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

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.

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.

OBJECTIVES: Determine the cognitive effect, safety, and tolerability of oral extended-release oxybutynin in cognitively impaired older nursing home residents with urge urinary incontinence. DESIGN: Randomized, double-blinded, 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 once-daily oral extended-release oxybutynin 5 mg or placebo. MEASUREMENTS: 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). CONCLUSION: 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.

Effectiveness of education and individualized counseling in reducing environmental hazards in the homes of community-dwelling older women.

OBJECTIVES: To test the effectiveness of an education and counseling intervention on reducing environmental hazards in the homes of older women. DESIGN: Secondary analysis from a randomized, controlled trial with two arms: fall prevention program and health education program (control). Environmental hazards were assessed at baseline and immediately posttreatment (12-weeks). SETTING: Participants' homes. PARTICIPANTS: Two hundred seventy-two community-dwelling women aged 70 and older at risk for falling. INTERVENTION: The fall prevention program involved a comprehensive fall risk evaluation, exercise, education, individualized counseling, and referrals. The health education program included topics unrelated to fall prevention. With the exception of the fall risk evaluation conducted by a nurse practitioner, baccalaureate-prepared nurses carried out the interventions. MEASUREMENTS: Summed and individual scores for hazards related to the bathroom, floor surfaces, lighting, furniture, stairways, and storage areas. RESULTS: Environmental hazards were found in all homes, with a baseline mean+/-standard deviation of 10.7+/-2.6 total hazards and range of four to 17 hazards. Analysis of within-group changes indicated that the fall prevention group had significantly fewer bathroom, lighting, and total hazards after the intervention, whereas the health education group had significantly fewer bathroom hazards but more floor hazards. At follow-up, the fall prevention group had significantly fewer lighting hazards and total hazards than the health education group. CONCLUSION: Education and counseling have only modest effects in helping older women make recommended home modifications. To be most effective in reducing environmental hazards, fall prevention programs may need to provide and install safety devices.