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RECRUITING
NCT07209397
NA

Detrusor Nerve Radiofrequency Ablation for Overactive Bladder in Women

Sponsor: InMode MD Ltd.

View on ClinicalTrials.gov

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

Interventions

DEVICE

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.

DEVICE

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