protocolSection identificationModule nctId: NCT06316778, orgStudyIdInfo id: 2023-038, briefTitle: Pelvic Floor Muscle Training for Women With Myotonic Dystrophy, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-03-11, primaryCompletionDateStruct date: 2024-12-01, completionDateStruct date: 2024-12-01, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Université de Sherbrooke, class: OTHER, collaborators name: Centre de recherche du Centre hospitalier universitaire de Sherbrooke, collaborators name: Interdisciplinary research team on neuromuscular diseases (GRIMN), collaborators name: CIUSSS Saguenay-Lac-Saint-Jean, descriptionModule briefSummary: 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., conditionsModule conditions: Myotonic Dystrophy Type 1, conditions: Urinary Incontinence, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: pre-treatment assessment - intervention (12 weeks) - post-treatment assessment, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: Pelvic floor muscle training, outcomesModule primaryOutcomes measure: Percentage of attended treatment sessions, primaryOutcomes measure: Percentage of home exercises performed, primaryOutcomes measure: Retention rate, primaryOutcomes measure: Recruitment rate, primaryOutcomes measure: Intervention Acceptability Questionnaire, secondaryOutcomes measure: Change in the frequency of urinary incontinence episodes, secondaryOutcomes measure: Change in urinary incontinence symptoms, secondaryOutcomes measure: Change in pelvic floor disorder symptoms, secondaryOutcomes measure: Change in pelvic floor disorder symptoms related impact on quality of life, secondaryOutcomes measure: Change in pelvic floor muscles morphometry, secondaryOutcomes measure: Change in pelvic floor muscles function, secondaryOutcomes measure: Patient's satisfaction, secondaryOutcomes measure: Patient's global impression of change, secondaryOutcomes measure: Patient's estimated improvement, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Clinique des maladies neuromusculaires, city: Jonquière, state: Quebec, zip: G7X 7X2, country: Canada, geoPoint lat: 48.41648, lon: -71.24884, hasResults: False