Asymptomatic BacteriuriaPeezy-DABNCT05554081
Effect of Standardization of Urine Collection Using PEEZY Device as Compared to Clean Peezy for DAB
A study testing Peezy urine collection device in people with Asymptomatic Bacteriuria and Urinary Tract Infections, run by Loyola University at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Asymptomatic Bacteriuria, Urinary Tract Infections
- What is being tested?
- Peezy urine collection device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2022to 31 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pregnant < 20 weeks gestational age
- Age > 18 years old
- English speaking
Who cannot join
- History of recurrent UTIs
- Need for ongoing antibiotics
- Urinary tract anomalies
Trial locations and contacts
1 site in 1 country.
United States1 site
Loyola University medical Center
Maywood, Illinois, 60153
About this study
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
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.
Read the 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.
- Conditions
- Asymptomatic Bacteriuria, Urinary Tract Infections
- Being tested
- Peezy urine collection device
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peezy urine collection deviceDevice
use peezy collection to obtain urine sample
| Study group | Role | What they receive |
|---|---|---|
| Clean catch BMI < 30 | Placebo comparator | Standard of care urine collection Receives: Device: Peezy urine collection device |
| Clean catch BMI > 30 | Placebo comparator | Standard of care urine collection Receives: Device: Peezy urine collection device |
| PEEZy collection BMI < 30 | Experimental | PEEZY device for urine collection Receives: Device: Peezy urine collection device |
| PEEZY collection BMI > 30 | Experimental | PEEZY device for urine collection Receives: Device: Peezy urine collection device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine contamination rates
- To compare the rates of contaminants between CC and PEEZY samples stratified by BMI status (i.e., BMI < 30 and BMI ≥30)
Measured: August 2022-August 2023
Secondary outcomes (1)
Maternal comorbidities and contamination
To compare the rates of contamination based on maternal medical comorbidities
Measured: August 2022-August 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2022
- Study start1 Aug 2022
- Primary completion1 Jan 2024
- Study completion31 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asymptomatic BacteriuriaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Loyola University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ann.lal, Loyola University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05554081
- Sponsor's protocol ID
- 216104
- Acronym
- Peezy-DAB
- Status last verified
- Oct 2024
- First submitted
- 21 Sep 2022
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05554081
- Acronym / sponsor ID
- Peezy-DAB / 216104
- Conditions
- Asymptomatic Bacteriuria, Urinary Tract Infections
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Loyola UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 31 Oct 2024 (estimated)
- First posted
- 26 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Clean catch BMI < 30 | Placebo comparator | Device: Peezy urine collection deviceStandard of care urine collection |
| Clean catch BMI > 30 | Placebo comparator | Device: Peezy urine collection deviceStandard of care urine collection |
| PEEZy collection BMI < 30 | Experimental | Device: Peezy urine collection devicePEEZY device for urine collection |
| PEEZY collection BMI > 30 | Experimental | Device: Peezy urine collection devicePEEZY device for urine collection |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Pregnant < 20 weeks gestational age
- Age > 18 years old
- English speaking
Key exclusion criteria (3 listed)
- History of recurrent UTIs
- Need for ongoing antibiotics
- Urinary tract anomalies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peezy urine collection deviceuse peezy collection to obtain urine sample | Device | Clean catch BMI < 30, Clean catch BMI > 30, PEEZY collection BMI > 30, PEEZy collection BMI < 30 |
Primary outcome
Urine contamination rates
Time frame: August 2022-August 2023
1. To compare the rates of contaminants between CC and PEEZY samples stratified by BMI status (i.e., BMI < 30 and BMI ≥30)
1 secondary outcome
Maternal comorbidities and contamination
Time frame: August 2022-August 2023
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
- Individual participant dataSharing planned: No
Related trials for Asymptomatic Bacteriuria
Not yet recruitingObservational study
Prevalence of Asymptomatic Bacteriuria Among Pregnant Women With Pre-eclampsia in Women Health Hospital Assiut University
Pre-Eclampsia, Asymptomatic Bacteriuria
Not yet recruiting
Empowerment Program to Reduce Treatment of Asymptomatic Bacteriuria in Veterans With Spinal Cord Injury
Spinal Cord Injury, Spinal Cord Disease
RecruitingPhase 1
Bacteriophage Therapy in Spinal Cord Injury Patients With Bacteriuria
Bacteriuria, Spinal Cord Injuries
RecruitingObservational study
Effects of Microbiological and Immunological Factors on the Lower Urinary Tract
Asymptomatic Bacteriuria in Subjects Not Requiring Assisted Bladder Emptying, Asymptomatic Bacteriuria in Subjects Relying on Some Type of Catheter
Not yet recruiting
De-implementing PreOp Urine Testing
Urinary Tract Infection, Asymptomatic Bacteriuria
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peezy urine collection device in people with Asymptomatic Bacteriuria and Urinary Tract Infections, run by Loyola University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urine contamination rates (time frame: August 2022-August 2023). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2024.