Catheter-Associated Urinary Tract InfectionsNCT07759986
Anti-fouling Silicone Urinary Catheter for Adults Needing Long-term Catheterisation: a Pilot and Feasibility Study
A study testing Anti-fouling zwitterionic silicone urinary catheter and Conventional silicone urinary catheter in people with Catheter-Associated Urinary Tract Infections and Urinary Catheterization, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial summary
This single-centre randomised pilot and feasibility study assessed whether an anti-fouling zwitterionic silicone urinary catheter can be deployed and evaluated in frail, elderly adults who require long-term indwelling catheterisation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Catheter-Associated Urinary Tract Infections, Urinary Catheterization, Biofilms
- What is being tested?
- Anti-fouling zwitterionic silicone urinary catheter and Conventional silicone urinary catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 13 Jun 2025to 7 May 2026
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older
- Require long-term indwelling urethral catheterisation
- At risk of catheter-associated urinary tract infection
- Written informed consent from the participant or a legal representative
Who cannot join
- Individuals who are not fully conscious or unable to clearly express their wishes
- Individuals who cannot cooperate with urine or blood tests or other related examinations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility and Acceptability of an Anti-fouling Silicone Urinary Catheter for Long-term Catheterisation: a Single-centre, Single-blind Randomised Pilot and Feasibility Study
This single-centre randomised pilot and feasibility study assessed whether an anti-fouling zwitterionic silicone urinary catheter can be deployed and evaluated in frail, elderly adults who require long-term indwelling catheterisation. In the experimental catheter, a zwitterionic polymer is blended into the silicone matrix rather than applied as a surface coating. Forty participants were randomly allocated to the anti-fouling catheter or a conventional commercial silicone catheter, with monthly catheter changes for up to eight cycles. The primary aim was to establish feasibility and acceptability (recruitment, retention, specimen completeness, safety and patient/family acceptability) and to obtain exploratory effect-size estimates (catheter-associated urinary tract infection, catheter-removal pain, urinalysis and urine culture) to inform the design of a future confirmatory trial. The study was not powered to test efficacy.
- Being tested
- Anti-fouling zwitterionic silicone urinary catheter, Conventional silicone urinary catheter
- Keywords
- anti-fouling catheter, zwitterionic polymer, long-term catheterisation, pilot and feasibility study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-fouling zwitterionic silicone urinary catheterDevice
Zwitterionic polymer bulk-blended into the medical-grade silicone matrix (not a surface coating); ethylene-oxide sterilised; changed monthly.
Conventional silicone urinary catheterDevice
Conventional commercial silicone Foley catheter, identical French size; changed monthly.
| Study group | Role | What they receive |
|---|---|---|
| Anti-fouling catheter | Experimental | Anti-fouling zwitterionic silicone urinary catheter, changed monthly for up to eight cycles (n=24). Receives: Device: Anti-fouling zwitterionic silicone urinary catheter |
| Conventional catheter | Active comparator | Conventional commercial silicone Foley catheter of identical French size, changed monthly for up to eight cycles (n=16). Receives: Device: Conventional silicone urinary catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention through the monthly catheter-change protocol
Proportion of participants completing at least one, and 5 or more, monthly catheter changes (feasibility outcome)
Measured: Up to 8 monthly cycles
Completeness of longitudinal specimen collection
Proportion of expected urinalysis and urine-culture specimens collected (feasibility outcome)
Measured: Up to 8 monthly cycles
Device-related adverse events
Number of device-related adverse events (safety feasibility outcome)
Measured: Up to 8 monthly cycles
Secondary outcomes (7)
Catheter-associated urinary tract infection (CAUTI) incidence
Exploratory outcome
Measured: Up to 8 monthly cycles
Catheter-removal pain measured by the Visual Analogue Scale (VAS)
Pain at catheter removal measured on a Visual Analogue Scale ranging from 0 (no pain) to 10 (worst imaginable pain); higher scores indicate worse pain (a worse outcome).
Measured: At each monthly catheter change, up to 8 cycles
Urinalysis white blood cell count
White blood cells per high-power field on microscopic urinalysis at each monthly visit (exploratory outcome).
Measured: At each monthly visit, up to 8 cycles
Urine occult blood
Urine occult blood measured semi-quantitatively on dipstick urinalysis at each monthly visit (exploratory outcome).
Measured: At each monthly visit, up to 8 cycles
Urinary bacteria on microscopic urinalysis
Bacteria graded semi-quantitatively on microscopic urinalysis at each monthly visit (exploratory outcome).
Measured: At each monthly visit, up to 8 cycles
Urine nitrite
Urine nitrite recorded as positive or negative on dipstick urinalysis at each monthly visit (exploratory outcome).
Measured: At each monthly visit, up to 8 cycles
Urine culture positivity
Proportion of urine cultures reported as positive at each monthly visit (exploratory outcome).
