World Journal of Urology

, Volume 23, Issue 4, pp 263–270

Transdermal oxybutynin in the treatment of adults with overactive bladder: combined results of two randomized clinical trials

  • Roger R. Dmochowski
  • Victor Nitti
  • David Staskin
  • Karl Luber
  • Rodney Appell
  • G. Willy Davila
Original Article

DOI: 10.1007/s00345-005-0012-8

Cite this article as:
Dmochowski, R.R., Nitti, V., Staskin, D. et al. World J Urol (2005) 23: 263. doi:10.1007/s00345-005-0012-8

Abstract

The safety and efficacy of oxybutynin transdermal delivery system (oxybutynin-TDS) versus placebo in adults with urge and mixed urinary incontinence was investigated using combined results from double-blind stages of 2 phase3 clinical trials. Study 1: placebo-controlled, parallel-group comparison of 3 oxybutynin–TDS doses in 12-week double-blind and open-label periods, followed by a 28-week open-label extension. Study 2 was a 12-week randomized, double-blind, placebo-controlled comparison of oxybutynin-TDS versus long-acting tolterodine and placebo, followed by a 52-week open-label extension. Efficacy analysis included 241 patients receiving oxybutynin-TDS, 244 receiving placebo. Most participants were Caucasian women (92%). Approximately 60% received prior anticholinergic therapy. Primary outcome was determined by changes from baseline to end of treatment in frequency of incontinence episodes, frequency of urination, and void volume. Oxybutynin-TDS was significantly more effective than placebo in reducing median daily incontinence episodes (−3.0 vs placebo −2.0; P=.00004) and daily urinary frequency (−2.0 vs −1.0; P=.0023), and in increasing void volume (25 mL vs 5.5 mL; P<.00001). Overall rates of anticholinergic adverse events (AEs) were 12.8% for oxybutynin-TDS and 11.0% for placebo (P=0.5421). The most common systemic anticholinergic AEs were dry mouth (7.0% for oxybutynin-TDS vs 5.3% for placebo) and constipation (2.1% vs 2.0%). Application site erythema occurred in 7.0% of participants who received oxybutynin-TDS (3.7% discontinuation rate); pruritus occurred in 16.1% (3.3% discontinuation rate). Transdermal oxybutynin was shown to be efficacious, with a proven safety profile. It may be utilized for patients with overactive bladder as a treatment option that could enhance compliance.

Keywords

Overactive bladder Urinary incontinence Anticholinergic drugs Oxybutynin Transdermal delivery 

Copyright information

© Springer-Verlag 2005

Authors and Affiliations

  • Roger R. Dmochowski
    • 1
  • Victor Nitti
    • 2
  • David Staskin
    • 3
  • Karl Luber
    • 4
  • Rodney Appell
    • 5
  • G. Willy Davila
    • 6
  1. 1.Department of Urologic SurgeryVanderbilt UniversityNashvilleNashvilleUSA
  2. 2.New York University School of MedicineNew YorkUSA
  3. 3.New York Presbyterian HospitalNew YorkUSA
  4. 4.University of CaliforniaSan DiegoUSA
  5. 5.Baylor College of MedicineHoustonUSA
  6. 6.Cleveland Clinic FloridaFort LauderdaleUSA

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