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

Part of paid clinical trials in Beverly Hills, California.

Sponsor
FemPulse Corporation
Study ID
NCT07195656
Status
Recruiting
Apply to this trial

Conditions

  • Overactive Bladder (OAB)

Eligibility Criteria

Sex
FEMALE
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Device Group — DEVICE
    non-implanted, vaginal electrical stimulation device
  • Medication Group — DRUG
    OAB Medication

Study Details

A study to evaluate the safety and effectiveness of FemPulse System

Key Dates

Start date
Sep 30, 2025
Status verified
Sep 2025
Primary completion
May 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
151 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Device Group
    Subjects receiving the FemPulse System
  • Other: Medication Group
    Subjects receiving medication

Primary Outcome Measure

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

Central Contacts

Locations (15)

FacilityCityStateZIPSite coordinators
Cedars SinaiBeverly HillsCalifornia90211
Maria Parco
[email protected]
310-423-1542
Karyn Eilber, MD (PRINCIPAL_INVESTIGATOR)
UCLALos AngelesCalifornia90095
Nassura Richard
310-267-4331
A Lenore Ackerman, MD (PRINCIPAL_INVESTIGATOR)
UC IrvineOrangeCalifornia92868
Bryan Robles
714-509-6130
Olivia Chang, MD (PRINCIPAL_INVESTIGATOR)
StanfordPalo AltoCalifornia94304
Kathryn Batham
650-724-7826
Eric Sokol, MD (PRINCIPAL_INVESTIGATOR)
USCDSan DiegoCalifornia92037
Melissa Saurez
858-249-4447
Yahir Santiago-Lastra, MD (PRINCIPAL_INVESTIGATOR)
Holy Cross Medical Group - Women's CenterFort LauderdaleFlorida33334
Judie Corbett
954-542-4841
Guillermo Davila, MD (PRINCIPAL_INVESTIGATOR)
Comprehensive UrologicBarringtonIllinois60010
Sunny Sian
847-852-1777
Tamra Lewis, MD (PRINCIPAL_INVESTIGATOR)
University of LouisvilleLouisvilleKentucky40205
Decora Whalen
502-588-4412
Sean Francis, MD (PRINCIPAL_INVESTIGATOR)
Chesapeake UrologyOwings MillsMaryland21117
Seema Shahi
410-616-8431
Laura Giusto, MD (PRINCIPAL_INVESTIGATOR)
Minnesota UrologyWoodburyMinnesota55125
Carrie McKenzie
651-999-6903
Jodi Michaels, MD (PRINCIPAL_INVESTIGATOR)
Adult & Pediatric UrologyOmahaNebraska68114
Peyton Schneider
402-399-7898
Rebecca McCrery, MD (PRINCIPAL_INVESTIGATOR)
Atrium HealthCharlotteNorth Carolina28204
Robbin Clark
704-355-7466
Michael Kennelly, MD (PRINCIPAL_INVESTIGATOR)
Southern UrogynecologyWest ColumbiaSouth Carolina29169
Tina McCready
803-457-7000
Andrea Pezzella, MD (PRINCIPAL_INVESTIGATOR)
Sanford HealthSioux FallsSouth Dakota57105
Jennifer Pratt
605-328-1391
Kevin Benson, MD (PRINCIPAL_INVESTIGATOR)
INOVAFalls ChurchVirginia22042
Claudia Lovo-Alvarez
703-776-4600
Abbas Shobeiri, MD (PRINCIPAL_INVESTIGATOR)

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