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

Radical Cystectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04152720
• Other study ID #: APL_P_01
• Status: Recruiting
• Phase: N/A
• Start date: August 3, 2018
• Est. completion date: March 30, 2020

Study information

• Verified date: November 2019
• Source: Seoul National University Hospital
• Contact: Ja Hyeon Ku, MD
• Phone: 82-2-2072-0361
• Email: randyku[@]hanmail.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: March 30, 2020
• Est. primary completion date: November 13, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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))

Related Conditions & MeSH terms

• Infection
• Radical Cystectomy
• Urologic Diseases
• Urological Disease

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (3)

Lead Sponsor	Collaborator
Seoul National University Hospital	Samsung Medical Center, Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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