A Phase 2/3 interventional study of Antiseptic-coated catheter and Hydrophilic catheter in Neurogenic Bladder and Catheter-Related Infections, sponsored by Children's Hospital Zagreb. Withdrawn at 1 site in Croatia. Open to participants aged 1 Month to 18 Years. Per ClinicalTrials.gov, last updated 2021-02-09.
Sponsored by Children's Hospital Zagreb · Phase 2/3, Interventional, and Prevention
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.
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Exclusion Criteria:
Hydrophilic intermittent urinary catheter coated with octenidine chloride
Device: Antiseptic-coated catheter · Drug: Octenidine chloride
Hydrophilic intermittent urinary catheter
Device: Hydrophilic catheter
Antiseptic-coated hydrophilic intermittent urinary catheter with octenidine chloride
Also known as: GuardianCath
Hydrophilic intermittent urinary catheter
Antiseptic
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
Time frame: 6 months after start of intervention
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).
Time frame: 6 months after start of intervention
Adverse reactions
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
Expenses of infection-associated treatment
Total expenses in diagnostics and treatment of urinary tract infections
Time frame: 6 months after start of intervention
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
Time frame: 6 months after start of intervention
Gut flora and catheter-associated infections
Impact of gut flora composition on incidence of catheter-associated urinary tract infections
Time frame: 2 years after start of intervention
Plan to share: Undecided
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This study is withdrawn, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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Children's Hospital Zagreb