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

Not Applicable

• Conditions: Radical Cystectomy; Urological Disease
• Interventions: Device: Foley catheter

• Registration Number: NCT04152720
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-03
• Status Verified: 2019-11
• Study First Submitted: 2019-11-03
• Study First Submitted QC: 2019-11-03
• Last Update Submitted: 2019-11-03
• Study First Posted: 2019-11-05
• Last Update Posted: 2019-11-05
• Primary Completion: 2019-11-13
• Study Completion: 2020-03-30

Recruitment & Eligibility

• Status: UNKNOWN
• 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 Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional Foley catheter	Foley catheter	-
Prevention of infection Foley catheter	Foley catheter	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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
1) Period until catheter-associated urinary tract infection (CAUTI) occurs	2 weeks
3) Catheter related complication rate	2 weeks

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of