FemPulse Therapy for Overactive Bladder in Women (EVANESCE-OAB)

February 4, 2026 updated by: FemPulse Corporation

Evaluation of a Non-Implanted Electrical Stimulation Continence Device for Overactive Bladder

The purpose of this clinical trial is to investigate a new medical device treatment for Overactive Bladder (OAB) in women.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The FemPulse System is a vaginal ring intended to provide mild electrical stimulation to nerves that regulate bladder function. It is believed that stimulation of these nerves may help relieve the symptoms of OAB.

Study Type

Interventional

Enrollment (Actual)

21

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 Locations

  • United States
    • Minnesota
      • Woodbury, Minnesota, United States, 55125
        • Minnesota Urology
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • McKay Urology
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington Medical Center

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

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Females 21 years or older with a diagnosis of Overactive Bladder
  • If of reproductive age, must use a reliable form of contraception

Exclusion Criteria:

  • Pregnant, was recently pregnant or is trying to conceive
  • Has a metal pelvic implant or any electrically active implanted medical device
  • Had a previous hysterectomy, pelvic radiation or pelvic cancer
  • Has significant pelvic organ prolapse
  • Had bladder treatment with onabotulinumtoxinA in the previous 12 months
  • Has a significant heart condition

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
FemPulse System at one device setting
Device: FemPulse System
Device therapy with the FemPulse System
Sham Comparator: Control
FemPulse System at a different device setting
Device: FemPulse System
Device therapy with the FemPulse System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All device- and procedure-related adverse events will be collected and tabulated
Time Frame: Approximately 11 days in total
Adverse events
Approximately 11 days in total
Urinary frequency
Time Frame: Approximately 11 days in total
Frequency of and intervals between urinary voids (voids per day and time between voids)
Approximately 11 days in total
Urinary urgency
Time Frame: Approximately 11 days in total
Presence or absence of urgency with each void
Approximately 11 days in total
Urge urinary incontinence (UUI)
Time Frame: Approximately 11 days in total
Presence or absence of UUI with each void
Approximately 11 days in total
OAB-q - Short Form
Time Frame: Approximately 11 days in total
OAB bother quality of life questionnaire
Approximately 11 days in total
OAB Symptom Score
Time Frame: Approximately 11 days in total
OAB symptoms quality of life questionnaire
Approximately 11 days in total
Urogenital Distress Inventory - Short Form
Time Frame: Approximately 11 days in total
OAB-related distress quality of life questionnaire
Approximately 11 days in total
Incontinence Impact Questionnaire - Short Form
Time Frame: Approximately 11 days in total
Impact of OAB quality of life questionnaire
Approximately 11 days in total

Collaborators and Investigators

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

Sponsor

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)

December 11, 2018

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

December 14, 2018

First Submitted That Met QC Criteria

December 19, 2018

First Posted (Actual)

December 21, 2018

Study Record Updates

Last Update Posted (Actual)

February 6, 2026

Last Update Submitted That Met QC Criteria

February 4, 2026

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIP-002

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

product manufactured in and exported from the U.S.

No

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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