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Antiseptic-coated Intermittent Urinary Catheter (GuardianCath)

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ClinicalTrials.gov Identifier: NCT02697162
Recruitment Status : Unknown
Verified March 2016 by Children's Hospital Zagreb.
Recruitment status was:  Not yet recruiting
First Posted : March 3, 2016
Last Update Posted : March 7, 2016
Sponsor:
Collaborator:
GuardianMed j.d.o.o. Research and development in medicine
Information provided by (Responsible Party):
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.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 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 : June 2016
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


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 Name: GuardianCath

Drug: Octenidine chloride
Antiseptic

Placebo Comparator: Hydrophilic catheter
Hydrophilic intermittent urinary catheter
Device: Hydrophilic catheter
Hydrophilic intermittent urinary catheter




Primary Outcome Measures :
  1. Number of urinary tract infections [ Time Frame: 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 :
  1. Safety [ Time Frame: 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).

  2. Adverse reactions [ Time Frame: 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.

  3. Expenses of infection-associated treatment [ Time Frame: 6 months after start of intervention ]
    Total expenses in diagnostics and treatment of urinary tract infections

  4. Improvement in health-related quality of life measured by PedsQL 4.0 Generic Core questionnaire [ Time Frame: 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:
  1. Gut flora and catheter-associated infections [ Time Frame: 2 years after start of intervention ]
    Impact of gut flora composition on incidence of catheter-associated urinary tract infections



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Ages Eligible for Study:   1 Month to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02697162


Contacts
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Contact: Slaven Abdovic, MD, PhD +385911144333 sabdovic@gmail.com
Contact: Luka Grgar +385981647518 lgrgar@guardianmed.eu

Locations
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Croatia
Children's Hospital Zagreb Not yet recruiting
Zagreb, Croatia, 10000
Contact: Slaven Abdovic, MD, PhD    +385911144333    sabdovic@gmail.com   
Principal Investigator: Slaven Abdovic, MD, PhD         
Sponsors and Collaborators
Children's Hospital Zagreb
GuardianMed j.d.o.o. Research and development in medicine
Investigators
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Principal Investigator: Slaven Abdovic, MD, PhD Children's Hospital Zagreb

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Responsible Party: Children's Hospital Zagreb
ClinicalTrials.gov Identifier: NCT02697162     History of Changes
Other Study ID Numbers: GCath-CHZ-01
First Posted: March 3, 2016    Key Record Dates
Last Update Posted: March 7, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Children's Hospital Zagreb:
Intermittent catheterisation
Antiseptic
Octenidine chloride
Children
Additional relevant MeSH terms:
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Infection
Catheter-Related Infections
Urinary Bladder, Neurogenic
Neurologic Manifestations
Nervous System Diseases
Urinary Bladder Diseases
Urologic Diseases
Signs and Symptoms
Anti-Infective Agents, Local
Octenidine
Anti-Infective Agents