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

Area of Science:

• Urology
• Medical Devices
• Infectious Disease Prevention

Background:

• Urinary tract infections (UTIs) are frequent complications of clean intermittent catheterisation (CIC), particularly in patients with incomplete bladder emptying.
• Residual urine is a significant risk factor for UTIs in CIC users.
• Conventional eyelet catheters (CECs) may contribute to incomplete bladder emptying and increased UTI risk.

Purpose of the Study:

• To compare the efficacy of a novel micro-hole zone catheter (MHZC) against a conventional eyelet catheter (CEC) in improving bladder emptying during CIC.
• To evaluate the impact of MHZC on reducing flow-stop episodes and residual urine volume.

Main Methods:

• A controlled crossover study involving 42 adult male CIC users.
• Participants were randomized to use either the MHZC or CEC in separate test visits.
• Co-primary endpoints were the number of flow-stop episodes and residual urine volume at the first flow-stop.

Main Results:

• The MHZC demonstrated significantly fewer flow-stop episodes (mean 0.17) compared to the CEC (mean 1.09) (p < 0.001).
• Significantly less residual urine was observed with the MHZC (mean 5.10 mL) versus the CEC (mean 39.40 mL) (p < 0.001).
• No adverse events were reported during the study with either catheter type.

Conclusions:

• The MHZC offers enhanced performance over CECs for CIC, promoting complete bladder emptying.
• The improved design of the MHZC leads to reduced flow-stops and residual urine, potentially lowering UTI incidence.
• The MHZC ensures uninterrupted urine flow, eliminating the need for catheter repositioning until bladder voiding is complete.