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

July 23, 2019 updated by: University of Florida

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: 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.
Other Names:
  • Covidien vented foley catheter
  • TopVent
  • Covidien Dover Precision Premium Drainage bag
Active Comparator: 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.
Device: 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.
Other Names:
  • Bard urine drainage system
  • Conventional catheter
  • Bard Silver-Coated

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bacteriuria
Time Frame: 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.
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retained Urine
Time Frame: 7 days
One potential source for the risk of developing a Urinary Tract Infection (UTI) is related to residual urine volume in the bladder
7 days
Presence of biofilms in catheter materials
Time Frame: 7 days
A key contributor to bacteriuria is formation of biofilms in the catheter and catheter tubing.
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Investigators

  • Principal Investigator: William B. Smith, MD, University of Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

January 30, 2014

First Submitted That Met QC Criteria

January 31, 2014

First Posted (Estimate)

February 3, 2014

Study Record Updates

Last Update Posted (Actual)

July 24, 2019

Last Update Submitted That Met QC Criteria

July 23, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201300634

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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