Clinical Use

Clinical Drug Investigation

, Volume 19, Issue 2, pp 83-91

First online:

Tolterodine, an Effective and Well Tolerated Treatment for Urge Incontinence and Other Overactive Bladder Symptoms

  • Michael ChancellorAffiliated withDepartment of Urology, University of Pittsburgh Medical Center Email author 
  • , S. FreedmanAffiliated with
  • , H.D. MitchesonAffiliated withBay State Urologists, Inc.
  • , G. PrimusAffiliated withUniversity Clinic of Urology
  • , A. WeinAffiliated withDivision of Urology, University of Pennsylvania Health System

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Abstract

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 (≥5 episodes/week) and urinary frequency (≥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.