Detrusor Nerve Radiofrequency Ablation for Overactive Bladder in Women

Recruiting now · Not applicable · Has a placebo group

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT07209397

Run by

InMode MD Ltd.

People needed

202

Starts

2025-11-25

Expected to finish

2027-11-30

Last updated by the study team

2026-01-30

Who can join

Age: 22 and older, up to 80. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Atrium Health Wake Forest Female Pelvic Health Division — Winston-Salem, North Carolina, United States (enrolling)
• Advanced Specialty Research — Boise, Idaho, United States (enrolling)
• Cypress Medical Research Center — Wichita, Kansas, United States (enrolling)
• Bay State Clinical Trials — Watertown, Massachusetts, United States (enrolling)
• Urology Center, P.C. — Omaha, Nebraska, United States (enrolling)
• MedStar Health Research Institute — Washington D.C., District of Columbia, United States
• UNLV Kirk Kerkorian School of Medicine Department of Gynecologic Surgery & Obstetrics — Las Vegas, Nevada, United States
• University of Chicago Medicine Urogynecology — Chicago, Illinois, United States
• Stanford Medicine Department of Obstetrics & Gynecology — Palo Alto, California, United States

Full record on ClinicalTrials.gov

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