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| Name | Class |
|---|---|
| Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal | OTHER |
| Réseau québécois de recherche sur le vieillissement (RQRV) | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group pelvic floor tele-rehabilitation | Experimental | 12 weekly treatment online sessions + daily home exercise program |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group pelvic floor telerehabilitation | Behavioral | Multimodal group physiotherapy: 12 weeks of weekly group physiotherapy treatments including education and pelvic floor muscle exercises delivered online + home exercise program |
| Measure | Description | Time Frame |
|---|---|---|
| number of UI episodes | number of UI episodes, evaluated with a 7-day bladder diary | at recruitment (PRE1) |
| number of UI episodes | number of UI episodes, evaluated with a 7-day bladder diary | just before the intervention (PRE2) |
| number of UI episodes | number of UI episodes, evaluated with a 7-day bladder diary | immediately after the 12-week intervention (POST) |
| number of UI episodes | number of UI episodes, evaluated with a 7-day bladder diary | 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 | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | at recruitment (PRE1) |
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive function | Cognitive function, evaluated using the Mini-Mental State Examination (MMSE) (0-30 overall score, with scores of 24 and over indicating a normal cognitive function) | at recruitment (PRE1) |
| Cognitive function |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chantale Dumoulin, PhD | Université de Montréal | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre de recherche de l'Institut universitaire de gériatrie de Montréal (CRIUGM) | Montreal | Quebec | H3W 1W4 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36325439 | Background | 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. | |
| 37239520 | Result |
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Data will be available on request to Prof Dumoulin for researchers whose proposed use of the data has been approved by ethics committee.
Available from 1 year after the publication of the main findings until five years after that publication
If proposed use of the data has been approved by ethics committee
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 25, 2026 | |
| Reset | Jun 18, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 25, 2026 | Jun 18, 2026 |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014550 | Urinary Incontinence, Stress |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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Feasibility pilot study
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N/A (single-arm study)
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| 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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 | at recruitment (PRE1) |
| UI-associated costs | UI-associated costs, using the adapted Dowell-Bryant Incontinence Cost Index (DBICI) questionnaire | immediately after the 12-week intervention (POST) |
| UI-associated costs | UI-associated costs, using the adapted Dowell-Bryant Incontinence Cost Index (DBICI) questionnaire | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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 | 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) | through intervention completion, for 12 weeks |
| Feasibility/Acceptability (dose) | Dose aspect feasibility/acceptability, evaluated using adherence to home exercises (exercises journal) | 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) | 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) | 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 | immediately after the intervention (POST) |
Cognitive function, evaluated using the Montreal Cognitive Assessment (MoCA) (0-30 overall score, with scores of 26 and over indicating a normal cognitive function)
| at recruitment (PRE1) |
| Sociodemographic characteristics | Sociodemographic characteristics, evaluated using a home-made questionnaire recording age, weight, height, living situation, marital status, education, annual income, gynecological and medical history, medication and hormones prescriptions, smoking status, along with the Questionnaire for female Urinary Incontinence Diagnosis (QUID) to determine UI type | at recruitment (PRE1) |
| Signs of vaginal atrophy | Signs of vaginal atrophy, observed during a gynecological evaluation, using the vaginal atrophy index (VAI) (6-15 overall score, with lower scores indicating more severe symptoms of vaginal atrophy) | at recruitment (PRE1) |
| Pelvic floor muscle function | Gynecological evaluation of pelvic floor muscle function, using the Laycock's PERFECT score (PERFECT is an acronym with P = power of the pelvic floor muscle contraction, measured with the modified Oxford 6-point scale: 0=no contraction, 1=flicker, 2=weak, 3=moderate, 4=good, and 5=strong; E = endurance of the pelvic floor muscle contraction, measured from 0 to 10 seconds, R = repetitions, measured from 0 to 10 contractions, F = fast contractions, measured as the number of fast maximal contractions over a period of 10 seconds, E = elevation of the posterior vaginal wall during the pelvic floor muscle contraction (yes/no), C = co-contraction of the lower abdominal muscles during the pelvic floor muscle contraction (yes/no), T = timing, with the presence of synchronous involuntary contraction of pelvic floor muscles on coughing (yes/no)) | at recruitment (PRE1) |
| Signs and severity of pelvic prolapse | Signs and severity of pelvic prolapse, observed during a gynecological evaluation, using the Baden-Walker prolapsus score (0-4 overall score, with higher scores indicating a higher severity) | at recruitment (PRE1) |
| Le 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. |
| 38315227 | Result | Le 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. |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |