Urinary IncontinenceNCT05182632
Tele-rehabilitation Group Program for Urinary Incontinence in Older Women
A study testing Group pelvic floor telerehabilitation in people with Urinary Incontinence and Urinary Stress Incontinence, run by Université de Montréal at 1 site in Canada.
Trial summary
The recommended treatment for urinary incontinence (UI) in women is individualized pelvic floor muscle training (PFMT), a costly and resource-intensive approach; one Canada is currently unable to meet. Read more about this study
- Who is it for?
- Ages 65 years and older, women only
- Conditions the study is for
- Urinary Incontinence, Urinary Stress Incontinence
- What is being tested?
- Group pelvic floor telerehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteCanada
- Study dates
- 6 Mar 2021to 6 Apr 2026
- 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 65 years and older
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- 65 or older, as older women will show a particular genitourinary profile compared with younger women, notably due to menopause. This age cut-off was used in other studies in UI;
- Ambulatory (able to walk, move about safely and autonomously without any mobility device);
- Describe a pattern of stress/mixed UI, confirmed using the Questionnaire for Incontinence Diagnosis (QUID);
- Have at least three urinary leakage per week, persisting for 3 months or more;
- Understand French or English instructions;
- Report no important cognitive deficit (determined with a Mini-Mental State Evaluation (MMSE) score of 24/30 or more);
- Have an internet access; and
- Able to give informed consent and complete a gynecological examination and fill 7-day bladder diaries and questionnaires.
Who cannot join
- Present risk factors known to interfere with the effects of PFMT or with the PFM evaluation, including chronic constipation (as defined by the International Working Committee for Chronic Constipation), important pelvic organ prolapse (Baden-Walker score > stage 2), or any other comorbidities with a potential impact on the treatment (i.e. cognitive impairment, diabetes, active cancer, respiratory or cardiovascular conditions, etc);
- Currently taking medication for UI or medications affecting skeletal muscles;
- Considered obese with a body mass index (BMI) over 35;
- Had an active urinary or vaginal infection in the past 3 months;
- Underwent a change in hormonal replacement therapy in the past 6 months;
- Received pelvic floor physiotherapy treatment or surgery for UI or pelvic organ prolapse in the past year
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre de recherche de l'Institut universitaire de gériatrie de Montréal (CRIUGM)
Montreal, Quebec, H3W 1W4
About this study
Official title: Feasibility, Acceptability and Effects of a Tele-rehabilitation Pelvic Floor Muscle Training Group Program for Urinary Incontinence in Older Women
The recommended treatment for urinary incontinence (UI) in women is individualized pelvic floor muscle training (PFMT), a costly and resource-intensive approach; one Canada is currently unable to meet.
A recent non-inferiority randomized controlled trial just confirmed that group-based PFMT is equally effective but less resource-intensive (more cost-effective) than individual PFMT to treat UI in older women (ClinicalTrials.gov Identifier: NCT02039830). In times of COVID-19 however, with the Quebec, Canada's public health authorities preventing gatherings to stop the virus' spread, the potential of in-person group approaches is temporarily limited. It is thus important to develop innovative ways to deliver this first-line treatment remotely, particularly for those confined at home for whom UI can have a detrimental impact on physical health and quality of life. Ensuring an online option for group-based PFMT would also allow to increase the accessibility of UI treatment for women living in rural or remote areas in Canada, where pelvic floor rehabilitation services are not available or scarce.
To this end, this study will assess the feasibility, acceptability and effects of a tele-rehabilitation PFMT group program for UI in older women.
