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Completed NCT05624645

Efficacy of a Non-invasive Pelvic Floor Muscle Trainer for Treatment of Stress Urinary Incontinence

Conditions: Stress Urinary Incontinence, Urinary Incontinence, Pelvic Floor Disorders

Sex: Female
Ages: 18 Years – N/A
Phase: NA
Enrollment: 5
Sponsor: Pelex

Location: United States

Summary

The goal of this clinical trial is to assess the efficacy and usability of the electromyography component of the company's pelvic health product in a patient population with stress urinary incontinence. The main questions it aims to answer are:Does treatment with the device under study improve symptoms of stress urinary incontinence as measured by the ICIQ?Participants will be given one of the devices under study, in addition to educational materials on use of the device, and a treatment schedule. Participants will perform a standardized biofeedback-mediated pelvic floor muscle training program with the study device 10 minutes a day, five times a week for 4 weeks. There will be a mid-study check in to assure all devices are functioning appropriately. At the end of the study, participants will complete a post-treatment urinary incontinence symptom questionnaire(ICIQ).

Eligibility Criteria

Inclusion Criteria:Female18 years of age or olderDocumented symptoms of predominantly stress urinary incontinence as determined by the ICIQ questionnaireExclusion Criteria:History of pelvic or lower back surgeryPregnancy or less than 12 months post partumHistory of physician-supervised PFMTHistory of Kegel exercises greater than once a monthHistory of prior operative deliverySelf-reported history of pelvic organ prolapse stage II or greater

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05624645). StuddyBuddy aggregates publicly available trial information.