Back to resultsTele-rehabilitation Group Program for Urinary Incontinence in Older Women
Primary Purpose
Urinary Incontinence, Urinary Stress Incontinence
Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Group pelvic floor telerehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Incontinence focused on measuring female, aging, physiotherapy, physical therapy, pelvic floor, rehabilitation, telerehabilitation
Eligibility Criteria
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
Sites / Locations
- Centre de recherche de l'Institut universitaire de gériatrie de Montréal (CRIUGM)
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Group pelvic floor tele-rehabilitation
Arm Description
12 weekly treatment online sessions + daily home exercise program
Outcomes
Primary Outcome Measures
number of UI episodes
number of UI episodes, evaluated with a 7-day bladder diary
number of UI episodes
number of UI episodes, evaluated with a 7-day bladder diary
number of UI episodes
number of UI episodes, evaluated with a 7-day bladder diary
number of UI episodes
number of UI episodes, evaluated with a 7-day bladder diary
percentage reduction (%) in the number of UI episodes
percentage reduction (%) in the number of UI episodes, evaluated with a 7-day bladder diary
Secondary Outcome Measures
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
UI-associated costs
UI-associated costs, using the adapted Dowell-Bryant Incontinence Cost Index (DBICI) questionnaire
UI-associated costs
UI-associated costs, using the adapted Dowell-Bryant Incontinence Cost Index (DBICI) questionnaire
UI-associated costs
UI-associated costs, using the adapted Dowell-Bryant Incontinence Cost Index (DBICI) questionnaire
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Feasibility/Acceptability (reach)
Reach aspect of feasibility/acceptability, evaluated using attendance to weekly sessions
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)
Feasibility/Acceptability (dose)
Dose aspect feasibility/acceptability, evaluated using adherence to home exercises (exercises journal)
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)
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)
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
Full Information
NCT ID
NCT05182632
First Posted
September 21, 2021
Last Updated
July 19, 2023
Sponsor
Université de Montréal
Collaborators
Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal, Réseau québécois de recherche sur le vieillissement (RQRV)
1. Study Identification
Unique Protocol Identification Number
NCT05182632
Brief Title
Tele-rehabilitation Group Program for Urinary Incontinence in Older Women
Official Title
Feasibility, Acceptability and Effects of a Tele-rehabilitation Pelvic Floor Muscle Training Group Program for Urinary Incontinence in Older Women
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 6, 2021 (Actual)
Primary Completion Date
April 6, 2022 (Actual)
Study Completion Date
March 6, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Université de Montréal
Collaborators
Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal, Réseau québécois de recherche sur le vieillissement (RQRV)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence, Urinary Stress Incontinence
Keywords
female, aging, physiotherapy, physical therapy, pelvic floor, rehabilitation, telerehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Feasibility pilot study
Masking
None (Open Label)
Masking Description
N/A (single-arm study)
Allocation
N/A
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group pelvic floor tele-rehabilitation
Arm Type
Experimental
Arm Description
12 weekly treatment online sessions + daily home exercise program
Intervention Type
Behavioral
Intervention Name(s)
Group pelvic floor telerehabilitation
Intervention Description
Multimodal group physiotherapy: 12 weeks of weekly group physiotherapy treatments including education and pelvic floor muscle exercises delivered online + home exercise program
Primary Outcome Measure Information:
Title
number of UI episodes
Description
number of UI episodes, evaluated with a 7-day bladder diary
Time Frame
at recruitment (PRE1)
Title
number of UI episodes
Description
number of UI episodes, evaluated with a 7-day bladder diary
Time Frame
just before the intervention (PRE2)
Title
number of UI episodes
Description
number of UI episodes, evaluated with a 7-day bladder diary
Time Frame
immediately after the 12-week intervention (POST)
Title
number of UI episodes
Description
number of UI episodes, evaluated with a 7-day bladder diary
Time Frame
6 months after the end of the 12-week intervention (FOLLOW-UP)
Title
percentage reduction (%) in the number of UI episodes
Description
percentage reduction (%) in the number of UI episodes, evaluated with a 7-day bladder diary
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)
Secondary Outcome Measure Information:
Title
urinary symptoms and degree to which UI-associated symptoms are troubling or bothersome
Description
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)
Time Frame
at recruitment (PRE1)
Title
urinary symptoms and degree to which UI-associated symptoms are troubling or bothersome
Description
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)
Time Frame
just before the intervention (PRE2)
Title
urinary symptoms and degree to which UI-associated symptoms are troubling or bothersome
Description
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)
Time Frame
immediately after the 12-week intervention (POST)
Title
urinary symptoms and degree to which UI-associated symptoms are troubling or bothersome
Description
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)
Time Frame
6 months after the end of the 12-week intervention (FOLLOW-UP)
Title
Changes in urinary symptoms and degree to which UI-associated symptoms are troubling or bothersome
Description
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)
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)
Title
bladder, bowel, pelvic organ prolapse and sexual function symptoms and degree to which these symptoms are troubling or bothersome
Description
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)
Time Frame
at recruitment (PRE1)
Title
bladder, bowel, pelvic organ prolapse and sexual function symptoms and degree to which these symptoms are troubling or bothersome
Description
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)
Time Frame
just before the intervention (PRE2)
Title
bladder, bowel, pelvic organ prolapse and sexual function symptoms and degree to which these symptoms are troubling or bothersome
Description
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)
Time Frame
immediately after the 12-week intervention (POST)
Title
bladder, bowel, pelvic organ prolapse and sexual function symptoms and degree to which these symptoms are troubling or bothersome
Description
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)
Time Frame
6 months after the end of the 12-week intervention (FOLLOW-UP)
Title
Changes in bladder, bowel, pelvic organ prolapse and sexual function symptoms and degree to which these symptoms are troubling or bothersome
Description
