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| ID | Type | Description | Link |
|---|---|---|---|
| CIHR258993 | Other Grant/Funding Number | Canadian Institute of Health Research |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group physiotherapy | Experimental | 12 weekly treatment visit + daily home exercise program |
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| Individual one-on-one physiotherapy | Active Comparator | 12 weekly treatment visit + daily home exercise program |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group physiotherapy | Behavioral | Multimodal Group physiotherapy 12 weeks of weekly Group physiotherapy treatments including education and pelvic floor muscle exercises |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in the number of UI episodes | evaluated with a 7-day bladder diary | at recruitment, 13 weeks after recruitment and 12 months after recruitment, and 8 years after recruitment for those who completed the 12-month evaluation |
| Measure | Description | Time Frame |
|---|---|---|
| Symptoms and degree to which UI-associated symptoms are troubling or bothersome | evaluated using the International Consultation on Incontinence questionnaire on urinary incontinence (ICIQ-UI short form) | at recruitment, 13 weeks after recruitment and 12 months after recruitment, and 8 years after recruitment for those who completed the 12-month evaluation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chantal Dumoulin, Ph.D. | Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laboratoire incontinence et vieillissement CRIUGM | Montreal | Quebec | H3W 1W5 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29145873 | Background | Dumoulin C, Morin M, Mayrand MH, Tousignant M, Abrahamowicz M. Group physiotherapy compared to individual physiotherapy to treat urinary incontinence in aging women: study protocol for a randomized controlled trial. Trials. 2017 Nov 16;18(1):544. doi: 10.1186/s13063-017-2261-4. | |
| 35753969 | Result | Cacciari LP, Kouakou CR, Poder TG, Vale L, Morin M, Mayrand MH, Tousignant M, Dumoulin C. Group-based pelvic floor muscle training is a more cost-effective approach to treat urinary incontinence in older women: economic analysis of a randomised trial. J Physiother. 2022 Jul;68(3):191-196. doi: 10.1016/j.jphys.2022.06.001. Epub 2022 Jun 23. |
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| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014550 | Urinary Incontinence, Stress |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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| Individual one-on-one physiotherapy | Behavioral | Multimodal Individual physiotherapy 12 weeks of weekly Individual physiotherapy treatments including education and pelvic floor muscle exercises |
|
| Symptoms and degree to which UI-associated symptoms are troubling or bothersome | evaluated using the International Consultation on Incontinence questionnaire on nocturia (ICIQ-Nocturia) | 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 | evaluated using the 24h PAD test | at recruitment, 13 weeks after recruitment and 12 months after recruitment. |
| Symptoms and degree to which UI-associated symptoms are troubling or bothersome | evaluated using the International Consultation on Incontinence Questionnaire - Vaginal Symptoms Module (ICIQ-VS) | at recruitment, 13 weeks after recruitment and 12 months after recruitment. |
| Symptoms and degree to which UI-associated symptoms are troubling or bothersome | evaluated using the International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms Modules (ICIQ-FLUTS) | at recruitment, 13 weeks after recruitment and 12 months after recruitment. |
| UI related QOL | evaluated using the International Consultation on Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life Module (ICIQ-LUTSqol) | at recruitment, 13 weeks after recruitment and 12 months after recruitment, and 8 years after recruitment for those who completed the 12-month evaluation |
| UI related self-efficacy | evaluated using the Geriatric self-efficacy index | at recruitment, 13 weeks after recruitment and 12 months after recruitment |
| 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, and 8 years after recruitment for those who completed the 12-month evaluation |
| Costs related to interventions | evaluated using the modified Dowel-Bryant Incontinence Cost Index | 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 | evaluated using height and weight measurements, which will be combined to report BMI in kg/m^2 | at recruitment, 13 weeks after recruitment and 12 months after recruitment |
| PFM function | evaluated combining digital palpation (Oxford scale), vaginal atrophy index and dynamometry | at recruitment, 13 weeks after recruitment and 12 months after recruitment |
| 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) and 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, and 8 years after recruitment for those who completed the 12-month evaluation |
| Qualitative interview | evaluated using homemade questionnaire including assiduity to lifestyle modification, changes in general health status, changes in medication, perceived change in UI symptoms, consultation with healthcare professionals for UI, and use of additional treatments for UI. | 8 years after recruitement for those who completed the 12-month evaluation |
| 32744599 | Result | Dumoulin C, Morin M, Danieli C, Cacciari L, Mayrand MH, Tousignant M, Abrahamowicz M; Urinary Incontinence and Aging Study Group. Group-Based vs Individual Pelvic Floor Muscle Training to Treat Urinary Incontinence in Older Women: A Randomized Clinical Trial. JAMA Intern Med. 2020 Oct 1;180(10):1284-1293. doi: 10.1001/jamainternmed.2020.2993. |
| 41405686 | Derived | Cacciari LP, Morin M, Mayrand MH, Dumoulin C. Incontinence in Older Women: When to Expect Meaningful Leakage Reduction from Pelvic Floor Muscle Training. Int Urogynecol J. 2026 Jun;37(6):1605-1612. doi: 10.1007/s00192-025-06486-3. Epub 2025 Dec 17. |
| 39704322 | Derived | Hay-Smith EJC, Starzec-Proserpio M, Moller B, Aldabe D, Cacciari L, Pitangui ACR, Vesentini G, Woodley SJ, Dumoulin C, Frawley HC, Jorge CH, Morin M, Wallace SA, Weatherall M. Comparisons of approaches to pelvic floor muscle training for urinary incontinence in women. Cochrane Database Syst Rev. 2024 Dec 20;12(12):CD009508. doi: 10.1002/14651858.CD009508.pub2. |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |