugs treating patients with urge-syndrome. Former study results of TCl and Tol in separate clinical studies suggest a similar efficacy and safety profile. Thus, the comparison of both drugs versus placebo as regards efficacy and tolerability was the primary aim of this study.
Methods:
Patients with urge-syndrome (motor urge, sensory urge and combined motor urge and stress incontinence) were randomly assigned to (\mathrm{TCl}(2 \times 20 \mathrm{mg} / \mathrm{day})), Tol ( (2 \times 2 \mathrm{mg} / \mathrm{day})), or placebo and treated for 3 weeks. Patients` medical history (pollakisuria >10/day, nykturia, imperative desire to void) and a urodynamic measurement (minimum one unstable detrusor contraction of (10 \mathrm{~cm} \mathrm{H}_{2} \mathrm{O}) or first desire to void at a bladder filling of <150 ml) verified the diagnosis urge-syndrome before the patients received the study medication.
The primary efficacy variable was the change from baseline in the micturition frequency in 24 hours assessed by data of the patients micturition diaries. The patients filled in the diaries during the wash-out period of 10 days and the entire treatment period. For tolerability and safety evaluation data of adverse events, laboratory tests, and physical examinations were analysed.