Myotonic Dystrophy Type 1, Urinary Incontinence
Conditions
Keywords
Neuromuscular disease, Physiotherapy, Exercises, Urinary incontinence
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.
Interventions
BEHAVIORALPelvic 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.
Sponsors
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Interdisciplinary research team on neuromuscular diseases (GRIMN)
CIUSSS Saguenay-Lac-Saint-Jean
Université de Sherbrooke
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
pre-treatment assessment - intervention (12 weeks) - post-treatment assessment
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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). |
| 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. |
| 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 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 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. |
Countries
Canada
Outcome results
None listed