RecruitingNot ApplicableNCT07209397

Detrusor Nerve Radiofrequency Ablation for Overactive Bladder in Women

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

Sponsor

InMode MD Ltd.

Enrollment

202 participants

Start Date

Nov 25, 2025

Study Type

INTERVENTIONAL

Conditions

Mixed urinary incontinence Overactive Bladder Overactive Bladder (OAB)Urge Urinary Incontinence Mixed Urinary Incontinence (Urge-Predominant)Idiopathic Overactive Bladder Idiopathic Overactive Bladder With Urinary Incontinence

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

Sex: FEMALEMin Age: 22 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Detrusor nerve radiofrequency ablation and a medical device called Simulated (sham) detrusor nerve radiofrequency ablation for people with idiopathic overactive bladder, idiopathic overactive bladder with urinary incontinence, and other related conditions. The study is currently recruiting participants at 9 locations. People eligible for this study include women aged 22 Years to 80 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEDetrusor 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.

DEVICESimulated (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.