FemPulse Therapy First-in-Human Experience

Not Applicable

Completed

• Conditions: Urinary Bladder, Overactive
• Interventions: Device: Sham Control; Device: Treament

• Registration Number: NCT03874637
• Lead Sponsor: FemPulse Corporation

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2017-02-14
• Primary Completion: 2017-05-17
• Study Completion: 2017-05-17
• Status Verified: 2019-02
• Study First Submitted: 2019-03-04
• Study First Submitted QC: 2019-03-12
• Last Update Submitted: 2019-03-12
• Study First Posted: 2019-03-14
• Last Update Posted: 2019-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sham Control	Sham Control	Sham Control
Treatment	Treament	Active therapy

Primary Outcome Measures

Name	Time	Method
Adverse Events	3 days in total	All device- and procedure-related adverse events will be collected and tabulated
Placeability and comfort of the device	3 days in total	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.

Secondary Outcome Measures

Name	Time	Method
Frequency of urinary voids	3 days in total	The number of voids per day will be tabulated
Intervals between urinary voids	3 days in total	The time between voids (hours:minutes) will be tabulated
Urge urinary incontinence (UUI)	3 days in total	Presence or absence of UUI with each void

Trial Locations

Locations (2)

Minnesota Urology; 🇺🇸 Woodbury, Minnesota, United States

University of Washington Medical Center; 🇺🇸 Seattle, Washington, United States