Recruiting

FemPulse System

Sponsor:

FemPulse Corporation

Code:

NCT07195656

Conditions

Overactive Bladder (OAB)

Eligibility Criteria

Sex: Female

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Device Group

Medication Group

Study Details

Brief summary:

A study to evaluate the safety and effectiveness of FemPulse System

Conditions

Overactive Bladder (OAB)

Study ID

NCT07195656

Start date

Sep 30, 2025

Status verified date

Sep, 2025

Completion date

Dec 31, 2027

Anticipated

Primary completion date

May 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 21+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

151 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Device Group

Subjects receiving the FemPulse System

other: Medication Group

Subjects receiving medication

Interventions

Device Group

non-implanted, vaginal electrical stimulation device

Medication Group

OAB Medication

Primary outcome measure

  • Mean Change in Voids per Day [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Monica Unger

7275123718monica.unger@moxieclinical.com

Locations

Cedars Sinai

Recruiting

Beverly Hills, California, United States, 90211

Contacts

Arman Jordan

310-248-6716arman.jordan@cshs.org

Principal Investigator:

Karyn Eilber, MD

UCLA

Recruiting

Los Angeles, California, United States, 90095

Contacts

Katie Levitt

(310) 794 - 6786KLevitt@mednet.ucla.edu

Principal Investigator:

A Lenore Ackerman, MD

UC Irvine

Recruiting

Orange, California, United States, 92868

Contacts

Bryan Robles

714-509-6130

Principal Investigator:

Olivia Chang, MD

Stanford

Recruiting

Palo Alto, California, United States, 94304

Contacts

Kathryn Batham

650-724-7826

Principal Investigator:

Eric Sokol, MD

USCD

Recruiting

San Diego, California, United States, 92037

Contacts

Melissa Saurez

858-249-4447

Principal Investigator:

Yahir Santiago-Lastra, MD

Holy Cross Medical Group - Women's Center

Recruiting

Fort Lauderdale, Florida, United States, 33334

Contacts

Judie Corbett

954-542-4841

Principal Investigator:

Guillermo Davila, MD

Comprehensive Urologic

Recruiting

Barrington, Illinois, United States, 60010

Contacts

Sunny Sian

847-852-1777

Principal Investigator:

Tamra Lewis, MD

Chesapeake Urology

Recruiting

Owings Mills, Maryland, United States, 21117

Contacts

Seema Shahi

410-616-8431

Principal Investigator:

Laura Giusto, MD

Adult & Pediatric Urology

Recruiting

Omaha, Nebraska, United States, 68114

Contacts

Peyton Schneider

402-399-7898

Principal Investigator:

Rebecca McCrery, MD

Atrium Health

Recruiting

Charlotte, North Carolina, United States, 28204

Contacts

Robbin Clark

704-355-7466

Principal Investigator:

Michael Kennelly, MD

Southern Urogynecology

Recruiting

West Columbia, South Carolina, United States, 29169

Contacts

Tina McCready

803-457-7000

Principal Investigator:

Andrea Pezzella, MD

Sanford Health

Recruiting

Sioux Falls, South Dakota, United States, 57105

Contacts

Jennifer Pratt

605-328-1391

Principal Investigator:

Kevin Benson, MD

More Information

Sponsor

FemPulse Corporation

Last update posted

Jul 13, 2026

Last verified

Sep, 2025

Keywords

  • neuromodulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-18. This information was provided to ClinicalTrials.gov by FemPulse Corporation on 2026-07-13.