Antiseptic-coated Intermittent Urinary Catheter

Neurogenic Bladder Clinical Trial

— GuardianCath  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02697162
• Other study ID #: GCath-CHZ-01
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• Start date: June 2016
• Est. completion date: June 2018

Study information

• Verified date: February 2021
• Source: Children's Hospital Zagreb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2018
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Catheter-Related Infections
• Infection
• Neurogenic Bladder
• Urinary Bladder, Neurogenic

Intervention

Device:
• Antiseptic-coated catheter
Antiseptic-coated hydrophilic intermittent urinary catheter with octenidine chloride
• Hydrophilic catheter
Hydrophilic intermittent urinary catheter

Drug:
• Octenidine chloride
Antiseptic

Locations

Country	Name	City	State
Croatia	Children's Hospital Zagreb	Zagreb

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital Zagreb	GuardianMed j.d.o.o. Research and development in medicine

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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
Secondary	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
Secondary	Expenses of infection-associated treatment	Total expenses in diagnostics and treatment of urinary tract infections	6 months after start of intervention
Secondary	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