Antiseptic-coated Intermittent Urinary Catheter (GuardianCath)
Primary Purpose
Neurogenic Bladder, Catheter-Related Infections
Status
Withdrawn
Phase
Phase 2
Locations
Croatia
Study Type
Interventional
Intervention
Antiseptic-coated catheter
Hydrophilic catheter
Octenidine chloride
Sponsored by
About this trial
This is an interventional prevention trial for Neurogenic Bladder focused on measuring Intermittent catheterisation, Antiseptic, Octenidine chloride, Children
Eligibility 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
Sites / Locations
- Children's Hospital Zagreb
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Antiseptic-coated catheter
Hydrophilic catheter
Arm Description
Hydrophilic intermittent urinary catheter coated with octenidine chloride
Hydrophilic intermittent urinary catheter
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Safety during catheterisation
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).
Adverse reactions
Adverse events (AEs) and serious AEs will be recorded by the investigator. The presence of visible bleeding will reported by the participants.
Expenses of infection-associated treatment
Total expenses in diagnostics and treatment of urinary tract infections
Improvement in health-related quality of life measured by PedsQL 4.0 Generic Core questionnaire
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
Full Information
NCT ID
NCT02697162
First Posted
February 23, 2016
Last Updated
February 5, 2021
Sponsor
Children's Hospital Zagreb
Collaborators
GuardianMed j.d.o.o. Research and development in medicine
1. Study Identification
Unique Protocol Identification Number
NCT02697162
Brief Title
Antiseptic-coated Intermittent Urinary Catheter
Acronym
GuardianCath
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 Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Withdrawal of research institution from participating
Study Start Date
June 2016 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
June 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Zagreb
Collaborators
GuardianMed j.d.o.o. Research and development in medicine
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurogenic Bladder, Catheter-Related Infections
Keywords
Intermittent catheterisation, Antiseptic, Octenidine chloride, Children
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Antiseptic-coated catheter
Arm Type
Experimental
Arm Description
Hydrophilic intermittent urinary catheter coated with octenidine chloride
Arm Title
Hydrophilic catheter
Arm Type
Placebo Comparator
Arm Description
Hydrophilic intermittent urinary catheter
Intervention Type
Device
Intervention Name(s)
Antiseptic-coated catheter
Other Intervention Name(s)
GuardianCath
Intervention Description
Antiseptic-coated hydrophilic intermittent urinary catheter with octenidine chloride
Intervention Type
Device
Intervention Name(s)
Hydrophilic catheter
Intervention Description
Hydrophilic intermittent urinary catheter
Intervention Type
Drug
Intervention Name(s)
Octenidine chloride
Intervention Description
Antiseptic
Primary Outcome Measure Information:
Title
Number of urinary tract infections
Description
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
Time Frame
6 months after start of intervention
Secondary Outcome Measure Information:
Title
Safety during catheterisation
Description
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).
Time Frame
6 months after start of intervention
Title
Adverse reactions
Description
Adverse events (AEs) and serious AEs will be recorded by the investigator. The presence of visible bleeding will reported by the participants.
Time Frame
6 months after start of intervention
Title
Expenses of infection-associated treatment
Description
Total expenses in diagnostics and treatment of urinary tract infections
Time Frame
6 months after start of intervention
Title
Improvement in health-related quality of life measured by PedsQL 4.0 Generic Core questionnaire
Description
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
Time Frame
6 months after start of intervention
Other Pre-specified Outcome Measures:
Title
Gut flora and catheter-associated infections
Description
Impact of gut flora composition on incidence of catheter-associated urinary tract infections
Time Frame
2 years after start of intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Slaven Abdovic, MD, PhD
Organizational Affiliation
Children's Hospital Zagreb
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital Zagreb
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Antiseptic-coated Intermittent Urinary Catheter
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