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.
OBJECTIVE
Determine the cognitive effect, safety, and tolerability of oral extended-release oxybutynin in cognitively impaired older nursing home residents with urge urinary incontinence.


METHODS
Randomized, double-blinded, placebo-controlled trial.


METHODS
Twelve skilled nursing homes.


METHODS
Fifty women aged 65 and older with urge incontinence and cognitive impairment.


METHODS
Four-week treatment with once-daily oral extended-release oxybutynin 5 mg or placebo.


METHODS
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.


RESULTS
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 One participant receiving oxybutynin was withdrawn because of urinary retention, which resolved without treatment. Mild adverse events occurred in 38.5% of participants receiving oxybutynin and 37.5% receiving placebo (P=.94).


CONCLUSIONS
Short-term treatment using oral extended-release oxybutynin 5 mg once daily was safe and well tolerated, with no delirium, in older female nursing home participants with mild to severe dementia. Future research should investigate different dosages and long-term treatment.
Lackner
Thomas E
TE
Department of Experimental and Clinical Pharmacology and Institute for the Study of Geriatric Pharmacotherapy, College of Pharmacy, University of Minnesota, Minneapolis, Minnesota 55455, USA. lackn001@umn.edu
Wyman
Jean F
JF
McCarthy
Teresa C
TC
Monigold
Melinda
M
Davey
Cynthia
C
D000058:Accidental Falls; D000284:Administration, Oral; D000368:Aged; D000369:Aged, 80 and over; D003071:Cognition / Q000187:drug effects*; D003221:Confusion / Q000139:chemically induced / Q000175:diagnosis; D003692:Delayed-Action Preparations; D003693:Delirium / Q000139:chemically induced / Q000175:diagnosis; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D006707:Homes for the Aged; D006801:Humans; D008333:Mandelic Acids / Q000008:administration & dosage* / Q000009:adverse effects; D008609:Mental Status Schedule; D009483:Neuropsychological Tests; D009735:Nursing Homes; D053202:Urinary Incontinence, Urge / Q000188:drug therapy*; D014563:Urodynamics / Q000187:drug effects
D003692:Delayed-Action Preparations; D008333:Mandelic Acids; C005419:oxybutynin