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

Loyola University

Status: Active, not recruiting

Conditions: Asymptomatic Bacteriuria; Urinary Tract Infections

Treatments: Device: Peezy urine collection device

Study type: Interventional

Funder types: Other

Identifiers

NCT05554081

216104

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 4 patient groups, including a placebo group

Clean catch BMI < 30

Placebo Comparator group

Description:

Standard of care urine collection

Treatment:

Device: Peezy urine collection device

Clean catch BMI > 30

Placebo Comparator group

Description:

Standard of care urine collection

Treatment:

Device: Peezy urine collection device

PEEZy collection BMI < 30

Experimental group

Description:

PEEZY device for urine collection

Treatment:

Device: Peezy urine collection device

PEEZY collection BMI > 30

Experimental group

Description:

PEEZY device for urine collection

Treatment:

Device: Peezy urine collection device