NCT05554081

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Loyola University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Asymptomatic Bacteriuria
• Urinary Tract Infections

Interventions

Type	Name	Description
DEVICE	Peezy urine collection device	use peezy collection to obtain urine sample

Timeline

• Start date: 2022-08-01
• Primary completion: 2024-01-01
• Completion: 2024-10-31
• First posted: 2022-09-26
• Last updated: 2024-10-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study