🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in the USA / NCT07209397
Recruiting Not applicable

Detrusor Nerve Radiofrequency Ablation for Overactive Bladder in Women

NCT07209397 · tracked via the Priya Life Science USA tracker
Sponsor
InMode MD Ltd.
Phase
Not applicable
Started
2025-11-25
Last updated
2026-01-30

Condition(s) studied

Overactive BladderOveractive Bladder (OAB)Urge Urinary IncontinenceMixed Urinary Incontinence (Urge-Predominant)Mixed Urinary IncontinenceIdiopathic Overactive Bladder With Urinary IncontinenceIdiopathic Overactive Bladder

Investigational drug(s) / intervention(s)

Detrusor nerve radiofrequency ablationSimulated (sham) detrusor nerve radiofrequency ablation

Detrusor nerve radiofrequency ablation: A single, vaginal radiofrequency (RF) treatment. The procedure is performed with a bipolar RF applicator and requires no anesthesia. Delivered in a single session in an outpatient setting.

Simulated (sham) detrusor nerve radiofrequency ablation: A simulated (sham) radiofrequency (RF) treatment, but with no energy delivered. The procedure mimics the appearance, duration, and positioning of the active device, without therapeutic effect.

Study 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 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.

Eligibility

Sex
FEMALE
Min age
22 Years
Max age
80 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (9)

FacilityCityRegionStatus
Stanford Medicine Department of Obstetrics & Gynecology Palo Alto California Not Yet Recruiting
MedStar Health Research Institute Washington D.C. District of Columbia Not Yet Recruiting
Advanced Specialty Research Boise Idaho Recruiting
University of Chicago Medicine Urogynecology Chicago Illinois Not Yet Recruiting
Cypress Medical Research Center Wichita Kansas Recruiting
Bay State Clinical Trials Watertown Massachusetts Recruiting
Urology Center, P.C. Omaha Nebraska Recruiting
UNLV Kirk Kerkorian School of Medicine Department of Gynecologic Surgery & Obstetrics Las Vegas Nevada Not Yet Recruiting
Atrium Health Wake Forest Female Pelvic Health Division Winston-Salem North Carolina Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07209397 on ClinicalTrials.gov ↗ ← All trials in the USA