Antiseptic-coated Intermittent Urinary Catheter

Phase 2

Withdrawn

• Conditions: Neurogenic Bladder; Catheter-Related Infections
• Interventions: Device: Antiseptic-coated catheter; Device: Hydrophilic catheter; Drug: Octenidine chloride

• Registration Number: NCT02697162
• Lead Sponsor: Children's Hospital Zagreb

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-02-23
• Study First Submitted QC: 2016-02-26
• Study First Posted: 2016-03-03
• Study Start: 2016-06
• Primary Completion: 2016-12
• Study Completion: 2018-06
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-05
• Last Update Posted: 2021-02-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Antiseptic-coated catheter	Antiseptic-coated catheter	Hydrophilic intermittent urinary catheter coated with octenidine chloride
Antiseptic-coated catheter	Octenidine chloride	Hydrophilic intermittent urinary catheter coated with octenidine chloride
Hydrophilic catheter	Hydrophilic catheter	Hydrophilic intermittent urinary catheter

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Children's Hospital Zagreb; 🇭🇷 Zagreb, Croatia