PEEZY Midstream Urine Device Compared to Catheterized Urine Sample (PEEZY)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03729336|
Recruitment Status : Completed
First Posted : November 2, 2018
Last Update Posted : June 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|Lower Urinary Tract Symptoms Lower Urinary Tract Infection||Device: Midstream urine collection device Device: Catheter for urine collection||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||74 participants|
|Intervention Model:||Crossover Assignment|
|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.|
|Masking:||None (Open Label)|
|Official Title:||Midstream Urine Collection Device Compared to Catheterized Sample: Contamination and Patient Satisfaction.|
|Actual Study Start Date :||February 6, 2019|
|Actual Primary Completion Date :||April 12, 2019|
|Actual Study Completion Date :||June 1, 2019|
Experimental: PEEZY specimen
All subjects will use PEEZY to give a urine specimen.
Device: Midstream urine collection device
Non-invasive midstream urine collection device
Other Name: PEEZY
Placebo Comparator: CATHETER specimen
All subjects will use CATHETER (performed by their clinician) to give a urine specimen, following PEEZY use.
Device: Catheter for urine collection
In-and-out catheter obtains urine through the urethra.
Other Name: Straight catheter
- Contamination of urine specimen with urethral and vaginal flora [ Time Frame: 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
- Visual Analog Scale (this is the only title for this scale) [ Time Frame: 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.
- Patient Preference [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03729336
|United States, Texas|
|Baylor Scott and White Health|
|Temple, Texas, United States, 76508|
|Principal Investigator:||Rachel High, DO||Baylor Scott and White Health|