Anti-fouling Silicone Urinary Catheter for Adults Needing Long-term Catheterisation: a Pilot and Feasibility Study

National Cheng-Kung University Hospital40 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Catheter-Associated Urinary Tract Infections Urinary Catheterization Biofilms

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.

Conventional silicone urinary catheterDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

National Cheng Kung University Hospital

Tainan, Taiwan

Outcomes

Primary Outcomes

Retention through the monthly catheter-change protocol

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

Time frame: Up to 8 monthly cycles

Completeness of longitudinal specimen collection

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

Time frame: Up to 8 monthly cycles

Device-related adverse events

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

Time frame: Up to 8 monthly cycles

Secondary Outcomes

Catheter-associated urinary tract infection (CAUTI) incidence

Exploratory outcome

Time frame: 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).

Time frame: 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).