- Conditions
- Urinary Incontinence, Urinary Stress Incontinence
- Being tested
- Group pelvic floor telerehabilitation
- Keywords
- female, aging, physiotherapy, physical therapy, pelvic floor, rehabilitation, telerehabilitation
- 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 pelvic floor telerehabilitationBehavioural
Multimodal group physiotherapy: 12 weeks of weekly group physiotherapy treatments including education and pelvic floor muscle exercises delivered online + home exercise program
| Study group | Role | What they receive |
|---|---|---|
| Group pelvic floor tele-rehabilitation | Experimental | 12 weekly treatment online sessions + daily home exercise program Receives: Behavioral: Group pelvic floor telerehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of UI episodes
number of UI episodes, evaluated with a 7-day bladder diary
Measured: at recruitment (PRE1)
number of UI episodes
number of UI episodes, evaluated with a 7-day bladder diary
Measured: just before the intervention (PRE2)
number of UI episodes
number of UI episodes, evaluated with a 7-day bladder diary
Measured: immediately after the 12-week intervention (POST)
number of UI episodes
number of UI episodes, evaluated with a 7-day bladder diary
Measured: 6 months after the end of the 12-week intervention (FOLLOW-UP)
percentage reduction (%) in the number of UI episodes
percentage reduction (%) in the number of UI episodes, evaluated with a 7-day bladder diary
Measured: at recruitment (PRE1), just before the intervention (PRE2), immediately after the 12-week intervention (POST), 6 months after the end of the 12-week intervention (FOLLOW-UP)
Secondary outcomes (38)
urinary symptoms and degree to which UI-associated symptoms are troubling or bothersome
urinary symptoms and degree to which UI-associated symptoms are troubling or bothersome, evaluated using the International Consultation on Incontinence Questionnaire module on UI symptoms (ICIQ-UI) short form (0-21 overall score, with higher scores indicating more sever symptoms)
Measured: at recruitment (PRE1)
urinary symptoms and degree to which UI-associated symptoms are troubling or bothersome
urinary symptoms and degree to which UI-associated symptoms are troubling or bothersome, evaluated using the International Consultation on Incontinence Questionnaire module on UI symptoms (ICIQ-UI) short form (0-21 overall score, with higher scores indicating more sever symptoms)
Measured: just before the intervention (PRE2)
urinary symptoms and degree to which UI-associated symptoms are troubling or bothersome
urinary symptoms and degree to which UI-associated symptoms are troubling or bothersome, evaluated using the International Consultation on Incontinence Questionnaire module on UI symptoms (ICIQ-UI) short form (0-21 overall score, with higher scores indicating more sever symptoms)
Measured: immediately after the 12-week intervention (POST)
urinary symptoms and degree to which UI-associated symptoms are troubling or bothersome
urinary symptoms and degree to which UI-associated symptoms are troubling or bothersome, evaluated using the International Consultation on Incontinence Questionnaire module on UI symptoms (ICIQ-UI) short form (0-21 overall score, with higher scores indicating more sever symptoms)
Measured: 6 months after the end of the 12-week intervention (FOLLOW-UP)
Changes in urinary symptoms and degree to which UI-associated symptoms are troubling or bothersome
urinary symptoms and degree to which UI-associated symptoms are troubling or bothersome, evaluated using the International Consultation on Incontinence Questionnaire module on UI symptoms (ICIQ-UI) short form (0-21 overall score, with higher scores indicating more sever symptoms)
Measured: at recruitment (PRE1), just before the intervention (PRE2), immediately after the 12-week intervention (POST), 6 months after the end of the 12-week intervention (FOLLOW-UP)
bladder, bowel, pelvic organ prolapse and sexual function symptoms and degree to which these symptoms are troubling or bothersome
bladder, bowel, pelvic organ prolapse and sexual function symptoms and degree to which these symptoms are troubling or bothersome, evaluated using the Australian Pelvic Floor Questionnaire (APFQ) (0-45 score for bladder symptoms, 0-34 score for bowel symptoms, 0-15 score for pelvic organ prolapse symptoms, and 0-21 score for sexual function symptoms, with higher scores indicating more severe symptoms)
Measured: at recruitment (PRE1)
bladder, bowel, pelvic organ prolapse and sexual function symptoms and degree to which these symptoms are troubling or bothersome
bladder, bowel, pelvic organ prolapse and sexual function symptoms and degree to which these symptoms are troubling or bothersome, evaluated using the Australian Pelvic Floor Questionnaire (APFQ) (0-45 score for bladder symptoms, 0-34 score for bowel symptoms, 0-15 score for pelvic organ prolapse symptoms, and 0-21 score for sexual function symptoms, with higher scores indicating more severe symptoms)
