BIP Foley in Prevention of CAUTI at Rehab Station

• Register: ClinicalTrials.gov
• Last refreshed on: 1 February 2021
• Main ID: NCT02808000
• Date of registration: 17/06/2016
• Prospective Registration: No
• Primary sponsor: Bactiguard AB
• Public title: BIP Foley in Prevention of CAUTI at Rehab Station CDOC
• Scientific title: Evaluation of Suprapubic Noble Metal Alloy BIP Foley Catheter in the Prevention of Catheter-associated Urinary Tract Infections in Spinal Cord Injured Patients
• Date of first enrolment: April 21, 2016
• Target sample size: 14
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02808000
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Prevention. Masking: Single (Outcomes Assessor).
• Phase: Phase 4

Countries of recruitment

Sweden

Contacts

• Name: Åke Seiger, MD, Prof
• Affiliation: Rehab Station Stockholm and Karolinska Institutet, Stockholm Sweden

Key inclusion & exclusion criteria

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))



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Complications; Catheter, Urinary Infection or Inflammation

Intervention(s)

Device: BIP Foley (latex) or BIP Foley -silicone

Device: Standard catheter

Primary Outcome(s)

Incidence of CAUTI [Time Frame: ~4 year observational time, the study has an open end and may be prolonged]

Secondary Outcome(s)

Incidence and typ of advese events [Time Frame: ~4 year observational time, the study has an open end and may be prolonged]

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 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]

Antibiotics dose [Time Frame: ~4 year observational time, the study has an open end and may be prolonged]

Antibiotics type [Time Frame: ~4 year observational time, the study has an open end and may be prolonged]

Antibiotics, number of treatment days [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 [Time Frame: ~4 year observational time, the study has an open end and may be prolonged]

Secondary ID(s)

3686-2031-CDOC

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Rehab Station Stockholm