Urinary IncontinenceGROUPNCT02039830
Group Versus Individual Physiotherapy for Urinary Incontinence in Aging Women
A study testing Group physiotherapy and Individual one-on-one physiotherapy in people with Urinary Incontinence and Urinary Stress Incontinence, run by Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older, women only
- Conditions the study is for
- Urinary Incontinence, Urinary Stress Incontinence
- What is being tested?
- Group physiotherapy and Individual one-on-one physiotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 362 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2012to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Laboratoire incontinence et vieillissement CRIUGM
Montreal, Quebec, H3W 1W5
About this study
Official 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.
Read the 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.
- Conditions
- Urinary Incontinence, Urinary Stress Incontinence
- Being tested
- Group physiotherapy, Individual one-on-one physiotherapy
- Keywords
- female, aging, physiotherapy, pelvic floor, rehabilitation
- Medical subject headings
- Urinary Incontinence, Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group physiotherapyBehavioural
Multimodal Group physiotherapy 12 weeks of weekly Group physiotherapy treatments including education and pelvic floor muscle exercises
Individual one-on-one physiotherapyBehavioural
Multimodal Individual physiotherapy 12 weeks of weekly Individual physiotherapy treatments including education and pelvic floor muscle exercises
| Study group | Role | What they receive |
|---|---|---|
| Group physiotherapy | Experimental | 12 weekly treatment visit + daily home exercise program Receives: Behavioral: Group physiotherapy |
| Individual one-on-one physiotherapy | Active comparator | 12 weekly treatment visit + daily home exercise program Receives: Behavioral: Individual one-on-one physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the number of UI episodes
evaluated with a 7-day bladder diary
Measured: at recruitment, 13 weeks after recruitment and 12 months after recruitment, and 8 years after recruitment for those who completed the 12-month evaluation
Secondary outcomes (15)
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)
Measured: 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 International Consultation on Incontinence questionnaire on nocturia (ICIQ-Nocturia)
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: at recruitment, 13 weeks after recruitment and 12 months after recruitment
UI related self-efficacy
evaluated using the Broom PFM Self-efficacy scale
Measured: 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
Measured: 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
Measured: at recruitment, 13 weeks after recruitment and 12 months after recruitment
PFM function
evaluated combining digital palpation (Oxford scale), vaginal atrophy index and dynamometry
Measured: at recruitment, 13 weeks after recruitment and 12 months after recruitment
PFM morphology
evaluated using transperineal US
Measured: 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
Measured: 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
Measured: 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.
Measured: 8 years after recruitement for those who completed the 12-month evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2014 (estimated)
- Study startJul 2012
- Primary completionJun 2018
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 362 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chantal Dumoulin, Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
- Investigators
- Chantal Dumoulin, Ph.D., Principal investigator, Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02039830
- Sponsor's protocol ID
- CRC01:GROUP
- Other IDs
- CIHR258993
- Acronym
- GROUP
- Status last verified
- Sep 2025
- First submitted
- 12 Dec 2013
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 29145873Cacciari 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.
PubMed 35753969Dumoulin 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.
PubMed 32744599Cacciari 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.
PubMed 41405686Hay-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.
PubMed 39704322
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Group Physiotherapy Compared to Individual Physiotherapy to Treat Urinary Incontinence in Aging Women: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT02039830
- Acronym / sponsor ID
- GROUP / CRC01:GROUP
- Conditions
- Urinary Incontinence, Urinary Stress Incontinence
- Keywords
- female, aging, physiotherapy, pelvic floor, rehabilitation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 362 participants (actual)
- Lead sponsor
- Centre de Recherche de l'Institut Universitaire de Geriatrie de MontrealUniversity, hospital or other
- Study start
- Jul 2012 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Dec 2027 (estimated)
- First posted
- 20 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group physiotherapy | Experimental | Behavioral: Group physiotherapy12 weekly treatment visit + daily home exercise program |
| Individual one-on-one physiotherapy | Active comparator | Behavioral: Individual one-on-one physiotherapy12 weekly treatment visit + daily home exercise program |
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group physiotherapyMultimodal Group physiotherapy 12 weeks of weekly Group physiotherapy treatments including education and pelvic floor muscle exercises | Behavioural | Group physiotherapy |
| Individual one-on-one physiotherapyMultimodal Individual physiotherapy 12 weeks of weekly Individual physiotherapy treatments including education and pelvic floor muscle exercises | Behavioural | Individual one-on-one physiotherapy |
Primary outcome
Change in the number of UI episodes
Time frame: at recruitment, 13 weeks after recruitment and 12 months after recruitment, and 8 years after recruitment for those who completed the 12-month evaluation
evaluated with a 7-day bladder diary
15 secondary outcomes
Symptoms and degree to which UI-associated symptoms are troubling or bothersome
Time frame: 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
Time frame: 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
Time frame: at recruitment, 13 weeks after recruitment and 12 months after recruitment.
Symptoms and degree to which UI-associated symptoms are troubling or bothersome
Time frame: at recruitment, 13 weeks after recruitment and 12 months after recruitment.
Symptoms and degree to which UI-associated symptoms are troubling or bothersome
Time frame: at recruitment, 13 weeks after recruitment and 12 months after recruitment.
UI related QOL
Time frame: 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
Time frame: at recruitment, 13 weeks after recruitment and 12 months after recruitment
UI related self-efficacy
Time frame: 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
Time frame: 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
Time frame: at recruitment, 13 weeks after recruitment and 12 months after recruitment
PFM function
Time frame: at recruitment, 13 weeks after recruitment and 12 months after recruitment
PFM morphology
Time frame: at recruitment, 13 weeks after recruitment and 12 months after recruitment
Patient reported improvement and satisfaction
Time frame: 13 weeks after recruitment and 12 months after recruitment
Adherence to intervention and home exercises
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, and 8 years after recruitment for those who completed the 12-month evaluation
Qualitative interview
Time frame: 8 years after recruitement for those who completed the 12-month evaluation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Background: PubMed 29145873Dumoulin 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 publication: PubMed 35753969Cacciari 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 publication: PubMed 32744599Dumoulin 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.
- Derived from this study: PubMed 41405686Cacciari 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.
- Derived from this study: PubMed 39704322Hay-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chantal Dumoulin, Ph.D. principal investigator
Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group physiotherapy and Individual one-on-one physiotherapy in people with Urinary Incontinence and Urinary Stress Incontinence, run by Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the number of UI episodes (time frame: at recruitment, 13 weeks after recruitment and 12 months after recruitment, and 8 years after recruitment for those who completed the 12-month evaluation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02039830, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.