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

• Sponsor: Seoul National University Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04152720
• Collaborator: Seoul National University Bundang Hospital (Other), Samsung Medical Center (Other)
• Enrollment: 160
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 19.9
• Patients Per Site Per Month: 8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Urological Disease; Radical Cystectomy	Device: Foley catheter	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 160 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• 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
• Actual Study Start Date: Aug 3, 2018
• Anticipated Primary Completion Date: Nov 13, 2019
• Anticipated Study Completion Date: Mar 30, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 1) Incidence of catheter-associated urinary tract infection (CAUTI) * 2 weeks after urethral catheterization [2 weeks]

Secondary Outcome Measures

1. 1) Period until catheter-associated urinary tract infection (CAUTI) occurs [2 weeks]

2. 2) Incidence of Significant Bacterial Cultures in Urethral Catheter Tip Culture [2 weeks]

3. 3) Catheter related complication rate [2 weeks]

4. 4) Catheter-associated urinary tract infection 2 weeks after urethral catheter insertion in test and control groups [2 weeks]

5. 5) Antibiotic administration period due to catheter-related urinary tract infection [2 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

1. Subjects who voluntarily decided to participate and signed the written informed consent

2. 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.

1. Inappropriate participation in the study, as determined by the investigator or investigator, as it may affect ethical or clinical trial results.

2. Patients on anti-thrombotic medication (excluding low-dose aspirin (100 mg, up to 300 mg / day))

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul		Korea, Republic of	110-744

Sponsors and Collaborators

• Seoul National University Hospital
• Seoul National University Bundang Hospital
• Samsung Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ja Hyeon Ku, Professor, Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT04152720
• Other Study ID Numbers: APL_P_01
• First Posted: Nov 5, 2019
• Last Update Posted: Nov 5, 2019
• Last Verified: Nov 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ja Hyeon Ku, Professor, Seoul National University Hospital: CAUTI; Catheter-associated urinary tract infection; Prevention of infection Foley Catheter
• Additional relevant MeSH terms: Infections; Urologic Diseases

Study Results

No Results Posted as of Nov 5, 2019