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The purpose of this clinical trial 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 |
|---|---|---|---|
| Treatment | Experimental | FemPulse System at one device setting |
|
| Control | Sham Comparator | FemPulse System at a different device setting |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FemPulse System | Device | Device therapy with the FemPulse System |
|
| Measure | Description | Time Frame |
|---|---|---|
| All device- and procedure-related adverse events will be collected and tabulated | Adverse events | Approximately 11 days in total |
| Urinary frequency | Frequency of and intervals between urinary voids (voids per day and time between voids) | Approximately 11 days in total |
| Urinary urgency | Presence or absence of urgency with each void | Approximately 11 days in total |
| Urge urinary incontinence (UUI) | Presence or absence of UUI with each void | Approximately 11 days in total |
| OAB-q - Short Form | OAB bother quality of life questionnaire | Approximately 11 days in total |
| OAB Symptom Score | OAB symptoms quality of life questionnaire | Approximately 11 days in total |
| Urogenital Distress Inventory - Short Form | OAB-related distress quality of life questionnaire | Approximately 11 days in total |
| Incontinence Impact Questionnaire - Short Form | Impact of OAB quality of life questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Minnesota Urology | Woodbury | Minnesota | 55125 | United States | ||
| McKay Urology |
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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 treated at 1 of 2 device settings for approximately 3 days.
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| Approximately 11 days in total |
| Charlotte |
| North Carolina |
| 28207 |
| United States |
| University of Washington Medical Center | Seattle | Washington | 98195 | United States |
| 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 |