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NOT YET RECRUITING
NCT07905586
NA

Feasibility of Resisted Expiratory Muscle Training for Females Assigned at Birth With Stress Urinary Incontinence: A Pilot Study

Sponsor: Thomas Jefferson University

View on ClinicalTrials.gov

Summary

The goal of this randomized pilot study is to determine whether adding expiratory muscle strength training (EMST) to standard pelvic floor muscle training (PFMT) is feasible and may help improve stress urinary incontinence (SUI) in females assigned at birth, ages 18 to 79. SUI is urine leakage that occurs during activities such as coughing, sneezing, laughing, or exercising. The main questions this study aims to answer are: Can participants complete the combined exercise program, and is it acceptable to them? Does adding EMST to PFMT lead to greater improvements in urinary leakage symptoms and participants' perceived improvement compared with PFMT alone? Does adding EMST improve breathing muscle strength and pelvic floor muscle activity? Researchers will enroll 24 participants and randomly assign them to one of two groups: Group 1: Standard physical therapy, including pelvic floor muscle training. Group 2: The same physical therapy and pelvic floor muscle training, with the addition of expiratory muscle strength training. Both groups will receive six weeks of supervised physical therapy, with one session each week. Participants will attend seven study visits over approximately seven weeks, including an initial assessment and six treatment visits. Participants will: Complete questionnaires about urinary leakage symptoms and perceived improvement. Have their breathing muscle strength measured using a test that measures how strongly they can breathe out. Have pelvic floor muscle activity measured using a surface electromyography (sEMG) sensor. Perform prescribed home exercises and record their exercise completion in a log. Participants in both groups will practice pelvic floor muscle exercises at home. Participants in the combined-treatment group will also use a device that provides resistance when breathing out. They will perform five sets of five breaths daily, with resistance based on their measured breathing muscle strength. Researchers will assess whether participants complete the study visits, follow the home exercise program, complete the study measures, and report satisfaction with the program. They will also monitor any unwanted effects related to the exercises or assessments. The study will explore whether adding EMST to PFMT may improve urinary leakage symptoms, breathing muscle strength, and pelvic floor muscle activity. Participants may experience improvements, but benefits are not guaranteed. The results will help researchers determine whether a larger study is needed to better evaluate this combined treatment for stress urinary incontinence.

Official title: Feasibility of Resisted Expiratory Muscle Training for Females Assigned at Birth With Stress Urinary Incontinence: a Pilot Study

Key Details

Gender

FEMALE

Age Range

18 Years - 79 Years

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2027-01-01

Completion Date

2028-06-30

Last Updated

2026-10-29

Healthy Volunteers

No

Interventions

OTHER

Pelvic floor muscle training

PFMT: Participants will be instructed in a home exercise program of pelvic floor muscle training (PFMT) at 5 sets of 5 submaximal repetitions daily. Through the 6 intervention sessions, exercise repetitions will increase to up to 100 per day in gravity dependent positions.

OTHER

Expiratory muscle strength training

EMST: Participants will use a calibrated expiratory resistance device at 50% of MEP, 5 sets of 5 breaths daily.