Antiseptic-coated Intermittent Urinary Catheter

• Status: Withdrawn
• Trial end date: 2018-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Hospital Zagreb
• Collaborator: GuardianMed j.d.o.o. Research and development in medicine
• Treatments: Anti-Infective Agents, Local; Octenidine

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