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FemPulse Therapy for Overactive Bladder in Women (EVANESCE-OAB)

Primary Purpose

Urinary Bladder, Overactive

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

FemPulse System

About this trial

This is an interventional treatment trial for Urinary Bladder, Overactive focused on measuring Overactive Bladder, OAB, Women, Neuromodulation, Bioelectronic Medicine

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Minnesota Urology
McKay Urology
University of Washington Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Treatment

Control

Arm Description

FemPulse System at one device setting

FemPulse System at a different device setting

Outcomes

Primary Outcome Measures

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

Adverse events

Urinary frequency

Frequency of and intervals between urinary voids (voids per day and time between voids)

Urinary urgency

Presence or absence of urgency with each void

Urge urinary incontinence (UUI)

Presence or absence of UUI with each void

OAB-q - Short Form

OAB bother quality of life questionnaire

OAB Symptom Score

OAB symptoms quality of life questionnaire

Urogenital Distress Inventory - Short Form

OAB-related distress quality of life questionnaire

Incontinence Impact Questionnaire - Short Form

Impact of OAB quality of life questionnaire

Secondary Outcome Measures

Full Information

NCT ID

NCT03784170

First Posted

December 14, 2018

Last Updated

November 6, 2019

Sponsor

FemPulse Corporation

1. Study Identification

Unique Protocol Identification Number

NCT03784170

Brief Title

FemPulse Therapy for Overactive Bladder in Women

Acronym

EVANESCE-OAB

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Unknown status

Study Start Date

December 11, 2018 (Actual)

Primary Completion Date

December 2019 (Anticipated)

Study Completion Date

December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

FemPulse Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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 that regulate bladder function. It is believed that stimulation of these nerves may help relieve the symptoms of OAB.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Urinary Bladder, Overactive

Keywords

Overactive Bladder, OAB, Women, Neuromodulation, Bioelectronic Medicine

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Subjects will wear a device and will be treated at 1 of 2 device settings for approximately 3 days.

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

21 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treatment

Arm Type

Experimental

Arm Description

FemPulse System at one device setting

Arm Title

Control

Arm Type

Sham Comparator

Arm Description

FemPulse System at a different device setting

Intervention Type

Device

Intervention Name(s)

FemPulse System

Intervention Description

Device therapy with the FemPulse System

Primary Outcome Measure Information:

Title

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

Description

Adverse events

Time Frame