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| Name | Class |
|---|---|
| Centre de recherche du Centre hospitalier universitaire de Sherbrooke | OTHER |
| Interdisciplinary research team on neuromuscular diseases (GRIMN) | UNKNOWN |
| CIUSSS Saguenay-Lac-Saint-Jean | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pelvic floor muscle training | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pelvic floor muscle training | Behavioral | 12 weekly sessions of 60 minutes with an experienced physiotherapist, including pelvic floor muscles (PFM) exercises with biofeedback, teaching home exercises and education. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Through treatment completion (session 1 to 12; 12 weeks of treatment) |
| Percentage of home exercises performed |
| 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. | 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. | 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. | At baseline and after 12 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the frequency of urinary incontinence episodes | Evaluated with the 7-day bladder diary (number of leak/week). | Baseline to post-treatment (after the 12-week program) |
| Change in urinary incontinence symptoms |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique des maladies neuromusculaires | Recruiting | Jonquière | Quebec | G7X 7X2 | Canada |
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| ID | Term |
|---|---|
| D009223 | Myotonic Dystrophy |
| D014549 | Urinary Incontinence |
| D009468 | Neuromuscular Diseases |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D009136 | Muscular Dystrophies |
| D020966 | Muscular Disorders, Atrophic |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
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pre-treatment assessment - intervention (12 weeks) - post-treatment assessment
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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).
| 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). | 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). | Baseline to post-treatment (after the 12-week program) |
| Change in pelvic floor muscles morphometry | Evaluated with transperineal ultrasound. | Baseline to post-treatment (after the 12-week program) |
| Change in pelvic floor muscles function | Evaluated with dynamometry. | 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". | 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. | 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". | Post-treatment (after the 12-week program) |
| D020967 | Myotonic Disorders |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D009422 | Nervous System Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |