NCT04001426
Completed
N/A
Pilot Phase for an Acute Evaluation of a Non-Implantable Electrical Continence Device
ConditionsUrinary Bladder, Overactive
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Urinary Bladder, Overactive
- Sponsor
- FemPulse Corporation
- Enrollment
- 2
- Locations
- 1
- Primary Endpoint
- Evoked Potential response
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Evoked Potential response
Time Frame: Up to 6 hours
Surface electrodes will be used to detect whether evoked potentials are generated during device activation
Autonomic nervous system response
Time Frame: Up to 6 hours
The Quantitative Sudomotor Axon Reflex Test (QSART) will be used to detect changes in autonomic nervous system activity during device activation
Study Sites (1)
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