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| Name | Class |
|---|---|
| Medtronics, Inc. | INDUSTRY |
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The purpose of this study is to find a noninvasive test to help physicians diagnose detrusor overactivity (DO), to use this urine test to help diagnose bladder problems, determine if treatments are working, and determine if patients are good candidates for interventions like sacral neuromodulation/Interstim Therapy.
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| Measure | Description | Time Frame |
|---|---|---|
| uNGF level in patients with urodynamically proven DO at baseline versus normal controls | 1 year | |
| Change in uNGF levels in patients with urodynamic DO at baseline and 5 days, 1 month, 3 months, and 12 months after treatment with Interstim | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Change in quality of life questionnaire scores in patients with urodynamic DO at baseline and at 5 days, 1 month, 3 months, and 12 months after treatment with Interstim | 1 year | |
| Correlation between uNGF levels and scores on validated quality of life questionnaires for urinary incontinence |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects over 18 years of age will be screened for eligibility relative to patient inclusion and exclusion criteria. If eligible to enroll, the nature and purpose of this study will be explained to the subject with a witness present. The subject will review and sign the written Informed Consent Form indicating informed consent and voluntary participation in the study. A copy of the consent form including all risks and benefits to research subjects is attached as a separate document.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Shore University Hospital | Manhasset | New York | 11030 | United States |
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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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| 1 year |
| 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 |