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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 in the lower abdomen 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 | Active therapy |
|
| Sham Control | Sham Comparator | Sham Control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treament | Device | Placement of the FemPulse System with therapy delivery |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | All device- and procedure-related adverse events will be collected and tabulated | 3 days in total |
| Placeability and comfort of the device | Subjects will be observed for their ability to place, orient and wear the device without discomfort. The outcome is Pass or Fail as determined by the investigator. | 3 days in total |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of urinary voids | The number of voids per day will be tabulated | 3 days in total |
| Intervals between urinary voids | The time between voids (hours:minutes) will be tabulated |
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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 | ||
| University of Washington Medical Center |
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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 be treated at 2 different device settings (one of which is Off) in random sequence during two 6-hour periods at least one week apart.
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| Sham Control |
| Device |
Placement of the FemPulse System without therapy delivery |
|
| 3 days in total |
| Urge urinary incontinence (UUI) | Presence or absence of UUI with each void | 3 days in total |
| 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 |