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Detrusor Nerve Radiofrequency Ablation for Overactive Bladder in Women

NCT07209397 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 202

Last updated 2026-01-30

No results posted yet for this 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.

Conditions

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

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.

Sponsors & Collaborators

  • Foundation for Female Health Awareness

    collaborator OTHER

  • InMode MD Ltd.

    lead INDUSTRY

Principal Investigators

  • Mickey Karram, MD · Foundation for Female Health Awareness (FFHA)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-25
Primary Completion
2027-06-30
Completion
2027-11-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07209397 on ClinicalTrials.gov