Department of Experimental and Clinical Pharmacology, College of Pharmacy, University of Minnesota, Minneapolis, MN, USA.
J Am Med Dir Assoc. 2011 Nov;12(9):639-47. doi: 10.1016/j.jamda.2010.05.003. Epub 2010 Oct 2.
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.
Randomized, double-blind, placebo-controlled trial.
Twelve skilled nursing homes.
Fifty women aged 65 and older with urge incontinence and cognitive impairment.
Four-week treatment with daily oral extended-release oxybutynin 5 mg or placebo.
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.
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).
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.
确定口服延长释放羟丁宁对轻度至重度认知障碍老年女性养老院居民急迫性尿失禁的疗效。
随机、双盲、安慰剂对照试验。
十二家熟练护理院。
50 名年龄在 65 岁及以上、有急迫性尿失禁和认知障碍的女性。
每日口服延长释放羟丁宁 5 毫克或安慰剂，为期四周。
每小时评估两次 8 小时（上午 8 点至下午 4 点）的尿失禁发作、尿频率和总干燥度，以及夜间和夜间护理人员对尿症状的评分。
在接受羟丁宁治疗的参与者中，有 96%（n=25）和接受安慰剂治疗的参与者中，有 92%（n=22）完成了试验。与基线相比，两组在 4 周时均显著降低了平均尿失禁发作和尿频率的中位数（P=.01-.05）。两组在任何泌尿系统结果上均无显著差异。在探索性分析中，与基线或安慰剂相比，在认知和/或活动能力轻度至中度受损的参与者中，与认知和身体功能严重受损的参与者相比，羟丁宁在任何泌尿系统结果上均无显著差异。工作人员的评估发现，与安慰剂相比，更多的参与者的尿症状从基线开始有改善，但只有在推迟夜间排尿方面有显著差异（P=0.02）。
在认知障碍老年女性养老院居民中，每天口服延长释放羟丁宁 5 毫克，持续 4 周，并未显著减少尿失禁和尿频率，也未达到干燥。在探索性分析中，认知和/或身体功能轻度至中度受损的参与者不太可能从羟丁宁中获益，而认知和身体功能严重受损的参与者则更不可能获益，但需要在更大的人群中进行进一步研究，也许需要使用更大的剂量。
