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Antiseptic-coated Intermittent Urinary Catheter

NCT02697162 · Status: WITHDRAWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL

Last updated 2021-02-09

No results posted yet for this study

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.

Conditions

  • Neurogenic Bladder
  • Catheter-Related Infections

Interventions

DEVICE

Antiseptic-coated catheter

Antiseptic-coated hydrophilic intermittent urinary catheter with octenidine chloride

DEVICE

Hydrophilic catheter

Hydrophilic intermittent urinary catheter

DRUG

Octenidine chloride

Antiseptic

Sponsors & Collaborators

  • GuardianMed j.d.o.o. Research and development in medicine

    collaborator UNKNOWN

  • Children's Hospital Zagreb

    lead OTHER

Principal Investigators

  • Slaven Abdovic, MD, PhD · Children's Hospital Zagreb

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2016-12-31
Completion
2018-06-30

Countries

  • Croatia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02697162 on ClinicalTrials.gov