Tele-rehabilitation Group Program for Urinary Incontinence in Older Women

Study Overview
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Brief Summary
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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.

Official Title
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Feasibility, Acceptability and Effects of a Tele-rehabilitation Pelvic Floor Muscle Training Group Program for Urinary Incontinence in Older Women

Conditions
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Urinary Incontinence, Urinary Stress Incontinence

Intervention / Treatment
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* Behavioral: Group pelvic floor telerehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Feasibility pilot study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group pelvic floor tele-rehabilitation<br>12 weekly treatment online sessions + daily home exercise program | Behavioral: Group pelvic floor telerehabilitation<br>* Multimodal group physiotherapy: 12 weeks of weekly group physiotherapy treatments including education and pelvic floor muscle exercises delivered online + home exercise program<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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female, aging, physiotherapy, physical therapy, pelvic floor, rehabilitation, telerehabilitation