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

NCT ID: NCT04152720

Last Updated: 2019-11-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-03
• Study Completion Date: 2020-03-30

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.

Conditions

Urological Disease; Radical Cystectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Prevention of infection Foley catheter

Group Type: ACTIVE_COMPARATOR

Foley catheter

Intervention Type: DEVICE

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.

Conventional Foley catheter

Group Type: ACTIVE_COMPARATOR

Foley catheter

Intervention Type: DEVICE

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.

Interventions

Foley catheter

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.

Intervention Type: DEVICE

Eligibility Criteria

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))

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Bundang Hospital

OTHER

Sponsor Role: collaborator

Samsung Medical Center

OTHER

Sponsor Role: collaborator

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ja Hyeon Ku

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Seoul National University Hospital

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Ja Hyeon Ku, MD

Role: CONTACT

randyku@hanmail.net

82-2-2072-0361

Facility Contacts

Ja Hyeon Ku, M.D, Ph.D

Role: primary

randyku@hanmail.net

82-2-2072-0361

Other Identifiers

APL_P_01

Identifier Type: -

Identifier Source: org_study_id