FemPulse Therapy for Overactive Bladder in Women

FemPulse Corporation21 enrolled

Overview

The purpose of this clinical trial 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

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Urinary Bladder, Overactive

Interventions

FemPulse SystemDEVICE

Device therapy with the FemPulse System

Eligibility

Sex: FEMALEMin age: 21 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Females 21 years or older with a diagnosis of Overactive Bladder * If of reproductive age, must use a reliable form of contraception Exclusion Criteria: * Pregnant, was recently pregnant or is trying to conceive * Has a metal pelvic implant or any electrically active implanted medical device * Had a previous hysterectomy, pelvic radiation or pelvic cancer * Has significant pelvic organ prolapse * Had bladder treatment with onabotulinumtoxinA in the previous 12 months * Has a significant heart condition

Locations (3)

Minnesota Urology

Woodbury, Minnesota, United States

McKay Urology

Charlotte, North Carolina, United States

University of Washington Medical Center

Seattle, Washington, United States