Lower Urinary Tract Infection, Lower Urinary Tract Symptoms
Conditions
Keywords
urine specimen, contamination
Brief summary
Urine culture and microscopic urinalysis will be compared between 2 collection methods: PEEZY midstream urine collection, and urethral catheter collection.
Detailed description
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.
Interventions
DEVICEMidstream urine collection device
Non-invasive midstream urine collection device
DEVICECatheter for urine collection
In-and-out catheter obtains urine through the urethra.
Sponsors
Forte Medical
Baylor Research Institute
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 95 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Contamination of urine specimen with urethral and vaginal flora | 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. | Contamination defined as: presence of urethral or vaginal flora on urine culture OR epithelial cell presence in urinalysis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale (this is the only title for this scale) | Performed one time immediately after intervention. This will not be repeated. | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Patient Preference | Performed one time immediately after intervention. This will not be repeated. | Questionnaire created by investigator asks: Which way would you prefer to give a urine sample, if needed in the future? PEEZY or catheter. |
Countries
United States
Outcome results
None listed