Measured: just before the intervention (PRE2)
bladder, bowel, pelvic organ prolapse and sexual function symptoms and degree to which these symptoms are troubling or bothersome
bladder, bowel, pelvic organ prolapse and sexual function symptoms and degree to which these symptoms are troubling or bothersome, evaluated using the Australian Pelvic Floor Questionnaire (APFQ) (0-45 score for bladder symptoms, 0-34 score for bowel symptoms, 0-15 score for pelvic organ prolapse symptoms, and 0-21 score for sexual function symptoms, with higher scores indicating more severe symptoms)
Measured: immediately after the 12-week intervention (POST)
bladder, bowel, pelvic organ prolapse and sexual function symptoms and degree to which these symptoms are troubling or bothersome
bladder, bowel, pelvic organ prolapse and sexual function symptoms and degree to which these symptoms are troubling or bothersome, evaluated using the Australian Pelvic Floor Questionnaire (APFQ) (0-45 score for bladder symptoms, 0-34 score for bowel symptoms, 0-15 score for pelvic organ prolapse symptoms, and 0-21 score for sexual function symptoms, with higher scores indicating more severe symptoms)
Measured: 6 months after the end of the 12-week intervention (FOLLOW-UP)
Changes in bladder, bowel, pelvic organ prolapse and sexual function symptoms and degree to which these symptoms are troubling or bothersome
bladder, bowel, pelvic organ prolapse and sexual function symptoms and degree to which these symptoms are troubling or bothersome, evaluated using the Australian Pelvic Floor Questionnaire (APFQ) (0-45 score for bladder symptoms, 0-34 score for bowel symptoms, 0-15 score for pelvic organ prolapse symptoms, and 0-21 score for sexual function symptoms, with higher scores indicating more severe symptoms)
Measured: at recruitment (PRE1), just before the intervention (PRE2), immediately after the 12-week intervention (POST), 6 months after the end of the 12-week intervention (FOLLOW-UP)
UI-related quality of life
UI-related quality of life, evaluated using the International Consultation on Incontinence Questionnaire module on Lower Urinary Tract Symptoms quality of life (ICIQ-LUTS QoL) (19-76 overall score with greater values indicating increased impact on quality of life)
Measured: at recruitment (PRE1)
UI-related quality of life
UI-related quality of life, evaluated using the International Consultation on Incontinence Questionnaire module on Lower Urinary Tract Symptoms quality of life (ICIQ-LUTS QoL) (19-76 overall score with greater values indicating increased impact on quality of life)
Measured: just before the intervention (PRE2)
UI-related quality of life
UI-related quality of life, evaluated using the International Consultation on Incontinence Questionnaire module on Lower Urinary Tract Symptoms quality of life (ICIQ-LUTS QoL) (19-76 overall score with greater values indicating increased impact on quality of life)
Measured: immediately after the 12-week intervention (POST)
UI-related quality of life
UI-related quality of life, evaluated using the International Consultation on Incontinence Questionnaire module on Lower Urinary Tract Symptoms quality of life (ICIQ-LUTS QoL) (19-76 overall score with greater values indicating increased impact on quality of life)
Measured: 6 months after the end of the 12-week intervention (FOLLOW-UP)
Changes in UI-related quality of life
UI-related quality of life, evaluated using the International Consultation on Incontinence Questionnaire module on Lower Urinary Tract Symptoms quality of life (ICIQ-LUTS QoL) (19-76 overall score with greater values indicating increased impact on quality of life)
Measured: at recruitment (PRE1), just before the intervention (PRE2), immediately after the 12-week intervention (POST), 6 months after the end of the 12-week intervention (FOLLOW-UP)
UI-associated costs
UI-associated costs, using the adapted Dowell-Bryant Incontinence Cost Index (DBICI) questionnaire
Measured: at recruitment (PRE1)
UI-associated costs
UI-associated costs, using the adapted Dowell-Bryant Incontinence Cost Index (DBICI) questionnaire
Measured: immediately after the 12-week intervention (POST)
UI-associated costs
UI-associated costs, using the adapted Dowell-Bryant Incontinence Cost Index (DBICI) questionnaire
Measured: 6 months after the end of the 12-week intervention (FOLLOW-UP)
technology self-efficacy
technology self-efficacy, evaluated using the Online Technologies Self-efficacy Scale (OTSES) questionnaire (30-120 overall score, with higher scores indicating lower level of technology self-efficacy)
Measured: at recruitment (PRE1)
technology self-efficacy
