FemPulse non-implanted electrical stimulation for overactive bladder.
Official title: Evaluation of a Non-Implanted Electrical Stimulation Device for Overactive Bladder (OAB) EVANESCE-II
Run by FemPulse Corporation · NCT07195656 · Data updated 2026-11-12
This trial will test whether the FemPulse external electrical stimulation device can reduce overactive bladder symptoms in adult women.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 21 Years and up |
| Sex | Women only |
| Enrollment | 151 (estimated) |
| Sponsor | FemPulse Corporation Industry-sponsored |
| Locations | 15 sites (Beverly Hills, California and 14 other locations) |
| Status | Recruiting |
| Started | September 30, 2025 |
| Main results expected | May 31, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | July 13, 2026 |
| Trial ID | NCT07195656 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
Cedars Sinai
Beverly Hills, California, United States Recruiting -
UCLA
Los Angeles, California, United States Recruiting -
UC Irvine
Orange, California, United States Recruiting -
Stanford
Palo Alto, California, United States Recruiting -
Uscd
San Diego, California, United States Recruiting -
Holy Cross Medical Group - Women's Center
Fort Lauderdale, Florida, United States Recruiting
Show 9 more locations
-
Comprehensive Urologic
Barrington, Illinois, United States Recruiting -
Chesapeake Urology
Owings Mills, Maryland, United States Recruiting -
Adult & Pediatric Urology
Omaha, Nebraska, United States Recruiting -
Atrium Health
Charlotte, North Carolina, United States Recruiting -
Southern Urogynecology
West Columbia, South Carolina, United States Recruiting -
Sanford Health
Sioux Falls, South Dakota, United States Recruiting -
University of Louisville
Louisville, Kentucky, United States Not yet recruiting -
Minnesota Urology
Woodbury, Minnesota, United States Not yet 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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Predictive value of inflammatory biomarkers for mirabegron response in women with overactive bladder
This study tests whether baseline blood inflammation markers can predict how well women with OAB respond to mirabegron after 3 months.
-
NT 201 therapy delivered via the Vibe System for idiopathic overactive bladder
This Phase 2b trial tests NT 201 given with the Vibe System to see if it helps adults with idiopathic overactive bladder compared to placebo or sham treatment.
-
Ambulatory tibial nerve stimulation for overactive bladder in adults
A portable nerve-stimulation device used at home is being tested to see if it can reduce urgency and improve bladder symptoms in adults with overactive bladder.
-
Low-intensity shockwave versus daily solifenacin for women's overactive bladder
This test compares once-weekly low-intensity shockwave therapy with daily solifenacin to see which better reduces overactive bladder symptoms in adult women.
-
Low-dose tadalafil versus solifenacin for treating overactive bladder in women
This trial will test whether taking daily low-dose tadalafil or daily solifenacin reduces overactive bladder symptoms in women aged 18–75.
-
Zinc plus phytase given before botulinum toxin injections for overactive bladder
This trial will test whether a short course of oral zinc plus phytase before botulinum toxin bladder injections helps adult women with overactive bladder go longer without needing another injection over six months.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.