GROUP: Group Versus Individual Physiotherapy for Urinary Incontinence in Aging Women
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Group physiotherapy 12 weekly treatment visit + daily home exercise program |
Behavioral: Group physiotherapy
Multimodal Group physiotherapy 12 weeks of weekly Group physiotherapy treatments including education and pelvic floor muscle exercises
|
| Active Comparator: Individual one-on-one physiotherapy 12 weekly treatment visit + daily home exercise program |
Behavioral: Individual one-on-one physiotherapy
Multimodal Individual physiotherapy 12 weeks of weekly Individual physiotherapy treatments including education and pelvic floor muscle exercises
|
Outcome Measures
Primary Outcome Measures
- Percent reduction in the number of UI episodes [at recruitment, 13 weeks after recruitment and 12 months after recruitment]
evaluated with a 7-day bladder diary
Secondary Outcome Measures
- Change in the symptoms and the degree to which UI-associated symptoms are troubling or bothersome [at recruitment, 13 weeks after recruitment and 12 months after recruitment]
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)
- Change in UI related QOL [at recruitment, 13 weeks after recruitment and 12 months after recruitment]
evaluated using the ICIQ-Lower UrinaryTract Symptoms quality of life(QOL)
- Change in UI related self-efficacy [at recruitment, 13 weeks after recruitment and 12 months after recruitment]
evaluated using the Geriatric self-efficacy index
- Change in UI related self-efficacy [13 weeks after recruitment (recollection of what was before recruitment and what is now) and 12 months after recruitment]
evaluated using the Broom PFM Self-efficacy scale
- Costs related to interventions [at recruitment, 13 weeks after recruitment and 12 months after recruitment]
evaluated using the modified Dowel-Bryant Incontinence Cost Index
- Changes in anthropometric measurements [at recruitment, 13 weeks after recruitment and 12 months after recruitment]
evaluated using height and weight measurements
- Change in PFM function [at recruitment, 13 weeks after recruitment and 12 months after recruitment]
evaluated using digital palpation (Oxford scale), Vaginal atrophy index, dynamometry
- Change in PFM morphology [at recruitment, 13 weeks after recruitment and 12 months after recruitment]
evaluated using transperineal US
- Patient reported improvement and satisfaction [13 weeks after recruitment and 12 months after recruitment]
evaluated using Patient global impression of improvement (PGI-I), Benefit and willingness
- 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]
evaluated using homemade questionnaire including attendance to intervention and assiduity to home exercises program
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Laboratoire incontinence et vieillissement CRIUGM | Montréal | Quebec | Canada | H3W 1W5 |
Sponsors and Collaborators
- Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
Investigators
- Principal Investigator: Chantal Dumoulin, Ph.D., Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CRC01:GROUP
- CIHR258993