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business reasons
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The purpose of this study is to determine the effectiveness of percutaneous tibial nerve stimulation (PTNS) therapy with the Urgent® PC Neuromodulation System (Uroplasty, Inc., Minnetonka, MN, USA) for the treatment of fecal incontinence (FI).
Pilot Study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Urgent(R) PC Neuromodulation System | Experimental | Urgent(R) PC Neuromodulation System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Urgent(R) PC Neuromodulation System | Device | The Urgent PC Neuromodulation System (Uroplasty, Inc., Minnetonka, MN, USA), device, is an easily administered neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. This method of treatment is referred to as percutaneous tibial nerve stimulation (PTNS). |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness | To assess the effectiveness of PTNS by measuring the proportion of patients with ≥50% decrease in the number of fecal incontinence episodes per week based on the results of the 14-day bowel diary at 18 weeks compared to baseline | 18 weeks |
| Safety | To characterize adverse events experienced throughout the study | 18 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente Los Angeles Medical Center | Los Angeles | California | 90027 | United States | ||
| UCSF Center for Colorectal Surgery |
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|
| San Francisco |
| California |
| 94158 |
| United States |
| Minnesota Colon and Rectal Surgery Associates, Ltd. | Minneapolis | Minnesota | 55407 | United States |
| The Lindner Center for Research and Education at The Christ Hospital | Cincinnati | Ohio | 45219 | United States |
| Colorectal Surgical Asociates | Houston | Texas | 77054 | United States |
| Providence Health and Services | Spokane | Washington | 99204 | United States |
| ID | Term |
|---|---|
| D005242 | Fecal Incontinence |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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