Vaginal radiofrequency treatment targeting bladder nerves for overactive bladder in women

A Randomized, Prospective, Multicenter, Double-Blind, Sham-Controlled Study to Assess the MORPHEUSV Radiofrequency (RF) Device in the Treatment of Female Patients With Idiopathic Overactive Bladder (OAB) With Urge Incontinence and/or Urge-Predominant Mixed Incontinence

This trial will test whether a single vaginal radiofrequency treatment with the MORPHEUSV device can reduce urgency-related urine leaks in adult women with overactive bladder.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 202 (estimated)
• Ages: 22 Years to 80 Years
• Sex: Female
• Sponsor: InMode MD Ltd. (Industry-sponsored)
• Drugs / interventions: radiation
• Locations: 9 sites (Palo Alto, California and 8 other locations)
• Trial ID: NCT07209397 on ClinicalTrials.gov

What this trial studies

This is a prospective, randomized, double-blind, sham-controlled multicenter trial enrolling about 202 women aged 22–80 with idiopathic overactive bladder and at least seven urge urinary incontinence episodes per week. Participants are randomized 2:1 to a single active MORPHEUSV radiofrequency treatment or a sham procedure and followed with bladder diaries and questionnaires over 12 months. The primary endpoint is the proportion of participants achieving a ≥50% reduction in urge urinary incontinence episodes, with safety monitored throughout. The device is investigational for this indication and the study is conducted under an FDA IDE at up to 12 U.S. sites.

Who should consider this trial

Good fit: Women aged 22–80 with idiopathic overactive bladder who have had symptoms ≥6 months and at least seven urge urinary incontinence episodes over three days, and who can stop OAB medications and attend follow-up visits, are the ideal candidates.

Not a fit: Patients whose incontinence is predominantly stress-related rather than urge-predominant or who do not meet the required frequency of urgency leaks are unlikely to benefit from this treatment.

Why it matters

Potential benefit: If successful, the device could offer a non-drug, single-session option to reduce urgency-related leakage with fewer systemic side effects.

How similar studies have performed: This specific vaginal RF approach for overactive bladder is investigational; some related RF or pelvic-floor energy treatments have been studied for pelvic symptoms but definitive efficacy for OAB is not established.

Eligibility criteria

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

Where this trial is running

Palo Alto, California and 8 other locations

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

Study contacts

• Study coordinator: FFHA Study Manager

Conditions Overactive Bladder; Urge Urinary Incontinence; Mixed Urinary Incontinence; Idiopathic Overactive Bladder With Urinary Incontinence; Idiopathic Overactive Bladder; Overactive bladder; Urge urinary incontinence; Mixed urinary incontinence