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

Urinary Tract Infections Clinical Trial

— Peezy-DAB  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05554081
• Other study ID #: 216104
• Status: Recruiting
• Phase: Phase 3
• Start date: August 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: September 2022
• Source: Loyola University
• Contact: Ann K Lal, MD
• Phone: 708-216-5439
• Email: ann.lal[@]lumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asymptomatic Bacteriuria
• Bacteriuria
• Urinary Tract Infections

Intervention

Device:
• Peezy urine collection device
use peezy collection to obtain urine sample

Locations

Country	Name	City	State
United States	Loyola University medical Center	Maywood	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Loyola University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Maternal comorbidities and contamination	To compare the rates of contamination based on maternal medical comorbidities	August 2022-August 2023