Measured: At each monthly visit, up to 8 cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start13 Jun 2025
- Primary completion7 May 2026
- Study completion7 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Catheter-Associated Urinary Tract InfectionsStudies of the same condition, open and under way.
- More trials run by National Cheng-Kung University HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Formosa Plastics Corporation, Fortune Medical Instrument Corp., Medical Device Innovation Center (MDIC), National Cheng Kung University
- Responsible party
- Principal investigator, Yuan-Yow Chiou, National Cheng-Kung University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07759986
- Sponsor's protocol ID
- A-BR-113-031
- Status last verified
- Aug 2026
- First submitted
- 3 Aug 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of an Anti-fouling Silicone Urinary Catheter for Long-term Catheterisation: a Single-centre, Single-blind Randomised Pilot and Feasibility Study
- ClinicalTrials.gov ID
- NCT07759986
- Acronym / sponsor ID
- A-BR-113-031
- Keywords
- anti-fouling catheter, zwitterionic polymer, long-term catheterisation, pilot and feasibility study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Collaborators
- Formosa Plastics Corporation, Fortune Medical Instrument Corp., Medical Device Innovation Center (MDIC), National Cheng Kung University
- Study start
- 13 Jun 2025 (actual)
- Primary completion
- 7 May 2026 (actual)
- Study completion
- 7 May 2026 (actual)
- First posted
- 12 Aug 2026 (actual)
- 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.
This single-centre randomised pilot and feasibility study assessed whether an anti-fouling zwitterionic silicone urinary catheter can be deployed and evaluated in frail, elderly adults who require long-term indwelling catheterisation. In the experimental catheter, a zwitterionic polymer is blended into the silicone matrix rather than applied as a surface coating. Forty participants were randomly allocated to the anti-fouling catheter or a conventional commercial silicone catheter, with monthly catheter changes for up to eight cycles. The primary aim was to establish feasibility and acceptability (recruitment, retention, specimen completeness, safety and patient/family acceptability) and to obtain exploratory effect-size estimates (catheter-associated urinary tract infection, catheter-removal pain, urinalysis and urine culture) to inform the design of a future confirmatory trial. The study was not powered to test efficacy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anti-fouling catheter | Experimental | Device: Anti-fouling zwitterionic silicone urinary catheterAnti-fouling zwitterionic silicone urinary catheter, changed monthly for up to eight cycles (n=24). |
| Conventional catheter | Active comparator | Device: Conventional silicone urinary catheterConventional commercial silicone Foley catheter of identical French size, changed monthly for up to eight cycles (n=16). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18 years or older
- Require long-term indwelling urethral catheterisation
- At risk of catheter-associated urinary tract infection
- Written informed consent from the participant or a legal representative
Key exclusion criteria (2 listed)
- Individuals who are not fully conscious or unable to clearly express their wishes
- Individuals who cannot cooperate with urine or blood tests or other related examinations
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 |
|---|---|---|
| Anti-fouling zwitterionic silicone urinary catheterZwitterionic polymer bulk-blended into the medical-grade silicone matrix (not a surface coating); ethylene-oxide sterilised; changed monthly. | Device | Anti-fouling catheter |
| Conventional silicone urinary catheterConventional commercial silicone Foley catheter, identical French size; changed monthly. | Device | Conventional catheter |
Primary outcome
Retention through the monthly catheter-change protocol
Time frame: Up to 8 monthly cycles
Proportion of participants completing at least one, and 5 or more, monthly catheter changes (feasibility outcome)
Completeness of longitudinal specimen collection
Time frame: Up to 8 monthly cycles
Proportion of expected urinalysis and urine-culture specimens collected (feasibility outcome)
Device-related adverse events
Time frame: Up to 8 monthly cycles
Number of device-related adverse events (safety feasibility outcome)
7 secondary outcomes
Catheter-associated urinary tract infection (CAUTI) incidence
Time frame: Up to 8 monthly cycles
Catheter-removal pain measured by the Visual Analogue Scale (VAS)
Time frame: At each monthly catheter change, up to 8 cycles
Urinalysis white blood cell count
Time frame: At each monthly visit, up to 8 cycles
Urine occult blood
Time frame: At each monthly visit, up to 8 cycles
Urinary bacteria on microscopic urinalysis
Time frame: At each monthly visit, up to 8 cycles
Urine nitrite
Time frame: At each monthly visit, up to 8 cycles
Urine culture positivity
Time frame: At each monthly visit, up to 8 cycles
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anti-fouling zwitterionic silicone urinary catheter and Conventional silicone urinary catheter in people with Catheter-Associated Urinary Tract Infections and Urinary Catheterization, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 12 Aug 2026. 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 Taiwan. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Retention through the monthly catheter-change protocol (time frame: Up to 8 monthly cycles). The study lists 3 primary outcomes in all. 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 12 Aug 2026.