Study of a Urethral Catheter Coated With Eluting Silver Salts (SUCCESS)

Study of a Urethral Catheter Coated With Eluting Silver Salts

Urinary catheters are often needed in hospital patients, but their use can increase the chance that a catheter associated urinary tract infection (called a CAUTI) may occur. This study will try to determine if patients who get a new silver coated catheter will have slower to time to development of a CAUTI compared to patients who get an uncoated catheter.

This study is a prospective, multicenter, randomized controlled pivotal study designed to compare the time to occurrence and incidence of CAUTI in subjects catheterized with a new hydrogel-silver salts latex catheter (test) to those of subjects catheterized with a silicone elastomer-coated latex catheter (control).

Inclusion Criteria:

• male or female at least 18 years of age
• life expectancy of 3 months or more
• expected to require a urinary catheter for at least 48 hours

Exclusion Criteria:

• recent urinary tract surgery or instrumentation
• presence of a urinary tract device
• concurrent genitourinary tract infection
• recent indwelling urinary catheter
• requires use of a non-study urinary catheter