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The objective of the study is to demonstrate that the FemPulse System can be used as indicated
The objective of the study is to demonstrate that the FemPulse System can be used as indicated in the Patient and Clinician Instructions for Use (IFU), as applicable.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects receiving the FemPulse System | Experimental | Subjects to receive the FemPulse System consisting of a non-implanted, vaginal electrical stimulation device (Ring) and other patient accessories. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FemPulse System | Device | Subjects to receive the FemPulse System consisting of a non-implanted, vaginal electrical stimulation device (Ring) and other patient accessories. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient Usability of System | A survery will be conducted to determine the overall usability of the system | 2 days |
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Key Inclusion Criteria:
Exclusion Criteria:
4. Systemic condition or disease that may interfere with study participation or not an appropriate study candidate, as determined by study investigator.
Females, defined as a person with a uterus and cervix.
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| Name | Affiliation | Role |
|---|---|---|
| Roshini Jain | FemPulse Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Holy Cross Women's Hospital | Fort Lauderdale | Florida | 33334 | 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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| 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 |