NCT07759986

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2025

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 13, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 7, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 7, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 3, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 12, 2026

Completed
Last Updated

August 12, 2026

Status Verified

August 1, 2026

Enrollment Period

11 months

First QC Date

August 3, 2026

Last Update Submit

August 9, 2026

Conditions

Catheter-Associated Urinary Tract InfectionsUrinary CatheterizationBiofilms

Keywords

anti-fouling catheterzwitterionic polymerlong-term catheterisationpilot and feasibility study

Outcome Measures

Primary Outcomes (3)

  • Retention through the monthly catheter-change protocol

    Proportion of participants completing at least one, and 5 or more, monthly catheter changes (feasibility outcome)

    Up to 8 monthly cycles

  • Completeness of longitudinal specimen collection

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

    Up to 8 monthly cycles

  • Device-related adverse events

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

    Up to 8 monthly cycles

Secondary Outcomes (7)

  • Catheter-associated urinary tract infection (CAUTI) incidence

    Up to 8 monthly cycles

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

    At each monthly catheter change, up to 8 cycles

  • Urinalysis white blood cell count

    At each monthly visit, up to 8 cycles

  • Urine occult blood

    At each monthly visit, up to 8 cycles

  • Urinary bacteria on microscopic urinalysis

    At each monthly visit, up to 8 cycles

  • +2 more secondary outcomes

Study Arms (2)

Anti-fouling catheter

EXPERIMENTAL

Anti-fouling zwitterionic silicone urinary catheter, changed monthly for up to eight cycles (n=24).

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).

Device: Conventional silicone urinary catheter

Interventions

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.

Anti-fouling catheter
Conventional silicone urinary catheterDEVICE

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

Conventional catheter

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cheng Kung University Hospital

Tainan, Taiwan

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Experimental and control catheters were identical in appearance and packaging and dispensed by research staff so that participants were masked. Laboratory outcome assessment was masked. Caregivers within the institution were aware of allocation for clinical management.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor / Attending Physician

Study Record Dates

First Submitted

August 3, 2026

First Posted

August 12, 2026

Study Start

June 13, 2025

Primary Completion

May 7, 2026

Study Completion

May 7, 2026

Last Updated

August 12, 2026

Record last verified: 2026-08

Locations

TW(1)