Comparison of Virtual Pelvic Floor Physical Therapy With a Pelvic Floor Trainer in the Treatment of Stress Urinary Incontinence.
Status unconfirmed · Not applicable
Conditions studied: Stress Urinary Incontinence, Pelvic Floor Disorders
In brief
The goal of this clinical trial is to compare the efficacy of the electromyography component of the company's pelvic health product in a patient population with stress urinary incontinence to treatment with pelvic floor physical therapy. 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 when compared to pelvic floor physical therapy? Does treatment with the device under study combined with pelvic floor physical therapy improve symptoms of stress urinary incontinence as measured by the ICIQ when compared to pelvic floor physical therapy alone and treatment with the device alone? Participants will be given one of three treatments: 1. The devices under study alone 2. The device under study plus 4 weekly visits with a pelvic floor physical therapist 3. Four weekly visits with a physical therapist alone Participants will perform a standardized pelvic floor muscle training program 10 minutes a day, four 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
- NCT06097234
- Run by
- Pelex
- People needed
- 45
- Starts
- 2024-01-01
- Expected to finish
- 2024-07-01
- Last updated by the study team
- 2024-03-29
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
- History of physician-supervised pelvic floor muscle training
- 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 (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.