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Completed

NCT Number: NCT02808000

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.

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Key information

Conditions

Complications; Catheter, Urinary Infection or Inflammation Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Inflammation Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Urinary Tract Infections Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Rehab Station Stockholm

Stockholm, Solna, 169 89, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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))

Treatment and study plan

BIP Foley (latex) or BIP Foley -silicone

Device

Other names: Noble metal coated urinary catheters

Standard catheter

Device

Other names: Standard urinary catheter

Primary outcomes

  1. Incidence of CAUTI

    Time frame: ~4 year observational time, the study has an open end and may be prolonged

    The frequency of CAUTI will be recorded and compared between the use of standard urinary catheter and BIP Foley (with noble metal coating)

Secondary outcomes

  1. Incidence and typ of advese events

    Time frame: ~4 year observational time, the study has an open end and may be prolonged

    To assess and compare the frequency and type of adverse events and catheter related adverse events in the two arms

  2. To compare ease of use of catheter by the nurse. Satisfaction assessed by ticking "easy" or "not easy" after each catheter exchange.

    Time frame: ~4 year observational time, the study has an open end and may be prolonged

    The coated and uncoated catheters will be compared with regards to number of easy catheterization.

  3. Antibiotics type

    Time frame: ~4 year observational time, the study has an open end and may be prolonged

    To assess and compare any differences of type of antibiotics used for CAUTI in the two arms.

  4. Antibiotics dose

    Time frame: ~4 year observational time, the study has an open end and may be prolonged

    To assess and compare any differences of antibiotic dose used for CAUTI in the two arms.

  5. Antibiotics, number of treatment days

    Time frame: ~4 year observational time, the study has an open end and may be prolonged

    To assess and compare any differences of number of treatment days of antibiotics used for CAUTI in the two arms.

  6. Incidence of spontaneous urinary and blood cultures and CRP blood

    Time frame: ~4 year observational time, the study has an open end and may be prolonged

    To asess and compare the spontaneous urinary and blood cultures and CRP blood in the two arms

  7. Incidence of bacteruria, bacteremia, urosepsis and asymptomatic bacteremia

    Time frame: ~4 year observational time, the study has an open end and may be prolonged

    To asess and compare the incidence of bacteruria, bacteremia, urosepsis and asymptomatic bacteremiain the two arms

Other outcomes

  1. 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,

    Time frame: ~4 year observational time, the study has an open end and may be prolonged

    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).

  2. To assess the comfort of BIP Foley Catheters. Comfort is measured by a questionnaire filled in by the patients.

    Time frame: ~4 year observational time, the study has an open end and may be prolonged

    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).

  3. To asess inflammatory markers in urine of the patients and compare their levels between the groups.

    Time frame: ~4 year observational time, the study has an open end and may be prolonged

    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. To assess bacterial type

    Time frame: ~4 year observational time, the study has an open end and may be prolonged

    The occurancy of bacterial strains in the two groups will be compared in urine samples collected at each study visit.

  5. To assess bacterial resistance pattern.

    Time frame: ~4 year observational time, the study has an open end and may be prolonged

    The resistance pattern of present urinary bacteria in the two groups will be compared in urine samples collected at each study visit.

  6. To assess and compare biofilm amount on the catheter surface.

    Time frame: ~4 year observational time, the study has an open end and may be prolonged

    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.

Sponsors and collaborators

Lead sponsor

Bactiguard AB

Industry

Collaborators

  • Rehab Station Stockholm

Registry information

Official study title

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

Acronym: CDOC

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Jun 21, 2016
Registry last updated
Jan 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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