technology self-efficacy, evaluated using the Online Technologies Self-efficacy Scale (OTSES) questionnaire (30-120 overall score, with higher scores indicating lower level of technology self-efficacy)
Measured: immediately after the 12-week intervention (POST)
technology self-efficacy
technology self-efficacy, evaluated using the Online Technologies Self-efficacy Scale (OTSES) questionnaire (30-120 overall score, with higher scores indicating lower level of technology self-efficacy)
Measured: 6 months after the end of the 12-week intervention (FOLLOW-UP)
UI related self-efficacy
UI related self-efficacy, evaluated using the geriatric self-efficacy scale (GES) (0-120 overall score, with higher scores indicating higher level of self-efficacy related to urinary incontinence)
Measured: at recruitment (PRE1)
UI related self-efficacy
UI related self-efficacy, evaluated using the geriatric self-efficacy scale (GES) (0-120 overall score, with higher scores indicating higher level of self-efficacy related to urinary incontinence)
Measured: immediately after the 12-week intervention (POST)
UI related self-efficacy
UI related self-efficacy, evaluated using the geriatric self-efficacy scale (GES) (0-120 overall score, with higher scores indicating higher level of self-efficacy related to urinary incontinence)
Measured: 6 months after the end of the 12-week intervention (FOLLOW-UP)
Pelvic floor muscles related self-efficacy
Pelvic floor muscles related self-efficacy, evaluated using the Broome's self-efficacy scale (14 items with responses ranging 0-100 for part A and 9 items with responses ranging 0-100 for part B; an overall mean self-efficacy score is calculated, also ranging 0-100)
Measured: at recruitment (PRE1)
Pelvic floor muscles related self-efficacy
Pelvic floor muscles related self-efficacy, evaluated using the Broome's self-efficacy scale (14 items with responses ranging 0-100 for part A and 9 items with responses ranging 0-100 for part B; an overall mean self-efficacy score is calculated, also ranging 0-100)
Measured: immediately after the 12-week intervention (POST)
Pelvic floor muscles related self-efficacy
Pelvic floor muscles related self-efficacy, evaluated using the Broome's self-efficacy scale (14 items with responses ranging 0-100 for part A and 9 items with responses ranging 0-100 for part B; an overall mean self-efficacy score is calculated, also ranging 0-100)
Measured: 6 months after the end of the 12-week intervention (FOLLOW-UP)
Vaginal atrophy symptoms
Vaginal atrophy symptoms, evaluated using the Atrophy Symptom Questionnaire (ASQ) (0-15 overall score, with higher scores indicating higher severity of vaginal atrophy symptoms)
Measured: at recruitment (PRE1)
Vaginal atrophy symptoms
Vaginal atrophy symptoms, evaluated using the Atrophy Symptom Questionnaire (ASQ) (0-15 overall score, with higher scores indicating higher severity of vaginal atrophy symptoms)
Measured: immediately after the 12-week intervention (POST)
Vaginal atrophy symptoms
Vaginal atrophy symptoms, evaluated using the Atrophy Symptom Questionnaire (ASQ) (0-15 overall score, with higher scores indicating higher severity of vaginal atrophy symptoms)
Measured: 6 months after the end of the 12-week intervention (FOLLOW-UP)
Patient reported improvement and satisfaction
Patient reported improvement and satisfaction, evaluated using the patient global impression of improvement (PGI-I) index, a single-item tool to capture perceived satisfaction with treatment: "satisfied" (does not need other treatments); "unsatisfied" (would like another treatment for UI)
Measured: immediately after the 12-week intervention (POST)
Patient reported improvement and satisfaction
Patient reported improvement and satisfaction, evaluated using the patient global impression of improvement (PGI-I) index, a single-item tool to capture perceived satisfaction with treatment: "satisfied" (does not need other treatments); "unsatisfied" (would like another treatment for UI)
Measured: 6 months after the end of the 12-week intervention (FOLLOW-UP)
Feasibility/Acceptability (reach)
Reach aspect of feasibility/acceptability, evaluated using attendance to weekly sessions
Measured: through intervention completion, for 12 weeks
Feasibility/Acceptability (fidelity)
Fidelity aspect of feasibility/acceptability, evaluated using the integrity of the GROUP program elements delivered by the physiotherapist during each session (checklist)
Measured: through intervention completion, for 12 weeks
Feasibility/Acceptability (dose)
Dose aspect feasibility/acceptability, evaluated using adherence to home exercises (exercises journal)
Measured: through intervention completion, for 12 weeks
Feasibility/Acceptability (perceived usability of the technology)
Perceived usability of the technology from the patients' experience as an aspect of feasibility/acceptability, evaluated using the System Usability Scale (SUS) (0-100 overall score, with higher scores indicating a higher usability)
