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

Primary Purpose

Urological Disease, Radical Cystectomy

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Foley catheter
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Urological Disease focused on measuring CAUTI, Catheter-associated urinary tract infection, Prevention of infection Foley Catheter

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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))

Sites / Locations

  • Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Prevention of infection Foley catheter

Conventional Foley catheter

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 3, 2019
Last Updated
November 3, 2019
Sponsor
Seoul National University Hospital
Collaborators
Seoul National University Bundang Hospital, Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04152720
Brief Title
Evaluate the Efficacy and Safety of Prevention of Infection Foley Catheter as Compared to Conventional Foley Catheter
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 3, 2018 (Actual)
Primary Completion Date
November 13, 2019 (Anticipated)
Study Completion Date
March 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Seoul National University Bundang Hospital, Samsung Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urological Disease, Radical Cystectomy
Keywords
CAUTI, Catheter-associated urinary tract infection, Prevention of infection Foley Catheter

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Prevention of infection Foley catheter
Arm Type
Active Comparator
Arm Title
Conventional Foley catheter
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Foley catheter
Intervention Description
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.
Primary Outcome Measure Information:
Title
1) Incidence of catheter-associated urinary tract infection (CAUTI) * 2 weeks after urethral catheterization
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
1) Period until catheter-associated urinary tract infection (CAUTI) occurs
Time Frame
2 weeks
Title
2) Incidence of Significant Bacterial Cultures in Urethral Catheter Tip Culture
Time Frame
2 weeks
Title
3) Catheter related complication rate
Time Frame
2 weeks
Title
4) Catheter-associated urinary tract infection 2 weeks after urethral catheter insertion in test and control groups
Time Frame
2 weeks
Title
5) Antibiotic administration period due to catheter-related urinary tract infection
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Between 19 and 80 years old Persons requiring urethral catheterization for more than 2 weeks after surgery * due to urological diseases * Radical cystectomy Subjects who voluntarily decided to participate and signed the written informed consent A person who can understand and follow the instructions and participate in the pre-clinical period. Exclusion Criteria: A person with a congenital abnormality in the urinary or reproductive system Immunodeficiency disease (eg HIV infected) Urinary tract fistula Allergic history of the material used in the catheter Symptomatic UTI by baseline time point Dermatitis at the catheter insertion site Pregnant or lactating women 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. Inappropriate participation in the study, as determined by the investigator or investigator, as it may affect ethical or clinical trial results. Patients on anti-thrombotic medication (excluding low-dose aspirin (100 mg, up to 300 mg / day))
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ja Hyeon Ku, MD
Phone
82-2-2072-0361
Email
randyku@hanmail.net
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ja Hyeon Ku, M.D, Ph.D
Phone
82-2-2072-0361
Email
randyku@hanmail.net

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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