Introduction

Catheter-associated urinary tract infection (CAUTI) is a major preventable cause of harm in hospitalized patients. Previous in vitro studies have shon wthat a unique surface micropattern on catheter surface reduces bacterial biofilm formation. This single center, open labelled, randomized interventional study evaluated if the Sharklet micropatterned catheter (SC) reduces UTI in catheterized patients, when compared to a standard silicone Foley catheter. (NCT02835456)

Methods

Fifty eligible adult men requiring temporary urethral catheterization for a period between 3 and 30 days were randomized into two groups with standard silicone Foley catheter insertion in one and SC in other. On removal, parts of the catheters (tip, middle part and base) were examined for bacterial colonization/biofilm using scanning electron microscopy. The patients were also assessed for incidence of symptomatic UTI, significant asymptomatic bacteriuria, pain and discomfort.

Results

The mean age and duration of catheterization were similar among both groups. None of the patients developed symptomatic CAUTI. The outer surface of the SC had significantly lower biofilm formation when compared to the standard silicone catheter in all parts of the catheter (Tip: P= 0.003, Middle part: P=0.013 and Base: P=0.013). However, this difference was not noted in the inner surface of the catheters (P= 0.511, P=0.245, P=0.810 respectively); which may be attributed to the absence of micropattern in the inner surface of SC. There was significantly lower pain and discomfort in patients using SC when compared to the standard catheter (p=0.018).

Conclusions

Catheters that can reduce CAUTI have the advantage of improving the care of millions of disabled and elderly patients and reducing the enormous costs of managing complications associated with indwelling Foley catheter. However, none of the numerous strategies tested until now, like antibiotic or silver impregnation on catheter surface have proved to be useful in this regard. This is the first trial to test the efficacy of Sharklet micropattern on urinary catheter surface in a clinical setting. The promising results of this study opens the arena for novel mechanical modifications on catheter surface which may be both cost effective and clinically beneficial.

Funding

None