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

A Prospective, Randomized, Controlled Study Comparing the DOVER Silver Foley Catheter to a Standard of Care Catheter and a Marketed Silver Coated Foley Catheter

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00203515

Enrollment

1000

Registered

2005-09-20

Start date

2005-01-31

Completion date

Unknown

Last updated

2008-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Tract Infections

Keywords

Urinary Catheterization

Brief 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.

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.

Interventions

DEVICEStandard Latex Foley Catheter

DEVICESilver Coated Latex Foley Catheter

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

* 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.

Design outcomes

Primary

Measure	Time frame
Catheter associated urinary tract infection (UTI)	—

Secondary

Measure	Time frame
Catheter tolerance	—
Cost of care	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026