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

Seoul National University

Status: Unknown

Conditions: Urological Disease; Radical Cystectomy

Treatments: Device: Foley catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT04152720

APL_P_01

Details and patient eligibility

About

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.

Enrollment: 160 estimated patients

Sex: All

Ages: 19 to 80 years old

Volunteers: No Healthy Volunteers

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))

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

Prevention of infection Foley catheter

Active Comparator group

Treatment:

Device: Foley catheter

Conventional Foley catheter

Active Comparator group

Treatment:

Device: Foley catheter