BIP Foley in Prevention of CAUTI at Rehab Station (CDOC)

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

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 Overview

• Status: Completed
• Conditions: Complications; Catheter, Urinary Infection or Inflammation
• Intervention / Treatment: Device: BIP Foley (latex) or BIP Foley -silicone; Device: Standard catheter

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 4

Contacts and Locations

Study Locations

• Sweden
  • Solna
    • Stockholm, Solna, Sweden, 169 89
      • Rehab Station Stockholm

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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))

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1 (also called Group A ); 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; Other Names: Noble metal coated urinary catheters; Device: Standard catheter; Other Names: Standard urinary catheter
Experimental: Group 2 (also called Group B); 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; Other Names: Noble metal coated urinary catheters; Device: Standard catheter; Other Names: Standard urinary catheter

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the stability of the coating during long term use, by measurement of the (i.e. Ag, Au and Pd) concentration in urine and in blood and on used catheters,	Urine and blood samples as well as used BIP Foley catheters, will be collected during the study visit, and the samples will be analysed with regards to metal concentrations (Ag, Au, and Pd).	~4 year observational time, the study has an open end and may be prolonged
To assess the comfort of BIP Foley Catheters. Comfort is measured by a questionnaire filled in by the patients.	The outcome of the questionnaire will be compared between the groups (standard versus coated catheter). The questions assess urine smell, appearance of the urine (i.e. colour), discomfort caused by the catheter, catheter blockage, discomfort at insertion/removal, and will be rated in a three-scale (not at all, little, much).	~4 year observational time, the study has an open end and may be prolonged
To asess inflammatory markers in urine of the patients and compare their levels between the groups.	Urine samples will be collected during the study visit, and will be analysed with regards to inflammatory markers. Inflammatory levels (e.g. cytokines IL-8 and microparticles) will be determined, and compared between the groups.	~4 year observational time, the study has an open end and may be prolonged
To assess bacterial type	The occurancy of bacterial strains in the two groups will be compared in urine samples collected at each study visit.	~4 year observational time, the study has an open end and may be prolonged
To assess bacterial resistance pattern.	The resistance pattern of present urinary bacteria in the two groups will be compared in urine samples collected at each study visit.	~4 year observational time, the study has an open end and may be prolonged
To assess and compare biofilm amount on the catheter surface.	Biofilm amount on the catheter surface of uncoated and coated catheters will be assessed and compared by using SEM. Amounts will be given as % biofilm covering the surface area.	~4 year observational time, the study has an open end and may be prolonged

Collaborators and Investigators

• Sponsor: Bactiguard AB
• Collaborators: Rehab Station Stockholm
• Investigators: Principal Investigator: Åke Seiger, MD, Prof, Rehab Station Stockholm and Karolinska Institutet, Stockholm Sweden

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2016
• Primary Completion (Actual): March 9, 2020
• Study Completion (Actual): March 9, 2020

Study Registration Dates

• First Submitted: June 17, 2016
• First Submitted That Met QC Criteria: June 17, 2016
• First Posted (Estimate): June 21, 2016

Study Record Updates

• Last Update Posted (Actual): January 22, 2021
• Last Update Submitted That Met QC Criteria: January 20, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Inflammation; Infections; Urinary Tract Infections
• Other Study ID Numbers: 3686-2031-CDOC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No