Trial | NCT02697162  Report issue

Title

Antiseptic-coated Intermittent Urinary Catheter
Antiseptic-coated Intermittent Urinary Catheter: Efficacy and Feasibility of Neurogenic Bladder Management and Prevention of Catheter-associated Urinary Tract Infections in Children

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Withdrawn

  • Intervention/Treatment

    octenidine ...

  • Study Participants

    0
Study design is a prospective, randomised, double-blind, and interventional. Primary aim of the study is to investigate efficacy of antiseptic-coated intermittent hydrophilic urinary catheters in prevention and reduction of catheter-associated urinary tract infections in children with neurogenic bladder. Secondary aim is to assess feasibility of antiseptic-coated intermittent hydrophilic urinary catheters in neurogenic bladder management. Octenidine chloride will be used as antiseptic.
Study Started
Jun 30
2016
Primary Completion
Dec 31
2016
Anticipated
Study Completion
Jun 30
2018
Anticipated
Last Update
Feb 09
2021

Device Antiseptic-coated catheter

Antiseptic-coated hydrophilic intermittent urinary catheter with octenidine chloride

  • Other names: GuardianCath

Device Hydrophilic catheter

Hydrophilic intermittent urinary catheter

Drug Octenidine chloride

Antiseptic

Antiseptic-coated catheter Experimental

Hydrophilic intermittent urinary catheter coated with octenidine chloride

Hydrophilic catheter Placebo Comparator

Hydrophilic intermittent urinary catheter

Criteria 

Inclusion Criteria:

neurogenic bladder
use of intermittent catheterisation for neurogenic bladder management
informed oral and written consent from the child and both parents/legal guardian

Exclusion Criteria:

Congenital anomalies of urinary tract or genitals
Immunodeficiency
Urinary tract fistula
No Results Posted