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

Authors
Category Primary study
Registry of TrialsClinicalTrials.gov
Year 2026
This single‐centre randomised pilot and feasibility study assessed whether ananti‐fouling zwitterionic silicone urinary catheter can be deployed and evaluated infrail, elderly adults who require long‐term indwelling catheterisation. In theexperimental catheter, a zwitterionic polymer is blended into the silicone matrix ratherthan applied as a surface coating. Forty participants were randomly allocated to theanti‐fouling catheter or a conventional commercial silicone catheter, with monthlycatheter changes for up to eight cycles. The primary aim was to establish feasibility andacceptability (recruitment, retention, specimen completeness, safety and patient/familyacceptability) and to obtain exploratory effect‐size estimates (catheter‐associatedurinary tract infection, catheter‐removal pain, urinalysis and urine culture) to informthe design of a future confirmatory trial. The study was not powered to test efficacy.
Epistemonikos ID: f6fb979ac5c553ea063b445c99134185736baad7
First added on: Aug 12, 2026