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NCT Number: NCT07759986

Anti-fouling Silicone Urinary Catheter for Adults Needing Long-term Catheterisation: a 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.

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Key information

Conditions

Catheter-Associated Urinary Tract Infections Biofilms Urinary Catheterization

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Cheng Kung University Hospital

Tainan, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Anti-fouling zwitterionic silicone urinary catheter

Device

Zwitterionic polymer bulk-blended into the medical-grade silicone matrix (not a surface coating); ethylene-oxide sterilised; changed monthly.

Conventional silicone urinary catheter

Device

Conventional commercial silicone Foley catheter, identical French size; changed monthly.

Primary outcomes

  1. 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)

  2. Completeness of longitudinal specimen collection

    Time frame: Up to 8 monthly cycles

    Proportion of expected urinalysis and urine-culture specimens collected (feasibility outcome)

  3. Device-related adverse events

    Time frame: Up to 8 monthly cycles

    Number of device-related adverse events (safety feasibility outcome)

Secondary outcomes

  1. Catheter-associated urinary tract infection (CAUTI) incidence

    Time frame: Up to 8 monthly cycles

    Exploratory outcome

  2. Catheter-removal pain measured by the Visual Analogue Scale (VAS)

    Time frame: At each monthly catheter change, up to 8 cycles

    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).

  3. Urinalysis white blood cell count

    Time frame: At each monthly visit, up to 8 cycles

    White blood cells per high-power field on microscopic urinalysis at each monthly visit (exploratory outcome).

  4. Urine occult blood

    Time frame: At each monthly visit, up to 8 cycles

    Urine occult blood measured semi-quantitatively on dipstick urinalysis at each monthly visit (exploratory outcome).

  5. Urinary bacteria on microscopic urinalysis

    Time frame: At each monthly visit, up to 8 cycles

    Bacteria graded semi-quantitatively on microscopic urinalysis at each monthly visit (exploratory outcome).

  6. Urine nitrite

    Time frame: At each monthly visit, up to 8 cycles

    Urine nitrite recorded as positive or negative on dipstick urinalysis at each monthly visit (exploratory outcome).

  7. Urine culture positivity

    Time frame: At each monthly visit, up to 8 cycles

    Proportion of urine cultures reported as positive at each monthly visit (exploratory outcome).

Sponsors and collaborators

Lead sponsor

National Cheng-Kung University Hospital

Other

Collaborators

  • Formosa Plastics Corporation
  • Fortune Medical Instrument Corp.
  • Medical Device Innovation Center (MDIC), National Cheng Kung University

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 12, 2026
Registry last updated
Aug 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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