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

Primary Purpose

Asymptomatic Bacteriuria, Urinary Tract Infections

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Peezy urine collection device
Sponsored by
Loyola University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asymptomatic Bacteriuria

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts 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

Sites / Locations

  • Loyola University medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Placebo Comparator

Experimental

Experimental

Arm Label

Clean catch BMI < 30

Clean catch BMI > 30

PEEZy collection BMI < 30

PEEZY collection BMI > 30

Arm Description

Standard of care urine collection

Standard of care urine collection

PEEZY device for urine collection

PEEZY device for urine collection

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Maternal comorbidities and contamination
To compare the rates of contamination based on maternal medical comorbidities

Full Information

First Posted
September 21, 2022
Last Updated
September 21, 2022
Sponsor
Loyola University
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1. Study Identification

Unique Protocol Identification Number
NCT05554081
Brief Title
Effect of Standardization of Urine Collection Using PEEZY Device as Compared to Clean Peezy for DAB
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Loyola University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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 All patients scheduled for "NOB" (new obstetrics) appointments at LOC will be screened for eligibility by residents and fellows Residents and fellows will recruit participants at LOC and obtain informed consent. There will not be any advertising for this study and no recruitment materials will be given to eligible participants. Study procedures 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. 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. Urine specimens will be handed to LOC nursing staff who will separate into 3 aliquots - 1 for clinical lab and 2 for Wolfe lab. 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 Clinical lab specimen will be labeled with patient label and transported to clinical lab for standard urine culture per routine obstetric care.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asymptomatic Bacteriuria, Urinary Tract Infections

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Clean catch BMI < 30
Arm Type
Placebo Comparator
Arm Description
Standard of care urine collection
Arm Title
Clean catch BMI > 30
Arm Type
Placebo Comparator
Arm Description
Standard of care urine collection
Arm Title
PEEZy collection BMI < 30
Arm Type
Experimental
Arm Description
PEEZY device for urine collection
Arm Title
PEEZY collection BMI > 30
Arm Type
Experimental
Arm Description
PEEZY device for urine collection
Intervention Type
Device
Intervention Name(s)
Peezy urine collection device
Intervention Description
use peezy collection to obtain urine sample
Primary Outcome Measure Information:
Title
Urine contamination rates
Description
1. To compare the rates of contaminants between CC and PEEZY samples stratified by BMI status (i.e., BMI < 30 and BMI ≥30)
Time Frame
August 2022-August 2023
Secondary Outcome Measure Information:
Title
Maternal comorbidities and contamination
Description
To compare the rates of contamination based on maternal medical comorbidities
Time Frame
August 2022-August 2023

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ann K Lal, MD
Phone
708-216-5439
Email
ann.lal@lumc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Namisha Dhillon, MD
Phone
708-216-5459
Email
namisha.k.dhillon@luhs.org
Facility Information:
Facility Name
Loyola University medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ann K Lal, MD
Phone
708-216-5459
Email
ann.lal@lumc.edu
First Name & Middle Initial & Last Name & Degree
Namisha K Dhillon
Phone
708-216-5459
Email
namisha.k.dhillon@luhs.org

12. IPD Sharing Statement

Plan to Share IPD
No

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

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