Pelvic Floor Muscle Training for Women with Myotonic Dystrophy

February 20, 2025 updated by: Mélanie Morin, Université de Sherbrooke

Pelvic Floor Muscle Training for Urinary Incontinence in Women with Myotonic Dystrophy Type 1: a Feasibility and Acceptability Study

Myotonic dystrophy type 1 (DM1) is a neuromuscular disease characterized by multisystem manifestations. DM1 can affect the urinary system through the impact of the pelvic floor muscles (PFM). Urinary incontinence can occur in this situation and is often offset with compensatory measures without restoring the PFM function (e.g. sanitary pads). PFM training have already been shown to be effective in reducing or even eliminating urinary incontinence in the general population. However, no study has been the subject of this modality in people with DM1. Having recently shown that it is possible to gain strength with DM1, a strengthening protocol targeting PFM could prove effective in treating urinary incontinence. The objectives of this study are i) to assess the feasibility and acceptability of PFM training and ii) to investigate the effects of PFM training in women with DM1 with adult phenotype. A quasi-experimental study will be conducted with 12 women having a confirmed diagnosis of DM1 with urinary incontinence. Participants will follow a 12-week PFM training program, comprising weekly sessions with an experienced physiotherapist as well as a home exercise program. Outcomes measures will be assessed at baseline and at post-treatment and will include: feasibility and acceptability variables, frequency of urinary incontinence, urogynecological symptoms and their impact on quality of life, morphometry and function of PFM, and the perceived improvement following the treatments. This study has the potential to improve the management of urinary incontinence and support the implementation of pelvic floor rehabilitation services in this population.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • confirmed medical diagnosis of myotonic dystrophy type 1 (DM1) with adult phenotype
  • symptoms of stress, urge or mixed urinary incontinence
  • able to give a free and informed consent

Exclusion Criteria:

  • being pregnant, have given birth by vaginal delivery in the last year or plan to become pregnant in the next six months
  • present post-void residual urine ≥ 150 ml
  • have medical conditions that may have an impact on the symptoms of urinary incontinence and the response to treatments
  • present fecal incontinence (≥ 1/week) or significant prolapse (beyond the hymen)
  • have already received physiotherapy treatments in pelvic floor rehabilitation or surgery on the perineum
  • have a defibrillator, pacemaker or bladder stimulator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pelvic floor muscle training
Behavioral: Pelvic floor muscle training
12 weekly sessions of 60 minutes with an experienced physiotherapist, including pelvic floor muscles (PFM) exercises with biofeedback, teaching home exercises and education.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of attended treatment sessions
Time Frame: Through treatment completion (session 1 to 12; 12 weeks of treatment)
To determine feasibility, the patients' adherence to treatment sessions will be recorded (present vs absent) as well as reasons for non-attendance.
Through treatment completion (session 1 to 12; 12 weeks of treatment)
Percentage of home exercises performed
Time Frame: Through treatment completion (session 1 to 12; 12 weeks of treatment)
  1. The adherence rate to home exercises for each treatment group will be assessed using a daily diary. The participants will record the frequency of the exercises completed.
  2. To determine feasibility by assessing adherence to treatment sessions.
Through treatment completion (session 1 to 12; 12 weeks of treatment)
Retention rate
Time Frame: Baseline to Post-treatment assessment (2-week post-treatment)
To determine feasibility by assessing the percentage of participants completing the post-treatment assessment. Reason for dropouts will be compiled.
Baseline to Post-treatment assessment (2-week post-treatment)
Recruitment rate
Time Frame: Baseline
To determine feasibility by assessing the percentage of participants included versus the participants screened. The barriers and reasons for refusing to participate as well as the reasons for exclusion will be documented.
Baseline
Intervention Acceptability Questionnaire
Time Frame: At baseline and after 12 weeks of treatment
The Intervention Acceptability Questionnaire will be used to assess the participants' acceptability of the interventions. This questionnaire consists of 4 items measured on a VAS scale (Minimum value: 0; Maximum Value: 10). Each item is analyzed separately, with a greater score meaning higher acceptability of the intervention. This outcome measure will contribute to identifying factors limiting the acceptability of each program.
At baseline and after 12 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the frequency of urinary incontinence episodes
Time Frame: Baseline to post-treatment (after the 12-week program)
Evaluated with the 7-day bladder diary (number of leak/week).
Baseline to post-treatment (after the 12-week program)
Change in urinary incontinence symptoms
Time Frame: Baseline to post-treatment (after the 12-week program)
Evaluated with the International Consultation Incontinence Questionnaire (ICIQ-UI-SF) Ranging from 0 to 21, higher scores indicate worse outcome (more urinary incontinence symptoms and a higher impact on their quality of life).
Baseline to post-treatment (after the 12-week program)
Change in pelvic floor disorder symptoms
Time Frame: Baseline to post-treatment (after the 12-week program)
Evaluated with the Pelvic Floor Disorder Inventory (PFDI). Ranging from 0 to 300, higher scores indicate worse outcome (more pelvic floor disorder symptoms).
Baseline to post-treatment (after the 12-week program)
Change in pelvic floor disorder symptoms related impact on quality of life
Time Frame: Baseline to post-treatment (after the 12-week program)
Evaluated with the Pelvic Floor Impact Questionnaire (PFIQ-SF). Ranging from 0 to 300, higher scores indicate a worse outcome (higher impact on their quality of life).
Baseline to post-treatment (after the 12-week program)
Patient's satisfaction
Time Frame: Post-treatment (after the 12-week program)
Evaluated with Patient satisfaction questionnaire (PSQ) ranging from "completely satisfied" to "not satisfied at all".
Post-treatment (after the 12-week program)
Patient's global impression of change
Time Frame: Post-treatment (after the 12-week program)
Evaluated with Patients' Global Impression of Improvement (PGI-I). Ranging from 1 "very much better" to 7 "very much worse" on a 7-point likert scale.
Post-treatment (after the 12-week program)
Patient's estimated improvement
Time Frame: Post-treatment (after the 12-week program)
Evaluated with Estimated percent improvement (EPI). Ranging from 0 "no amelioration" to 100 "complete amelioration".
Post-treatment (after the 12-week program)
Change in pelvic floor muscles morphometry
Time Frame: Baseline to post-treatment (after the 12-week program)
Evaluated with transperineal ultrasound.
Baseline to post-treatment (after the 12-week program)
Change in pelvic floor muscles function
Time Frame: Baseline to post-treatment (after the 12-week program)
Evaluated with dynamometry.
Baseline to post-treatment (after the 12-week program)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Université de Sherbrooke

Collaborators

Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Interdisciplinary research team on neuromuscular diseases (GRIMN)
CIUSSS Saguenay-Lac-Saint-Jean

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 11, 2024

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

March 7, 2024

First Submitted That Met QC Criteria

March 14, 2024

First Posted (Actual)

March 18, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 20, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-038

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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