FemPulse Therapy First-in-Human Experience

March 12, 2019 updated by: FemPulse Corporation

Evaluation of a Wearable Electrical Incontinence Device in Subjects: A Non-significant Risk Clinical Evaluation of FemPulse Therapy in Women With OAB

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 in the lower abdomen that regulate bladder function. It is believed that stimulation of these nerves may help relieve the symptoms of OAB.

Study Type

Interventional

Enrollment (Actual)

15

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
    • 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

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Females ≥21 yrs with Overactive Bladder

Exclusion Criteria:

  • Is or was recently pregnant
  • Has a metal pelvic implant or any electrically active implanted medical device
  • Has a urinary tract or vaginal infection
  • Had a previous hysterectomy, pelvic radiation or pelvic cancer
  • Has significant pelvic organ prolapse
  • Had bladder treatment with onabotulinumtoxinA in the previous 12 months or Tibial Nerve stimulation within the previous 30 days
  • Has a significant heart condition or a history of vasovagal reaction or low blood pressure

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: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
Active therapy
Device: Treament
Placement of the FemPulse System with therapy delivery
Sham Comparator: Sham Control
Device: Sham Control
Placement of the FemPulse System without therapy delivery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: 3 days in total
All device- and procedure-related adverse events will be collected and tabulated
3 days in total
Placeability and comfort of the device
Time Frame: 3 days in total
Subjects will be observed for their ability to place, orient and wear the device without discomfort. The outcome is Pass or Fail as determined by the investigator.
3 days in total

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of urinary voids
Time Frame: 3 days in total
The number of voids per day will be tabulated
3 days in total
Intervals between urinary voids
Time Frame: 3 days in total
The time between voids (hours:minutes) will be tabulated
3 days in total
Urge urinary incontinence (UUI)
Time Frame: 3 days in total
Presence or absence of UUI with each void
3 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)

February 14, 2017

Primary Completion (Actual)

May 17, 2017

Study Completion (Actual)

May 17, 2017

Study Registration Dates

First Submitted

March 4, 2019

First Submitted That Met QC Criteria

March 12, 2019

First Posted (Actual)

March 14, 2019

Study Record Updates

Last Update Posted (Actual)

March 14, 2019

Last Update Submitted That Met QC Criteria

March 12, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIP-001

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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