Antiseptic-coated Intermittent Urinary Catheter (GuardianCath)

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Status and phase: Withdrawn; Phase 3; Phase 2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

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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