Antiseptic-coated Intermittent Urinary Catheter (GuardianCath)

C

Children's Hospital Zagreb

Status and phase

Withdrawn
Phase 3
Phase 2

Conditions

Neurogenic Bladder
Catheter-Related Infections

Treatments

Device: Antiseptic-coated catheter
Device: Hydrophilic catheter
Drug: Octenidine chloride

Study type

Interventional

Funder types

Other

Identifiers

NCT02697162
GCath-CHZ-01

Details and patient eligibility

About

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.

Sex

All

Ages

1 month to 18 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

0 participants in 2 patient groups, including a placebo group

Antiseptic-coated catheter
Experimental group
Description:
Hydrophilic intermittent urinary catheter coated with octenidine chloride
Treatment:
Drug: Octenidine chloride
Device: Antiseptic-coated catheter
Hydrophilic catheter
Placebo Comparator group
Description:
Hydrophilic intermittent urinary catheter
Treatment:
Device: Hydrophilic catheter

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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