Efficacy of oral extended-release oxybutynin in cognitively impaired older nursing home residents with urge urinary incontinence: A randomized placebo-controlled trial

Thomas E. Lackner, Jean F. Wyman, Teresa C. McCarthy, Melinda Monigold, Cynthia Davey

Research output: Contribution to journalArticlepeer-review

17 Scopus citations


Objectives: To determine the efficacy of oral extended-release oxybutynin for urge urinary incontinence in older female nursing home residents with mild to severe cognitive impairment. Design: Randomized, double-blind, placebo-controlled trial. Setting: Twelve skilled nursing homes. Participants: Fifty women aged 65 and older with urge incontinence and cognitive impairment. Intervention: Four-week treatment with daily oral extended-release oxybutynin 5 mg or placebo. Measurements: Urinary incontinence episodes, urinary frequency, and total dryness assessed hourly over two 8-hour days (8 AM TO 4 PM), and evening and night nursing staff ratings of urinary symptoms. Results: Of the participants, 96% (n = 25) on oxybutynin and 92% (n = 22) on placebo completed the trial. Compared with baseline, both groups achieved a significant median decrease in mean urinary incontinence episodes and urinary frequency at 4 weeks (P =.01-.05). There were no significant between-group differences in any urological outcome. In the exploratory analysis, there were no significant differences from baseline or placebo in any urological outcome with oxybutynin in participants with mild to moderate cognitive impairment and/or adequate mobility compared with participants with more severe cognitive and physical impairment. Staff ratings found that more participants had improvement in urinary symptoms from baseline with oxybutynin than placebo but significant only for delaying evening voiding (P =.02). Conclusion: Extended-release oxybutynin 5 mg per day for 4 weeks in older cognitively impaired female nursing home residents did not significantly reduce urinary incontinence and urinary frequency or achieve dryness. Participants with mild to moderate cognitive and/or physical impairment were no more likely to benefit from oxybutynin than more severely impaired individuals in an exploratory analysis but further research in a larger population and perhaps using a larger dose is needed.

Original languageEnglish (US)
Pages (from-to)639-647
Number of pages9
JournalJournal of the American Medical Directors Association
Issue number9
StatePublished - Nov 2011

Bibliographical note

Funding Information:
This research was supported by a research grant from Ortho-McNeil Pharmaceuticals, Raritan, NJ . Oxybutynin extended-release (Ditropan XL) 5-mg tablets and matching placebo tablets were supplied by ALZA Pharmaceuticals, Mountain View, CA, a subsidiary of Ortho-McNeil Pharmaceuticals, Raritan, NJ.

Copyright 2018 Elsevier B.V., All rights reserved.


  • Aged
  • Anticholinergics
  • Efficacy, cognition
  • Urinary incontinence

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