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Detrusor Nerve Radiofrequency Ablation for Overactive Bladder in Women
Sponsor: InMode MD Ltd.
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.
Official title: A Randomized, Prospective, Multicenter, Double-Blind, Sham-Controlled Study to Assess the MORPHEUSV Radiofrequency (RF) Device in the Treatment of Female Patients With Idiopathic Overactive Bladder (OAB) With Urge Incontinence and/or Urge-Predominant Mixed Incontinence
Key Details
Gender
FEMALE
Age Range
22 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
202
Start Date
2025-11-25
Completion Date
2027-11-30
Last Updated
2026-01-30
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (9)
Stanford Medicine Department of Obstetrics & Gynecology
Palo Alto, California, United States
MedStar Health Research Institute
Washington D.C., District of Columbia, United States
Advanced Specialty Research
Boise, Idaho, United States
University of Chicago Medicine Urogynecology
Chicago, Illinois, United States
Cypress Medical Research Center
Wichita, Kansas, United States
Bay State Clinical Trials
Watertown, Massachusetts, United States
Urology Center, P.C.
Omaha, Nebraska, United States
UNLV Kirk Kerkorian School of Medicine Department of Gynecologic Surgery & Obstetrics
Las Vegas, Nevada, United States
Atrium Health Wake Forest Female Pelvic Health Division
Winston-Salem, North Carolina, United States