NCT07209397 · InMode MD Ltd.
Detrusor Nerve Radiofrequency Ablation for Overactive Bladder in Women
(DENARA)
What this 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Palo Alto, California
- Washington D.C., District of Columbia
- Boise, Idaho
- Chicago, Illinois
- Wichita, Kansas
- Watertown, Massachusetts
- Omaha, Nebraska
- Las Vegas, Nevada
- Winston-Salem, North Carolina
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 30, 2026 · Source of record for eligibility and locations