Effect of Standardization of Urine Collection Using PEEZY Device as Compared to Clean Peezy for DAB (Peezy-DAB)

Effect of Standardization of Urine Collection Using PEEZY Device as Compared to Clean Catch in the Detection of Asymptomatic Bacteriuria in an Obstetric Population

This study aims specifically to compare the rates of contaminants between standard clean-catch urine collection and urine collected using the PEEZY device. In particular, this study will compare the rates of contamination as stratified by BMI status (i.e., BMI < 30 and BMI ≥30). Based on previous studies through LUHS and the Wolfe lab, we anticipate a reduction in contamination from sample collected using the PEEZY device, particularly among those pregnant women with BMI ≥30. To investigate this hypothesis we have designed a prospective unblinded randomized controlled trial comparing voided urine specimens obtained for asymptomatic bacteriuria in pregnant women presenting for obstetric care with use of standard clean-catch (CC) sampling method versus specimen obtained using PEEZY collection device.

Study Overview

• Status: Active, not recruiting
• Conditions: Urinary Tract Infections; Asymptomatic Bacteriuria
• Intervention / Treatment: Device: Peezy urine collection device

Detailed Description

Recruitment procedures

1. All patients scheduled for "NOB" (new obstetrics) appointments at LOC will be screened for eligibility by residents and fellows
2. Residents and fellows will recruit participants at LOC and obtain informed consent.

3. There will not be any advertising for this study and no recruitment materials will be given to eligible participants.

   Study procedures

4. Residents and fellows will use a REDCaps database to assign randomization, generate de-identified study labels, and provide study participants with assigned urine collection device as well as instructions on use.
5. Participants will use a private bathroom to void and collect their urine specimen using either the PEEZY device or standard clean catch method as assigned.
6. Urine specimens will be handed to LOC nursing staff who will separate into 3 aliquots - 1 for clinical lab and 2 for Wolfe lab.
7. Wolfe lab aliquots will be labeled with the subject's study ID and placed at 4°C for <4 hours before transport to Dr. Wolfe's laboratory for inventory, storage and analysis
8. Clinical lab specimen will be labeled with patient label and transported to clinical lab for standard urine culture per routine obstetric care.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Maywood, Illinois, United States, 60153
      • Loyola University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Pregnant < 20 weeks gestational age
• Age > 18 years old
• English speaking

Exclusion Criteria:

• History of recurrent UTIs
• Need for ongoing antibiotics
• Urinary tract anomalies

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Clean catch BMI < 30; Standard of care urine collection	Device: Peezy urine collection device; use peezy collection to obtain urine sample
Placebo Comparator: Clean catch BMI > 30; Standard of care urine collection	Device: Peezy urine collection device; use peezy collection to obtain urine sample
Experimental: PEEZy collection BMI < 30; PEEZY device for urine collection	Device: Peezy urine collection device; use peezy collection to obtain urine sample
Experimental: PEEZY collection BMI > 30; PEEZY device for urine collection	Device: Peezy urine collection device; use peezy collection to obtain urine sample

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urine contamination rates	1. To compare the rates of contaminants between CC and PEEZY samples stratified by BMI status (i.e., BMI < 30 and BMI ≥30)	August 2022-August 2023

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal comorbidities and contamination	To compare the rates of contamination based on maternal medical comorbidities	August 2022-August 2023

Collaborators and Investigators

• Sponsor: Loyola University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Actual): January 1, 2024
• Study Completion (Estimated): October 31, 2024

Study Registration Dates

• First Submitted: September 21, 2022
• First Submitted That Met QC Criteria: September 21, 2022
• First Posted (Actual): September 26, 2022

Study Record Updates

• Last Update Posted (Estimated): October 9, 2024
• Last Update Submitted That Met QC Criteria: October 7, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Tract Infections; Bacteriuria
• Other Study ID Numbers: 216104

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: Yes