Pilot Phase for an Acute Evaluation of a Non-Implantable Electrical Continence Device
Not Applicable
Completed
- Conditions
- Urinary Bladder, Overactive
- Interventions
- Device: The FemPulse System
- Registration Number
- NCT04001426
- Lead Sponsor
- FemPulse Corporation
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 2
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Monitoring during activation of the FemPulse System The FemPulse System Subjects will undergo non-invasive monitoring during activation of the FemPulse System.
- Primary Outcome Measures
Name Time Method Evoked Potential response Up to 6 hours Surface electrodes will be used to detect whether evoked potentials are generated during device activation
Autonomic nervous system response 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Hennepin Healthcare
🇺🇸Minneapolis, Minnesota, United States