Antiseptic-coated Intermittent Urinary Catheter

NCT ID: NCT02697162

Last Updated: 2021-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2/PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2018-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Neurogenic Bladder Catheter-Related Infections

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Antiseptic-coated catheter

Hydrophilic intermittent urinary catheter coated with octenidine chloride

Group Type EXPERIMENTAL

Antiseptic-coated catheter

Intervention Type DEVICE

Antiseptic-coated hydrophilic intermittent urinary catheter with octenidine chloride

Octenidine chloride

Intervention Type DRUG

Antiseptic

Hydrophilic catheter

Hydrophilic intermittent urinary catheter

Group Type PLACEBO_COMPARATOR

Hydrophilic catheter

Intervention Type DEVICE

Hydrophilic intermittent urinary catheter

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Antiseptic-coated catheter

Antiseptic-coated hydrophilic intermittent urinary catheter with octenidine chloride

Intervention Type DEVICE

Hydrophilic catheter

Hydrophilic intermittent urinary catheter

Intervention Type DEVICE

Octenidine chloride

Antiseptic

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

GuardianCath

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

1 Month

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

GuardianMed j.d.o.o. Research and development in medicine

UNKNOWN

Sponsor Role collaborator

Children's Hospital Zagreb

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Slaven Abdovic, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Zagreb

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Children's Hospital Zagreb

Zagreb, , Croatia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Croatia

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

GCath-CHZ-01

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.