FemPulse Therapy for Overactive Bladder in Women

Urinary Bladder, Overactive Clinical Trial

— EVANESCE-OAB  

Official title:

Evaluation of a Non-Implanted Electrical Stimulation Continence Device for Overactive Bladder

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03784170
• Other study ID #: CIP-002
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 11, 2018
• Est. completion date: December 2019

Study information

• Verified date: October 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 that regulate bladder function. It is believed that stimulation of these nerves may help relieve the symptoms of OAB.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 21
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Urinary Bladder, Overactive

Intervention

Device:
• FemPulse System
Device therapy with the FemPulse System

Locations

Country	Name	City	State
United States	McKay Urology	Charlotte	North Carolina
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	All device- and procedure-related adverse events will be collected and tabulated	Adverse events	Approximately 11 days in total
Primary	Urinary frequency	Frequency of and intervals between urinary voids (voids per day and time between voids)	Approximately 11 days in total
Primary	Urinary urgency	Presence or absence of urgency with each void	Approximately 11 days in total
Primary	Urge urinary incontinence (UUI)	Presence or absence of UUI with each void	Approximately 11 days in total
Primary	OAB-q - Short Form	OAB bother quality of life questionnaire	Approximately 11 days in total
Primary	OAB Symptom Score	OAB symptoms quality of life questionnaire	Approximately 11 days in total
Primary	Urogenital Distress Inventory - Short Form	OAB-related distress quality of life questionnaire	Approximately 11 days in total
Primary	Incontinence Impact Questionnaire - Short Form	Impact of OAB quality of life questionnaire	Approximately 11 days in total