A new vaginal device (MORPHEUSV) for urge urinary incontinence in women with overactive bladder

You may qualify if

• 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.

You can't join if

• 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