Recruiting

Pelvic Floor Training

Sponsor:

Université de Sherbrooke

Code:

NCT06316778

Conditions

Myotonic Dystrophy Type 1

Urinary Incontinence

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pelvic floor muscle training

Study Details

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

Study ID

NCT06316778

Start date

Mar 11, 2024

Status verified date

Feb, 2025

Completion date

Dec 30, 2026

Anticipated

Primary completion date

Dec 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

12 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Pelvic floor muscle training

Interventions

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.

Primary outcome measure

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

Central Contacts and Locations

Locations

Clinique des maladies neuromusculaires

Recruiting

Jonquière, Quebec, Canada, G7X 7X2

Contacts

More Information

Sponsor

Université de Sherbrooke

Last update posted

Feb 24, 2025

Last verified

Feb, 2025

Keywords

  • Neuromuscular disease
  • Physiotherapy
  • Exercises
  • Urinary incontinence

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Université de Sherbrooke on 2025-02-24.