Group Physiotherapy Compared to Individual Physiotherapy to Treat Urinary Incontinence in Aging Women: A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 362
- 试验地点
- 2
- 主要终点
- Change in the number of UI episodes
研究概览
简要总结
The recommended treatment for urinary incontinence (UI) in women is individualised pelvic floor muscle (PFM) training, a costly and resource-intense approach; one Canada is currently unable to meet. This non-inferiority randomized control trial seeks to determine if group-based PFM training is as effective as individualised PFM training for treating UI in women 65 and over, and to establish the cost-effectiveness of both. Demonstrating that group-based treatment is at least as good as individualised one-on-one treatment and more cost-effective would warrant including group-based PFM training as a first-line UI treatment.
详细描述
The incidence of urinary incontinence (UI) in women increases with age but, unbeknownst to many, it is not a normal part of aging and, in most cases, can be effectively treated. Yet today, the majority of senior women go untreated due to a lack of both human and financial resources. In Canada, there are currently 3 million senior women. Over the next 15 years their numbers are expected to grow significantly, as will the incidence of UI. The number of senior women requiring treatment, let alone the future demand, makes it imperative that more cost-effective treatments be identified. The prevalence of UI in community- dwelling women 65 and over is high - 55% experience stress or urge UI, or even both, and of these, 20 to 25% are classified as having severe symptoms. Not only is UI a serious medical condition but it is also undeniably a social problem, engendering embarrassment and negative self-perceptions. It is associated with reduced social interactions and physical activities, with poor self-rated health, impaired emotional and psychological well-being and impaired sexual relationships. Moreover, it doubles women's risk of being admitted to a nursing home, independent of age or the presence of any other co-morbid conditions. It severely undermines a woman's right to healthy aging. Without doubt, this pervasive and serious condition requires immediate attention. Demographics, the negative impact on older women's functional autonomy and the current unmet treatment needs alone renders improving continence care for older women a priority for the Institute of Aging. This study aims to evaluate if group- based physiotherapy treatment is at least as good as individualized one-on-one physiotherapy treatment for treating urinary incontinence in aging women. The treatment efficacy will be assessed in 364 women (aged 60 years and older) suffering from stress or mixed urinary incontinence and recruited in 4 hospitals and in the community.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •60 years or older
- •suffering from stress urinary incontinence (SUI) or mixed urinary incontinence (MUI) symptoms
- •at least 3 urinary incontinence episodes per week x 3 months or more
- •ambulatory without the need of assisted device
- •understand French or English instruction
- •hormonal replacement stable for 6 months
排除标准
- •present risk factors known to interfere with the effects of PFM training
- •>2 degree Pop-Q
- •body mass index >35
- •chronic constipation
- •have received physiotherapy or surgical treatment within the last year
结局指标
主要结局
Change in the number of UI episodes
时间窗: at recruitment, 13 weeks after recruitment and 12 months after recruitment, and 8 years after recruitment for those who completed the 12-month evaluation
evaluated with a 7-day bladder diary
次要结局
- Patient reported improvement and satisfaction(13 weeks after recruitment and 12 months after recruitment)
- UI related QOL(at recruitment, 13 weeks after recruitment and 12 months after recruitment, and 8 years after recruitment for those who completed the 12-month evaluation)
- Symptoms and degree to which UI-associated symptoms are troubling or bothersome(at recruitment, 13 weeks after recruitment and 12 months after recruitment.)
- Adherence to intervention and home exercises(after recruitment (once/week during 12 weeks), 13 weeks after after recruitment, 6 months after recruitment, at 9 months after recruitment, 12 months after recruitment, and 8 years after recruitment for those who completed the 12-month evaluation)
- UI related self-efficacy(13 weeks after recruitment (recollection of what was before recruitment and what is now) and 12 months after recruitment, and 8 years after recruitment for those who completed the 12-month evaluation)
- Costs related to interventions(at recruitment, 13 weeks after recruitment and 12 months after recruitment, and 8 years after recruitment for those who completed the 12-month evaluation)
- Anthropometric measurements(at recruitment, 13 weeks after recruitment and 12 months after recruitment)
- PFM function(at recruitment, 13 weeks after recruitment and 12 months after recruitment)
- PFM morphology(at recruitment, 13 weeks after recruitment and 12 months after recruitment)
- Patient reported improvement and satisfaction(13 weeks after recruitment and 12 months after recruitment)
- Qualitative interview(8 years after recruitement for those who completed the 12-month evaluation)
研究者
Chantal Dumoulin
Dr Chantal Dumoulin, researcher and laboratory director
Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal