Clinical trial NCT06316778: Pelvic Floor Muscle Training for Women with Myotonic Dystrophy
Official title: Pelvic Floor Muscle Training for Urinary Incontinence in Women with Myotonic Dystrophy Type 1: a Feasibility and Acceptability Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Myotonic Dystrophy Type 1
Urinary Incontinence
Keywords: Neuromuscular disease
Physiotherapy
Exercises
Urinary incontinence
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
Collaborators: name: Centre de recherche du Centre hospitalier universitaire de Sherbrooke
name: Interdisciplinary research team on neuromuscular diseases (GRIMN)
name: CIUSSS Saguenay-Lac-Saint-Jean
First posted: 2024-03-18
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: pre-treatment assessment - intervention (12 weeks) - post-treatment assessment
Primary purpose: TREATMENT

Brief summary: 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.


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

Primary outcomes:
measure: Percentage of attended treatment sessions
timeFrame: Through treatment completion (session 1 to 12; 12 weeks of treatment)
measure: Percentage of home exercises performed
timeFrame: Through treatment completion (session 1 to 12; 12 weeks of treatment)
measure: Retention rate
timeFrame: Baseline to Post-treatment assessment (2-week post-treatment)
measure: Recruitment rate
timeFrame: Baseline
measure: Intervention Acceptability Questionnaire
timeFrame: At baseline and after 12 weeks of treatment
Secondary outcomes:
measure: Change in the frequency of urinary incontinence episodes
timeFrame: Baseline to post-treatment (after the 12-week program)
measure: Change in urinary incontinence symptoms
timeFrame: Baseline to post-treatment (after the 12-week program)
measure: Change in pelvic floor disorder symptoms
timeFrame: Baseline to post-treatment (after the 12-week program)
measure: Change in pelvic floor disorder symptoms related impact on quality of life
timeFrame: Baseline to post-treatment (after the 12-week program)
measure: Change in pelvic floor muscles morphometry
timeFrame: Baseline to post-treatment (after the 12-week program)
measure: Change in pelvic floor muscles function
timeFrame: Baseline to post-treatment (after the 12-week program)
measure: Patient's satisfaction
timeFrame: Post-treatment (after the 12-week program)
measure: Patient's global impression of change
timeFrame: Post-treatment (after the 12-week program)
measure: Patient's estimated improvement
timeFrame: Post-treatment (after the 12-week program)
Other outcomes:
Locations:
city: Jonquière
country: Canada
facility: Clinique des maladies neuromusculaires
state: Quebec
Study officials:
References: