Pelvic Floor Muscle Training for Women with Myotonic Dystrophy

NCT ID: NCT06316778

Last Updated: 2025-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-11

Study Completion Date

2026-12-30

Brief Summary

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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.

Detailed Description

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Conditions

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Myotonic Dystrophy Type 1 Urinary Incontinence

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

pre-treatment assessment - intervention (12 weeks) - post-treatment assessment
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pelvic floor muscle training

Group Type EXPERIMENTAL

Pelvic floor muscle training

Intervention Type BEHAVIORAL

12 weekly sessions of 60 minutes with an experienced physiotherapist, including pelvic floor muscles (PFM) exercises with biofeedback, teaching home exercises and education.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Centre de recherche du Centre hospitalier universitaire de Sherbrooke

OTHER

Sponsor Role collaborator

Interdisciplinary research team on neuromuscular diseases (GRIMN)

UNKNOWN

Sponsor Role collaborator

CIUSSS Saguenay-Lac-Saint-Jean

UNKNOWN

Sponsor Role collaborator

Université de Sherbrooke

OTHER

Sponsor Role lead

Responsible Party

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Mélanie Morin

Researcher and full professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Clinique des maladies neuromusculaires

Jonquière, Quebec, Canada

Site Status RECRUITING

Countries

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Canada

Facility Contacts

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Mélanie Morin, PhD

Role: primary

819-346-1110 ext. 13818

Cynthia Gagnon, PhD

Role: backup

418-695-7700 ext. 2756

Other Identifiers

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2023-038

Identifier Type: -

Identifier Source: org_study_id

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