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

FemPulse Corporation2 enrolled

Overview

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

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

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Urinary Bladder, Overactive

Interventions

The FemPulse SystemDEVICE

Non-invasive monitoring during activation of the FemPulse System

Eligibility

Sex: FEMALEMin age: 21 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Hennepin Healthcare

Minneapolis, Minnesota, United States

Outcomes

Primary Outcomes

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

Time frame: Up to 6 hours

Evoked Potential response

Surface electrodes will be used to detect whether evoked potentials are generated during device activation

Time frame: Up to 6 hours

Data from ClinicalTrials.gov

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