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

Not Applicable

Recruiting

• Conditions: Diseases of The genitoruinary system

• Registration Number: KCT0004493
• Lead Sponsor: Seoul National University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

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

Exclusion Criteria

1)A person with a congenital abnormality in the urinary or reproductive system
2)Immunodeficiency disease (eg HIV infected)
3)Urinary tract fistula
4)Allergic history of the material used in the catheter
5)Symptomatic UTI by baseline time point
6)Dermatitis at the catheter insertion site
7)Pregnant or lactating women
8)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.
9)Inappropriate participation in the study, as determined by the investigator or investigator, as it may affect ethical or clinical trial results.
10)Patients on anti-thrombotic medication (excluding low-dose aspirin (100 mg, up to 300 mg / day))

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of catheter-associated urinary tract infection 2 weeks after urethral catheterization

Secondary Outcome Measures

Name	Time	Method
Duration of catheter-associated urinary tract infection (CAUTI);Incidence of Significant * Bacterial Cultures on Urethral Catheter Tip Culture 2 Weeks After Urethral Catheterization;Catheter-Related Complications;Incidence of fever and symptomatic urinary tract infections in catheter-associated urinary tract infection (CAUTI) 2 weeks after urethral catheterization in test and control groups;Duration of antibiotics due to catheter-associated urinary tract infection in test and control groups