Detrusor Nerve Radiofrequency Ablation for Overactive Bladder in Women
Condition(s) studied
Investigational drug(s) / intervention(s)
Detrusor nerve radiofrequency ablation: A single, vaginal radiofrequency (RF) treatment. The procedure is performed with a bipolar RF applicator and requires no anesthesia. Delivered in a single session in an outpatient setting.
Simulated (sham) detrusor nerve radiofrequency ablation: A simulated (sham) radiofrequency (RF) treatment, but with no energy delivered. The procedure mimics the appearance, duration, and positioning of the active device, without therapeutic effect.
Study summary
The goal of this clinical trial is to learn if a vaginal radiofrequency (RF) device called MORPHEUSV works to treat overactive bladder (OAB) in women. Researchers also want to learn how safe the device is for this indication. This study will include women ages 22 to 80 who have had OAB symptoms for at least 6 months. The main questions it aims to answer are: Does the MORPHEUSV device lower the number of daily episodes of accidental urine leakage caused by urgency? Does it work better than a sham (placebo) treatment? Researchers will compare the MORPHEUSV device to a sham treatment to see how well it reduces symptoms of overactive bladder. Participants will: 1) Receive one session of either the MORPHEUSV or sham treatment. 2) Track their symptoms using a diary and questionnaires 3) Return for three to six follow-up visits over 12 months. This study is being conducted at multiple clinics in the United States.
Eligibility
Primary outcome measure(s)
- Proportion of participants achieving ≥50% reduction in weekly urge urinary incontinence (UUI) episodes — 6 months post-treatment
The percentage of participants who achieve at least a 50% reduction from baseline in the number of UUI episodes per week, as recorded in a 7-day bladder diary. This is the primary efficacy endpoint used to evaluate the effectiveness of the MORPHEUSV device compared to sham.
Trial sites (9)
| Facility | City | Region | Status |
|---|---|---|---|
| Stanford Medicine Department of Obstetrics & Gynecology | Palo Alto | California | Not Yet Recruiting |
| MedStar Health Research Institute | Washington D.C. | District of Columbia | Not Yet Recruiting |
| Advanced Specialty Research | Boise | Idaho | Recruiting |
| University of Chicago Medicine Urogynecology | Chicago | Illinois | Not Yet Recruiting |
| Cypress Medical Research Center | Wichita | Kansas | Recruiting |
| Bay State Clinical Trials | Watertown | Massachusetts | Recruiting |
| Urology Center, P.C. | Omaha | Nebraska | Recruiting |
| UNLV Kirk Kerkorian School of Medicine Department of Gynecologic Surgery & Obstetrics | Las Vegas | Nevada | Not Yet Recruiting |
| Atrium Health Wake Forest Female Pelvic Health Division | Winston-Salem | North Carolina | Recruiting |
More InMode MD Ltd. trials in the USA
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07209397 on ClinicalTrials.gov ↗ ← All trials in the USA