NCT02052674

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2015

Shorter than P25 for phase_1

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 3, 2014

Completed
1.1 years until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

July 24, 2019

Status Verified

July 1, 2019

Enrollment Period

1 month

First QC Date

January 30, 2014

Last Update Submit

July 23, 2019

Conditions

Bacteriuria

Keywords

Precursor to CAUTI

Outcome Measures

Primary Outcomes (1)

  • Bacteriuria

    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 Outcomes (2)

  • Retained Urine

    7 days

  • Presence of biofilms in catheter materials

    7 days

Study Arms (2)

Vented urinary drainage system

EXPERIMENTAL

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

Non-vented urinary drainage system

ACTIVE COMPARATOR

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

Interventions

Vented urinary drainage systemDEVICE

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.

Also known as: Covidien vented foley catheter, TopVent, Covidien Dover Precision Premium Drainage bag
Vented urinary drainage system
Non-vented urinary drainage systemDEVICE

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.

Also known as: Bard urine drainage system, Conventional catheter, Bard Silver-Coated
Non-vented urinary drainage system

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Bacteriuria

Condition Hierarchy (Ancestors)

Urinary Tract InfectionsInfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • William B. Smith, MD

    University of Florida

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2014

First Posted

February 3, 2014

Study Start

March 1, 2015

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

July 24, 2019

Record last verified: 2019-07