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

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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.

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Acknowledgements

This study was supported by Pharmacia & Upjohn.

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Authors and Affiliations

  1. Department of Urology, University of Pittsburgh Medical Center, 3471 Fifth Avenue, Suite 700, Pittsburgh, Pennsylvania, 15213, USA

    Michael Chancellor

  2. Las Vegas, Nevada, USA

    S. Freedman

  3. Bay State Urologists, Inc., Brighton, Massachusetts, USA

    H.D. Mitcheson

  4. University Clinic of Urology, Graz, Austria

    G. Primus

  5. Division of Urology, University of Pennsylvania Health System, Philadelphia, Pennsylvania, USA

    A. Wein

Authors
  1. Michael Chancellor
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  2. S. Freedman
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  3. H.D. Mitcheson
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  4. G. Primus
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  5. A. Wein
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Correspondence to Michael Chancellor.

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Chancellor, M., Freedman, S., Mitcheson, H. et al. Tolterodine, an Effective and Well Tolerated Treatment for Urge Incontinence and Other Overactive Bladder Symptoms. Clin. Drug Investig. 19, 83–91 (2000). https://doi.org/10.2165/00044011-200019020-00001

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