PEEZY Midstream Urine Device Compared to Catheterized Urine Sample

Study Overview
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Brief Summary
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Urine culture and microscopic urinalysis will be compared between 2 collection methods: PEEZY midstream urine collection, and urethral catheter collection.

Detailed Description
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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.

Official Title
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Midstream Urine Collection Device Compared to Catheterized Sample: Contamination and Patient Satisfaction.

Conditions
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Lower Urinary Tract Symptoms, Lower Urinary Tract Infection

Intervention / Treatment
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* Device: Midstream urine collection device
* Device: Catheter for urine collection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Females presenting to the Urology or Urogynecology clinic for consultation or evaluation of lower urinary tract complaints. Exclusion Criteria: Known pregnancy Use of antimicrobial oral or vaginal therapy in the past 4 weeks Use of Pyridium in the past 4 weeks

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PEEZY specimen<br>All subjects will use PEEZY to give a urine specimen. | Device: Midstream urine collection device<br>* Non-invasive midstream urine collection device<br>* Other names: PEEZY;|
| Placebo Comparator: CATHETER specimen<br>All subjects will use CATHETER (performed by their clinician) to give a urine specimen, following PEEZY use. | Device: Catheter for urine collection<br>* In-and-out catheter obtains urine through the urethra.<br>* Other names: Straight catheter;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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. | Performed one time immediately after intervention. This will not be repeated. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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urine specimen, contamination