Comparison of Virtual Pelvic Floor Physical Therapy With a Pelvic Floor Trainer in the Treatment of Stress Urinary Incontinence.

Status: Recruiting
Location: See location...
Intervention Type: Device, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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).

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ Female

• 18 years of age or older

• Documented symptoms of predominantly stress urinary incontinence as determined by the ICIQ questionnaire

Locations
United States
New York
Pelex
RECRUITING
Little Neck
Contact Information
Primary
Jeremy B Wiygul, MD
jeremy@pelex-med.com
3476840176
Backup
Ben Russo, MBA
ben@pelex-med.com
9084197531
Time Frame
Start Date: 2024-01-01
Estimated Completion Date: 2024-07-01
Participants
Target number of participants: 45
Treatments
Active_comparator: Pelex Upp Device
Subjects will receive treatment with the Pelex Upp device, the device under study. The subjects will use the device for treatment four times a week, ten minutes a day, for four weeks.
Active_comparator: Pelex Upp Device + Pelvic Floor Physical Therapy
Subjects will receive treatment with the Pelex Upp device, the device under study. The subjects will use the device for treatment four times a week, ten minutes a day, for four weeks.~In addition, subjects will have four weekly virtual visits with a pelvic floor physical therapist, who will provide further care instructions and pelvic floor training.
Active_comparator: Pelvic Floor Physical Therapy
Subjects will have four weekly virtual visits with a pelvic floor physical therapist, who will provide care instructions and pelvic floor training, as well as provide a weekly treatment schedule for Kegel exercises.
Sponsors
Leads: Pelex

This content was sourced from clinicaltrials.gov