CClinicalTrials.gg
RecruitingNCT07195656EVANESCE-IIUpdated Jul 13, 2026

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

An interventional study of Device Group and Medication Group in Overactive Bladder (OAB), sponsored by FemPulse Corporation. Recruiting at 15 sites in United States. Open to female participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-07-13.

Sponsored by FemPulse Corporation · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
151
Allocation
Randomized
Ages
21 Years and older
Sex
Female
01

Study summary

A study to evaluate the safety and effectiveness of FemPulse System

02

Conditions studied

  • Overactive Bladder (OAB)

Keywords

  • neuromodulation
03

Who can participate

Ages eligible
21 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Eligibility criteria

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
151 participants (estimated)

Study arms

  • Experimental
    Device Group

    Subjects receiving the FemPulse System

    Device: Device Group

  • Other
    Medication Group

    Subjects receiving medication

    Drug: Medication Group

Interventions

  • DeviceDevice Group

    non-implanted, vaginal electrical stimulation device

  • DrugMedication Group

    OAB Medication

05

What researchers measure

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)

    Time frame: 6 months

06

Study locations

12 of 15 sites recruiting
  • Cedars Sinai
    Beverly Hills, California 90211, United States
    • Arman Jordan · Contact · arman.jordan@cshs.org · 310-248-6716
    • Karyn Eilber, MD · Principal investigator
    Recruiting
  • UCLA
    Los Angeles, California 90095, United States
    • Katie Levitt · Contact · KLevitt@mednet.ucla.edu · (310) 794 - 6786
    • A Lenore Ackerman, MD · Principal investigator
    Recruiting
  • UC Irvine
    Orange, California 92868, United States
    • Bryan Robles · Contact · 714-509-6130
    • Olivia Chang, MD · Principal investigator
    Recruiting
  • Stanford
    Palo Alto, California 94304, United States
    • Kathryn Batham · Contact · 650-724-7826
    • Eric Sokol, MD · Principal investigator
    Recruiting
  • USCD
    San Diego, California 92037, United States
    • Melissa Saurez · Contact · 858-249-4447
    • Yahir Santiago-Lastra, MD · Principal investigator
    Recruiting
  • Holy Cross Medical Group - Women's Center
    Fort Lauderdale, Florida 33334, United States
    • Judie Corbett · Contact · 954-542-4841
    • Guillermo Davila, MD · Principal investigator
    Recruiting
  • Comprehensive Urologic
    Barrington, Illinois 60010, United States
    • Sunny Sian · Contact · 847-852-1777
    • Tamra Lewis, MD · Principal investigator
    Recruiting
  • University of Louisville
    Louisville, Kentucky 40205, United States
    Not yet recruiting
  • Chesapeake Urology
    Owings Mills, Maryland 21117, United States
    • Seema Shahi · Contact · 410-616-8431
    • Laura Giusto, MD · Principal investigator
    Recruiting
  • Minnesota Urology
    Woodbury, Minnesota 55125, United States
    • Carrie McKenzie · Contact · 651-999-6903
    • Jodi Michaels, MD · Principal investigator
    Not yet recruiting
  • Adult & Pediatric Urology
    Omaha, Nebraska 68114, United States
    • Peyton Schneider · Contact · 402-399-7898
    • Rebecca McCrery, MD · Principal investigator
    Recruiting
  • Atrium Health
    Charlotte, North Carolina 28204, United States
    • Robbin Clark · Contact · 704-355-7466
    • Michael Kennelly, MD · Principal investigator
    Recruiting
  • Southern Urogynecology
    West Columbia, South Carolina 29169, United States
    • Tina McCready · Contact · 803-457-7000
    • Andrea Pezzella, MD · Principal investigator
    Recruiting
  • Sanford Health
    Sioux Falls, South Dakota 57105, United States
    • Jennifer Pratt · Contact · 605-328-1391
    • Kevin Benson, MD · Principal investigator
    Recruiting
  • INOVA
    Falls Church, Virginia 22042, United States
    • Claudia Lovo-Alvarez · Contact · 703-776-4600
    • Abbas Shobeiri, MD · Principal investigator
    Not yet recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07195656
Lead sponsor
FemPulse Corporation
Collaborators
Moxie Clinical
Responsible party
Sponsor
First posted
Sep 29, 2025
Start date
Sep 30, 2025
Primary completion
May 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Jul 13, 2026

Study contacts

Monica Unger
Contact
monica.unger@moxieclinical.com
7275123718
Suzette Sutherland, MD
principal investigator · FemPulse Corporation

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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