Pelvic Floor Muscle Training for Women with Myotonic Dystrophy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pelvic floor muscle training.
- Who it may be relevant to
- Registry conditions: Myotonic Dystrophy Type 1, Urinary Incontinence. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Pelvic Floor Muscle Training for Urinary Incontinence in Women with Myotonic Dystrophy Type 1: a Feasibility and Acceptability Study
Overview
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.
Interventions
- 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.
Primary outcome measures
- Percentage of attended treatment sessions [Time frame: 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)]
- Retention rate [Time frame: Baseline to Post-treatment assessment (2-week post-treatment)]
- Recruitment rate [Time frame: Baseline]
- Intervention Acceptability Questionnaire [Time frame: At baseline and after 12 weeks of treatment]
Secondary outcome measures (9)
- Change in the frequency of urinary incontinence episodes [Time frame: 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)]
- Change in pelvic floor disorder symptoms [Time frame: 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)]
- Change in pelvic floor muscles morphometry [Time frame: 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)]
- Patient's satisfaction [Time frame: Post-treatment (after the 12-week program)]
- Patient's global impression of change [Time frame: Post-treatment (after the 12-week program)]
- Patient's estimated improvement [Time frame: Post-treatment (after the 12-week program)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Canada · 1 center
- Clinique des maladies neuromusculaires — Jonquière
Identifiers
NCT: NCT06316778 · 2023-038