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

NCT ID: NCT04001426

Last Updated: 2021-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-04

Study Completion Date

2019-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Urinary Bladder, Overactive

Keywords

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Overactive Bladder Women Neuromodulation Bioelectronic Medicine

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Subjects will wear a device and will be monitored non-invasively during activation of the device.
Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Monitoring during activation of the FemPulse System

Subjects will undergo non-invasive monitoring during activation of the FemPulse System.

Group Type EXPERIMENTAL

The FemPulse System

Intervention Type DEVICE

Non-invasive monitoring during activation of the FemPulse System

Interventions

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The FemPulse System

Non-invasive monitoring during activation of the FemPulse System

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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FemPulse Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hennepin Healthcare

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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CIP-003

Identifier Type: -

Identifier Source: org_study_id