Group Versus Individual Physiotherapy for Urinary Incontinence in Aging Women (GROUP)
Primary Purpose
Urinary Incontinence, Urinary Stress Incontinence
Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Group physiotherapy
Individual one-on-one physiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Incontinence focused on measuring female, aging, physiotherapy, pelvic floor, rehabilitation
Eligibility 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
Sites / Locations
- Laboratoire incontinence et vieillissement CRIUGM
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group physiotherapy
Individual one-on-one physiotherapy
Arm Description
12 weekly treatment visit + daily home exercise program
12 weekly treatment visit + daily home exercise program
Outcomes
Primary Outcome Measures
Percent reduction in the number of UI episodes
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
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
evaluated using the ICIQ-Lower UrinaryTract Symptoms quality of life(QOL)
Change in UI related self-efficacy
evaluated using the Geriatric self-efficacy index
Change in UI related self-efficacy
evaluated using the Broom PFM Self-efficacy scale
Costs related to interventions
evaluated using the modified Dowel-Bryant Incontinence Cost Index
Changes in anthropometric measurements
evaluated using height and weight measurements
Change in PFM function
evaluated using digital palpation (Oxford scale), Vaginal atrophy index, dynamometry
Change in PFM morphology
evaluated using transperineal US
Patient reported improvement and satisfaction
evaluated using Patient global impression of improvement (PGI-I), Benefit and willingness
Adherence to intervention and home exercises
evaluated using homemade questionnaire including attendance to intervention and assiduity to home exercises program
Full Information
NCT ID
NCT02039830
First Posted
December 12, 2013
Last Updated
February 13, 2023
Sponsor
Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
1. Study Identification
Unique Protocol Identification Number
NCT02039830
Brief Title
Group Versus Individual Physiotherapy for Urinary Incontinence in Aging Women
Acronym
GROUP
Official Title
Group Physiotherapy Compared to Individual Physiotherapy to Treat Urinary Incontinence in Aging Women: A Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 2012 (Actual)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence, Urinary Stress Incontinence
Keywords
female, aging, physiotherapy, pelvic floor, rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
362 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group physiotherapy
Arm Type
Experimental
Arm Description
12 weekly treatment visit + daily home exercise program
Arm Title
Individual one-on-one physiotherapy
Arm Type
Active Comparator
Arm Description
12 weekly treatment visit + daily home exercise program
Intervention Type
Behavioral
Intervention Name(s)
Group physiotherapy
Intervention Description
Multimodal Group physiotherapy 12 weeks of weekly Group physiotherapy treatments including education and pelvic floor muscle exercises
Intervention Type
Behavioral
Intervention Name(s)
Individual one-on-one physiotherapy
Intervention Description
Multimodal Individual physiotherapy 12 weeks of weekly Individual physiotherapy treatments including education and pelvic floor muscle exercises
Primary Outcome Measure Information:
Title
Percent reduction in the number of UI episodes
Description
evaluated with a 7-day bladder diary
Time Frame
at recruitment, 13 weeks after recruitment and 12 months after recruitment
Secondary Outcome Measure Information:
Title
Change in the symptoms and the degree to which UI-associated symptoms are troubling or bothersome
Description
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)
Time Frame
at recruitment, 13 weeks after recruitment and 12 months after recruitment
Title
Change in UI related QOL
Description
evaluated using the ICIQ-Lower UrinaryTract Symptoms quality of life(QOL)
Time Frame
at recruitment, 13 weeks after recruitment and 12 months after recruitment
Title
Change in UI related self-efficacy
Description
evaluated using the Geriatric self-efficacy index
Time Frame
at recruitment, 13 weeks after recruitment and 12 months after recruitment
Title
Change in UI related self-efficacy
Description
evaluated using the Broom PFM Self-efficacy scale
Time Frame
13 weeks after recruitment (recollection of what was before recruitment and what is now) and 12 months after recruitment
Title
Costs related to interventions
Description
evaluated using the modified Dowel-Bryant Incontinence Cost Index
Time Frame
at recruitment, 13 weeks after recruitment and 12 months after recruitment
Title
Changes in anthropometric measurements
Description
evaluated using height and weight measurements
Time Frame
at recruitment, 13 weeks after recruitment and 12 months after recruitment
Title
Change in PFM function
Description
evaluated using digital palpation (Oxford scale), Vaginal atrophy index, dynamometry
Time Frame
at recruitment, 13 weeks after recruitment and 12 months after recruitment
Title
Change in PFM morphology
Description
evaluated using transperineal US
Time Frame
at recruitment, 13 weeks after recruitment and 12 months after recruitment
Title
Patient reported improvement and satisfaction
Description
evaluated using Patient global impression of improvement (PGI-I), Benefit and willingness
Time Frame
13 weeks after recruitment and 12 months after recruitment
Title
Adherence to intervention and home exercises
Description
evaluated using homemade questionnaire including attendance to intervention and assiduity to home exercises program
Time Frame
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chantal Dumoulin, Ph.D.
Organizational Affiliation
Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laboratoire incontinence et vieillissement CRIUGM
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3W 1W5
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
35753969
Citation
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.
Results Reference
derived
PubMed Identifier
32744599
Citation
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.
Results Reference
derived
PubMed Identifier
29145873
Citation
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.
Results Reference
derived
Learn more about this trial
Group Versus Individual Physiotherapy for Urinary Incontinence in Aging Women
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