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)
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)
Title
UI-related quality of life
Description
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)
Time Frame
at recruitment (PRE1)
Title
UI-related quality of life
Description
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)
Time Frame
just before the intervention (PRE2)
Title
UI-related quality of life
Description
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)
Time Frame
immediately after the 12-week intervention (POST)
Title
UI-related quality of life
Description
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)
Time Frame
6 months after the end of the 12-week intervention (FOLLOW-UP)
Title
Changes in UI-related quality of life
Description
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)
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)
Title
UI-associated costs
Description
UI-associated costs, using the adapted Dowell-Bryant Incontinence Cost Index (DBICI) questionnaire
Time Frame
at recruitment (PRE1)
Title
UI-associated costs
Description
UI-associated costs, using the adapted Dowell-Bryant Incontinence Cost Index (DBICI) questionnaire
Time Frame
immediately after the 12-week intervention (POST)
Title
UI-associated costs
Description
UI-associated costs, using the adapted Dowell-Bryant Incontinence Cost Index (DBICI) questionnaire
Time Frame
6 months after the end of the 12-week intervention (FOLLOW-UP)
Title
technology self-efficacy
Description
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)
Time Frame
at recruitment (PRE1)
Title
technology self-efficacy
Description
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)
Time Frame
immediately after the 12-week intervention (POST)
Title
technology self-efficacy
Description
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)
Time Frame
6 months after the end of the 12-week intervention (FOLLOW-UP)
Title
UI related self-efficacy
Description
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)
Time Frame
at recruitment (PRE1)
Title
UI related self-efficacy
Description
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)
Time Frame
immediately after the 12-week intervention (POST)
Title
UI related self-efficacy
Description
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)
Time Frame
6 months after the end of the 12-week intervention (FOLLOW-UP)
Title
Pelvic floor muscles related self-efficacy
Description
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)
Time Frame
at recruitment (PRE1)
Title
Pelvic floor muscles related self-efficacy
Description
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)
Time Frame
immediately after the 12-week intervention (POST)
Title
Pelvic floor muscles related self-efficacy
Description
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)
Time Frame
6 months after the end of the 12-week intervention (FOLLOW-UP)
Title
Vaginal atrophy symptoms
Description
Vaginal atrophy symptoms, evaluated using the Atrophy Symptom Questionnaire (ASQ) (0-15 overall score, with higher scores indicating higher severity of vaginal atrophy symptoms)
Time Frame
at recruitment (PRE1)
Title
Vaginal atrophy symptoms
Description
Vaginal atrophy symptoms, evaluated using the Atrophy Symptom Questionnaire (ASQ) (0-15 overall score, with higher scores indicating higher severity of vaginal atrophy symptoms)
Time Frame
immediately after the 12-week intervention (POST)
Title
Vaginal atrophy symptoms
Description
Vaginal atrophy symptoms, evaluated using the Atrophy Symptom Questionnaire (ASQ) (0-15 overall score, with higher scores indicating higher severity of vaginal atrophy symptoms)
Time Frame
6 months after the end of the 12-week intervention (FOLLOW-UP)
Title
Patient reported improvement and satisfaction
Description
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)
Time Frame
immediately after the 12-week intervention (POST)
Title
Patient reported improvement and satisfaction
Description
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)
Time Frame
6 months after the end of the 12-week intervention (FOLLOW-UP)
Title
Feasibility/Acceptability (reach)
Description
Reach aspect of feasibility/acceptability, evaluated using attendance to weekly sessions
Time Frame
through intervention completion, for 12 weeks
Title
Feasibility/Acceptability (fidelity)
Description
Fidelity aspect of feasibility/acceptability, evaluated using the integrity of the GROUP program elements delivered by the physiotherapist during each session (checklist)
Time Frame
through intervention completion, for 12 weeks
Title
Feasibility/Acceptability (dose)
Description
Dose aspect feasibility/acceptability, evaluated using adherence to home exercises (exercises journal)
Time Frame
through intervention completion, for 12 weeks
Title
Feasibility/Acceptability (perceived usability of the technology)
Description
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)
Time Frame
immediately after the 12-week intervention (POST)
Title
Feasibility/Acceptability (perceived usability of the technology)
Description
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)
Time Frame
6 months after the end of the 12-week intervention (FOLLOW-UP)
Title
Potential challenges and satisfaction with the program from the patients' perspective
Description
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
Time Frame
immediately after the intervention (POST)
Other Pre-specified Outcome Measures:
Title
Cognitive function
Description
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)
Time Frame
at recruitment (PRE1)
Title
Cognitive function
Description
Cognitive function, evaluated using the Montreal Cognitive Assessment (MoCA) (0-30 overall score, with scores of 26 and over indicating a normal cognitive function)
Time Frame
at recruitment (PRE1)
Title
Sociodemographic characteristics
Description
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
Time Frame
at recruitment (PRE1)
Title
Signs of vaginal atrophy
Description
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)
Time Frame
at recruitment (PRE1)
Title
Pelvic floor muscle function
Description
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))
Time Frame
at recruitment (PRE1)
Title
Signs and severity of pelvic prolapse
Description
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)
Time Frame
at recruitment (PRE1)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chantale Dumoulin, PhD
Organizational Affiliation
Université de Montréal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre de recherche de l'Institut universitaire de gériatrie de Montréal (CRIUGM)
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3W 1W4
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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
IPD Sharing Time Frame
Available from 1 year after the publication of the main findings until five years after that publication
IPD Sharing Access Criteria
If proposed use of the data has been approved by ethics committee
Learn more about this trial
Tele-rehabilitation Group Program for Urinary Incontinence in Older Women
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