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

Not Applicable

Active, not recruiting

• Conditions: Urinary Tract Infections; Asymptomatic Bacteriuria
• Interventions: Device: Peezy urine collection device

• Registration Number: NCT05554081
• Lead Sponsor: Loyola University

Brief Summary

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.

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 Timeline

• Study Start: 2022-08-01
• Study First Submitted: 2022-09-21
• Study First Submitted QC: 2022-09-21
• Study First Posted: 2022-09-26
• Primary Completion: 2024-01-01
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-07
• Last Update Posted: 2024-10-09
• Study Completion: 2024-10-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PEEZy collection BMI < 30	Peezy urine collection device	PEEZY device for urine collection
Clean catch BMI < 30	Peezy urine collection device	Standard of care urine collection
Clean catch BMI > 30	Peezy urine collection device	Standard of care urine collection
PEEZY collection BMI > 30	Peezy urine collection device	PEEZY device for urine collection

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Maternal comorbidities and contamination	August 2022-August 2023	To compare the rates of contamination based on maternal medical comorbidities

Trial Locations

Locations (1)

Loyola University medical Center; 🇺🇸 Maywood, Illinois, United States