Efficacy of a Non-invasive Pelvic Floor Muscle Trainer for Treatment of Stress Urinary Incontinence
Completed · Not applicable
Conditions studied: Stress Urinary Incontinence, Urinary Incontinence, Pelvic Floor Disorders
In brief
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).
Key facts
- Study ID
- NCT05624645
- Run by
- Pelex
- People needed
- 5
- Starts
- 2021-02-25
- Expected to finish
- 2022-01-18
- Last updated by the study team
- 2022-11-22
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Female
- 18 years of age or older
- Documented symptoms of predominantly stress urinary incontinence as determined by the ICIQ questionnaire
You may not qualify if…
- History of pelvic or lower back surgery
- Pregnancy or less than 12 months post partum
- History of physician-supervised PFMT
- History of Kegel exercises greater than once a month
- History of prior operative delivery
- Self-reported history of pelvic organ prolapse stage II or greater
Where it is running
- Pelex — Little Neck, New York, United States
Full record on ClinicalTrials.gov
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