Efficacy of Micro-Patterned Foley Catheter to Reduce Catheter-Associated Urinary Tract Infection

Roughly half of the two million nosocomial infections that occur each year are associated
with the use of a medical device. Approximately 30 million urinary catheters are inserted
each year into the bladder of over five million patients, and each catheterized patient is
at risk of developing catheter-associated symptomatic urinary tract infection. About 95% of
urinary tract infections are associated with the use of a urinary catheter. Not only is
catheter associated urinary tract infection the most common nosocomial infection in general,
but it is also the most common infectious reason for admission to the hospital among the
population of 275 thousand Americans with spinal cord injury, which expands by approximately
12 thousand persons each year. Hospital-acquired infections boost today's healthcare costs
by billions of dollars and healthcare providers are increasingly responsible for shouldering
these costs.

Catheter-associated symptomatic urinary tract infection is usually caused by organisms that
originate from the patient's own colonic and perineal flora, or the hands of healthcare
personnel during catheter insertion and manipulation of the collection system. Microbial
species predominantly migrate into the bladder extraluminally via the mucoid film that forms
between the catheter surface and the urethra. Current approaches for preventing
catheter-related infections include antimicrobial modification of the catheter surface.
Although these antimicrobial-based catheters aim to eradicate bacteria residing in the
vicinity of the catheter surface, they can result in antibiotic resistance, which could have
serious implications on patient care.

A novel urinary catheter, the Micro-Patterned Foley catheter has been developed that
incorporates a micro-pattern texture on the surface; the texture is too small to see or
feel, but has demonstrated an impressive effect in the laboratory inhibiting microbial
attachment to the surface and microbial migration along the micro-patterned catheter
segments. The objective of the study is to determine whether the novel Micro-Patterned
catheter can delay the onset of catheter associated urinary tract infection in catheterized
spinal cord injured patients. If successful, this catheter will help improve quality of
patient care and reduce cost of care by reducing the need for antibiotic treatment. This
finding could extend to other patient populations that require urinary catheterization.

Inclusion Criteria

- Veteran

- Hospitalized in one of the two participating Spinal Cord Injury Units

- Require a size 14, 16, or 18 French catheter

- Sign and date the written informed consent document acknowledging his/her desire to
participate in the study, or if unable to sign due to spinal cord injury give verbal
consent in front of two impartial witnesses who sign and date the informed consent
document in the presence of the participant

- Be able to understand and comply with written and verbal protocol requirements,
instructions, and protocol-stated restrictions

- Require insertion or exchange of a Foley catheter for no longer than 15 days.

Exclusion Criteria

- Unable to provide informed consent

- Has a current symptomatic urinary tract infection

- Has persistent bacteriuria that cannot be cleared with antimicrobial agents to a
nominal level of less than 1,000 Colony Forming Units/mL prior to study catheter
insertion

- Has a known bloodstream infection or an infection that requires prolonged antibiotic
therapy

- Has periurethral inflammation or infection

- Has a known urethral anatomical anomaly which makes catheterization difficult

- Has a known silicone allergy or sensitivity

- Cannot accommodate a size 14,16 or 18 French Foley catheter.