Tele-rehabilitation Group Program for Urinary Incontinence in Older Women (NCT05182632) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Tele-rehabilitation Group Program for Urinary Incontinence in Older Women
Canada32 participantsStarted 2021-03-06
Plain-language 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.
Who can participate
Age range65 Years
SexFEMALE
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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);
What they're measuring
1
number of UI episodes
Timeframe: at recruitment (PRE1)
2
number of UI episodes
Timeframe: just before the intervention (PRE2)
3
number of UI episodes
Timeframe: immediately after the 12-week intervention (POST)
4
number of UI episodes
Timeframe: 6 months after the end of the 12-week intervention (FOLLOW-UP)
5
percentage reduction (%) in the number of UI episodes
Timeframe: 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)