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.

NCT Number	NCT07759986
Lead Sponsor	National Cheng-Kung University Hospital Collaborators: Formosa Plastics Corporation, Fortune Medical Instrument Corp., Medical Device Innovation Center (MDIC), National Cheng Kung University
Conditions	Catheter-Associated Urinary Tract Infections, Urinary Catheterization, Biofilms
Enrollment	40 participants
Start Date	2025-06-13
Primary Completion	2026-05-07 (estimated)
Study Completion	2026-05-07 (estimated)
Updated on ClinicalTrials.gov	2026-08-12