Antiseptic-coated Intermittent Urinary Catheter: Efficacy and Feasibility of Neurogenic Bladder Management and Prevention of Catheter-associated Urinary Tract Infections in Children
Overview
- Phase
- Phase 2
- Intervention
- Antiseptic-coated catheter
- Conditions
- Neurogenic Bladder
- Sponsor
- Children's Hospital Zagreb
- Locations
- 1
- Primary Endpoint
- Number of urinary tract infections
- Status
- Withdrawn
- Last Updated
- 5 years ago
Overview
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.
Investigators
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
Arms & Interventions
Antiseptic-coated catheter
Hydrophilic intermittent urinary catheter coated with octenidine chloride
Intervention: Antiseptic-coated catheter
Antiseptic-coated catheter
Hydrophilic intermittent urinary catheter coated with octenidine chloride
Intervention: Octenidine chloride
Hydrophilic catheter
Hydrophilic intermittent urinary catheter
Intervention: Hydrophilic catheter
Outcomes
Primary Outcomes
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
Secondary Outcomes
- 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)