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NCT07209397 · ClinicalTrials.gov registry record · NA
Detrusor Nerve Radiofrequency Ablation for Overactive Bladder in Women
A NA study of Overactive Bladder and Overactive Bladder (OAB), sponsored by InMode MD.
- Recruiting
- Registry status
- NA
- Development phase
- 202
- Enrollment target
- 9
- Study locations
NCT07209397: Recruiting NA study of Overactive Bladder and Overactive Bladder (OAB), sponsored by InMode MD.
NCT07209397 is a NA study of Overactive Bladder and Overactive Bladder (OAB) that is actively recruiting participants, run by InMode MD. The registered enrollment target is 202 participants, roughly in line with the 203-participant average among 46 other Overactive Bladder trials with a reported enrollment target. The trial reports 9 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07209397, a NA study of Overactive Bladder and Overactive Bladder (OAB), is actively recruiting participants, sponsored by InMode MD.
- RECRUITING
- Registry status
- NA
- Development phase
- 202 participants
- Enrollment target
- 9
- Study locations
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.
Primary Outcome
The percentage of participants who achieve at least a 50% reduction from baseline in the number of UUI episodes per week, as recorded in a 7-day bladder diary. This is the primary efficacy endpoint used to evaluate the effectiveness of the MORPHEUSV device compared to sham.
Conditions Studied
Interventions
- DEVICE Detrusor nerve radiofrequency ablation
- DEVICE Simulated (sham) detrusor nerve radiofrequency ablation
Study Locations (9)
California
- Stanford Medicine Department of Obstetrics & Gynecology - Palo Alto
District of Columbia
- MedStar Health Research Institute - Washington D.C.
Idaho
- Advanced Specialty Research - Boise
Illinois
- University of Chicago Medicine Urogynecology - Chicago
Kansas
- Cypress Medical Research Center - Wichita
Massachusetts
- Bay State Clinical Trials - Watertown
Nebraska
- Urology Center, P.C. - Omaha
Nevada
- UNLV Kirk Kerkorian School of Medicine Department of Gynecologic Surgery & Obstetrics - Las Vegas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 202 participants |
| Start Date | 2025-11-25 |
| Est. Completion | 2027-11-30 |
| Phase | NA |
What NCT07209397 shows while recruiting
NCT07209397 is an interventional study that assigns participants to a tested intervention. The registered 202 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 203-participant average among 46 other Overactive Bladder trials with a reported enrollment target.
The record links to 7 conditions, with Overactive Bladder appearing as the primary indexed condition, and to 2 interventions - of which Detrusor nerve radiofrequency ablation is the first listed.
NCT07209397 lists 9 locations in 9 states (California, District of Columbia, Idaho).
Frequently Asked Questions
What is clinical trial NCT07209397 about?
NCT07209397 is a clinical study titled "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 ...
What is the current status of trial NCT07209397?
This trial is currently recruiting. It is a NA study. The enrollment target is 202 participants. The study started on 2025-11-25. Estimated completion is 2027-11-30.
What conditions does trial NCT07209397 study?
This clinical trial studies the following conditions: Overactive Bladder, Overactive Bladder (OAB), Urge Urinary Incontinence, Mixed Urinary Incontinence, Mixed Urinary Incontinence (Urge-Predominant).
What interventions are being tested in trial NCT07209397?
The interventions under investigation include: Detrusor nerve radiofrequency ablation (DEVICE), Simulated (sham) detrusor nerve radiofrequency ablation (DEVICE).
Who is sponsoring clinical trial NCT07209397?
This trial is sponsored by InMode MD, which has 22 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07209397 being conducted?
This trial has 9 study locations across California, District of Columbia, Idaho, Illinois, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT07209397's enrollment target sits among peer trials
202 12th of 46 higher than 35 of 46 other Overactive Bladder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Overactive Bladder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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