Neurogenic BladderPhase 2/3GuardianCathNCT02697162
Antiseptic-coated Intermittent Urinary Catheter
A Phase 2/3 study testing Antiseptic-coated catheter, Hydrophilic catheter and Octenidine chloride in people with Neurogenic Bladder and Catheter-Related Infections, run by Children's Hospital Zagreb at 1 site in Croatia.
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. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Neurogenic Bladder, Catheter-Related Infections
- What is being tested?
- Antiseptic-coated catheter, Hydrophilic catheter and Octenidine chloride
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteCroatia
- Study dates
- Jun 2016to Jun 2018
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- neurogenic bladder
- use of intermittent catheterisation for neurogenic bladder management
- informed oral and written consent from the child and both parents/legal guardian
Who cannot join
- Congenital anomalies of urinary tract or genitals
- Immunodeficiency
- Urinary tract fistula
Trial locations and contacts
1 site in 1 country.
About this study
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 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.
- Conditions
- Neurogenic Bladder, Catheter-Related Infections
- Being tested
- Antiseptic-coated catheter, Hydrophilic catheter, Octenidine chloride
- Keywords
- Intermittent catheterisation, Antiseptic, Octenidine chloride, Children
- Medical subject headings
- Urinary Bladder, Neurogenic, Catheter-Related Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antiseptic-coated catheterDevice
Also called GuardianCath
Antiseptic-coated hydrophilic intermittent urinary catheter with octenidine chloride
Hydrophilic catheterDevice
Hydrophilic intermittent urinary catheter
Octenidine chlorideDrug
Antiseptic
| Study group | Role | What they receive |
|---|---|---|
| Antiseptic-coated catheter | Experimental | Hydrophilic intermittent urinary catheter coated with octenidine chloride Receives: Device: Antiseptic-coated catheter; Drug: Octenidine chloride |
| Hydrophilic catheter | Placebo comparator | Hydrophilic intermittent urinary catheter Receives: Device: Hydrophilic catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months after start of intervention
Secondary outcomes (4)
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).
Measured: 6 months after start of intervention
Adverse reactions
Adverse events (AEs) and serious AEs will be recorded by the investigator. The presence of visible bleeding will reported by the participants.
Measured: 6 months after start of intervention
Expenses of infection-associated treatment
Total expenses in diagnostics and treatment of urinary tract infections
Measured: 6 months after start of intervention
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
Measured: 6 months after start of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2016 (estimated)
- Study startJun 2016
- Primary completionDec 2016 (estimated)
- Study completionJun 2018 (estimated)
Why it stopped: Withdrawal of research institution from participating
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurogenic BladderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Zagreb
- Sponsor type
- University, hospital or other
- Collaborators
- GuardianMed j.d.o.o. Research and development in medicine
- Responsible party
- Sponsor
- Investigators
- Slaven Abdovic, MD, PhD, Principal investigator, Children's Hospital Zagreb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02697162
- Sponsor's protocol ID
- GCath-CHZ-01
- Acronym
- GuardianCath
- Status last verified
- Feb 2021
- First submitted
- 23 Feb 2016
- Last updated
- 9 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antiseptic-coated Intermittent Urinary Catheter: Efficacy and Feasibility of Neurogenic Bladder Management and Prevention of Catheter-associated Urinary Tract Infections in Children
- ClinicalTrials.gov ID
- NCT02697162
- Acronym / sponsor ID
- GuardianCath / GCath-CHZ-01
- Conditions
- Neurogenic Bladder, Catheter-Related Infections
- Keywords
- Intermittent catheterisation, Antiseptic, Octenidine chloride, Children
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Withdrawal of research institution from participating
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Children's Hospital ZagrebUniversity, hospital or other
- Collaborators
- GuardianMed j.d.o.o. Research and development in medicine
- Study start
- Jun 2016
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 3 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antiseptic-coated catheter | Experimental | Device: Antiseptic-coated catheter, Drug: Octenidine chlorideHydrophilic intermittent urinary catheter coated with octenidine chloride |
| Hydrophilic catheter | Placebo comparator | Device: Hydrophilic catheterHydrophilic intermittent urinary catheter |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- neurogenic bladder
- use of intermittent catheterisation for neurogenic bladder management
- informed oral and written consent from the child and both parents/legal guardian
Key exclusion criteria (3 listed)
- Congenital anomalies of urinary tract or genitals
- Immunodeficiency
- Urinary tract fistula
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antiseptic-coated catheterAlso: GuardianCathAntiseptic-coated hydrophilic intermittent urinary catheter with octenidine chloride | Device | Antiseptic-coated catheter |
| Hydrophilic catheterHydrophilic intermittent urinary catheter | Device | Hydrophilic catheter |
| Octenidine chlorideAntiseptic | Drug | Antiseptic-coated catheter |
Primary outcome
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
4 secondary outcomes
Safety during catheterisation
Time frame: 6 months after start of intervention
Adverse reactions
Time frame: 6 months after start of intervention
Expenses of infection-associated treatment
Time frame: 6 months after start of intervention
Improvement in health-related quality of life measured by PedsQL 4.0 Generic Core questionnaire
Time frame: 6 months after start of intervention
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2021.
- Individual participant dataSharing planned: Undecided
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Pediatric Locomotor Training Bladder Study
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Concomitant Renal and Urinary Bladder Allograft Transplantation
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Slaven Abdovic, MD, PhD principal investigator
Children's Hospital Zagreb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Antiseptic-coated catheter, Hydrophilic catheter and Octenidine chloride in people with Neurogenic Bladder and Catheter-Related Infections, run by Children's Hospital Zagreb at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of urinary tract infections (time frame: 6 months after start of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2021.