GuardianCath: Antiseptic-coated Intermittent Urinary Catheter

Sponsor

Children's Hospital Zagreb (Other)

Overall Status

Withdrawn

CT.gov ID

NCT02697162

Collaborator

GuardianMed j.d.o.o. Research and development in medicine (Other)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neurogenic Bladder Catheter-Related Infections	Device: Antiseptic-coated catheter Device: Hydrophilic catheter Drug: Octenidine chloride	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Jun 1, 2016

Anticipated Primary Completion Date :

Dec 1, 2016

Anticipated Study Completion Date :

Jun 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Antiseptic-coated catheter Hydrophilic intermittent urinary catheter coated with octenidine chloride	Device: Antiseptic-coated catheter Antiseptic-coated hydrophilic intermittent urinary catheter with octenidine chloride Other Names: GuardianCath Drug: Octenidine chloride Antiseptic
Placebo Comparator: Hydrophilic catheter Hydrophilic intermittent urinary catheter	Device: Hydrophilic catheter Hydrophilic intermittent urinary catheter

Arm

Intervention/Treatment

Experimental: Antiseptic-coated catheter

Hydrophilic intermittent urinary catheter coated with octenidine chloride

Device: Antiseptic-coated catheter

Antiseptic-coated hydrophilic intermittent urinary catheter with octenidine chloride

Other Names:

GuardianCath

Drug: Octenidine chloride

Antiseptic

Placebo Comparator: Hydrophilic catheter

Hydrophilic intermittent urinary catheter

Device: Hydrophilic catheter

Hydrophilic intermittent urinary catheter

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Month to 18 Years

Sexes Eligible for Study:

All

Accepts 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