Measured: immediately after the 12-week intervention (POST)
Feasibility/Acceptability (perceived usability of the technology)
Perceived usability of the technology from the patients' experience as an aspect of feasibility/acceptability, evaluated using the System Usability Scale (SUS) (0-100 overall score, with higher scores indicating a higher usability)
Measured: 6 months after the end of the 12-week intervention (FOLLOW-UP)
Potential challenges and satisfaction with the program from the patients' perspective
Potential challenges and satisfaction with the program from the patients' perspective, evaluated during focus groups or interviews using an interview guide developed from the seven dimensions of the Theoretical Framework of Acceptability (TFA), three of the five Consolidated Framework for Implementation Research (CFIR) domains and additional open-ended questions on satisfaction
Measured: immediately after the intervention (POST)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2022
- Study start6 Mar 2021
- Primary completion6 Apr 2022
- Study completion6 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Not applicable
- Intervention model
- Single group
- Model description
- Feasibility pilot study
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Montréal
- Sponsor type
- University, hospital or other
- Collaborators
- Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal, Réseau québécois de recherche sur le vieillissement (RQRV)
- Responsible party
- Sponsor
- Investigators
- Chantale Dumoulin, PhD, Principal investigator, Université de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05182632
- Sponsor's protocol ID
- CER VN 20-21-33
- Status last verified
- Apr 2025
- First submitted
- 21 Sep 2021
- Last updated
- 23 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be available on request to Prof Dumoulin for researchers whose proposed use of the data has been approved by ethics committee. Email: chantal.dumoulin@umontreal.ca
Publications
Le Berre M, Filiatrault J, Reichetzer B, Dumoulin C. Feasibility, acceptability and effects of a group pelvic floor muscle telerehabilitation program to treat urinary incontinence in older women. Digit Health. 2022 Oct 26;8:20552076221123720. doi: 10.1177/20552076221123720. eCollection 2022 Jan-Dec.
PubMed 36325439Le Berre M, Filiatrault J, Reichetzer B, Dumoulin C. Group-Based Pelvic Floor Telerehabilitation to Treat Urinary Incontinence in Older Women: A Feasibility Study. Int J Environ Res Public Health. 2023 May 11;20(10):5791. doi: 10.3390/ijerph20105791.
PubMed 37239520Le Berre M, Filiatrault J, Reichetzer B, Kairy D, Lachance C, Dumoulin C. Online Group-based Pelvic Floor Muscle Training for Urinary Incontinence in Older Women: a Pilot Study. Int Urogynecol J. 2024 Apr;35(4):811-822. doi: 10.1007/s00192-024-05728-0. Epub 2024 Feb 5.
PubMed 38315227
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility, Acceptability and Effects of a Tele-rehabilitation Pelvic Floor Muscle Training Group Program for Urinary Incontinence in Older Women
- ClinicalTrials.gov ID
- NCT05182632
- Acronym / sponsor ID
- CER VN 20-21-33
- Conditions
- Urinary Incontinence, Urinary Stress Incontinence
- Keywords
- female, aging, physiotherapy, physical therapy, pelvic floor, rehabilitation, telerehabilitation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Université de MontréalUniversity, hospital or other
- Collaborators
- Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal, Réseau québécois de recherche sur le vieillissement (RQRV)
- Study start
- 6 Mar 2021 (actual)
- Primary completion
- 6 Apr 2022 (actual)
- Study completion
- 6 Apr 2026 (estimated)
- First posted
- 10 Jan 2022 (actual)
- 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 individualized pelvic floor muscle training (PFMT), a costly and resource-intensive approach; one Canada is currently unable to meet.
A recent non-inferiority randomized controlled trial just confirmed that group-based PFMT is equally effective but less resource-intensive (more cost-effective) than individual PFMT to treat UI in older women (ClinicalTrials.gov Identifier: NCT02039830). In times of COVID-19 however, with the Quebec, Canada's public health authorities preventing gatherings to stop the virus' spread, the potential of in-person group approaches is temporarily limited. It is thus important to develop innovative ways to deliver this first-line treatment remotely, particularly for those confined at home for whom UI can have a detrimental impact on physical health and quality of life. Ensuring an online option for group-based PFMT would also allow to increase the accessibility of UI treatment for women living in rural or remote areas in Canada, where pelvic floor rehabilitation services are not available or scarce.
