小组式、社区成员干预对尿失禁和大便失禁的效果：一项随机对照试验。
Small-Group, Community-Member Intervention for Urinary and Bowel Incontinence: A Randomized Controlled Trial.
机构信息
Departments of Obstetrics and Gynecology, Urology, Biostatistics, Population Health Sciences, and Medicine, University of Wisconsin-Madison School of Medicine and Public Health, the University of Wisconsin-Madison School of Pharmacy, Sonderegger Research Center, and the Wisconsin Institute for Healthy Aging, Community-Academic Aging Research Network, Madison, and the Medical College of Wisconsin, Milwaukee, Wisconsin; and the Department of Women's Health, Dell Medical School, the University of Texas at Austin, Austin, Texas.
出版信息
Obstet Gynecol. 2019 Sep;134(3):600-610. doi: 10.1097/AOG.0000000000003422.
OBJECTIVE
To evaluate the effects of Mind Over Matter: Healthy Bowels, Healthy Bladder, a small-group intervention, on urinary and bowel incontinence symptoms among older women with incontinence.
METHODS
In this individually randomized group treatment trial, women aged 50 years and older with urinary, bowel incontinence, or both, were randomly allocated at baseline to participate in Mind Over Matter: Healthy Bowels, Healthy Bladder immediately (treatment group) or after final data collection (waitlist control group). The primary outcome was urinary incontinence (UI) improvement on the Patient Global Impression of Improvement at 4 months. Validated instruments assessed incontinence, self-efficacy, depression, and barriers to care-seeking. Intent-to-treat analyses compared differences between groups. Target sample size, based on an anticipated improvement rate of 45% in treated women vs 11% in the control group, 90% power, type I error of 0.05, with anticipated attrition of 25%, was 110.
RESULTS
Among 121 women randomized (62 treatment group; 59 control group), 116 (95%) completed the 4-month assessment. Most participants were non-Hispanic white (97%), with a mean age of 75 years (SD 9.2, range 51-98); 66% had attended some college. There were no significant between-group differences at baseline. At 4 months, 71% of treated women vs 23% of women in the control group reported improved UI on Patient Global Impression of Improvement (P<.001); 39% vs 5% were much improved (P<.001). Regarding bowel incontinence, 55% of treated women vs 27% of women in the control group improved on Patient Global Impression of Improvement (P<.005), with 35% vs 11% reporting much improvement (P<.005). Treated women improved significantly more than women in the control group on all validated instruments of incontinence severity, quality of life, and self-efficacy. Care-seeking rates were similar between groups.
CONCLUSION
Participation in a small-group intervention improves symptoms of both urinary and bowel incontinence in older women. Mind Over Matter is a feasible model with potential to bring effective behavioral solutions to the community.
CLINICAL TRIAL REGISTRATION
ClinicalTrials.gov, NCT03140852.
目的
评估“心灵掌控：健康肠道，健康膀胱”这一小组干预措施对有尿失禁的老年女性的尿失禁和肠道失禁症状的影响。
方法
在这项个体随机分组治疗试验中，年龄在 50 岁及以上、有尿失禁、肠道失禁或同时有两种失禁的女性，在基线时被随机分配立即参加“心灵掌控：健康肠道，健康膀胱”（治疗组）或在最后一次数据收集后参加（候补对照组）。主要结局是在 4 个月时患者整体改善印象评估中的尿失禁（UI）改善。使用经过验证的工具评估失禁、自我效能、抑郁和寻求护理的障碍。意向治疗分析比较了两组之间的差异。基于治疗组妇女预期改善率为 45%，对照组为 11%，90%的功效，0.05 的Ⅰ型错误，预计 25%的流失率，目标样本量为 110。
结果
在 121 名随机分配的女性中（62 名治疗组；59 名对照组），116 名（95%）完成了 4 个月的评估。大多数参与者是非西班牙裔白人（97%），平均年龄为 75 岁（标准差 9.2，范围 51-98）；66%的人上过一些大学。基线时两组之间没有显著差异。在 4 个月时，71%的治疗组女性和 23%的对照组女性在患者整体改善印象上报告了 UI 的改善（P<.001）；39%和 5%有明显改善（P<.001）。关于肠道失禁，55%的治疗组女性和 27%的对照组女性在患者整体改善印象上有改善（P<.005），35%和 11%有明显改善（P<.005）。治疗组女性在所有经过验证的尿失禁严重程度、生活质量和自我效能的工具上的改善均显著大于对照组女性。两组的寻求护理的比率相似。
结论
参加小组干预可以改善老年女性的尿失禁和肠道失禁症状。“心灵掌控”是一种可行的模式，有可能将有效的行为解决方案带到社区。
临床试验注册
ClinicalTrials.gov，NCT03140852。
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