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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Multimodal group physiotherapy: 12 weeks of weekly group physiotherapy treatments including education and pelvic floor muscle exercises delivered online + home exercise program
Centre de recherche de l'Institut universitaire de gériatrie de Montréal (CRIUGM)
Montreal, Quebec, Canada
number of UI episodes
number of UI episodes, evaluated with a 7-day bladder diary
Time frame: at recruitment (PRE1)
number of UI episodes
number of UI episodes, evaluated with a 7-day bladder diary
Time frame: just before the intervention (PRE2)
number of UI episodes
number of UI episodes, evaluated with a 7-day bladder diary
Time frame: immediately after the 12-week intervention (POST)
number of UI episodes
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)
percentage reduction (%) in the number of UI episodes
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)
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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
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
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)
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)
Time frame: 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)
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
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)
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)
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
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)
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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
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
UI-associated costs, using the adapted Dowell-Bryant Incontinence Cost Index (DBICI) questionnaire
Time frame: at recruitment (PRE1)
UI-associated costs
UI-associated costs, using the adapted Dowell-Bryant Incontinence Cost Index (DBICI) questionnaire
Time frame: immediately after the 12-week intervention (POST)
UI-associated costs
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)
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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: through intervention completion, for 12 weeks
Feasibility/Acceptability (dose)
Dose aspect feasibility/acceptability, evaluated using adherence to home exercises (exercises journal)
Time frame: 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)
Time frame: 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)
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
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)
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