A prospective randomised pilot study evaluating the safety of the novel LubriShield™ Foley catheter: a permanently coated indwelling urinary catheter.

OBJECTIVE: Catheter-associated urinary tract infections (CAUTIs) are prevalent healthcare-associated infections, arising from biofilm-forming bacteria. This may be prevented by coating the catheter with an antifouling substance. The novel LubriShield™ Foley catheter is coated with a superhydrophilic surface and a covalently bonded antifouling ligand. Preclinical studies revealed that the coating established a persistent local antifouling environment, inhibiting uropathogenic bacteria from forming biofilms. No substance release has been detected from the coating. The coating achieved a 28-fold reduction in surface friction compared to an uncoated catheter. The aim of this study is to assess the clinical safety of the catheter in patients.

MATERIALS & METHODS: In a prospective single-centre randomised study, 30 patients undergoing transurethral resection of bladder tumour were enrolled and randomly assigned to receive either a standard control catheter or the novel LubriShield™ catheter. Urinary cultures were obtained twice. The duration of catheterisation for the patients ranged from 3 to 24 h. The primary outcome was the assessment of device-specific adverse events (AEs). Secondary outcomes included evaluations of pain, irritation and discomfort, measured using the Numeric Rating Scale (NRS) (0-10) via a patient questionnaire.

RESULTS: There were no serious adverse events (SAEs) or AEs reported for the coated catheters. Urinary cultures showed no significant differences between the coated and uncoated catheters. Both patients and healthcare professionals rated the NRS equally for the two types of catheters.

CONCLUSIONS: The novel-coated LubriShield™ catheter was found to be safe for short-term clinical use.