Back to resultsPilot Phase for an Acute Evaluation of a Non-Implantable Electrical Continence Device
Primary Purpose
Urinary Bladder, Overactive
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
The FemPulse System
Sponsored by
About this trial
This is an interventional device feasibility trial for Urinary Bladder, Overactive focused on measuring Overactive Bladder, Women, Neuromodulation, Bioelectronic Medicine
Eligibility Criteria
Inclusion Criteria:
- Normal healthy women ≥ 21 years old
- Using contraception if of reproductive age
Exclusion Criteria:
- Pregnant, recently pregnant or actively trying to conceive
- Prior hysterectomy
- Current or recent urinary tract or vaginal infection
Sites / Locations
- Hennepin Healthcare
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Monitoring during activation of the FemPulse System
Arm Description
Subjects will undergo non-invasive monitoring during activation of the FemPulse System.
Outcomes
Primary Outcome Measures
Autonomic nervous system response
The Quantitative Sudomotor Axon Reflex Test (QSART) will be used to detect changes in autonomic nervous system activity during device activation
Evoked Potential response
Surface electrodes will be used to detect whether evoked potentials are generated during device activation
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04001426
Brief Title
Pilot Phase for an Acute Evaluation of a Non-Implantable Electrical Continence Device
Official Title
Pilot Phase for an Acute Evaluation of a Non-Implantable Electrical Continence Device
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
April 4, 2019 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)
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
No
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.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this feasibility clinical investigation 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, Women, Neuromodulation, Bioelectronic Medicine
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Subjects will wear a device and will be monitored non-invasively during activation of the device.
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Monitoring during activation of the FemPulse System
Arm Type
Experimental
Arm Description
Subjects will undergo non-invasive monitoring during activation of the FemPulse System.
Intervention Type
Device
Intervention Name(s)
The FemPulse System
Intervention Description
Non-invasive monitoring during activation of the FemPulse System
Primary Outcome Measure Information:
Title
Autonomic nervous system response
Description
The Quantitative Sudomotor Axon Reflex Test (QSART) will be used to detect changes in autonomic nervous system activity during device activation
Time Frame
Up to 6 hours
Title
Evoked Potential response
Description
Surface electrodes will be used to detect whether evoked potentials are generated during device activation
Time Frame
Up to 6 hours
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Normal healthy women ≥ 21 years old
Using contraception if of reproductive age
Exclusion Criteria:
Pregnant, recently pregnant or actively trying to conceive
Prior hysterectomy
Current or recent urinary tract or vaginal infection
Facility Information:
Facility Name
Hennepin Healthcare
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Pilot Phase for an Acute Evaluation of a Non-Implantable Electrical Continence Device
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