FemPulse Therapy First-in-Human Experience

FemPulse Corporation15 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 in the lower abdomen 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

OTHER

Masking

TRIPLE

Enrollment

Conditions

Urinary Bladder, Overactive

Interventions

TreamentDEVICE

Placement of the FemPulse System with therapy delivery

Sham ControlDEVICE

Placement of the FemPulse System without therapy delivery

Eligibility

Sex: FEMALEMin age: 21 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Females ≥21 yrs with Overactive Bladder Exclusion Criteria: * Is or was recently pregnant * Has a metal pelvic implant or any electrically active implanted medical device * Has a urinary tract or vaginal infection * Had a previous hysterectomy, pelvic radiation or pelvic cancer * Has significant pelvic organ prolapse * Had bladder treatment with onabotulinumtoxinA in the previous 12 months or Tibial Nerve stimulation within the previous 30 days * Has a significant heart condition or a history of vasovagal reaction or low blood pressure

Locations (2)

Minnesota Urology

Woodbury, Minnesota, United States

University of Washington Medical Center

Seattle, Washington, United States

Outcomes

Primary Outcomes

Adverse Events

All device- and procedure-related adverse events will be collected and tabulated

Time frame: 3 days in total

Placeability and comfort of the device

Subjects will be observed for their ability to place, orient and wear the device without discomfort. The outcome is Pass or Fail as determined by the investigator.

Time frame: 3 days in total

Secondary Outcomes

Frequency of urinary voids

The number of voids per day will be tabulated

Time frame: 3 days in total

Intervals between urinary voids

The time between voids (hours:minutes) will be tabulated

Time frame: 3 days in total

Urge urinary incontinence (UUI)

Presence or absence of UUI with each void

Time frame: 3 days in total

Data from ClinicalTrials.gov

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