Pelvic Floor Muscle Training for Women with Myotonic Dystrophy

Официальное название

Pelvic Floor Muscle Training for Urinary Incontinence in Women with Myotonic Dystrophy Type 1: a Feasibility and Acceptability Study

Обзор

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.

Вмешательства

• Поведенческое Pelvic 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.

Первичные конечные точки

• Percentage of attended treatment sessions [Срок оценки: Through treatment completion (session 1 to 12; 12 weeks of treatment)]
• Percentage of home exercises performed [Срок оценки: Through treatment completion (session 1 to 12; 12 weeks of treatment)]
• Retention rate [Срок оценки: Baseline to Post-treatment assessment (2-week post-treatment)]
• Recruitment rate [Срок оценки: Baseline]
• Intervention Acceptability Questionnaire [Срок оценки: At baseline and after 12 weeks of treatment]

Вторичные конечные точки (9)

• Change in the frequency of urinary incontinence episodes [Срок оценки: Baseline to post-treatment (after the 12-week program)]
• Change in urinary incontinence symptoms [Срок оценки: Baseline to post-treatment (after the 12-week program)]
• Change in pelvic floor disorder symptoms [Срок оценки: Baseline to post-treatment (after the 12-week program)]
• Change in pelvic floor disorder symptoms related impact on quality of life [Срок оценки: Baseline to post-treatment (after the 12-week program)]
• Change in pelvic floor muscles morphometry [Срок оценки: Baseline to post-treatment (after the 12-week program)]
• Change in pelvic floor muscles function [Срок оценки: Baseline to post-treatment (after the 12-week program)]
• Patient's satisfaction [Срок оценки: Post-treatment (after the 12-week program)]
• Patient's global impression of change [Срок оценки: Post-treatment (after the 12-week program)]
• Patient's estimated improvement [Срок оценки: Post-treatment (after the 12-week program)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• Clinique des maladies neuromusculaires — Jonquière

Идентификаторы

NCT: NCT06316778 · 2023-038

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