GuardianCath: Antiseptic-coated Intermittent Urinary Catheter

Sponsor
Children's Hospital Zagreb (Other)
Overall Status
Withdrawn
CT.gov ID
NCT02697162
Collaborator
GuardianMed j.d.o.o. Research and development in medicine (Other)
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Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: Antiseptic-coated catheter
  • Device: Hydrophilic catheter
  • Drug: Octenidine chloride
Phase 2/Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Antiseptic-coated Intermittent Urinary Catheter: Efficacy and Feasibility of Neurogenic Bladder Management and Prevention of Catheter-associated Urinary Tract Infections in Children
Study Start Date :
Jun 1, 2016
Anticipated Primary Completion Date :
Dec 1, 2016
Anticipated Study Completion Date :
Jun 1, 2018

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Number of urinary tract infections [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

    Secondary Outcome Measures

    1. Safety during catheterisation [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).

    2. Adverse reactions [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.

    3. Expenses of infection-associated treatment [6 months after start of intervention]

      Total expenses in diagnostics and treatment of urinary tract infections

    4. Improvement in health-related quality of life measured by PedsQL 4.0 Generic Core questionnaire [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

    Other Outcome Measures

    1. Gut flora and catheter-associated infections [2 years after start of intervention]

      Impact of gut flora composition on incidence of catheter-associated urinary tract infections

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Month to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Children's Hospital Zagreb Zagreb Croatia 10000

    Sponsors and Collaborators

    • Children's Hospital Zagreb
    • GuardianMed j.d.o.o. Research and development in medicine

    Investigators

    • Principal Investigator: Slaven Abdovic, MD, PhD, Children's Hospital Zagreb

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Children's Hospital Zagreb
    ClinicalTrials.gov Identifier:
    NCT02697162
    Other Study ID Numbers:
    • GCath-CHZ-01
    First Posted:
    Mar 3, 2016
    Last Update Posted:
    Feb 9, 2021
    Last Verified:
    Feb 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by Children's Hospital Zagreb
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 9, 2021