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Detrusor Nerve Radiofrequency Ablation for Overactive Bladder in Women

InMode MD Ltd. · with Foundation for Female Health Awareness · NCT07209397

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 22–80 · Women only
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Not applicable
Target enrollment
202
US sites recruiting
5
Study start
November 25, 2025
Record last updated
January 30, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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.

Being studied: Detrusor nerve radiofrequency ablation; Simulated (sham) detrusor nerve radiofrequency ablation

Conditions: 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

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • Advanced Specialty Research

    Boise, ID 83702

    Site contact: Jennifer Poralla · (208)-906-1600 · Jennifer@idahoasr.com

  • Cypress Medical Research Center

    Wichita, KS 67226

    Site contact: Addie Hayes · 316-369-0515 · addiehayes@cypressmrc.com

  • Bay State Clinical Trials

    Watertown, MA 02472

    Site contact: Alexia DeOliveira · 617-923-0328 · deoliveira415@gmail.com

  • Urology Center, P.C.

    Omaha, NE 68114

    Site contact: Amy Nelson · 402-399-7894 · anelson@adultpediatricuro.com

  • Atrium Health Wake Forest Female Pelvic Health Division

    Winston-Salem, NC 27103

    Site contact: Sachin Vyas · 336-713-4098 · svyas@wakehealth.edu

Study contacts (from the official record)

  • FFHA Study Manager · 573-300-9185 · nicholas@femalehealthawareness.org
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Detrusor Nerve Radiofrequency Ablation for Overactive Bladder in Women (NCT07209397) | Bored Studies