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Retained Urine Volume and Bacteriuria in Traditional Versus Vented Urine Drainage Systems

Retained Urine Volume and Bacteriuria in Traditional Versus Vented Urine Drainage Systems

Status
Withdrawn
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02052674
Enrollment
0
Registered
2014-02-03
Start date
2015-03-31
Completion date
2015-04-30
Last updated
2019-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacteriuria

Keywords

Precursor to CAUTI

Brief summary

The purpose of this study is to see if there are differences in urine drainage between two types of indwelling bladder catheter systems (Foley catheter) in hospitalized patients. The difference between the two catheters is that one catheter is vented (the study catheter) and the other is a standard non-vented catheter. The vented catheter may drain urine better than a standard non-vented catheter. If a vented catheter drains the bladder better than a non-vented catheter it may lower the risk of retained urine in the bladder which could help prevent urinary tract infections.

Detailed description

During hospitalization, while in the surgical intensive care unit beginning the day after surgery, measurements of the subject's urine drainage system will be taken at daily study visits: retained urine volume, dependent loops, incidence of bacteriuria, and thigh diameter.

Interventions

DEVICEVented urinary drainage system

This group will be catheterized with a vented urinary drainage system. Several data sets will be evaluated to compare the two arms of the study: retained urine volume, the difference (ΔH) in meniscus heights in the dependent loops, time necessary for drainage of dependent loops, and incidence of bacteriuria.

DEVICENon-vented urinary drainage system

This group will be catheterized with a non-vented urinary drainage system. Several data sets will be evaluated to compare the two arms of the study: retained urine volume, the difference (ΔH) in meniscus heights in the dependent loops, time necessary for drainage of dependent loops, and incidence of bacteriuria.

Sponsors

University of Florida
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

Inclusion criteria

* Scheduled for a planned surgery * Anticipated indwelling bladder catheter placement for greater than 24 hours * Anticipated post-op admission to a surgical ICU

Exclusion criteria

* Unstable renal function as self-reported * Anticipated bandaged postoperative suprapubic incisions * Anatomical deformity that precludes appropriate suprapubic access for ultrasound bladder scanning * Surgical procedure that prevents accurate core body temperature by any means other than by bladder temperature

Design outcomes

Primary

MeasureTime frameDescription
Bacteriuria7 daysEvidence of bacteriuria, a potential precursor to Catheter Associated Urinary Tract Infection (CAUTI), will be used to study the potential effect of the vented urinary drainage system intervention on CAUTI.

Secondary

MeasureTime frameDescription
Retained Urine7 daysOne potential source for the risk of developing a Urinary Tract Infection (UTI) is related to residual urine volume in the bladder
Presence of biofilms in catheter materials7 daysA key contributor to bacteriuria is formation of biofilms in the catheter and catheter tubing.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026