Group Versus Individual Physiotherapy for Urinary Incontinence in Aging Women

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Group Physiotherapy Compared to Individual Physiotherapy to Treat Urinary Incontinence in Aging Women: A Randomized Control Trial

Conditions
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Urinary Incontinence, Urinary Stress Incontinence

Intervention / Treatment
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* Behavioral: Group physiotherapy
* Behavioral: Individual one-on-one physiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group physiotherapy<br>12 weekly treatment visit + daily home exercise program | Behavioral: Group physiotherapy<br>* Multimodal Group physiotherapy 12 weeks of weekly Group physiotherapy treatments including education and pelvic floor muscle exercises<br>|
| Active Comparator: Individual one-on-one physiotherapy<br>12 weekly treatment visit + daily home exercise program | Behavioral: Individual one-on-one physiotherapy<br>* Multimodal Individual physiotherapy 12 weeks of weekly Individual physiotherapy treatments including education and pelvic floor muscle exercises<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent reduction in the number of UI episodes | evaluated with a 7-day bladder diary | at recruitment, 13 weeks after recruitment and 12 months after recruitment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the symptoms and the degree to which UI-associated symptoms are troubling or bothersome | evaluated using the 24h PAD test, International Consultation on Incontinence questionnaire on urinary incontinence (ICIQ-UI short form (symptoms), ICIQ-Nocturia (symptoms), ICIQ-Vaginal Symptoms(symptoms), ICIQ-FemaleLowerUrinaryTractSsex (symptoms) | at recruitment, 13 weeks after recruitment and 12 months after recruitment | 
| Change in UI related QOL | evaluated using the ICIQ-Lower UrinaryTract Symptoms quality of life(QOL) | at recruitment, 13 weeks after recruitment and 12 months after recruitment | 
| Change in UI related self-efficacy | evaluated using the Geriatric self-efficacy index | at recruitment, 13 weeks after recruitment and 12 months after recruitment | 
| Change in UI related self-efficacy | evaluated using the Broom PFM Self-efficacy scale | 13 weeks after recruitment (recollection of what was before recruitment and what is now) and 12 months after recruitment | 
| Costs related to interventions | evaluated using the modified Dowel-Bryant Incontinence Cost Index | at recruitment, 13 weeks after recruitment and 12 months after recruitment | 
| Changes in anthropometric measurements | evaluated using height and weight measurements | at recruitment, 13 weeks after recruitment and 12 months after recruitment | 
| Change in PFM function | evaluated using digital palpation (Oxford scale), Vaginal atrophy index, dynamometry | at recruitment, 13 weeks after recruitment and 12 months after recruitment | 
| Change in PFM morphology | evaluated using transperineal US | at recruitment, 13 weeks after recruitment and 12 months after recruitment | 
| Patient reported improvement and satisfaction | evaluated using Patient global impression of improvement (PGI-I), Benefit and willingness | 13 weeks after recruitment and 12 months after recruitment | 
| Adherence to intervention and home exercises | evaluated using homemade questionnaire including attendance to intervention and assiduity to home exercises program | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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female, aging, physiotherapy, pelvic floor, rehabilitation