PEEZY Midstream Urine Device Compared to Catheterized Urine Sample

Not Applicable

Completed

• Conditions: Lower Urinary Tract Infection; Lower Urinary Tract Symptoms
• Interventions: Device: Midstream urine collection device; Device: Catheter for urine collection

• Registration Number: NCT03729336
• Lead Sponsor: Baylor Research Institute

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.

Study Timeline

• Study First Submitted: 2018-10-26
• Study First Submitted QC: 2018-11-01
• Study First Posted: 2018-11-02
• Status Verified: 2019-02
• Study Start: 2019-02-06
• Primary Completion: 2019-04-12
• Study Completion: 2019-06-01
• Last Update Submitted: 2019-06-04
• Last Update Posted: 2019-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 74

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
PEEZY specimen	Midstream urine collection device	All subjects will use PEEZY to give a urine specimen.
CATHETER specimen	Catheter for urine collection	All subjects will use CATHETER (performed by their clinician) to give a urine specimen, following PEEZY use.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Baylor Scott and White Health; 🇺🇸 Temple, Texas, United States