BIP Foley in Prevention of CAUTI at Rehab Station

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of Suprapubic Noble Metal Alloy BIP Foley Catheter in the Prevention of Catheter-associated Urinary Tract Infections in Spinal Cord Injured Patients

Conditions
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Complications; Catheter, Urinary Infection or Inflammation

Intervention / Treatment
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* Device: BIP Foley (latex) or BIP Foley -silicone
* Device: Standard catheter


Participation Criteria
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Eligibility Criteria
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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))

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1 (also called Group A )<br>Group 1/A will use standard catheter during the first  6 months (observational period 1). Then the patients in this group will switch to the noble metal alloy urinary catheter (BIP Foley catheter of latex or silicone produced by Bactiguard AB) and be observed for another  6 months (the second observational period). | Device: BIP Foley (latex) or BIP Foley -silicone<br> <br> * Other names: Noble metal coated urinary catheters;Device: Standard catheter<br> <br> * Other names: Standard urinary catheter;|
| Experimental: Group 2 (also called Group B)<br>Group 2/B will use the BIP Foley (latex or silicone) during the first  6 months (observational period 1). Then the patients in this group will switch to the standard catheter and be observed for another  6 months (the second observational period). | Device: BIP Foley (latex) or BIP Foley -silicone<br> <br> * Other names: Noble metal coated urinary catheters;Device: Standard catheter<br> <br> * Other names: Standard urinary catheter;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |  4 year observational time, the study has an open end and may be prolonged | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  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. |  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. |  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. |  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. |  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 |  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 |  4 year observational time, the study has an open end and may be prolonged |