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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
12 weekly sessions of 60 minutes with an experienced physiotherapist, including pelvic floor muscles (PFM) exercises with biofeedback, teaching home exercises and education.
Clinique des maladies neuromusculaires
Jonquière, Quebec, Canada
RECRUITINGPercentage 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)
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)
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)
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: Baseline
Intervention Acceptability Questionnaire
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.
Time frame: At baseline and after 12 weeks of treatment
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)
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)
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)
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)
Change in pelvic floor muscles morphometry
Evaluated with transperineal ultrasound.
Time frame: Baseline to post-treatment (after the 12-week program)
Change in pelvic floor muscles function
Evaluated with dynamometry.
Time frame: Baseline to post-treatment (after the 12-week program)
Patient's satisfaction
Evaluated with Patient satisfaction questionnaire (PSQ) ranging from "completely satisfied" to "not satisfied at all".
Time frame: Post-treatment (after the 12-week program)
Patient's global impression of change
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.
Time frame: Post-treatment (after the 12-week program)
Patient's estimated improvement
Evaluated with Estimated percent improvement (EPI). Ranging from 0 "no amelioration" to 100 "complete amelioration".
Time frame: Post-treatment (after the 12-week program)
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