Actively Recruiting
Detrusor Nerve Radiofrequency Ablation for Overactive Bladder in Women
Led by InMode MD Ltd. · Updated on 2026-01-30
202
Participants Needed
9
Research Sites
105 weeks
Total Duration
On this page
Sponsors
I
InMode MD Ltd.
Lead Sponsor
F
Foundation for Female Health Awareness
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Detrusor Nerve Radiofrequency Ablation for Overactive Bladder in Women
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female, aged 22 to 80 years inclusive at the time of consent
- History of idiopathic overactive bladder symptoms for 6 months or more
- At least 7 episodes of urge urinary incontinence over 3 days recorded in a bladder diary
- Urge-predominant incontinence (more urge urinary incontinence episodes than stress urinary incontinence)
- Willing and able to complete a 3-day bladder diary
- Willing to stop OAB medications at least 2 weeks before treatment, if currently taking them
- Willing to use reliable contraception during the study if of childbearing potential and sexually active
- Negative pregnancy test at screening if applicable
- Able to provide informed consent and comply with study procedures and follow-up
You will not qualify if you...
- Predominant stress urinary incontinence based on bladder diary
- Currently pregnant, breastfeeding, or planning pregnancy during the study
- History of neurologic conditions affecting bladder function (e.g., multiple sclerosis, spinal cord injury, Parkinson's disease)
- Active urinary tract infection at screening
- History of interstitial cystitis, bladder pain syndrome, or chronic pelvic pain
- Prior or current bladder cancer, pelvic malignancy, or pelvic radiation
- Pelvic organ prolapse beyond the hymen (POP-Q stage > II)
- Implanted neuromodulation device or prior sacral nerve stimulation
- Use of bulking agents, Botox, or surgery for incontinence within 12 months
- Prior pelvic floor radiofrequency treatment or laser vaginal rejuvenation
- Significant pelvic anatomical abnormalities interfering with treatment
- Use of investigational drug or device within 30 days before screening
- Any condition interfering with safe participation or data integrity as judged by investigator
- Uncontrolled systemic diseases (e.g., uncontrolled diabetes, cardiovascular disease)
- Unable or unwilling to comply with study requirements or follow-up
AI-Screening
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Trial Site Locations
Total: 9 locations
1
Stanford Medicine Department of Obstetrics & Gynecology
Palo Alto, California, United States, 94304
Not Yet Recruiting
2
MedStar Health Research Institute
Washington D.C., District of Columbia, United States, 20010
Not Yet Recruiting
3
Advanced Specialty Research
Boise, Idaho, United States, 83702
Actively Recruiting
4
University of Chicago Medicine Urogynecology
Chicago, Illinois, United States, 60062
Not Yet Recruiting
5
Cypress Medical Research Center
Wichita, Kansas, United States, 67226
Actively Recruiting
6
Bay State Clinical Trials
Watertown, Massachusetts, United States, 02472
Actively Recruiting
7
Urology Center, P.C.
Omaha, Nebraska, United States, 68114
Actively Recruiting
8
UNLV Kirk Kerkorian School of Medicine Department of Gynecologic Surgery & Obstetrics
Las Vegas, Nevada, United States, 89154
Not Yet Recruiting
9
Atrium Health Wake Forest Female Pelvic Health Division
Winston-Salem, North Carolina, United States, 27103
Actively Recruiting
Research Team
F
FFHA Study Manager
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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