At a glance
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Efficacy of a Non-invasive Pelvic Floor Muscle Trainer for Treatment of Stress Urinary Incontinence
In Brief
A clinical study evaluating Pelex Upp for Stress Urinary Incontinence and 2 related conditions. Completed, enrolled 5 participants across 1 site.
Detailed 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).
Study Details
Timeline
Interventions
Patients were given the Pelex Upp is a non-invasive device that is designed to guide a user through personalized pelvic floor strengthening exercises. Patients used device for four weeks to treat stress urinary incontinence