NCT07195656

Brief Summary

A study to evaluate the safety and effectiveness of FemPulse System

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
151

participants targeted

Target at P75+ for not_applicable

Timeline
20mo left

Started Sep 2025

Typical duration for not_applicable

Geographic Reach
1 country

15 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress27%
Sep 2025Dec 2027

First Submitted

Initial submission to the registry

September 24, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 29, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

September 30, 2025

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2027

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

February 6, 2026

Status Verified

September 1, 2025

Enrollment Period

1.7 years

First QC Date

September 24, 2025

Last Update Submit

February 4, 2026

Conditions

Overactive Bladder (OAB)

Keywords

neuromodulation

Outcome Measures

Primary Outcomes (1)

  • Mean Change in Voids per Day

    Difference in mean change between device and medication groups in number of voids per day (VPD)

    6 months

Study Arms (2)

Device Group

EXPERIMENTAL

Subjects receiving the FemPulse System

Device: Device Group

Medication Group

OTHER

Subjects receiving medication

Drug: Medication Group

Interventions

Device GroupDEVICE

non-implanted, vaginal electrical stimulation device

Device Group
Medication GroupDRUG

OAB Medication

Medication Group

Eligibility Criteria

Age21 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Cedars Sinai

Beverly Hills, California, 90211, United States

RECRUITING

UCLA

Los Angeles, California, 90095, United States

NOT YET RECRUITING

UC Irvine

Orange, California, 92868, United States

RECRUITING

Stanford

Palo Alto, California, 94304, United States

RECRUITING

USCD

San Diego, California, 92037, United States

NOT YET RECRUITING

Holy Cross Medical Group - Women's Center

Fort Lauderdale, Florida, 33334, United States

NOT YET RECRUITING

Comprehensive Urologic

Barrington, Illinois, 60010, United States

RECRUITING

University of Louisville

Louisville, Kentucky, 40205, United States

NOT YET RECRUITING

Chesapeake Urology

Owings Mills, Maryland, 21117, United States

RECRUITING

Minnesota Urology

Woodbury, Minnesota, 55125, United States

NOT YET RECRUITING

Adult & Pediatric Urology

Omaha, Nebraska, 68114, United States

RECRUITING

Atrium Health

Charlotte, North Carolina, 28204, United States

NOT YET RECRUITING

Southern Urogynecology

West Columbia, South Carolina, 29169, United States

RECRUITING

Sanford Health

Sioux Falls, South Dakota, 57105, United States

RECRUITING

INOVA

Falls Church, Virginia, 22042, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Suzette Sutherland, MD

    FemPulse Corporation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Monica Unger

CONTACT

7275123718monica.unger@moxieclinical.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2025

First Posted

September 29, 2025

Study Start

September 30, 2025

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

February 6, 2026

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

US(15)