Clinical trial NCT05182632: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Urinary Incontinence
Urinary Stress Incontinence
Keywords: female
aging
physiotherapy
physical therapy
pelvic floor
rehabilitation
telerehabilitation
Lead sponsor: Université de Montréal
Sponsor class: OTHER
Collaborators: name: Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
name: Réseau québécois de recherche sur le vieillissement (RQRV)
First posted: 2022-01-10
Enrollment: 32
Sex: FEMALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Feasibility pilot study
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: number of UI episodes
timeFrame: at recruitment (PRE1)
measure: number of UI episodes
timeFrame: just before the intervention (PRE2)
measure: number of UI episodes
timeFrame: immediately after the 12-week intervention (POST)
measure: number of UI episodes
timeFrame: 6 months after the end of the 12-week intervention (FOLLOW-UP)
measure: 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)
Secondary outcomes:
measure: urinary symptoms and degree to which UI-associated symptoms are troubling or bothersome
timeFrame: at recruitment (PRE1)
measure: urinary symptoms and degree to which UI-associated symptoms are troubling or bothersome
timeFrame: just before the intervention (PRE2)
measure: urinary symptoms and degree to which UI-associated symptoms are troubling or bothersome
timeFrame: immediately after the 12-week intervention (POST)
measure: urinary symptoms and degree to which UI-associated symptoms are troubling or bothersome
timeFrame: 6 months after the end of the 12-week intervention (FOLLOW-UP)
measure: Changes in urinary symptoms and degree to which UI-associated symptoms are troubling or bothersome
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)
measure: bladder, bowel, pelvic organ prolapse and sexual function symptoms and degree to which these symptoms are troubling or bothersome
timeFrame: at recruitment (PRE1)
measure: bladder, bowel, pelvic organ prolapse and sexual function symptoms and degree to which these symptoms are troubling or bothersome
timeFrame: just before the intervention (PRE2)
measure: bladder, bowel, pelvic organ prolapse and sexual function symptoms and degree to which these symptoms are troubling or bothersome
timeFrame: immediately after the 12-week intervention (POST)
measure: bladder, bowel, pelvic organ prolapse and sexual function symptoms and degree to which these symptoms are troubling or bothersome
timeFrame: 6 months after the end of the 12-week intervention (FOLLOW-UP)
measure: Changes in bladder, bowel, pelvic organ prolapse and sexual function symptoms and degree to which these symptoms are troubling or bothersome
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)
measure: UI-related quality of life
timeFrame: at recruitment (PRE1)
measure: UI-related quality of life
timeFrame: just before the intervention (PRE2)
measure: UI-related quality of life
timeFrame: immediately after the 12-week intervention (POST)
measure: UI-related quality of life
timeFrame: 6 months after the end of the 12-week intervention (FOLLOW-UP)
measure: Changes in UI-related quality of life
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)
measure: UI-associated costs
timeFrame: at recruitment (PRE1)
measure: UI-associated costs
timeFrame: immediately after the 12-week intervention (POST)
measure: UI-associated costs
timeFrame: 6 months after the end of the 12-week intervention (FOLLOW-UP)
measure: technology self-efficacy
timeFrame: at recruitment (PRE1)
measure: technology self-efficacy
timeFrame: immediately after the 12-week intervention (POST)
measure: technology self-efficacy
timeFrame: 6 months after the end of the 12-week intervention (FOLLOW-UP)
measure: UI related self-efficacy
timeFrame: at recruitment (PRE1)
measure: UI related self-efficacy
timeFrame: immediately after the 12-week intervention (POST)
measure: UI related self-efficacy
timeFrame: 6 months after the end of the 12-week intervention (FOLLOW-UP)
measure: Pelvic floor muscles related self-efficacy
timeFrame: at recruitment (PRE1)
measure: Pelvic floor muscles related self-efficacy
timeFrame: immediately after the 12-week intervention (POST)
measure: Pelvic floor muscles related self-efficacy
timeFrame: 6 months after the end of the 12-week intervention (FOLLOW-UP)
measure: Vaginal atrophy symptoms
timeFrame: at recruitment (PRE1)
measure: Vaginal atrophy symptoms
timeFrame: immediately after the 12-week intervention (POST)
measure: Vaginal atrophy symptoms
timeFrame: 6 months after the end of the 12-week intervention (FOLLOW-UP)
measure: Patient reported improvement and satisfaction
timeFrame: immediately after the 12-week intervention (POST)
measure: Patient reported improvement and satisfaction
timeFrame: 6 months after the end of the 12-week intervention (FOLLOW-UP)
measure: Feasibility/Acceptability (reach)
timeFrame: through intervention completion, for 12 weeks
measure: Feasibility/Acceptability (fidelity)
timeFrame: through intervention completion, for 12 weeks
measure: Feasibility/Acceptability (dose)
timeFrame: through intervention completion, for 12 weeks
measure: Feasibility/Acceptability (perceived usability of the technology)
timeFrame: immediately after the 12-week intervention (POST)
measure: Feasibility/Acceptability (perceived usability of the technology)
timeFrame: 6 months after the end of the 12-week intervention (FOLLOW-UP)
measure: Potential challenges and satisfaction with the program from the patients' perspective
timeFrame: immediately after the intervention (POST)
Other outcomes:
measure: Cognitive function
timeFrame: at recruitment (PRE1)
measure: Cognitive function
timeFrame: at recruitment (PRE1)
measure: Sociodemographic characteristics
timeFrame: at recruitment (PRE1)
measure: Signs of vaginal atrophy
timeFrame: at recruitment (PRE1)
measure: Pelvic floor muscle function
timeFrame: at recruitment (PRE1)
measure: Signs and severity of pelvic prolapse
timeFrame: at recruitment (PRE1)
Locations:
city: Montréal
country: Canada
facility: Centre de recherche de l'Institut universitaire de gériatrie de Montréal (CRIUGM)
state: Quebec
Study officials:
affiliation: Université de Montréal
name: Chantale Dumoulin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Le Berre M, Filiatrault J, Reichetzer B, Dumoulin C. Feasibility, acceptability and effects of a group pelvic floor muscle telerehabilitation program to treat urinary incontinence in older women. Digit Health. 2022 Oct 26;8:20552076221123720. doi: 10.1177/20552076221123720. eCollection 2022 Jan-Dec.
citation: Le Berre M, Filiatrault J, Reichetzer B, Dumoulin C. Group-Based Pelvic Floor Telerehabilitation to Treat Urinary Incontinence in Older Women: A Feasibility Study. Int J Environ Res Public Health. 2023 May 11;20(10):5791. doi: 10.3390/ijerph20105791.
citation: Le Berre M, Filiatrault J, Reichetzer B, Kairy D, Lachance C, Dumoulin C. Online Group-based Pelvic Floor Muscle Training for Urinary Incontinence in Older Women: a Pilot Study. Int Urogynecol J. 2024 Apr;35(4):811-822. doi: 10.1007/s00192-024-05728-0. Epub 2024 Feb 5.