Tannenbaum Cara, van den Heuvel Eleanor, Fritel Xavier, Southall Kenneth, Jutai Jeffrey, Rajabali Saima, Wagg Adrian
Institut Universitaire de Gériatrie de Montréal, Faculté de Médecine, Université de Montréal, Montréal, QC, Canada.
Brunel Institute for Ageing Studies, Brunel University, Uxbridge, UK.
Trials. 2015 Dec 10;16:565. doi: 10.1186/s13063-015-1099-x.
Urinary incontinence occurs in 40 % of women aged 65 years and over; however, only 15 % seek care and many delay healthcare seeking for years. Incontinence is associated with depression, social isolation, reduced quality of life, falls and other comorbidities. It is accompanied by an enormous cost to the individual and society. Despite the substantial implications of urinary incontinence on social, psychological and physical well-being of older women, the impact of continence promotion on urinary symptom improvement and subsequent effects on falls, quality of life, stigma, social participation and the cost of care remains unknown.
This study is a mixed methods multi-national open-label 2-arm parallel cluster randomized controlled trial aiming to recruit 1000 community-dwelling incontinent women aged 65 years and older across Quebec, Western Canada, France and United Kingdom. Participants will be recruited through community organizations. Data will be collected at 6 time points: baseline and 1 week, 3 months, 6 months, 9 months and 12 months after baseline. One of the primary objectives is to evaluate whether the continence promotion intervention improves incontinence symptoms (measured with the Patient Global Impression of Improvement questionnaire, PGI-I) at 12 months post intervention compared to the control group. Other co-primary outcomes include changes in incontinence-related stigma, fall reduction, and incremental cost-effectiveness ratio and quality-adjusted life years. Data analysis will account for correlation of outcomes (clustering) within community organizations. A qualitative sub-study will explore stigma reduction.
Community-based continence promotion programs may be a cost-effective strategy to reduce urinary incontinence, stigma and falls among older women with untreated incontinence, and simultaneously improve quality of life and healthy active life expectancy.
ClinicalTrials.gov: NCT01858493 , registered 13 May 2013.
65岁及以上女性中，40%存在尿失禁问题；然而，只有15%的患者寻求治疗，许多人拖延数年才就医。尿失禁与抑郁、社交孤立、生活质量下降、跌倒及其他合并症有关。它给个人和社会带来巨大成本。尽管尿失禁对老年女性的社会、心理和身体健康有重大影响，但促进控尿对改善泌尿症状以及对跌倒、生活质量、耻辱感、社会参与和护理成本的后续影响仍不明确。
本研究是一项混合方法的多国开放标签双臂平行整群随机对照试验，旨在招募魁北克、加拿大西部、法国和英国1000名65岁及以上社区居住的尿失禁女性。参与者将通过社区组织招募。将在6个时间点收集数据：基线以及基线后1周、3个月、6个月、9个月和12个月。主要目标之一是评估与对照组相比，促进控尿干预在干预后12个月时是否能改善尿失禁症状（用患者总体改善印象问卷，PGI-I测量）。其他共同主要结局包括尿失禁相关耻辱感的变化、跌倒减少、增量成本效益比和质量调整生命年。数据分析将考虑社区组织内结局的相关性（聚类）。一项定性子研究将探索耻辱感的减轻。
基于社区的控尿促进项目可能是一种具有成本效益的策略，可减少未治疗尿失禁老年女性的尿失禁、耻辱感和跌倒情况，同时改善生活质量和健康积极预期寿命。
ClinicalTrials.gov：NCT01858493，2013年5月13日注册。
