Urinary Incontinence Clinical Trial
— GROUPOfficial title:
Group Physiotherapy Compared to Individual Physiotherapy to Treat Urinary Incontinence in Aging Women: A Randomized Control Trial
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.
Status | Active, not recruiting |
Enrollment | 362 |
Est. completion date | December 2024 |
Est. primary completion date | June 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 60 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Laboratoire incontinence et vieillissement CRIUGM | Montréal | Quebec |
Lead Sponsor | Collaborator |
---|---|
Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | Change in UI related self-efficacy | evaluated using the Geriatric self-efficacy index | at recruitment, 13 weeks after recruitment and 12 months after recruitment | |
Secondary | 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 | |
Secondary | Costs related to interventions | evaluated using the modified Dowel-Bryant Incontinence Cost Index | at recruitment, 13 weeks after recruitment and 12 months after recruitment | |
Secondary | Changes in anthropometric measurements | evaluated using height and weight measurements | at recruitment, 13 weeks after recruitment and 12 months after recruitment | |
Secondary | 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 | |
Secondary | Change in PFM morphology | evaluated using transperineal US | at recruitment, 13 weeks after recruitment and 12 months after recruitment | |
Secondary | 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 | |
Secondary | 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 |
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