NCT06316778 Pelvic Floor Muscle Training for Women with Myotonic Dystrophy
| NCT ID | NCT06316778 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Université de Sherbrooke |
| Condition | Myotonic Dystrophy Type 1 |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2024-03-11 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 12 participants in total. It began in 2024-03-11 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Frequently Asked Questions
Who can join the NCT06316778 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Myotonic Dystrophy Type 1. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06316778 currently recruiting?
Yes, NCT06316778 is actively recruiting participants. Visit ClinicalTrials.gov or contact Université de Sherbrooke to inquire about joining.
Where is the NCT06316778 trial being conducted?
This trial is being conducted at Jonquière, Canada.
Who is sponsoring the NCT06316778 clinical trial?
NCT06316778 is sponsored by Université de Sherbrooke. The trial plans to enroll 12 participants.