Vaginal radiofrequency treatment targeting bladder nerves for overactive bladder in women

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Advanced Specialty Research
  Boise, Idaho, United States 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
• Atrium Health Wake Forest Female Pelvic Health Division
  Winston-Salem, North Carolina, United States Recruiting
• Stanford Medicine Department of Obstetrics & Gynecology
  Palo Alto, California, United States Not yet recruiting

Study contacts

• Study coordinator: FFHA Study Manager
• Email: nicholas@femalehealthawareness.org
• Phone: 573-300-9185

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.