Status:
NOT_YET_RECRUITING
Detrusor Nerve Radiofrequency Ablation for Overactive Bladder in Women: A Randomized Controlled Trial
Lead Sponsor:
InMode MD Ltd.
Collaborating Sponsors:
Foundation for Female Health Awareness
Conditions:
Overactive Bladder
Overactive Bladder (OAB)
Eligibility:
FEMALE
22-80 years
Phase:
NA
Brief 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 devic...
Detailed Description
Overactive bladder (OAB) is a common condition that significantly impacts the quality of life in women, especially those with urge urinary incontinence (UUI) or mixed incontinence with a predominant u...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Female, aged 22 to 80 years inclusive at the time of consent.
- History of idiopathic overactive bladder (OAB) symptoms for ≥6 months.
- At least 7 episodes of urge urinary incontinence (UUI) over 3 days, as recorded in a 3-day bladder diary during screening.
- Urge-predominant incontinence, defined as greater number of UUI episodes than stress urinary incontinence (SUI) episodes during screening.
- Willing and able to complete the 3-day bladder diary.
- Willing to discontinue OAB medications (e.g., anticholinergics, beta-3 agonists) at least 2 weeks prior to baseline treatment visit, if currently taking such medications.
- Willing to use a reliable method of contraception during the study period, if of childbearing potential and sexually active.
- Negative pregnancy test at screening (if applicable).
- Willing and able to provide written informed consent and comply with study procedures and follow-up schedule.
- EXCLUSION CRITERIA:
- Predominant stress urinary incontinence (SUI) 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 (UTI) 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 surgical treatment for incontinence within 12 months
- Prior pelvic floor RF treatment or laser vaginal rejuvenation
- Significant pelvic anatomical abnormalities that interfere with treatment
- Use of investigational drug or device within 30 days before screening
- Any condition that, in the investigator's opinion, would interfere with safe study participation or data integrity
- Uncontrolled systemic disease (e.g., uncontrolled diabetes, cardiovascular disease)
- Inability or unwillingness to comply with study requirements or follow-up
Exclusion
Key Trial Info
Start Date :
October 13 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2027
Estimated Enrollment :
202 Patients enrolled
Trial Details
Trial ID
NCT07209397
Start Date
October 13 2025
End Date
November 30 2027
Last Update
October 7 2025
Active Locations (11)
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1
Stanford Medicine Department of Obstetrics & Gynecology
Palo Alto, California, United States, 94304
2
MedStar Health Research Institute
Washington D.C., District of Columbia, United States, 20010
3
Advanced Specialty Research
Boise, Idaho, United States, 83702
4
University of Chicago Medicine Urogynecology
Chicago, Illinois, United States, 60062