Tele-rehabilitation Group Program for Urinary Incontinence in Older Women

NCT05182632 | Active Not Recruiting

• 1 other identifier: CER VN 20-21-33
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Incontinence; Urinary Stress Incontinence

Keywords

female; aging; physiotherapy; physical therapy; pelvic floor; rehabilitation; telerehabilitation

Outcome Measures

Primary Outcomes (5)

• number of UI episodes

  number of UI episodes, evaluated with a 7-day bladder diary

  at recruitment (PRE1)

• number of UI episodes

  number of UI episodes, evaluated with a 7-day bladder diary

  just before the intervention (PRE2)

• number of UI episodes

  number of UI episodes, evaluated with a 7-day bladder diary

  immediately after the 12-week intervention (POST)

• number of UI episodes

  number of UI episodes, evaluated with a 7-day bladder diary

  6 months after the end of the 12-week intervention (FOLLOW-UP)

• percentage reduction (%) in the number of UI episodes

  percentage reduction (%) in the number of UI episodes, evaluated with a 7-day bladder diary

  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 (38)

• urinary symptoms and degree to which UI-associated symptoms are troubling or bothersome

  at recruitment (PRE1)

• urinary symptoms and degree to which UI-associated symptoms are troubling or bothersome

  just before the intervention (PRE2)

• urinary symptoms and degree to which UI-associated symptoms are troubling or bothersome

  immediately after the 12-week intervention (POST)

• 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)

• 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)

Other Outcomes (6)

• Cognitive function

  at recruitment (PRE1)

• Cognitive function

  at recruitment (PRE1)

• Sociodemographic characteristics

  at recruitment (PRE1)

Study Arms (1)

Group pelvic floor tele-rehabilitation

EXPERIMENTAL

12 weekly treatment online sessions + daily home exercise program

Behavioral: Group pelvic floor telerehabilitation

Interventions

Group pelvic floor telerehabilitation BEHAVIORAL

Multimodal group physiotherapy: 12 weeks of weekly group physiotherapy treatments including education and pelvic floor muscle exercises delivered online + home exercise program

Group pelvic floor tele-rehabilitation

Eligibility Criteria

• Age: 65 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Université de Montréal: lead
• Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal: collaborator
• Réseau québécois de recherche sur le vieillissement (RQRV): collaborator

Study Sites (1)

Centre de recherche de l'Institut universitaire de gériatrie de Montréal (CRIUGM)

Montreal, Quebec, H3W 1W4, Canada

Location

Related Publications (3)

• 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.

  PMID: 36325439 BACKGROUND

• 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.

  PMID: 37239520 BACKGROUND

• 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.

  PMID: 38315227 BACKGROUND

MeSH Terms

Conditions

Urinary Incontinence; Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Chantale Dumoulin, PhD

  Université de Montréal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: N/A (single-arm study)
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Feasibility pilot study

Study Record Dates

• First Submitted: September 21, 2021
• First Posted: January 10, 2022
• Study Start: March 6, 2021
• Primary Completion: April 6, 2022
• Study Completion: April 6, 2026
• Last Updated: April 23, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Available from 1 year after the publication of the main findings until five years after that publication
• Access Criteria: If proposed use of the data has been approved by ethics committee

Locations

CA (1)