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No longer with institution
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To determine differences in the urinary microbiomes, identified by polymerase change reaction (PCR) (UTIP™), of female patients with urgency and frequency syndrome with or without pelvic pain (Group A) compared to female controls without symptoms of lower urinary tract symptoms (LUTS) (Group B).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Female patients with overactive bladder (OAB) | Patients with urgency and frequency syndrome with or without pelvic pain (Group A) will provide two urine samples. One urine sample is a clean catch and the other is a catheterized specimen. Both will be sent for analysis. A perineal swab will also be collect and analyzed for each patient. | ||
| Female control patients without LUTS | Patients without LUTS (Group B) will provide two urine samples. One urine sample is a clean catch and the other is a catheterized specimen. Both will be sent for analysis. A perineal swab will also be collect and analyzed for each patient. |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with Lactobacillus in samples. | Evaluation of urine and perineal samples by PCR. | Day 1 |
| Proportion of patients negative for repeat sequencing. | Evaluation of urine and perineal samples by PCR. | Day 1 |
| Proportion of patients with change in UDI-6 score | UDI 6 question 1 and 2 has a total score from 0-6 with a high score indicating more distress. Proportion of patients with a decrease in score from baseline will be reported for this outcome. | Up to 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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Female patients with OAB and controls will be enrolled from University of Miami's or Holy Cross Hospital's female pelvic medicine and reconstructive surgery clinics.
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| Name | Affiliation | Role |
|---|---|---|
| Laura Martin, DO | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Holy Cross Hospital | Fort Lauderdale | Florida | 33301 | United States | ||
| University of Miami |
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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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| Miami |
| Florida |
| 33136 |
| 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 |