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

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.

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.

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.