Tolterodine, an effective and well tolerated treatment for urge incontinence and other overactive bladder symptoms

Objective: This double-blind, multinational study was performed to further evaluate the efficacy of tolterodine, a new bladder-selective antimuscarinic agent, for reducing urge incontinence episodes and other urinary symptoms in patients with overactive bladder. Patients and Methods: 1022 patients with urge incontinence (greater than or equal to 5 episodes/week) and urinary frequency (greater than or equal to 8 micturitions/24 hours) were randomised to treatment with tolterodine 2mg twice daily (n = 514) or placebo (n = 508). Changes in micturition diary variables were evaluated after 12 weeks' treatment. Tolerability end-points, and patients' perceptions of their bladder condition, urgency and treatment benefit, were also determined. Results: Tolterodine 2mg twice daily reduced urge incontinence episodes by 46% versus baseline, and this decrease was significant compared with the change with placebo (p = 0.0005). Significant decreases from baseline were also observed for micturition frequency (-15%) and pad usage (-36%) compared with placebo (p < 0.01 for both comparisons), while there was a significant increase from baseline in volume voided per micturition (+21%) compared with placebo (p = 0.0001). These changes were meaningful to tolterodine-treated patients; a greater proportion of patients on tolterodine reported less severe urgency and had improvements in their bladder condition than placebo recipients, while 40% perceived 'much benefit' from treatment (22% on placebo, p < 0.001). Withdrawals were essentially the same between the two treatment groups. No clinically relevant changes in blood pressure or laboratory parameters were observed. Conclusions: Tolterodine 2mg twice daily is effective against all the troublesome symptoms of overactive bladder and these effects are meaningful to patients. Tolterodine was well tolerated.