Antiseptic-coated Intermittent Urinary Catheter

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

Status

Withdrawn

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02697162

Acronym

GuardianCath

Enrollment

Registered

2016-03-03

Start date

2016-06-30

Completion date

2018-06-30

Last updated

2021-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Catheter-Related Infections, Neurogenic Bladder

Keywords

Intermittent catheterisation, Antiseptic, Octenidine chloride, Children

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.

Interventions

DEVICEAntiseptic-coated catheter

Antiseptic-coated hydrophilic intermittent urinary catheter with octenidine chloride

DEVICEHydrophilic catheter

Hydrophilic intermittent urinary catheter

DRUGOctenidine chloride

Antiseptic

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

1 Months to 18 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Number of urinary tract infections	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

Measure	Time frame	Description
Safety during catheterisation	6 months after start of intervention	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	6 months after start of intervention	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	6 months after start of intervention	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	6 months after start of intervention	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

Other

Measure	Time frame	Description
Gut flora and catheter-associated infections	2 years after start of intervention	Impact of gut flora composition on incidence of catheter-associated urinary tract infections

Countries

Croatia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026