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

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

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.

Study Overview

• Status: Unknown
• Conditions: Radical Cystectomy; Urological Disease
• Intervention / Treatment: Device: Foley catheter

• Study Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ja Hyeon Ku, MD; Phone Number: 82-2-2072-0361; Email: randyku@hanmail.net

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 110-744
    • Recruiting
    • Seoul National University Hospital
    • Contact: Ja Hyeon Ku, M.D, Ph.D; Phone Number: 82-2-2072-0361; Email: randyku@hanmail.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Prevention of infection Foley catheter	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.
Active Comparator: Conventional Foley catheter	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
1) Incidence of catheter-associated urinary tract infection (CAUTI) * 2 weeks after urethral catheterization	2 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: Samsung Medical Center; Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2018
• Primary Completion (Anticipated): November 13, 2019
• Study Completion (Anticipated): March 30, 2020

Study Registration Dates

• First Submitted: November 3, 2019
• First Submitted That Met QC Criteria: November 3, 2019
• First Posted (Actual): November 5, 2019

Study Record Updates

• Last Update Posted (Actual): November 5, 2019
• Last Update Submitted That Met QC Criteria: November 3, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: CAUTI; Catheter-associated urinary tract infection; Prevention of infection Foley Catheter
• Additional Relevant MeSH Terms: Infections; Urologic Diseases
• Other Study ID Numbers: APL_P_01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No