Antiseptic-coated Intermittent Urinary Catheter (GuardianCath)

February 5, 2021 updated by: Children's Hospital Zagreb

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

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 Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Croatia
      • Zagreb, Croatia, 10000
        • Children's Hospital Zagreb

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Antiseptic-coated catheter
Hydrophilic intermittent urinary catheter coated with octenidine chloride
Device: Antiseptic-coated catheter
Antiseptic-coated hydrophilic intermittent urinary catheter with octenidine chloride
Other Names:
  • GuardianCath
Drug: Octenidine chloride
Antiseptic
Placebo Comparator: Hydrophilic catheter
Hydrophilic intermittent urinary catheter
Device: Hydrophilic catheter
Hydrophilic intermittent urinary catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of urinary tract infections
Time Frame: 6 months after start of intervention
Urinary tract infection is diagnosed when both urinalysis results disclose pyuria and/or bacteriuria and the presence of at least 1000 colony-forming units per mL of a uropathogen cultured from a urine specimen obtained through catheterization
6 months after start of intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety during catheterisation
Time Frame: 6 months after start of intervention
Discomfort during catheterisation will be measured by subjective evaluation on a 10-cm visual analogue scale (VAS), where 0 is 'no discomfort' and 10 is 'worst discomfort imaginable'. Pain, stinging, or resistance will be measured on a four-point scale (for example for pain: 1=no pain; 4=severe pain).
6 months after start of intervention
Adverse reactions
Time Frame: 6 months after start of intervention
Adverse events (AEs) and serious AEs will be recorded by the investigator. The presence of visible bleeding will reported by the participants.
6 months after start of intervention
Expenses of infection-associated treatment
Time Frame: 6 months after start of intervention
Total expenses in diagnostics and treatment of urinary tract infections
6 months after start of intervention
Improvement in health-related quality of life measured by PedsQL 4.0 Generic Core questionnaire
Time Frame: 6 months after start of intervention
Improvement is defined by increase in total and subscale scores by more than defined minimally clinical important difference for PedsQL 4.0 Generic Core questionnaire
6 months after start of intervention

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gut flora and catheter-associated infections
Time Frame: 2 years after start of intervention
Impact of gut flora composition on incidence of catheter-associated urinary tract infections
2 years after start of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital Zagreb

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

June 1, 2018

Study Registration Dates

First Submitted

February 23, 2016

First Submitted That Met QC Criteria

February 26, 2016

First Posted (Estimate)

March 3, 2016

Study Record Updates

Last Update Posted (Actual)

February 9, 2021

Last Update Submitted That Met QC Criteria

February 5, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCath-CHZ-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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