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Myotonic Dystrophy Type 1NCT06316778

Pelvic Floor Muscle Training for Women with Myotonic Dystrophy

A study testing Pelvic floor muscle training in people with Myotonic Dystrophy Type 1 and Urinary Incontinence, run by Université de Sherbrooke at 1 site in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Pelvic floor muscle training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteCanada
Study dates
11 Mar 2024to 30 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Canada1 site, 1 recruiting

  • Clinique des maladies neuromusculaires

    Jonquière, Quebec, G7X 7X2

    Mélanie Morin, PhD, 819-346-1110 ext. 13818, melanie.m.morin@usherbrooke.ca

    Cynthia Gagnon, PhD, 418-695-7700 ext. 2756, Cynthia.gagnon4@usherbrooke.ca

    Recruiting

Other trials in Canada

About this study

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

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.

Being tested
Pelvic floor muscle training
Keywords
Neuromuscular disease, Physiotherapy, Exercises, Urinary incontinence
Medical subject headings
Myotonic Dystrophy, Urinary Incontinence, Neuromuscular Diseases, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pelvic floor muscle trainingBehavioural

    12 weekly sessions of 60 minutes with an experienced physiotherapist, including pelvic floor muscles (PFM) exercises with biofeedback, teaching home exercises and education.

Study groups in NCT06316778
Study groupRoleWhat they receive
Pelvic floor muscle trainingExperimentalNot described
Receives: Behavioral: Pelvic floor muscle training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

  3. Retention rate

    To determine feasibility by assessing the percentage of participants completing the post-treatment assessment. Reason for dropouts will be compiled.

    Measured: Baseline to Post-treatment assessment (2-week post-treatment)

  4. 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.

    Measured: Baseline

  5. 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.

    Measured: At baseline and after 12 weeks of treatment

Secondary outcomes (9)

  1. Change in the frequency of urinary incontinence episodes

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

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

  2. Change in urinary incontinence symptoms

    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).

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

  3. Change in pelvic floor disorder symptoms

    Evaluated with the Pelvic Floor Disorder Inventory (PFDI). Ranging from 0 to 300, higher scores indicate worse outcome (more pelvic floor disorder symptoms).

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

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

    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).

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

  5. Change in pelvic floor muscles morphometry

    Evaluated with transperineal ultrasound.

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

  6. Change in pelvic floor muscles function

    Evaluated with dynamometry.

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

  7. Patient's satisfaction

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

    Measured: Post-treatment (after the 12-week program)

  8. Patient's global impression of change

    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.

    Measured: Post-treatment (after the 12-week program)

  9. Patient's estimated improvement

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

    Measured: Post-treatment (after the 12-week program)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2024
  2. Study start11 Mar 2024
  3. Primary completion30 Dec 2026 (estimated)
  4. Study completion30 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
pre-treatment assessment - intervention (12 weeks) - post-treatment assessment
Masking
None (open label)
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06316778
Sponsor's protocol ID
2023-038
Status last verified
Feb 2025
First submitted
7 Mar 2024
Last updated
24 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Pelvic floor muscle training in people with Myotonic Dystrophy Type 1 and Urinary Incontinence, run by Université de Sherbrooke at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of attended treatment sessions (time frame: Through treatment completion (session 1 to 12; 12 weeks of treatment)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06316778.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2025.

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