Efficacy of oral extended-release oxybutynin in cognitively impaired older
nursing home residents with urge urinary incontinence: a randomized
placebo-controlled trial.
Author(s): Lackner TE, Wyman JF, McCarthy TC, Monigold M, Davey C.
Affiliation(s): Department of Experimental and Clinical Pharmacology, College of Pharmacy,
University of Minnesota, Minneapolis, MN, USA. lackn001@umn.edu
Publication date & source: 2011, J Am Med Dir Assoc. , 12(9):639-47
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.
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