Clinical trial Recruiting at 12 sites Interventional Ages 21 and up Women only

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 typeInterventional
Ages21 Years and up
SexWomen only
Enrollment151 (estimated)
SponsorFemPulse Corporation
Industry-sponsored
Locations15 sites (Beverly Hills, California and 14 other locations)
StatusRecruiting
StartedSeptember 30, 2025
Main results expectedMay 31, 2027
Study endsDecember 31, 2027
Registry record updatedJuly 13, 2026
Trial IDNCT07195656 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.