New Intermittent Urinary Micro-Hole Zone Catheter Shows Enhanced Performance in Emptying the Bladder: A Randomised, Controlled Crossover Study

Abstract

Urinary tract infections (UTIs) are common and troublesome complications of clean intermittent catheterisation (CIC) in individuals suffering from incomplete bladder emptying, which may exacerbate the underlying disease and lead to hospitalisation. Aside from the design of the intermittent catheter and its handling, a recent review highlighted residual urine as one of several UTI risk factors. A new urinary intermittent catheter with multiple micro-holes has been developed for improved bladder emptying. In a controlled crossover study, adult male CIC users were randomised for a health care professional-led catheterisation with the new micro-hole zone catheter (MHZC) and a conventional eyelet catheter (CEC) in two individual test visits to compare the number of flow-stops and the residual urine at the first flow-stop as co-primary endpoints. In 42 male CIC users, the MHZC resulted in significantly fewer flow-stop episodes compared to the CEC (mean 0.17, 95% CI [0.06, 0.45] vs. mean 1.09, 95% CI [0.75, 1.6], respectively; p < 0.001) and significantly less residual urine at the first flow-stop (mean 5.10 mL, SE [1.14] vs. mean 39.40 mL, SE [9.65], respectively; p < 0.001). No adverse events were observed in this study. The results confirm the enhanced performance of the MHZC compared to a CEC, ensuring an uninterrupted free urine flow with no need to reposition the catheter until the bladder is thoroughly empty.