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NCT04001426 Clinical Trial

Pilot Phase for an Acute Evaluation of a Non-Implantable Electrical Continence Device

Urinary Bladder, Overactive Clinical Trial

Official title:
Pilot Phase for an Acute Evaluation of a Non-Implantable Electrical Continence Device

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04001426
Other study ID # CIP-003
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 4, 2019
Est. completion date December 31, 2019

Study information
Verified date November 2021
Source FemPulse Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 2
Est. completion date December 31, 2019
Est. primary completion date December 31, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 21 Years and older
Eligibility Inclusion Criteria: - Normal healthy women = 21 years old - Using contraception if of reproductive age Exclusion Criteria: - Pregnant, recently pregnant or actively trying to conceive - Prior hysterectomy - Current or recent urinary tract or vaginal infection

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• The FemPulse System
Non-invasive monitoring during activation of the FemPulse System

Locations
Country Name City State
United States Hennepin Healthcare Minneapolis Minnesota

Sponsors (1)
Lead Sponsor Collaborator
FemPulse Corporation

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Autonomic nervous system response The Quantitative Sudomotor Axon Reflex Test (QSART) will be used to detect changes in autonomic nervous system activity during device activation Up to 6 hours
Primary Evoked Potential response Surface electrodes will be used to detect whether evoked potentials are generated during device activation Up to 6 hours
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