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NCT Number: NCT06316778

Pelvic Floor Muscle Training for Women with Myotonic Dystrophy

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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Key information

Conditions

Myotonic Dystrophy Type 1 Behavior Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Lower Urinary Tract Symptoms Male Urogenital Diseases Motor Activity Muscular Diseases Muscular Disorders, Atrophic Muscular Dystrophies Musculoskeletal Diseases Myotonic Disorders Myotonic Dystrophy Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Percentage of attended treatment sessions

    Time frame: 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.

  2. Percentage of home exercises performed

    Time frame: Through treatment completion (session 1 to 12; 12 weeks of treatment)

    • 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.
    • To determine feasibility by assessing adherence to treatment sessions.

  3. Retention rate

    Time frame: 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.

  4. Recruitment rate

    Time frame: 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.

  5. Intervention Acceptability Questionnaire

    Time frame: 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 outcomes

  1. Change in the frequency of urinary incontinence episodes

    Time frame: Baseline to post-treatment (after the 12-week program)

    Evaluated with the 7-day bladder diary (number of leak/week).

  2. Change in urinary incontinence symptoms

    Time frame: 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).

  3. Change in pelvic floor disorder symptoms

    Time frame: 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).

  4. Change in pelvic floor disorder symptoms related impact on quality of life

    Time frame: 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).

  5. Change in pelvic floor muscles morphometry

    Time frame: Baseline to post-treatment (after the 12-week program)

    Evaluated with transperineal ultrasound.

  6. Change in pelvic floor muscles function

    Time frame: Baseline to post-treatment (after the 12-week program)

    Evaluated with dynamometry.

  7. Patient's satisfaction

    Time frame: Post-treatment (after the 12-week program)

    Evaluated with Patient satisfaction questionnaire (PSQ) ranging from "completely satisfied" to "not satisfied at all".

  8. Patient's global impression of change

    Time frame: 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.

  9. Patient's estimated improvement

    Time frame: Post-treatment (after the 12-week program)

    Evaluated with Estimated percent improvement (EPI). Ranging from 0 "no amelioration" to 100 "complete amelioration".

Sponsors and collaborators

Lead sponsor

Université de Sherbrooke

Other

Collaborators

  • CIUSSS Saguenay-Lac-Saint-Jean
  • Centre de recherche du Centre hospitalier universitaire de Sherbrooke
  • Interdisciplinary research team on neuromuscular diseases (GRIMN)

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 18, 2024
Registry last updated
Feb 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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