Detrusor Nerve Radiofrequency Ablation for Overactive Bladder in Women

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.

NCT Number	NCT07209397
Lead Sponsor	InMode MD Ltd. Collaborators: Foundation for Female Health Awareness
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
Enrollment	202 participants
Start Date	2025-11-25
Primary Completion	2027-06-30 (estimated)
Study Completion	2027-11-30 (estimated)
Updated on ClinicalTrials.gov	2026-01-30