Pelvic Floor Muscle Training for Women with Myotonic Dystrophy
- Conditions
- Myotonic Dystrophy Type 1Urinary Incontinence
- Interventions
- Behavioral: Pelvic floor muscle training
- Registration Number
- NCT06316778
- Lead Sponsor
- Université de Sherbrooke
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 12
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Pelvic floor muscle training Pelvic floor muscle training -
- Primary Outcome Measures
Name Time Method Percentage of attended treatment sessions Through treatment completion (session 1 to 12; 12 weeks of treatment) To determine feasibility, the patients' adherence to treatment sessions will be recorded (present vs absent) as well as reasons for non-attendance.
Retention rate Baseline to Post-treatment assessment (2-week post-treatment) To determine feasibility by assessing the percentage of participants completing the post-treatment assessment. Reason for dropouts will be compiled.
Percentage of home exercises performed Through treatment completion (session 1 to 12; 12 weeks of treatment) 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.Recruitment rate Baseline 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.
Intervention Acceptability Questionnaire At baseline and after 12 weeks of treatment 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.
- Secondary Outcome Measures
Name Time Method Change in urinary incontinence symptoms Baseline to post-treatment (after the 12-week program) 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).
Change in the frequency of urinary incontinence episodes Baseline to post-treatment (after the 12-week program) Evaluated with the 7-day bladder diary (number of leak/week).
Change in pelvic floor disorder symptoms Baseline to post-treatment (after the 12-week program) Evaluated with the Pelvic Floor Disorder Inventory (PFDI). Ranging from 0 to 300, higher scores indicate worse outcome (more pelvic floor disorder symptoms).
Change in pelvic floor disorder symptoms related impact on quality of life Baseline to post-treatment (after the 12-week program) 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).
Change in pelvic floor muscles morphometry Baseline to post-treatment (after the 12-week program) Evaluated with transperineal ultrasound.
Patient's global impression of change Post-treatment (after the 12-week program) 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.
Change in pelvic floor muscles function Baseline to post-treatment (after the 12-week program) Evaluated with dynamometry.
Patient's satisfaction Post-treatment (after the 12-week program) Evaluated with Patient satisfaction questionnaire (PSQ) ranging from "completely satisfied" to "not satisfied at all".
Patient's estimated improvement Post-treatment (after the 12-week program) Evaluated with Estimated percent improvement (EPI). Ranging from 0 "no amelioration" to 100 "complete amelioration".
Trial Locations
- Locations (1)
Clinique des maladies neuromusculaires
🇨🇦Jonquière, Quebec, Canada