Pelvic Floor Muscle Training for Women With Myotonic Dystrophy

Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06316778
• Other study ID #: 2023-038
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 11, 2024
• Est. completion date: December 1, 2024

Study information

• Verified date: March 2024
• Source: Université de Sherbrooke
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 12
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Myotonic Dystrophy
• Myotonic Dystrophy Type 1
• Urinary Incontinence

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Canada	Clinique des maladies neuromusculaires	Jonquière	Quebec

Sponsors (4)

Lead Sponsor	Collaborator
Université de Sherbrooke	Centre de recherche du Centre hospitalier universitaire de Sherbrooke, CIUSSS Saguenay-Lac-Saint-Jean, Interdisciplinary research team on neuromuscular diseases (GRIMN)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	Percentage of home exercises performed	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.	Through treatment completion (session 1 to 12; 12 weeks of treatment)
Primary	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)
Primary	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
Primary	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	Change in the frequency of urinary incontinence episodes	Evaluated with the 7-day bladder diary (number of leak/week).	Baseline to post-treatment (after the 12-week program)
Secondary	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).	Baseline to post-treatment (after the 12-week program)
Secondary	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).	Baseline to post-treatment (after the 12-week program)
Secondary	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).	Baseline to post-treatment (after the 12-week program)
Secondary	Change in pelvic floor muscles morphometry	Evaluated with transperineal ultrasound.	Baseline to post-treatment (after the 12-week program)
Secondary	Change in pelvic floor muscles function	Evaluated with dynamometry.	Baseline to post-treatment (after the 12-week program)
Secondary	Patient's satisfaction	Evaluated with Patient satisfaction questionnaire (PSQ) ranging from "completely satisfied" to "not satisfied at all".	Post-treatment (after the 12-week program)
Secondary	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.	Post-treatment (after the 12-week program)
Secondary	Patient's estimated improvement	Evaluated with Estimated percent improvement (EPI). Ranging from 0 "no amelioration" to 100 "complete amelioration".	Post-treatment (after the 12-week program)