Actively Recruiting
A Randomized, Double-Blind, Sham-Controlled Study to Assess the MORPHEUSV Radiofrequency Device for Treating Female Patients With Idiopathic Overactive Bladder and Urge Incontinence
Led by InMode MD Ltd. · Updated on 2026-01-30
202
Participants Needed
9
Research Sites
21 weeks
Total Duration
On this page
Sponsors
I
InMode MD Ltd.
Lead Sponsor
F
Foundation for Female Health Awareness
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the MORPHEUSV vaginal radiofrequency (RF) device to treat overactive bladder (OAB) in women aged 22 to 80 with symptoms lasting at least 6 months. This clinical trial aims to determine if the device reduces episodes of accidental urine leakage caused by urgency better than a sham treatment, while also assessing its safety. The study includes women with idiopathic OAB and at least 7 urge urinary incontinence episodes per week, comparing active treatment to placebo in a randomized, double-blind design. Participants will be randomly assigned in a 2:1 ratio to receive either a single session of vaginal RF treatment using the MORPHEUSV device or a sham procedure that looks identical but delivers no energy. No anesthesia is needed. Those in the sham group who complete 6 months of follow-up can opt to receive the active treatment. All participants will be followed for 12 months to evaluate long-term safety and effectiveness. The study is conducted at multiple sites in the United States under Good Clinical Practice guidelines. During the study, participants will track their symptoms using bladder diaries and questionnaires, with follow-up visits scheduled three to six times over 12 months. Researchers will monitor the proportion of participants achieving at least a 50% reduction in weekly urge urinary incontinence episodes at 6 months, along with changes in urgency, frequency, quality of life, and any adverse events. Safety data will be reviewed periodically by an internal committee to ensure participant well-being throughout the trial.
CONDITIONS
Brief Title
Detrusor Nerve Radiofrequency Ablation for Overactive Bladder in Women
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female, aged 22 to 80 years inclusive at the time of consent
- History of idiopathic overactive bladder symptoms for at least 6 months
- At least 7 episodes of urge urinary incontinence over 3 days, recorded in a bladder diary
- Urge-predominant incontinence, with more UUI episodes than stress urinary incontinence
- Willing and able to complete a 3-day bladder diary
- Willing to stop OAB medications at least 2 weeks before baseline visit if currently taking
- Willing to use reliable contraception during the study if of childbearing potential and sexually active
- Negative pregnancy test at screening if applicable
- Able to provide informed consent and comply with study procedures and follow-up
You will not qualify if you...
- Predominant stress urinary incontinence based on bladder diary
- Currently pregnant, breastfeeding, or planning pregnancy during the study
- History of neurologic conditions affecting bladder function such as multiple sclerosis, spinal cord injury, or Parkinson's disease
- Active urinary tract infection 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 greater than 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 radiofrequency treatment or laser vaginal rejuvenation
- Significant pelvic anatomical abnormalities interfering with treatment
- Use of investigational drug or device within 30 days before screening
- Any condition interfering with safe study participation or data integrity
- Uncontrolled systemic disease such as uncontrolled diabetes or cardiovascular disease
- Inability or unwillingness to comply with study requirements or follow-up
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single session
Participants receive a single session of vaginal radiofrequency treatment or a simulated sham procedure using the MORPHEUSV device in an outpatient setting without anesthesia.
1 treatment visit (in-person)
Duration - 12 months
Participants are followed for 12 months after the initial procedure to evaluate safety, effectiveness, and durability of response. Sham participants may opt to receive active treatment after 6 months.
Follow-up visits over 12 months
Trial Site Locations
Total: 9 locations
1
Stanford Medicine Department of Obstetrics & Gynecology
Palo Alto, California, United States, 94304
Not Yet Recruiting
2
MedStar Health Research Institute
Washington D.C., District of Columbia, United States, 20010
Not Yet Recruiting
3
Advanced Specialty Research
Boise, Idaho, United States, 83702
Actively Recruiting
4
University of Chicago Medicine Urogynecology
Chicago, Illinois, United States, 60062
Not Yet Recruiting
5
Cypress Medical Research Center
Wichita, Kansas, United States, 67226
Actively Recruiting
6
Bay State Clinical Trials
Watertown, Massachusetts, United States, 02472
Actively Recruiting
7
Urology Center, P.C.
Omaha, Nebraska, United States, 68114
Actively Recruiting
8
UNLV Kirk Kerkorian School of Medicine Department of Gynecologic Surgery & Obstetrics
Las Vegas, Nevada, United States, 89154
Not Yet Recruiting
9
Atrium Health Wake Forest Female Pelvic Health Division
Winston-Salem, North Carolina, United States, 27103
Actively Recruiting
Research Team
F
FFHA Study Manager
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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