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
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
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.
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))
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