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NCT07195656NARecruiting

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

FemPulse Corporation

Start Date

9/30/2025

Completion Date

12/31/2027

Summary

A study to evaluate the safety and effectiveness of FemPulse System

Eligibility Criteria

Age Range: 21 years to No maximum

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.

Interventions

DEVICE

Device Group

DRUG

Medication Group

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Conditions

Overactive Bladder (OAB)

Locations

Cedars Sinai

Beverly Hills, California 90211

United States

UCLA

Los Angeles, California 90095

United States

UC Irvine

Orange, California 92868

United States

Stanford

Palo Alto, California 94304

United States

USCD

San Diego, California 92037

United States

Holy Cross Medical Group - Women's Center

Fort Lauderdale, Florida 33334

United States

Comprehensive Urologic

Barrington, Illinois 60010

United States

University of Louisville

Louisville, Kentucky 40205

United States

Chesapeake Urology

Owings Mills, Maryland 21117

United States

Minnesota Urology

Woodbury, Minnesota 55125

United States

Adult & Pediatric Urology

Omaha, Nebraska 68114

United States

Atrium Health

Charlotte, North Carolina 28204

United States

Southern Urogynecology

West Columbia, South Carolina 29169

United States

Sanford Health

Sioux Falls, South Dakota 57105

United States

INOVA

Falls Church, Virginia 22042

United States