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

Last updated: November 3, 2019
Sponsor: Seoul National University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT04152720
APL_P_01
  • Ages 19-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Between 19 and 80 years old

  2. Persons requiring urethral catheterization for more than 2 weeks after surgery * dueto urological diseases

  • Radical cystectomy
  1. Subjects who voluntarily decided to participate and signed the written informedconsent

  2. A person who can understand and follow the instructions and participate in thepre-clinical period.

Exclusion

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 untilthe end of the study and 4 weeks after the end of the study. Medically acceptable contraceptive methods: condoms, oral contraceptives lasting atleast 12 weeks, injectable or injectable contraceptives, intrauterine contraceptives,etc.

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

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

Study Design

Total Participants: 160
Study Start date:
August 03, 2018
Estimated Completion Date:
March 30, 2020

Connect with a study center

  • Seoul National University Hospital

    Seoul, 110-744
    Korea, Republic of

    Active - Recruiting

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