Randomized, placebo-controlled trial of the cognitive effect, safety, and tolerability of oral extended-release oxybutynin in cognitively impaired nursing home residents with urge urinary incontinence

Journal of the American Geriatrics Society
Thomas E LacknerCynthia Davey

Abstract

Determine the cognitive effect, safety, and tolerability of oral extended-release oxybutynin in cognitively impaired older nursing home residents with urge urinary incontinence. Randomized, double-blinded, placebo-controlled trial. Twelve skilled nursing homes. Fifty women aged 65 and older with urge incontinence and cognitive impairment. Four-week treatment with once-daily oral extended-release oxybutynin 5 mg or placebo. Withdrawal rates and delirium or change in cognition from baseline at 1, 3, 7, 14, 21, and 28 days after starting treatment using the Confusion Assessment Method (CAM), Mini-Mental State Examination (MMSE), and Severe Impairment Battery (SIB). The Brief Agitation Rating Scale, adverse events, falls incidence, and serum anticholinergic activity change with treatment were also assessed. Participants' mean age +/-standard deviation was 88.6+/-6.2, and MMSE baseline score was 14.5+/-4.3. Ninety-six percent of subjects receiving oxybutynin (n=26) and 92% receiving placebo (n=24) completed treatment (P=.50). The differences in mean change in CAM score from baseline to all time points were equivalent between the oxybutynin and placebo groups. Delirium did not occur in either group. One participant receiving oxybutyn...Continue Reading

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