NCT02697162

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2016

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 3, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

February 9, 2021

Status Verified

February 1, 2021

Enrollment Period

6 months

First QC Date

February 23, 2016

Last Update Submit

February 5, 2021

Conditions

Neurogenic BladderCatheter-Related Infections

Keywords

Intermittent catheterisationAntisepticOctenidine chlorideChildren

Outcome Measures

Primary Outcomes (1)

  • Number of urinary tract infections

    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 Outcomes (4)

  • Safety during catheterisation

    6 months after start of intervention

  • Adverse reactions

    6 months after start of intervention

  • Expenses of infection-associated treatment

    6 months after start of intervention

  • Improvement in health-related quality of life measured by PedsQL 4.0 Generic Core questionnaire

    6 months after start of intervention

Other Outcomes (1)

  • Gut flora and catheter-associated infections

    2 years after start of intervention

Study Arms (2)

Antiseptic-coated catheter

EXPERIMENTAL

Hydrophilic intermittent urinary catheter coated with octenidine chloride

Device: Antiseptic-coated catheterDrug: Octenidine chloride

Hydrophilic catheter

PLACEBO COMPARATOR

Hydrophilic intermittent urinary catheter

Device: Hydrophilic catheter

Interventions

Antiseptic-coated catheterDEVICE

Antiseptic-coated hydrophilic intermittent urinary catheter with octenidine chloride

Also known as: GuardianCath
Antiseptic-coated catheter
Hydrophilic catheterDEVICE

Hydrophilic intermittent urinary catheter

Hydrophilic catheter
Octenidine chlorideDRUG

Antiseptic

Antiseptic-coated catheter

Eligibility Criteria

Age1 Month - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • neurogenic bladder
  • use of intermittent catheterisation for neurogenic bladder management
  • informed oral and written consent from the child and both parents/legal guardian

You may not qualify if:

  • Congenital anomalies of urinary tract or genitals
  • Immunodeficiency
  • Urinary tract fistula

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital Zagreb

Zagreb, 10000, Croatia

Location

MeSH Terms

Conditions

Urinary Bladder, NeurogenicCatheter-Related Infections

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesUrinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsInfections

Study Officials

  • Slaven Abdovic, MD, PhD

    Children's Hospital Zagreb

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2016

First Posted

March 3, 2016

Study Start

June 1, 2016

Primary Completion

December 1, 2016

Study Completion

June 1, 2018

Last Updated

February 9, 2021

Record last verified: 2021-02

Locations

CR(1)