To this end, this study will assess the feasibility, acceptability and effects of a tele-rehabilitation PFMT group program for UI in older women.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Feasibility pilot study
| Arm | Type | Receives |
|---|---|---|
| Group pelvic floor tele-rehabilitation | Experimental | Behavioral: Group pelvic floor telerehabilitation12 weekly treatment online sessions + daily home exercise program |
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- 65 or older, as older women will show a particular genitourinary profile compared with younger women, notably due to menopause. This age cut-off was used in other studies in UI;
- Ambulatory (able to walk, move about safely and autonomously without any mobility device);
- Describe a pattern of stress/mixed UI, confirmed using the Questionnaire for Incontinence Diagnosis (QUID);
- Have at least three urinary leakage per week, persisting for 3 months or more;
- Understand French or English instructions;
Key exclusion criteria (6 listed)
- Present risk factors known to interfere with the effects of PFMT or with the PFM evaluation, including chronic constipation (as defined by the International Working Committee for Chronic Constipation), important pelvic organ prolapse (Baden-Walker score > stage 2), or any other comorbidities with a potential impact on the treatment (i.e. cognitive impairment, diabetes, active cancer, respiratory or cardiovascular conditions, etc);
- Currently taking medication for UI or medications affecting skeletal muscles;
- Considered obese with a body mass index (BMI) over 35;
- Had an active urinary or vaginal infection in the past 3 months;
- Underwent a change in hormonal replacement therapy in the past 6 months;
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 pelvic floor telerehabilitationMultimodal group physiotherapy: 12 weeks of weekly group physiotherapy treatments including education and pelvic floor muscle exercises delivered online + home exercise program | Behavioural | Group pelvic floor tele-rehabilitation |
Primary outcome
number of UI episodes
Time frame: at recruitment (PRE1)
number of UI episodes, evaluated with a 7-day bladder diary
number of UI episodes
Time frame: just before the intervention (PRE2)
number of UI episodes, evaluated with a 7-day bladder diary
number of UI episodes
Time frame: immediately after the 12-week intervention (POST)
number of UI episodes, evaluated with a 7-day bladder diary
number of UI episodes
Time frame: 6 months after the end of the 12-week intervention (FOLLOW-UP)
number of UI episodes, evaluated with a 7-day bladder diary
percentage reduction (%) in the number of UI episodes
Time frame: at recruitment (PRE1), just before the intervention (PRE2), immediately after the 12-week intervention (POST), 6 months after the end of the 12-week intervention (FOLLOW-UP)
percentage reduction (%) in the number of UI episodes, evaluated with a 7-day bladder diary
38 secondary outcomes
urinary symptoms and degree to which UI-associated symptoms are troubling or bothersome
Time frame: at recruitment (PRE1)
urinary symptoms and degree to which UI-associated symptoms are troubling or bothersome
Time frame: just before the intervention (PRE2)
urinary symptoms and degree to which UI-associated symptoms are troubling or bothersome
Time frame: immediately after the 12-week intervention (POST)
urinary symptoms and degree to which UI-associated symptoms are troubling or bothersome
Time frame: 6 months after the end of the 12-week intervention (FOLLOW-UP)
Changes in urinary symptoms and degree to which UI-associated symptoms are troubling or bothersome
Time frame: at recruitment (PRE1), just before the intervention (PRE2), immediately after the 12-week intervention (POST), 6 months after the end of the 12-week intervention (FOLLOW-UP)
bladder, bowel, pelvic organ prolapse and sexual function symptoms and degree to which these symptoms are troubling or bothersome
Time frame: at recruitment (PRE1)
bladder, bowel, pelvic organ prolapse and sexual function symptoms and degree to which these symptoms are troubling or bothersome
Time frame: just before the intervention (PRE2)
bladder, bowel, pelvic organ prolapse and sexual function symptoms and degree to which these symptoms are troubling or bothersome
Time frame: immediately after the 12-week intervention (POST)
bladder, bowel, pelvic organ prolapse and sexual function symptoms and degree to which these symptoms are troubling or bothersome
Time frame: 6 months after the end of the 12-week intervention (FOLLOW-UP)
Changes in bladder, bowel, pelvic organ prolapse and sexual function symptoms and degree to which these symptoms are troubling or bothersome
Time frame: at recruitment (PRE1), just before the intervention (PRE2), immediately after the 12-week intervention (POST), 6 months after the end of the 12-week intervention (FOLLOW-UP)
