Feasibility, Acceptability and Effects of a Tele-rehabilitation Pelvic Floor Muscle Training Group Program for Urinary Incontinence in Older Women
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Urinary Incontinence
- Sponsor
- Université de Montréal
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- percentage reduction (%) in the number of UI episodes
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
percentage reduction (%) in the number of UI episodes
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)
percentage reduction (%) in the number of UI episodes, evaluated with a 7-day bladder diary
number of UI episodes
Time Frame: 6 months after the end of the 12-week intervention (FOLLOW-UP)
number of UI episodes, evaluated with a 7-day bladder diary
Secondary Outcomes
- 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))
- 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))
- Vaginal atrophy symptoms(6 months after the end of the 12-week intervention (FOLLOW-UP))
- Feasibility/Acceptability (dose)(through intervention completion, for 12 weeks)
- Feasibility/Acceptability (perceived usability of the technology)(6 months after the end of the 12-week intervention (FOLLOW-UP))
- UI-related quality of life(6 months after the end of the 12-week intervention (FOLLOW-UP))
- UI-associated costs(6 months after the end of the 12-week intervention (FOLLOW-UP))
- Pelvic floor muscles related self-efficacy(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(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))
- 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))
- technology self-efficacy(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(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 self-efficacy(6 months after the end of the 12-week intervention (FOLLOW-UP))
- Patient reported improvement and satisfaction(6 months after the end of the 12-week intervention (FOLLOW-UP))
- Feasibility/Acceptability (reach)(through intervention completion, for 12 weeks)
- Feasibility/Acceptability (fidelity)(through intervention completion, for 12 weeks)
- Potential challenges and satisfaction with the program from the patients' perspective(immediately after the intervention (POST))