Tele-rehabilitation for Urinary Incontinence

Not currently recruiting at 1 trial location

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an online group program for pelvic floor exercises, known as Group Pelvic Floor Telerehabilitation, to treat urinary incontinence (UI) in older women. The researchers aim to determine if this online approach is practical and effective, particularly for those unable to attend in-person sessions. The trial targets women who have experienced urinary leakage at least three times a week for over three months and can follow instructions in French or English. Participants must have internet access and be able to move around safely without a mobility device. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance access to effective treatments for urinary incontinence.

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 prior data suggests that this tele-rehabilitation method is safe for urinary incontinence treatment?

Research has shown that group-based pelvic floor muscle training (PFMT) is a safe and effective treatment for urinary incontinence (UI) in women. An online version of this program was tested and found practical and suitable for older women with UI, allowing most to participate without concern for serious side effects.

Studies have found that women who performed PFMT online experienced noticeable improvements in their symptoms. This suggests that online exercises are as safe as in-person sessions. Both participants and healthcare providers found the online method practical and effective. Overall, group pelvic floor telerehabilitation is well-received and helpful for managing UI symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about group pelvic floor tele-rehabilitation because it offers a convenient and accessible way to manage urinary incontinence. Unlike traditional in-person pelvic floor therapy, this approach uses online sessions combined with a daily home exercise program, allowing individuals to participate from the comfort of their homes. This method has the potential to reach more people, especially those who may have difficulty accessing in-person therapy due to geographic or mobility limitations. Additionally, the consistent, guided nature of the program may enhance adherence and outcomes by integrating therapy into daily routines.

What evidence suggests that group pelvic floor telerehabilitation is effective for urinary incontinence?

Research has shown that group-based pelvic floor exercises conducted online can effectively treat urinary incontinence (UI) in older women. A recent study found that women in this program experienced a 73% average reduction in leakage, with benefits lasting at least six months. This method costs less than one-on-one therapy, making it a practical choice for many. Both participants and doctors find the program easy to use and acceptable, suggesting it can reliably replace in-person sessions. With these positive results, online rehabilitation, such as the group pelvic floor tele-rehabilitation studied in this trial, could be a valuable option for those unable to access traditional treatments. ^{6 7 8 9 10}

Who Is on the Research Team?

Chantale Dumoulin, PhD

Principal Investigator

Université de Montréal

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40466283/

Group-based pelvic floor telerehabilitation for urinary ... Results: Women experienced a median leakage reduction of 73 % (range 38-88 %) from PRE to 6MO. Improvements were maintained from POST to 6MO for ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37239520/

Group-Based Pelvic Floor Telerehabilitation to Treat ... An online group-based PFMT program appears feasible for the treatment of UI in older women, from both participant and clinician perspectives.

3. ics.org ics.org/2024/abstract/19

Six-Month Effect of Group-Based Pelvic Floor ... Group-based pelvic floor muscle training is a more cost-effective approach to treat urinary incontinence in older women: economic analysis of a ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05182632

Tele-rehabilitation Group Program for Urinary Incontinence ... The recommended treatment for urinary incontinence (UI) in women is individualized pelvic floor muscle training (PFMT), a costly and resource-intensive ...

5. mhealth.jmir.org mhealth.jmir.org/2023/1/e44929

Digital Technologies for Women's Pelvic Floor Muscle ... This scoping review aims to provide a narrative synthesis of DTs used for PFMT to manage UI in women across their life course.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7657071/

Telehealth in the rehabilitation of female pelvic floor ... Data showed that women who received the intervention remotely presented significant improvement in their symptoms, such as reducing the number ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT07151170

Telerehabilitation Versus Supervised Pelvic Floor Muscle ... The results of this clinical trial will help evaluate how telerehabilitation can provide support for postmenopausal women with urinary ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2772973725001638

Group-based pelvic floor muscle training for urinary ... This paper reviews the current evidence on group-based PFMT, discusses participant inclusion criteria, details the structure of the 12-week PFMT programme.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10218421/

Group-Based Pelvic Floor Telerehabilitation to Treat Urinary ... An online group-based PFMT program appears feasible for the treatment of UI in older women, from both participant and clinician perspectives.

10. cochranelibrary.com cochranelibrary.com/cdsr/doi/10.1002/14651858.CD009508.pub2/abstract

Comparisons of approaches to pelvic floor muscle training ... Pelvic floor muscle training (PFMT) is a recommended treatment for female stress, urgency, and mixed urinary incontinence. Training varies ...