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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT02052674
First received: January 30, 2014
Last updated: May 6, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Bacteriuria
Device: Vented urinary drainage system
Device: Non-vented urinary drainage system
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Retained Urine Volume and Bacteriuria in Traditional Versus Vented Urine Drainage Systems

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Bacteriuria [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
    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:
  • Retained Urine [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
    A key contributor to bacteriuria is formation of biofilms in the catheter and catheter tubing.


Estimated Enrollment: 162
Study Start Date: April 2014
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02052674

Locations
United States, Florida
UF Health
Gainesville, Florida, United States, 32618
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: William B. Smith, MD University of Florida
  More Information

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02052674     History of Changes
Other Study ID Numbers: 201300634
Study First Received: January 30, 2014
Last Updated: May 6, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
Precursor to CAUTI

Additional relevant MeSH terms:
Bacteriuria
Urinary Tract Infections
Infection
Urologic Diseases

ClinicalTrials.gov processed this record on September 16, 2014