BIP Foley in Prevention of CAUTI at Rehab Station
BIP Foley in Prevention of CAUTI at Rehab Station
This is a prospective, cross-over, randomized, controlled, partly blinded study evaluating
 safety and performance of noble metal alloy urinary Catheters (BIP Foley, Bactiguard AB) of
 both latex and silicone. The included patients are permanently catheterized spinal cord
 injured patients at the Spinalis clinic at Rehab station in Stockholm, Sweden.

 Primary Outcome Measures:

 • The primary objective is to evaluate the efficacy of long term suprapubic use of BIP Foley
 catheters, compared to the use of standard catheters for the same time period, on re-current
 symptomatic catheter associated urinary tract infection (CAUTIs).

 Secondary Outcome Measures:

 • to evaluate safety/performance of the catheter, i.e. antibiotic use, bacteriuria,
 bacteremia, urosepsis and ICU stay.

 Exploratory Outcome Measures:

 • assessment of levels of immunological markers in urine, urinary bacterial type and
 resistance pattern, catheter comfort, stability of the coating, and bacterial biofilm on the
 catheter surface after use.
Inclusion Criteria:

 -  Adult patients (≥18 years)

 -  Patients with permanent suprapubic urethral catheter (Foley catheter) of latex or
 silicone

 -  At least 3 documented CAUTI infections during last year

 -  Spinal Cord Injured, changing catheters at Rehab Station every 10 weeks (+/- 2 weeks)

 Exclusion Criteria:

 -  Children (˂18 years)

 -  Participating in other clinical trial(s) with exposure/treatment that could affect the
 outcome of the present study

 -  Stones (calculi) in the urinary tract (these patients can be included after the stones
 have been removed)

 -  Patients on antibiotic treatment (these patients can be included after the treatment
 is completed (+10 days of expectance))