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To evaluate the safety and feasibility of non-invasive magnetic stimulation of the posterior tibial nerve using the EMKinetics LoFIT Pulse System for treating patients with documented overactive bladder.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EMKinetics non-invasive Magnetic neurostimulator | Device | Patients will be treated with 12 weekly sessions of magnetic stimulation of the posterior tibial nerve at 20 hz using the EMKinetics non-invasive Magnetic neurostimulator. |
| Measure | Description | Time Frame |
|---|---|---|
| Global Response Assessment | Improved score on the Global Response Assessment (GRA) scale after 12 weeks of therapy. A score of 2 (moderately improved) or 3 (markedly improved) constitutes a responder on the 7 point scale | After 12 weeks of therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Urinary Frequency | Change in Urinary Frequency (Voiding Diary) from Baseline to 12 weeks | After 12 weeks of therapy |
| Urinary Incontinence | Change in Urinary Incontinence (Voiding Diary) from Baseline to 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Incontinence and Pelvic Support Institute | Mission Viejo | California | 92691 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 3, 2015 | |
| Reset | Aug 28, 2015 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 3, 2015 | Aug 28, 2015 |
| 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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| After 12 weeks of therapy |
| Overactive Bladder Symptoms (OAB-q SF) | Change in Overactive Bladder Symptoms (OAB-q SF) from Baseline to 12 weeks | After 12 weeks of therapy |
| 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 |