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Clinical Trials/NCT04152720
NCT04152720UnknownNot Applicable

A Randomized, Multi-center, Open, Active-controlled Prospective Design Pilot Clinical Study to Evaluate the Efficacy and Safety of Prevention of Infection Foley Catheter as Compared to Conventional Foley Catheter in Patient Who Underwent Radical Cystectomy for Urological Disease

Seoul National University Hospital2 sites in 1 country160 target enrollmentStarted: August 3, 2018Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
160
Locations
2
Primary Endpoint
1) Incidence of catheter-associated urinary tract infection (CAUTI) * 2 weeks after urethral catheterization
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

Comparison of effectiveness and safety of infection prevention silicone urinary catheters and conventional catheters for patients scheduled to perform urinary catheterization after radical cystectomy for urological diseases for more than 2 weeks Want to prove the clinical efficacy and safety.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
19 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Between 19 and 80 years old
  • •Persons requiring urethral catheterization for more than 2 weeks after surgery * due to urological diseases
  • •* Radical cystectomy
  • •Subjects who voluntarily decided to participate and signed the written informed consent
  • •A person who can understand and follow the instructions and participate in the pre-clinical period.

Exclusion Criteria

  • •A person with a congenital abnormality in the urinary or reproductive system
  • •Immunodeficiency disease (eg HIV infected)
  • •Urinary tract fistula
  • •Allergic history of the material used in the catheter
  • •Symptomatic UTI by baseline time point
  • •Dermatitis at the catheter insertion site
  • •Pregnant or lactating women
  • •A person who does not agree to contraceptive * in a medically accepted manner until the end of the study and 4 weeks after the end of the study.
  • •Medically acceptable contraceptive methods: condoms, oral contraceptives lasting at least 12 weeks, injectable or injectable contraceptives, intrauterine contraceptives, etc.
  • •Inappropriate participation in the study, as determined by the investigator or investigator, as it may affect ethical or clinical trial results.
  • •Patients on anti-thrombotic medication (excluding low-dose aspirin (100 mg, up to 300 mg / day))

Outcomes

Primary Outcomes

1) Incidence of catheter-associated urinary tract infection (CAUTI) * 2 weeks after urethral catheterization

Time Frame: 2 weeks

Secondary Outcomes

  • 4) Catheter-associated urinary tract infection 2 weeks after urethral catheter insertion in test and control groups(2 weeks)
  • 2) Incidence of Significant Bacterial Cultures in Urethral Catheter Tip Culture(2 weeks)
  • 5) Antibiotic administration period due to catheter-related urinary tract infection(2 weeks)
  • 3) Catheter related complication rate(2 weeks)
  • 1) Period until catheter-associated urinary tract infection (CAUTI) occurs(2 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ja Hyeon Ku

Professor

Seoul National University Hospital

Study Sites (2)

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