Antiseptic-coated Intermittent Urinary Catheter

Study Overview
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Brief Summary
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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.

Official Title
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Antiseptic-coated Intermittent Urinary Catheter: Efficacy and Feasibility of Neurogenic Bladder Management and Prevention of Catheter-associated Urinary Tract Infections in Children

Conditions
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Neurogenic Bladder, Catheter-Related Infections

Intervention / Treatment
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* Device: Antiseptic-coated catheter
* Device: Hydrophilic catheter
* Drug: Octenidine chloride


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Antiseptic-coated catheter<br>Hydrophilic intermittent urinary catheter coated with octenidine chloride | Device: Antiseptic-coated catheter<br>* Antiseptic-coated hydrophilic intermittent urinary catheter with octenidine chloride<br>* Other names: GuardianCath;Drug: Octenidine chloride<br>* Antiseptic<br>|
| Placebo Comparator: Hydrophilic catheter<br>Hydrophilic intermittent urinary catheter | Device: Hydrophilic catheter<br>* Hydrophilic intermittent urinary catheter<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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. | 6 months after start of intervention | 
| Expenses of infection-associated treatment | Total expenses in diagnostics and treatment of urinary tract infections | 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 | 6 months after start of intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intermittent catheterisation, Antiseptic, Octenidine chloride, Children