Comparing a pelvic health device with physical therapy for urinary incontinence
Comparison of Virtual Pelvic Floor Physical Therapy With a Pelvic Floor Trainer in the Treatment of Stress Urinary Incontinence.
This study is testing whether a new pelvic health device works better than physical therapy alone for treating urinary incontinence in women.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Pelex Industry-sponsored |
| Locations | 1 site (Little Neck, New York) |
| Trial ID | NCT06097234 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of the Pelex Upp device in treating stress urinary incontinence compared to traditional pelvic floor physical therapy. Participants will be randomly assigned to one of three treatment groups: using the Pelex Upp device alone, using the device in conjunction with physical therapy, or receiving physical therapy alone. The study will measure changes in urinary incontinence symptoms using the ICIQ questionnaire before and after treatment. The trial will involve a standardized pelvic floor muscle training program for all participants.
Who should consider this trial
Good fit: Ideal candidates for this study are women over 18 years old who experience symptoms of stress urinary incontinence.
Not a fit: Patients with a history of pelvic or lower back surgery, pregnancy, or significant pelvic organ prolapse may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new, effective treatment option for women suffering from stress urinary incontinence.
How similar studies have performed: Other studies have shown promising results with similar approaches, but this specific combination of device and therapy is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Little Neck, New York
- Pelex — Little Neck, New York, United States (Recruiting)
Study contacts
- Study coordinator: Jeremy B Wiygul, MD
- Email: jeremy@pelex-med.com
- Phone: 3476840176
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.