title: 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.
abstract: 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 One participant receiving oxybutynin was withdrawn because of urinary retention, which resolved without treatment.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.
authors.affiliation: 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
authors.forename: Thomas E
authors.initials: TE
authors.lastname: Lackner
authors.forename: Jean F
authors.initials: JF
authors.lastname: Wyman
authors.forename: Teresa C
authors.initials: TC
authors.lastname: McCarthy
authors.forename: Melinda
authors.initials: M
authors.lastname: Monigold
authors.forename: Cynthia
authors.initials: C
authors.lastname: Davey
mesh_terms: 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
chemical_list: D003692:Delayed-Action Preparations; D008333:Mandelic Acids; C005419:oxybutynin