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CompletedNCT00203515Updated Jan 14, 2008

Study Comparing the DOVER Silver Foley Catheter to a Standard of Care Catheter and a Marketed Silver Coated Foley Catheter

An interventional study of Standard Latex Foley Catheter and Silver Coated Latex Foley Catheter in Urinary Tract Infections, sponsored by Tyco Healthcare Group. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-01-14.

Sponsored by Tyco Healthcare Group · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
1,000
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of the study is to determine if the commercially available device called the DOVER™ Silver Foley catheter prevents infections of the urinary tract.

Read the detailed description

Over 1 million catheter-associated urinary tract infections (CAUTIs) occur annually in U.S. healthcare facilities and account for approximately 40% of the nosocomial infections. This investigation is a multi-center, blinded, prospective, randomized, controlled, parallel comparison of the intervention catheter (Tyco Healthcare DOVER Silver Foley catheter) to a usual care catheter and another commercially available silver-coated catheter. 1000 subjects total will be randomized at the multiple study centers.

02

Conditions studied

  • Urinary Tract Infections

Keywords

  • Urinary Catheterization
03

In context

Urinary Tract Infections

779 studies on the registry are indexed under Urinary Tract Infections; 132 are open to participants now.

This study's enrollment of 1,000 is above the median of 130 across 544 interventional studies indexed under Urinary Tract Infections.

Browse Urinary Tract Infections studies →

Lead sponsor

Tyco Healthcare Group is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Subject is at least 18 years of age.
  • Subject is expected to be catheterized with a 14, 16 or 18 French Foley catheter for at least 72 hours.
  • Subject or his/her legally authorized representative is able to grant informed consent to participate in this investigation.

Exclusion criteria

Exclusion Criteria:

  • Subjects who present with ongoing, active, symptomatic UTI.
  • Subjects with a known or suspected allergy to silver or silver compounds causing delayed hypersensitivity reactions or contact dermatitis.
  • Subjects with a known or suspected allergy to natural rubber latex or natural rubber latex compounds causing delayed hypersensitivity reactions or contact dermatitis.
  • Subjects known to be pregnant.
  • Prisoners.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single
Enrollment
1,000 participants

Interventions

  • DeviceStandard Latex Foley Catheter
  • DeviceSilver Coated Latex Foley Catheter
06

What researchers measure

Primary outcomes

  1. Catheter associated urinary tract infection (UTI)

Secondary outcomes

  1. Catheter tolerance

  2. Cost of care

07

Study locations

1 site
  • University of Wisconsin Hospital and Clinics
    Madison, Wisconsin 53705, United States
08

References and documents

Publications

  • Tambyah PA, Maki DG. The relationship between pyuria and infection in patients with indwelling urinary catheters: a prospective study of 761 patients. Arch Intern Med. 2000 Mar 13;160(5):673-7. doi: 10.1001/archinte.160.5.673. PubMed 10724053 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2005 and a primary completion of Mar 2007. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 12, 2005
First posted
Sep 20, 2005
Start
Jan 2005
Primary completionActual
Mar 2007
Last update
Jan 14, 2008
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 14, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00203515
Lead sponsor
Tyco Healthcare Group
First posted
Sep 20, 2005
Start date
Jan 2005
Primary completion
Mar 2007
Last update
Jan 14, 2008

Study contacts

Bethany A Quinn
study director · Tyco Healthcare Group/Kendall
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2008. You cannot join it, but the record below documents what was studied.

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Discussion

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