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

February 4, 2026 updated by: FemPulse Corporation

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

A study to evaluate the safety and effectiveness of FemPulse System

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

151

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Beverly Hills, California, United States, 90211
        • Recruiting
        • Cedars Sinai
        • Principal Investigator:
          • Karyn Eilber, MD
        • Contact:
      • Los Angeles, California, United States, 90095
        • Not yet recruiting
        • UCLA
        • Contact:
          • Nassura Richard
          • Phone Number: 310-267-4331
        • Principal Investigator:
          • A Lenore Ackerman, MD
      • Orange, California, United States, 92868
        • Recruiting
        • UC Irvine
        • Contact:
          • Bryan Robles
          • Phone Number: 714-509-6130
        • Principal Investigator:
          • Olivia Chang, MD
      • Palo Alto, California, United States, 94304
        • Recruiting
        • Stanford
        • Principal Investigator:
          • Eric Sokol, MD
        • Contact:
          • Kathryn Batham
          • Phone Number: 650-724-7826
      • San Diego, California, United States, 92037
        • Not yet recruiting
        • USCD
        • Principal Investigator:
          • Yahir Santiago-Lastra, MD
        • Contact:
          • Melissa Saurez
          • Phone Number: 858-249-4447
    • Florida
      • Fort Lauderdale, Florida, United States, 33334
        • Not yet recruiting
        • Holy Cross Medical Group - Women's Center
        • Contact:
          • Judie Corbett
          • Phone Number: 954-542-4841
        • Principal Investigator:
          • Guillermo Davila, MD
    • Illinois
      • Barrington, Illinois, United States, 60010
        • Recruiting
        • Comprehensive Urologic
        • Contact:
          • Sunny Sian
          • Phone Number: 847-852-1777
        • Principal Investigator:
          • Tamra Lewis, MD
    • Kentucky
      • Louisville, Kentucky, United States, 40205
        • Not yet recruiting
        • University of Louisville
        • Principal Investigator:
          • Sean Francis, MD
        • Contact:
          • Decora Whalen
          • Phone Number: 502-588-4412
    • Maryland
      • Owings Mills, Maryland, United States, 21117
        • Recruiting
        • Chesapeake Urology
        • Principal Investigator:
          • Laura Giusto, MD
        • Contact:
          • Seema Shahi
          • Phone Number: 410-616-8431
    • Minnesota
      • Woodbury, Minnesota, United States, 55125
        • Not yet recruiting
        • Minnesota Urology
        • Contact:
          • Carrie McKenzie
          • Phone Number: 651-999-6903
        • Principal Investigator:
          • Jodi Michaels, MD
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Recruiting
        • Adult & Pediatric Urology
        • Principal Investigator:
          • Rebecca McCrery, MD
        • Contact:
          • Peyton Schneider
          • Phone Number: 402-399-7898
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Not yet recruiting
        • Atrium Health
        • Principal Investigator:
          • Michael Kennelly, MD
        • Contact:
          • Robbin Clark
          • Phone Number: 704-355-7466
    • South Carolina
      • West Columbia, South Carolina, United States, 29169
        • Recruiting
        • Southern Urogynecology
        • Principal Investigator:
          • Andrea Pezzella, MD
        • Contact:
          • Tina McCready
          • Phone Number: 803-457-7000
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Recruiting
        • Sanford Health
        • Principal Investigator:
          • Kevin Benson, MD
        • Contact:
          • Jennifer Pratt
          • Phone Number: 605-328-1391
    • Virginia
      • Falls Church, Virginia, United States, 22042
        • Not yet recruiting
        • Inova
        • Contact:
          • Claudia Lovo-Alvarez
          • Phone Number: 703-776-4600
        • Principal Investigator:
          • Abbas Shobeiri, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Device Group
Subjects receiving the FemPulse System
Device: Device Group
non-implanted, vaginal electrical stimulation device
Other: Medication Group
Subjects receiving medication
Drug: Medication Group
OAB Medication

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change in Voids per Day
Time Frame: 6 months
Difference in mean change between device and medication groups in number of voids per day (VPD)
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

FemPulse Corporation

Collaborators

Moxie Clinical

Investigators

  • Principal Investigator: Suzette Sutherland, MD, FemPulse Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2025

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

September 24, 2025

First Submitted That Met QC Criteria

September 24, 2025

First Posted (Actual)

September 29, 2025

Study Record Updates

Last Update Posted (Actual)

February 6, 2026

Last Update Submitted That Met QC Criteria

February 4, 2026

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIP012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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