Comparison of Virtual Pelvic Floor Physical Therapy With a Pelvic Floor Trainer in the Treatment of Stress Urinary Incontinence.
Launched by PELEX · Oct 18, 2023
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at two different ways to treat stress urinary incontinence, which is when you accidentally leak urine during activities like sneezing or exercising. The researchers want to see if using a special device that helps with pelvic floor muscles is more effective than traditional pelvic floor physical therapy, or if combining both treatments gives better results. Participants will be randomly assigned to one of three groups: using the device alone, using the device along with four sessions of physical therapy, or attending four sessions of physical therapy alone.
To join the study, participants must be women aged 18 and older who have been diagnosed with stress urinary incontinence. They should not have had certain pelvic surgeries or other specific medical histories that might affect the study. Over four weeks, participants will do a simple muscle training program for about 10 minutes a day, four times a week. At the end of the study, they will complete a questionnaire to measure how their symptoms have changed. This research aims to find the most effective way to help women manage their urinary incontinence symptoms.
Gender
FEMALE
Eligibility criteria
- Inclusion Criteria:
- • Female
- • 18 years of age or older
- • Documented symptoms of predominantly stress urinary incontinence as determined by the ICIQ questionnaire
- Exclusion Criteria:
- • 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
About Pelex
Pelex is a leading clinical trial sponsor focused on advancing innovative therapies through rigorous research and development. With a commitment to enhancing patient outcomes, Pelex specializes in designing and conducting clinical trials across various therapeutic areas, leveraging cutting-edge technologies and methodologies. The organization collaborates with healthcare professionals, regulatory bodies, and stakeholders to ensure the highest standards of safety and efficacy in clinical research. By fostering a culture of transparency and collaboration, Pelex aims to accelerate the journey from discovery to market, ultimately contributing to improved health solutions for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Little Neck, New York, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported