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| Name | Class |
|---|---|
| Forte Medical | UNKNOWN |
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Urine culture and microscopic urinalysis will be compared between 2 collection methods: PEEZY midstream urine collection, and urethral catheter collection.
Female patients presenting to the Baylor Scott & White Health (Temple, TX) Urology clinic for complaints of lower urinary tract symptoms will be included. They will be approached by a clinical research coordinator and given more information. If they meet eligibility by screening, consents will be completed.
Patients will proceed with their regular clinic visit with their clinician. Just prior to the physical exam, patients will use the PEEZY device to give a urine specimen in the privacy of the bathroom. The package with PEEZY includes the simple instructions for use. Patients return to the clinic room and the physical exam proceeds. An in-and-out catheter is used to obtain a post-void residual as well as a control urine specimen. After the remainder of the patient routine exam is complete, they will fill out a brief questionnaire.
The 2 specimens will then be delivered to the lab. The clinical research coordinator will store consents and questionnaires that include the subjects study identification number in individual opaque envelopes that will be kept in a locked drawer accessible to only the investigators.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEEZY specimen | Experimental | All subjects will use PEEZY to give a urine specimen. |
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| CATHETER specimen | Placebo Comparator | All subjects will use CATHETER (performed by their clinician) to give a urine specimen, following PEEZY use. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Midstream urine collection device | Device | Non-invasive midstream urine collection device |
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| Measure | Description | Time Frame |
|---|---|---|
| Contamination of urine specimen with urethral and vaginal flora | Contamination defined as: presence of urethral or vaginal flora on urine culture OR epithelial cell presence in urinalysis | 2 specimens from each subject (1 from each arm) will be taken to the lab for urinalysis and culture immediately after specimens are given. Culture results will be reported in 48 hours. After results are recorded, no further assessment of this outcome. |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale (this is the only title for this scale) | On a questionnaire: patient rates level of distress experienced during each urine donation method. The scale is from 1 to 10. On this scale 10 is associated with the word "agonizing", 8 is associated with "horrible", 4 is associated with "uncomfortable", 2 is associated with "annoying", and 0 is associated with "None". Unbearable distress is marked near 10. No distress is marked near 0. On this scale responses can only be reported as a number from 0-10, and a lower number indicates a better outcome. There are no subscales. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Preference | Questionnaire created by investigator asks: Which way would you prefer to give a urine sample, if needed in the future? PEEZY or catheter. | Performed one time immediately after intervention. This will not be repeated. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rachel High, DO | Baylor Scott and White Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baylor Scott and White Health | Temple | Texas | 76508 | United States |
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| ID | Term |
|---|---|
| D059411 | Lower Urinary Tract Symptoms |
| ID | Term |
|---|---|
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D057785 | Catheters |
| D059349 | Urine Specimen Collection |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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Patient spontaneously voids in the bathroom using PEEZY (research sample). Within 10 minutes, patient is catheterized during physical exam (control sample) for post-void residual.
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| Catheter for urine collection | Device | In-and-out catheter obtains urine through the urethra. |
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| Performed one time immediately after intervention. This will not be repeated. |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |