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

Phase 1

Withdrawn

• Conditions: Bacteriuria
• Interventions: Device: Vented urinary drainage system; Device: Non-vented urinary drainage system

• Registration Number: NCT02052674
• Lead Sponsor: University of Florida

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2014-01-30
• Study First Submitted QC: 2014-01-31
• Study First Posted: 2014-02-03
• Study Start: 2015-03
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-23
• Last Update Posted: 2019-07-24

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vented urinary drainage system	Vented 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.
Non-vented urinary drainage system	Non-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.

Primary Outcome Measures

Name	Time	Method
Bacteriuria	7 days	Evidence 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 Outcome Measures

Name	Time	Method
Retained Urine	7 days	One 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 materials	7 days	A key contributor to bacteriuria is formation of biofilms in the catheter and catheter tubing.