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New treatment option for Overactive Bladder
Official title Detrusor Nerve Radiofrequency Ablation for Overactive Bladder in Women
ClinicalTrials.gov ID: NCT07209397
What this study is testing
- What it's testing
- 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.
- Time commitment: about 12 months
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 to 80, women only
You may be able to join 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.
You likely 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
See the full eligibility 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Palo Alto, California, United States
- Washington D.C., District of Columbia, United States
- Boise, Idaho, United States
- Chicago, Illinois, United States
- Wichita, Kansas, United States
- Watertown, Massachusetts, United States
- Omaha, Nebraska, United States
- Las Vegas, Nevada, United States
- Winston-Salem, North Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling female, 22 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Palo Alto, California, United States; Washington D.C., District of Columbia, United States; Boise, Idaho, United States; Chicago, Illinois, United States; Wichita, Kansas, United States; Watertown, Massachusetts, United States and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.