Tele-rehabilitation Group Program for Urinary Incontinence in Older Women

Not Applicable

Active, not recruiting

• Conditions: Urinary Stress Incontinence; Urinary Incontinence
• Interventions: Behavioral: Group pelvic floor telerehabilitation

• Registration Number: NCT05182632
• Lead Sponsor: Université de Montréal

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-06
• Study First Submitted: 2021-09-21
• Study First Submitted QC: 2021-12-21
• Study First Posted: 2022-01-10
• Primary Completion: 2022-04-06
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-17
• Last Update Posted: 2025-04-23
• Study Completion: 2026-04-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 32

Inclusion Criteria

1. 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;
2. Ambulatory (able to walk, move about safely and autonomously without any mobility device);
3. Describe a pattern of stress/mixed UI, confirmed using the Questionnaire for Incontinence Diagnosis (QUID);
4. Have at least three urinary leakage per week, persisting for 3 months or more;
5. Understand French or English instructions;
6. Report no important cognitive deficit (determined with a Mini-Mental State Evaluation (MMSE) score of 24/30 or more);
7. Have an internet access; and
8. Able to give informed consent and complete a gynecological examination and fill 7-day bladder diaries and questionnaires.

Exclusion Criteria

1. 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);
2. Currently taking medication for UI or medications affecting skeletal muscles;
3. Considered obese with a body mass index (BMI) over 35;
4. Had an active urinary or vaginal infection in the past 3 months;
5. Underwent a change in hormonal replacement therapy in the past 6 months;
6. Received pelvic floor physiotherapy treatment or surgery for UI or pelvic organ prolapse in the past year

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group pelvic floor tele-rehabilitation	Group pelvic floor telerehabilitation	12 weekly treatment online sessions + daily home exercise program

Primary Outcome Measures

Name	Time	Method
percentage reduction (%) in the number of UI episodes	at recruitment (PRE1), just before the intervention (PRE2), immediately after the 12-week intervention (POST), 6 months after the end of the 12-week intervention (FOLLOW-UP)	percentage reduction (%) in the number of UI episodes, evaluated with a 7-day bladder diary
number of UI episodes	6 months after the end of the 12-week intervention (FOLLOW-UP)	number of UI episodes, evaluated with a 7-day bladder diary

Secondary Outcome Measures

Name	Time	Method
bladder, bowel, pelvic organ prolapse and sexual function symptoms and degree to which these symptoms are troubling or bothersome	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, 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)
urinary symptoms and degree to which UI-associated symptoms are troubling or bothersome	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, 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)
Vaginal atrophy symptoms	6 months after the end of the 12-week intervention (FOLLOW-UP)	Vaginal atrophy symptoms, evaluated using the Atrophy Symptom Questionnaire (ASQ) (0-15 overall score, with higher scores indicating higher severity of vaginal atrophy symptoms)
Feasibility/Acceptability (dose)	through intervention completion, for 12 weeks	Dose aspect feasibility/acceptability, evaluated using adherence to home exercises (exercises journal)
Feasibility/Acceptability (perceived usability of the technology)	6 months after the end of the 12-week intervention (FOLLOW-UP)	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)
UI-related quality of life	6 months after the end of the 12-week intervention (FOLLOW-UP)	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	6 months after the end of the 12-week intervention (FOLLOW-UP)	UI-associated costs, using the adapted Dowell-Bryant Incontinence Cost Index (DBICI) questionnaire
Pelvic floor muscles related self-efficacy	6 months after the end of the 12-week intervention (FOLLOW-UP)	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)
Changes in urinary symptoms and degree to which UI-associated symptoms are troubling or bothersome	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, 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 UI-related 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-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)
technology self-efficacy	6 months after the end of the 12-week intervention (FOLLOW-UP)	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)
Changes in bladder, bowel, pelvic organ prolapse and sexual function symptoms and degree to which these symptoms are troubling or bothersome	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, 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 self-efficacy	6 months after the end of the 12-week intervention (FOLLOW-UP)	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)
Patient reported improvement and satisfaction	6 months after the end of the 12-week intervention (FOLLOW-UP)	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)	through intervention completion, for 12 weeks	Reach aspect of feasibility/acceptability, evaluated using attendance to weekly sessions
Feasibility/Acceptability (fidelity)	through intervention completion, for 12 weeks	Fidelity aspect of feasibility/acceptability, evaluated using the integrity of the GROUP program elements delivered by the physiotherapist during each session (checklist)
Potential challenges and satisfaction with the program from the patients' perspective	immediately after the intervention (POST)	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

Trial Locations

Locations (1)

Centre de recherche de l'Institut universitaire de gériatrie de Montréal (CRIUGM); 🇨🇦 Montréal, Quebec, Canada