PEEZY Midstream Urine Device Compared to Catheterized Urine Sample (PEEZY)

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

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

Study Overview

• Status: Completed
• Conditions: Lower Urinary Tract Symptoms; Lower Urinary Tract Infection
• Intervention / Treatment: Device: Midstream urine collection device; Device: Catheter for urine 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 Type: Interventional
• Enrollment (Actual): 74
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Temple, Texas, United States, 76508
      • Baylor Scott and White Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: Straight catheter

What is the study measuring?

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.

Other Outcome Measures

Outcome Measure	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.

Collaborators and Investigators

• Sponsor: Baylor Research Institute
• Collaborators: Forte Medical
• Investigators: Principal Investigator: Rachel High, DO, Baylor Scott and White Health

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2019
• Primary Completion (Actual): April 12, 2019
• Study Completion (Actual): June 1, 2019

Study Registration Dates

• First Submitted: October 26, 2018
• First Submitted That Met QC Criteria: November 1, 2018
• First Posted (Actual): November 2, 2018

Study Record Updates

• Last Update Posted (Actual): June 5, 2019
• Last Update Submitted That Met QC Criteria: June 4, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: contamination; urine specimen
• Additional Relevant MeSH Terms: Infections; Urologic Diseases; Urological Manifestations; Lower Urinary Tract Symptoms; Urinary Tract Infections
• Other Study ID Numbers: 018-702

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No