Tele-rehabilitation for Urinary Incontinence

Overseen By Mélanie Le Berre, MSc

Age: 65+

Sex: Female

Trial Phase: Academic

Sponsor: Université de Montréal

Must not be taking: UI medications, Skeletal muscle medications

Disqualifiers: Chronic constipation, Obesity, Active cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 13

Duration: 12 weeks

32 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

If you are currently taking medication for urinary incontinence or medications affecting skeletal muscles, you will not be eligible to participate in this trial.

What data supports the effectiveness of the treatment Pelvic Floor Telerehabilitation for Urinary Incontinence?

Research shows that telerehabilitation, which involves remote therapy sessions, is as effective as in-person care for conditions like hip and knee surgeries. This suggests that similar remote approaches could be effective for pelvic floor exercises to help with urinary incontinence. ^{1 2 3 4 5}

Is tele-rehabilitation for urinary incontinence safe for humans?

The studies reviewed did not report any specific safety concerns related to tele-rehabilitation for urinary incontinence, suggesting it is generally safe for humans. ^{6 7 8 9 10}

How is the treatment of pelvic floor telerehabilitation for urinary incontinence different from other treatments?

Pelvic floor telerehabilitation is unique because it allows patients to participate in group-based pelvic floor muscle training sessions online, making it more accessible and less resource-intensive than traditional individual therapy. This approach has been shown to be as effective as in-person sessions, providing a convenient option for older women who may have difficulty attending regular appointments. ^{6 7 8 11 12}

Research Team

Chantale Dumoulin, PhD

Principal Investigator

Université de Montréal

Eligibility Criteria

This trial is for women aged 65 or older with stress/mixed urinary incontinence, experiencing at least three leakages per week for over three months. Participants must be able to walk independently, understand French or English, have no significant cognitive deficits, and have internet access. Women with certain medical conditions like severe prolapse, chronic constipation, obesity (BMI over 35), or those on UI medication are excluded.

Inclusion Criteria

I understand instructions in either French or English.

My mental function test score shows no significant cognitive issues.

I have been experiencing urinary leakage three times a week for at least 3 months.

Exclusion Criteria

You are very overweight, with a body mass index (BMI) over 35.

I have had a urinary or vaginal infection in the last 3 months.

I have had treatment for urinary issues or pelvic organ prolapse in the last year.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (virtual)

Treatment

Participants undergo 12 weekly online sessions of tele-rehabilitation pelvic floor muscle training and a daily home exercise program

12 weeks

12 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of urinary symptoms and quality of life

6 months

Periodic assessments (virtual)

Treatment Details

Interventions

• Group Pelvic Floor Telerehabilitation

Trial Overview The study tests a group pelvic floor muscle training program delivered via tele-rehabilitation to treat urinary incontinence in older women. It aims to see if this online method is feasible and effective compared to traditional face-to-face sessions especially during times when gatherings are restricted.

Participant Groups

Group I: Group pelvic floor tele-rehabilitation Experimental Treatment 1 Intervention

12 weekly treatment online sessions + daily home exercise program

Who Is Running the Clinical Trial?

Université de Montréal

Lead Sponsor

Trials

223

Recruited

104,000+

Réseau québécois de recherche sur le vieillissement (RQRV)

Collaborator

Trials

2

Recruited

60+

Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal

Collaborator

Trials

26

Recruited

9,500+

Findings from Research

A study involving 604 users of a digital medical device (DMD) for home-based rehabilitation after knee injuries showed that users had significantly higher adherence to their rehabilitation program (86%) compared to a control group (74%), indicating that the DMD effectively supports patient engagement.

The DMD not only improved adherence but also allowed users to perform rehabilitation exercises with greater intensity, contributing to clinically expected improvements in rehabilitation outcomes without any reported adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sensor-based telerehabilitation system increases patient adherence after knee surgery. Höher, J., Lischke, B., Petersen, W., et al.[2023]

A randomized controlled trial involving 142 patients showed that a 2-week interactive virtual telerehabilitation program is as effective as conventional outpatient physical therapy in improving knee function after total knee arthroplasty.

Both rehabilitation methods led to significant improvements in knee movement, muscle strength, walking speed, and pain levels, suggesting that telerehabilitation could be a viable option for patients who face challenges in attending traditional therapy sessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of an interactive virtual telerehabilitation system in patients after total knee arthoplasty: a randomized controlled trial. Piqueras, M., Marco, E., Coll, M., et al.[2022]

Guided telerehabilitation has shown to be at least as effective as traditional rehabilitation methods for improving functional performance in older adults, based on a systematic review of 26 randomized controlled trials.

No control interventions were found to be superior to telerehabilitation, indicating that this approach could be a viable alternative for community-dwelling older adults, although further studies with lower bias are needed to refine intervention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of guided telerehabilitation on functional performance in community-dwelling older adults: A systematic review. Gamble, CJ., van Haastregt, J., van Dam van Isselt, EF., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Telerehabilitation is non-inferior to usual care following total hip replacement - a randomized controlled non-inferiority trial. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Sensor-based telerehabilitation system increases patient adherence after knee surgery. [2023]

3. Sweden pubmed.ncbi.nlm.nih.gov

Effectiveness of an interactive virtual telerehabilitation system in patients after total knee arthoplasty: a randomized controlled trial. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Effectiveness of guided telerehabilitation on functional performance in community-dwelling older adults: A systematic review. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of Telerehabilitation in Physical Therapy: A Rapid Overview. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Pelvic floor muscle training: Novel versus traditional remote rehabilitation methods. A systematic review and meta-analysis on their effectiveness for women with urinary incontinence. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Feasibility, acceptability and effects of a group pelvic floor muscle telerehabilitation program to treat urinary incontinence in older women. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Feasibility of Telerehabilitation-Based Pelvic Floor Muscle Training for Urinary Incontinence in People With Multiple Sclerosis: A Randomized, Controlled, Assessor-Blinded Study. [2023]

9. Italy pubmed.ncbi.nlm.nih.gov

Comparisons of approaches to pelvic floor muscle training for urinary incontinence in women: an abridged Cochrane systematic review. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

An effective treatment for functional urinary incoordination. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Evidence for the Appropriate Use of Telemedicine in Female Pelvic Medicine and Reconstructive Surgery. [2022]

12. England pubmed.ncbi.nlm.nih.gov

A Hybrid-Telerehabilitation Versus a Conventional Program for Urinary Incontinence: a Randomized Trial during COVID-19 Pandemic. [2023]