FemPulse non-implanted electrical stimulation for overactive bladder.
Evaluation of a Non-Implanted Electrical Stimulation Device for Overactive Bladder (OAB) EVANESCE-II
NA · FemPulse Corporation · NCT07195656
This trial will test whether the FemPulse external electrical stimulation device can reduce overactive bladder symptoms in adult women.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 151 (estimated) |
| Ages | 21 Years and up |
| Sex | Female |
| Sponsor | FemPulse Corporation (industry) |
| Locations | 15 sites (Beverly Hills, California and 14 other locations) |
| Trial ID | NCT07195656 on ClinicalTrials.gov |
What this trial studies
This interventional study compares a non-implanted FemPulse electrical stimulation device to standard medication management in adult women with overactive bladder. Participants are enrolled at multiple Southern California centers and must have physician-confirmed OAB symptoms for more than six months and be able to comply with study procedures. Study procedures include assignment to a device or medication group, scheduled clinic visits, symptom diaries, and safety monitoring. Primary outcomes focus on device safety and changes in urgency, frequency, nocturia, and incontinence over the treatment period.
Who should consider this trial
Good fit: Adult females age 21 or older with physician-confirmed OAB symptoms lasting more than six months who can follow study procedures and complete symptom diaries are ideal candidates.
Not a fit: Patients with systemic conditions that interfere with participation or safety, or those deemed inappropriate by the investigator, may not receive benefit or may be excluded.
Why it matters
Potential benefit: If successful, the device could provide a non-invasive, non-implant alternative to medications for reducing urgency, frequency, and incontinence in women with OAB.
How similar studies have performed: Related neuromodulation methods like sacral and tibial nerve stimulation have demonstrated benefit for OAB, but non-implanted external devices such as FemPulse have less published evidence and are relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Key Inclusion Criteria: * Females, defined as a person with a uterus and cervix, ≥21 years old, with a diagnosis of OAB and symptoms for more than 6 months, as confirmed by a physician. OAB is defined by urinary urgency, usually with urinary frequency and nocturia, with or without urgency urinary incontinence with symptoms * Willing and able to comply with study required procedures and visits (e.g., maintaining consistent medication use, fluid intake, diary completion). Key Exclusion Criteria: * Systemic condition or disease that may interfere with study participation (e.g., current systemic infection, uncontrolled autoimmune disease, uncontrolled immunodeficiency disease, history of myocardial infarction, etc.) as determined by study investigator. * Not an appropriate study candidate as determined by investigator.
Where this trial is running
Beverly Hills, California and 14 other locations
- Cedars Sinai — Beverly Hills, California, United States (RECRUITING)
- UCLA — Los Angeles, California, United States (NOT_YET_RECRUITING)
- UC Irvine — Orange, California, United States (RECRUITING)
- Stanford — Palo Alto, California, United States (RECRUITING)
- USCD — San Diego, California, United States (NOT_YET_RECRUITING)
- Holy Cross Medical Group - Women's Center — Fort Lauderdale, Florida, United States (NOT_YET_RECRUITING)
- Comprehensive Urologic — Barrington, Illinois, United States (RECRUITING)
- University of Louisville — Louisville, Kentucky, United States (NOT_YET_RECRUITING)
- Chesapeake Urology — Owings Mills, Maryland, United States (RECRUITING)
- Minnesota Urology — Woodbury, Minnesota, United States (NOT_YET_RECRUITING)
- Adult & Pediatric Urology — Omaha, Nebraska, United States (RECRUITING)
- Atrium Health — Charlotte, North Carolina, United States (NOT_YET_RECRUITING)
- Southern Urogynecology — West Columbia, South Carolina, United States (RECRUITING)
- Sanford Health — Sioux Falls, South Dakota, United States (RECRUITING)
- INOVA — Falls Church, Virginia, United States (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Suzette Sutherland, MD — FemPulse Corporation
- Study coordinator: Monica Unger
- Email: monica.unger@moxieclinical.com
- Phone: 7275123718
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Overactive Bladder, neuromodulation