Evaluate the Efficacy and Safety of Prevention of Infection Foley Catheter as Compared to Conventional Foley Catheter

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Urological Disease, Radical Cystectomy

Intervention / Treatment
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* Device: Foley catheter


Participation Criteria
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Eligibility Criteria
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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))

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Prevention of infection Foley catheter<br> | Device: Foley catheter<br>* If the subject is enrolled in this clinical trial, the test and control devices will be applied at baseline. All subjects will receive a urinary catheter at the site of the artificial bladder and the urethra after surgery, and temporary urinary replacement should be selected by the investigator at each institution in preparation for the possibility of postoperative blockage of the urinary catheter. After surgery, urine analysis and culture are performed on the 4th and 7th day, and urine analysis and culture are performed before the urethral catheter removal on the 14th (2 weeks) and the urethral catheter is removed. At this time, the urethral catheter tip is cut about 5-8 cm and cultured.<br>|
| Active Comparator: Conventional Foley catheter<br> | Device: Foley catheter<br>* If the subject is enrolled in this clinical trial, the test and control devices will be applied at baseline. All subjects will receive a urinary catheter at the site of the artificial bladder and the urethra after surgery, and temporary urinary replacement should be selected by the investigator at each institution in preparation for the possibility of postoperative blockage of the urinary catheter. After surgery, urine analysis and culture are performed on the 4th and 7th day, and urine analysis and culture are performed before the urethral catheter removal on the 14th (2 weeks) and the urethral catheter is removed. At this time, the urethral catheter tip is cut about 5-8 cm and cultured.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1) Incidence of catheter-associated urinary tract infection (CAUTI) * 2 weeks after urethral catheterization |  | 2 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CAUTI, Catheter-associated urinary tract infection, Prevention of infection Foley Catheter