Pelvic Floor Muscle Training for Women with Myotonic Dystrophy

NCT06316778 | Recruiting

• 1 other identifier: 2023-038
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Myotonic Dystrophy Type 1; Urinary Incontinence

Keywords

Neuromuscular disease; Physiotherapy; Exercises; Urinary incontinence

Outcome Measures

Primary Outcomes (5)

• 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

  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.

  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

Secondary Outcomes (9)

• Change in the frequency of urinary incontinence episodes

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

• Change in urinary incontinence symptoms

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

• Change in 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

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

• Change in pelvic floor muscles morphometry

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

Study Arms (1)

Pelvic floor muscle training

EXPERIMENTAL

Behavioral: Pelvic floor muscle training

Interventions

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.

Pelvic floor muscle training

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Clinique des maladies neuromusculaires

Jonquière, Quebec, G7X 7X2, Canada

RECRUITING

MeSH Terms

Conditions

Myotonic Dystrophy; Urinary Incontinence; Neuromuscular Diseases; Motor Activity

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher and full professor

Model Details: pre-treatment assessment - intervention (12 weeks) - post-treatment assessment

Study Record Dates

• First Submitted: March 7, 2024
• First Posted: March 18, 2024
• Study Start: March 11, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: February 24, 2025

Record last verified: 2025-02

Locations

CA (1)