Urinary Bladder, Overactive
Conditions
Keywords
Overactive Bladder, Women, Neuromodulation, Bioelectronic Medicine
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.
Interventions
DEVICEThe FemPulse System
Non-invasive monitoring during activation of the FemPulse System
Sponsors
FemPulse Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
Subjects will wear a device and will be monitored non-invasively during activation of the device.
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Evoked Potential response | Up to 6 hours | Surface electrodes will be used to detect whether evoked potentials are generated during device activation |
Countries
United States
Outcome results
None listed