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

FemPulse

Status: Completed

Conditions: Urinary Bladder, Overactive

Treatments: Device: The FemPulse System

Study type: Interventional

Funder types: Industry

Identifiers

NCT04001426

CIP-003

Details and patient eligibility

About

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

Full 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.

Enrollment: 2 patients

Sex: Female

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2 participants in 1 patient group

Monitoring during activation of the FemPulse System

Experimental group

Description:

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

Treatment:

Device: The FemPulse System