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The purpose of this feasibility clinical investigation is to investigate a new medical device treatment for Overactive Bladder (OAB) in women.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monitoring during activation of the FemPulse System | Experimental | Subjects will undergo non-invasive monitoring during activation of the FemPulse System. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The FemPulse System | Device | Non-invasive monitoring during activation of the FemPulse System |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to 6 hours |
| Evoked Potential response | Surface electrodes will be used to detect whether evoked potentials are generated during device activation | Up to 6 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hennepin Healthcare | Minneapolis | Minnesota | 55404 | United States |
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| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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Subjects will wear a device and will be monitored non-invasively during activation of the device.
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |