Clinical trial NCT05554081: Effect of Standardization of Urine Collection Using PEEZY Device as Compared to Clean Peezy for 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Asymptomatic Bacteriuria
Urinary Tract Infections
Lead sponsor: Loyola University
Sponsor class: OTHER
First posted: 2022-09-26
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Urine contamination rates
timeFrame: August 2022-August 2023
Secondary outcomes:
measure: Maternal comorbidities and contamination
timeFrame: August 2022-August 2023
Other outcomes:
Locations:
city: Maywood
country: United States
facility: Loyola University medical Center
state: Illinois
Study officials:
References: