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Withdrawal of research institution from participating
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| Name | Class |
|---|---|
| GuardianMed j.d.o.o. Research and development in medicine | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Antiseptic-coated catheter | Experimental | Hydrophilic intermittent urinary catheter coated with octenidine chloride |
|
| Hydrophilic catheter | Placebo Comparator | Hydrophilic intermittent urinary catheter |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antiseptic-coated catheter | Device | Antiseptic-coated hydrophilic intermittent urinary catheter with octenidine chloride |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Gut flora and catheter-associated infections | Impact of gut flora composition on incidence of catheter-associated urinary tract infections | 2 years after start of intervention |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Slaven Abdovic, MD, PhD | Children's Hospital Zagreb | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Zagreb | Zagreb | 10000 | Croatia |
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| ID | Term |
|---|---|
| D001750 | Urinary Bladder, Neurogenic |
| D055499 | Catheter-Related Infections |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
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| Hydrophilic catheter | Device | Hydrophilic intermittent urinary catheter |
|
| Octenidine chloride | Drug | Antiseptic |
|
| 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 |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007239 | Infections |