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The purpose of this study is to evaluate the use of the Needle Guide as an assist in properly guiding an injection needle into the appropriate tissue plane during an injectable bulking agent procedure in women using a FDA approved injectable bulking agent. The injectable bulking agent will be Durasphere EXP.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Injection with Needle Guide | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Needle Guided Periurethral Injection | Device | Bulking Agent injection using a needle guide |
|
| Measure | Description | Time Frame |
|---|---|---|
| to evaluate the consistency of the location of the injection site and resulting location of bulking effect | at procedure | |
| Safety will be demonstrated through an analysis of morbidity and complication rates, (if any), associated with the use of the Needle Guide. | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| to evaluate the comparative ease of the injection procedure using the Bulking Agent Needle Guide as compared to the traditional transurethral or periurethral injection technique. | at procedure |
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Individuals satisfying the "Indications" and "Contraindications" criteria in the Durasphere EXP Directions for Use may participate.
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| Name | Affiliation | Role |
|---|---|---|
| Dean Klein | Carbon Medical Technologies | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Jacksonville | Jacksonville | Florida | 32224 | United States | ||
| Advanced Urogynecology |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| West Chester |
| Ohio |
| 45069 |
| 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 |