UI-related quality of life
Time frame: at recruitment (PRE1)
UI-related quality of life
Time frame: just before the intervention (PRE2)
UI-related quality of life
Time frame: immediately after the 12-week intervention (POST)
UI-related quality of life
Time frame: 6 months after the end of the 12-week intervention (FOLLOW-UP)
Changes in UI-related quality of life
Time frame: at recruitment (PRE1), just before the intervention (PRE2), immediately after the 12-week intervention (POST), 6 months after the end of the 12-week intervention (FOLLOW-UP)
UI-associated costs
Time frame: at recruitment (PRE1)
UI-associated costs
Time frame: immediately after the 12-week intervention (POST)
UI-associated costs
Time frame: 6 months after the end of the 12-week intervention (FOLLOW-UP)
technology self-efficacy
Time frame: at recruitment (PRE1)
technology self-efficacy
Time frame: immediately after the 12-week intervention (POST)
technology self-efficacy
Time frame: 6 months after the end of the 12-week intervention (FOLLOW-UP)
UI related self-efficacy
Time frame: at recruitment (PRE1)
UI related self-efficacy
Time frame: immediately after the 12-week intervention (POST)
UI related self-efficacy
Time frame: 6 months after the end of the 12-week intervention (FOLLOW-UP)
Pelvic floor muscles related self-efficacy
Time frame: at recruitment (PRE1)
Pelvic floor muscles related self-efficacy
Time frame: immediately after the 12-week intervention (POST)
Pelvic floor muscles related self-efficacy
Time frame: 6 months after the end of the 12-week intervention (FOLLOW-UP)
Vaginal atrophy symptoms
Time frame: at recruitment (PRE1)
Vaginal atrophy symptoms
Time frame: immediately after the 12-week intervention (POST)
Vaginal atrophy symptoms
Time frame: 6 months after the end of the 12-week intervention (FOLLOW-UP)
Patient reported improvement and satisfaction
Time frame: immediately after the 12-week intervention (POST)
Patient reported improvement and satisfaction
Time frame: 6 months after the end of the 12-week intervention (FOLLOW-UP)
Feasibility/Acceptability (reach)
Time frame: through intervention completion, for 12 weeks
Feasibility/Acceptability (fidelity)
Time frame: through intervention completion, for 12 weeks
Feasibility/Acceptability (dose)
Time frame: through intervention completion, for 12 weeks
Feasibility/Acceptability (perceived usability of the technology)
Time frame: immediately after the 12-week intervention (POST)
Feasibility/Acceptability (perceived usability of the technology)
Time frame: 6 months after the end of the 12-week intervention (FOLLOW-UP)
Potential challenges and satisfaction with the program from the patients' perspective
Time frame: immediately after the intervention (POST)
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 23 Apr 2025.
- Background: PubMed 36325439Le Berre M, Filiatrault J, Reichetzer B, Dumoulin C. Feasibility, acceptability and effects of a group pelvic floor muscle telerehabilitation program to treat urinary incontinence in older women. Digit Health. 2022 Oct 26;8:20552076221123720. doi: 10.1177/20552076221123720. eCollection 2022 Jan-Dec.
- Results publication: PubMed 37239520Le Berre M, Filiatrault J, Reichetzer B, Dumoulin C. Group-Based Pelvic Floor Telerehabilitation to Treat Urinary Incontinence in Older Women: A Feasibility Study. Int J Environ Res Public Health. 2023 May 11;20(10):5791. doi: 10.3390/ijerph20105791.
- Results publication: PubMed 38315227Le Berre M, Filiatrault J, Reichetzer B, Kairy D, Lachance C, Dumoulin C. Online Group-based Pelvic Floor Muscle Training for Urinary Incontinence in Older Women: a Pilot Study. Int Urogynecol J. 2024 Apr;35(4):811-822. doi: 10.1007/s00192-024-05728-0. Epub 2024 Feb 5.
- Individual participant dataSharing planned: Yes. Data will be available on request to Prof Dumoulin for researchers whose proposed use of the data has been approved by ethics committee. Email: chantal.dumoulin@umontreal.ca
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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.
Chantale Dumoulin, PhD principal investigator
Université de Montréal
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 pelvic floor telerehabilitation in people with Urinary Incontinence and Urinary Stress Incontinence, run by Université de Montréal 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 8 inclusion and 6 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 23 Apr 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?
number of UI episodes (time frame: at recruitment (PRE1)). The study lists 5 primary outcomes in all. 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 NCT05182632, which also lists 3 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 23 Apr 2025.