NCT04152720

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 3, 2018

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 3, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 5, 2019

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 13, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2020

Completed
Last Updated

November 5, 2019

Status Verified

November 1, 2019

Enrollment Period

1.3 years

First QC Date

November 3, 2019

Last Update Submit

November 3, 2019

Conditions

Urological DiseaseRadical Cystectomy

Keywords

CAUTICatheter-associated urinary tract infectionPrevention of infection Foley Catheter

Outcome Measures

Primary Outcomes (1)

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

    2 weeks

Secondary Outcomes (5)

  • 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

Study Arms (2)

Prevention of infection Foley catheter

ACTIVE COMPARATOR
Device: Foley catheter

Conventional Foley catheter

ACTIVE COMPARATOR
Device: Foley catheter

Interventions

Foley catheterDEVICE

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 catheterPrevention of infection Foley catheter

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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))

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

RECRUITING

MeSH Terms

Conditions

Urologic Diseases

Condition Hierarchy (Ancestors)

Female Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Central Study Contacts

Ja Hyeon Ku, MD

CONTACT

82-2-2072-0361randyku@hanmail.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 3, 2019

First Posted

November 5, 2019

Study Start

August 3, 2018

Primary Completion

November 13, 2019

Study Completion

March 30, 2020

Last Updated

November 5, 2019

Record last verified: 2019-11

Locations

KR(1)