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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
14
Rehab Station Stockholm
Stockholm, Solna, Sweden
Incidence of CAUTI
The frequency of CAUTI will be recorded and compared between the use of standard urinary catheter and BIP Foley (with noble metal coating)
Time frame: ~4 year observational time, the study has an open end and may be prolonged
Incidence and typ of advese events
To assess and compare the frequency and type of adverse events and catheter related adverse events in the two arms
Time frame: ~4 year observational time, the study has an open end and may be prolonged
To compare ease of use of catheter by the nurse. Satisfaction assessed by ticking "easy" or "not easy" after each catheter exchange.
The coated and uncoated catheters will be compared with regards to number of easy catheterization.
Time frame: ~4 year observational time, the study has an open end and may be prolonged
Antibiotics type
To assess and compare any differences of type of antibiotics used for CAUTI in the two arms.
Time frame: ~4 year observational time, the study has an open end and may be prolonged
Antibiotics dose
To assess and compare any differences of antibiotic dose used for CAUTI in the two arms.
Time frame: ~4 year observational time, the study has an open end and may be prolonged
Antibiotics, number of treatment days
To assess and compare any differences of number of treatment days of antibiotics used for CAUTI in the two arms.
Time frame: ~4 year observational time, the study has an open end and may be prolonged
Incidence of spontaneous urinary and blood cultures and CRP blood
To asess and compare the spontaneous urinary and blood cultures and CRP blood in the two arms
Time frame: ~4 year observational time, the study has an open end and may be prolonged
Incidence of bacteruria, bacteremia, urosepsis and asymptomatic bacteremia
To asess and compare the incidence of bacteruria, bacteremia, urosepsis and asymptomatic bacteremiain the two arms
Time frame: ~4 year observational time, the study has an open end and may be prolonged
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