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Not Yet Recruiting NCT07905586

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

Conditions: Stress Urinary Incontinence

Sex: Female
Ages: 18 Years – 79 Years
Healthy volunteers: No
Phase: NA
Enrollment: 24
Sponsor: Thomas Jefferson University

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.

Eligibility Criteria

Inclusion Criteria: * Female assigned at birth, 18-79 years of age Self-reported stress urinary incontinence for greater than 3 months International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) score \>6 Able to understand the study procedures and provide informed consent English language proficiency Exclusion Criteria: * Males assigned at birth Individuals \80 years old Current pregnancy or planning to become pregnant during the study period Pelvic, abdominal, esophageal, or head/neck surgery within the previous 6 months Healing rib fractures Neurologic conditions Active urinary tract infection Current participation in supervised pelvic floor muscle training outside of the study Inability to safely perform maximal expiratory efforts Contraindications to expiratory muscle strength training (EMST), including presence of untreated or uncontrolled hypertension, unstable heart conditions, history of spontaneous pneumothorax, active hemoptysis, history of ruptured eardrum or active ear conditions, history of high intraocular pressure including glaucoma and retinal disease, elevated intracranial pressure, severe chronic obstructive pulmonary disease, or healing rib fractures History of lung surgery

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07905586). StuddyBuddy aggregates publicly available trial information.