RecruitingNot Applicable

Detrusor Nerve Radiofrequency Ablation for Overactive Bladder in Women

United States202 participantsStarted 2025-11-25

Plain-language 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.

Who can participate

Age range22 Years – 80 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

What they're measuring

Proportion of participants achieving ≥50% reduction in weekly urge urinary incontinence (UUI) episodes

Timeframe: 6 months post-treatment

Trial details

NCT IDNCT07209397

SponsorInMode MD Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-06-30

Contact for this trial

FFHA Study Manager

573-300-9185 nicholas@femalehealthawareness.org