Pelvic Floor Muscle Training for Women with Myotonic Dystrophy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversité de Sherbrooke
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Single group
Treatments tested in this trial
Pelvic floor muscle training
Behavioral12 weekly sessions of 60 minutes with an experienced physiotherapist, including pelvic floor muscles (PFM) exercises with biofeedback, teaching home exercises and education.
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: Pelvic floor muscle trainingExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Percentage of attended treatment sessions
To determine feasibility, the patients' adherence to treatment sessions will be recorded (present vs absent) as well as reasons for non-attendance.
Time frame
Through treatment completion (session 1 to 12; 12 weeks of treatment)2
Percentage of home exercises performed
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.
Time frame
Through treatment completion (session 1 to 12; 12 weeks of treatment)3
Retention rate
To determine feasibility by assessing the percentage of participants completing the post-treatment assessment. Reason for dropouts will be compiled.
Time frame
Baseline to Post-treatment assessment (2-week post-treatment)4
Recruitment rate
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.
Time frame
BaselineSecondary outcomes
1
Change in the frequency of urinary incontinence episodes
Evaluated with the 7-day bladder diary (number of leak/week).
Time frame
Baseline to post-treatment (after the 12-week program)2
Change in urinary incontinence symptoms
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).
Time frame
Baseline to post-treatment (after the 12-week program)3
Change in pelvic floor disorder symptoms
Evaluated with the Pelvic Floor Disorder Inventory (PFDI). Ranging from 0 to 300, higher scores indicate worse outcome (more pelvic floor disorder symptoms).
Time frame
Baseline to post-treatment (after the 12-week program)4
Change in pelvic floor disorder symptoms related impact on quality of life
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).
Time frame
Baseline to post-treatment (after the 12-week program)Sponsors and contacts
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Université de Sherbrooke
Lead sponsor
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Collaborator
Interdisciplinary research team on neuromuscular diseases (GRIMN)
Collaborator
CIUSSS Saguenay-Lac-Saint-Jean
Collaborator
Source ClinicalTrials.gov