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Recruiting Not applicable

Evaluation of a Non-Implanted Electrical Stimulation Device for Overactive Bladder (OAB)

NCT07195656 · tracked via the Priya Life Science USA tracker
Sponsor
FemPulse Corporation
Phase
Not applicable
Started
2025-09-30
Last updated
2026-07-13

Condition(s) studied

Overactive Bladder (OAB)

Investigational drug(s) / intervention(s)

Device GroupMedication Group

Device Group: non-implanted, vaginal electrical stimulation device

Medication Group: OAB Medication

Study summary

A study to evaluate the safety and effectiveness of FemPulse System

Eligibility

Sex
FEMALE
Min age
21 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Mean Change in Voids per Day — 6 months
    Difference in mean change between device and medication groups in number of voids per day (VPD)

Trial sites (15)

FacilityCityRegionStatus
Cedars Sinai Beverly Hills California Recruiting
UCLA Los Angeles California Recruiting
UC Irvine Orange California Recruiting
Stanford Palo Alto California Recruiting
USCD San Diego California Recruiting
Holy Cross Medical Group - Women's Center Fort Lauderdale Florida Recruiting
Comprehensive Urologic Barrington Illinois Recruiting
University of Louisville Louisville Kentucky Not Yet Recruiting
Chesapeake Urology Owings Mills Maryland Recruiting
Minnesota Urology Woodbury Minnesota Not Yet Recruiting
Adult & Pediatric Urology Omaha Nebraska Recruiting
Atrium Health Charlotte North Carolina Recruiting
Southern Urogynecology West Columbia South Carolina Recruiting
Sanford Health Sioux Falls South Dakota Recruiting
INOVA Falls Church Virginia Not Yet Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07195656 on ClinicalTrials.gov ↗ ← All trials in the USA