FemPulse Therapy First-in-Human Experience

Urinary Bladder, Overactive Clinical Trial

Official title:

Evaluation of a Wearable Electrical Incontinence Device in Subjects: A Non-significant Risk Clinical Evaluation of FemPulse Therapy in Women With OAB

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03874637
• Other study ID #: CIP-001
• Status: Completed
• Phase: N/A
• Start date: February 14, 2017
• Est. completion date: May 17, 2017

Study information

• Verified date: February 2019
• Source: FemPulse Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: May 17, 2017
• Est. primary completion date: May 17, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Urinary Bladder, Overactive

Intervention

Device:
• Treament
Placement of the FemPulse System with therapy delivery
• Sham Control
Placement of the FemPulse System without therapy delivery

Locations

Country	Name	City	State
United States	University of Washington Medical Center	Seattle	Washington
United States	Minnesota Urology	Woodbury	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
FemPulse Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events	All device- and procedure-related adverse events will be collected and tabulated	3 days in total
Primary	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.	3 days in total
Secondary	Frequency of urinary voids	The number of voids per day will be tabulated	3 days in total
Secondary	Intervals between urinary voids	The time between voids (hours:minutes) will be tabulated	3 days in total
Secondary	Urge urinary incontinence (UUI)	Presence or absence of UUI with each void	3 days in total