Drugs & Aging

, Volume 18, Issue 7, pp 551–560

Twelve-Month Treatment of Overactive Bladder

Efficacy and Tolerability of Tolterodine
  • Paul Abrams
  • James Malone-Lee
  • Bernard Jacquetin
  • Jean-Jacques Wyndaele
  • Tuevo Tammela
  • Udo Jonas
  • Alan Wein
Original Research Article

DOI: 10.2165/00002512-200118070-00007

Cite this article as:
Abrams, P., Malone-Lee, J., Jacquetin, B. et al. Drugs & Aging (2001) 18: 551. doi:10.2165/00002512-200118070-00007


Context: Tolterodine is a bladder-selective antimuscarinic agent designed for the treatment of overactive bladder. Traditional antimuscarinic therapies are poorly tolerated due to a high incidence of anticholinergic adverse events and consequently few patients remain on long term therapy.

Objective: To evaluate the long term efficacy and tolerability of tolterodine in patients with symptoms of overactive bladder.

Design: Twelve-month open-label extension of 4 randomised, placebo-controlled, double-blind, multinational, multicentre trials of 4 weeks’ duration.

Patients: 714 patients (aged 18 to 92 years) with symptoms of overactive bladder who completed the double-blind portion of the studies.

Intervention: Tolterodine 2mg twice daily for up to 12 months.

Main outcome measures: Micturition diary variables: number of micturitions per 24 hours, number of urge incontinence episodes per 24 hours, mean urine volume voided per micturition. Safety variables: adverse events, study discontinuation rate.

Results: A total of 441 patients (62%) completed 12 months’ open-label treatment with tolterodine, which significantly reduced the number of micturitions per 24 hours [mean change −2.4, 95% confidence interval (CI) −2.7 to −2.2, median change −20%, p < 0.0001] and number of urge incontinence episodes per 24 hours (mean change −1.3, 95% CI −1.6 to −1.0, median change −74%, p < 0.0001), while the mean volume voided per micturition was significantly increased (+33ml, 95% CI +28 to +38, median change +18%; p < 0.0001). 41% of patients reported dry mouth (27% mild, 10% moderate, 3% severe). Dosage reduction to 1mg twice daily was required in 23% of patients. 15% of patients withdrew from the study due to adverse events, with 5% having associated dry mouth.

Conclusions: The high percentage of patients completing 12 months’ treatment indicates that tolterodine is an effective and well tolerated agent for long term treatment of overactive bladder.

Copyright information

© Adis International Limited 2001

Authors and Affiliations

  • Paul Abrams
    • 1
  • James Malone-Lee
    • 2
  • Bernard Jacquetin
    • 3
  • Jean-Jacques Wyndaele
    • 4
  • Tuevo Tammela
    • 5
  • Udo Jonas
    • 6
  • Alan Wein
    • 7
  1. 1.Southmead HospitalBristol Urological InstituteWestbury-on-Trym, BristolEngland
  2. 2.Department of MedicineRoyal Free and University College Medical School, St Pancras HospitalLondonEngland
  3. 3.Maternité, Hôpital Hôtel DieuClermont-FerrandFrance
  4. 4.Department of UrologyUniversitair Ziekenhuis AntwerpenAntwerpBelgium
  5. 5.Division of UrologyTampere University HospitalTampereFinland
  6. 6.Urolog, UniversitätsklinikMedizinische Hochschule HannoverHannoverGermany
  7. 7.Division of UrologyUniversity of Pennsylvania Health SystemPhiladelphiaUSA