New compact micro-hole zone catheter enables women to achieve effective bladder emptying without flow-stops

Abstract

Background: Clean intermittent self-catheterisation (CISC) with conventional eyelet catheters (CECs) is associated with urine flow-stops, which require the catheter to be repositioned so flow can resume. Flow-stops often occur because bladder mucosa is sucked into the eyelets. Aims: This investigation aimed to compare the bladder-emptying performance of the micro-hole zone catheter (MHZC) with the CEC. Methods: This was a multi-centre, randomised, open-label, controlled cross-over study with 82 women comparing the MHZC to the CEC. The endpoints relating to bladder-emptying performance included the residual volume at first flow-stop, the number of flow-stops and the proportion of successful treatment responses. The women's perception of the catheters was assessed as well as device discomfort. Findings: Catheterisations with MHZC significantly reduced the risk of flow-stops, with relative risk results showing a 2.74 times lower risk of flow-stops with a health professional-led catheterisation and a 2.52 times lower risk during self-catheterisation. There was no statistical difference in residual urine volume at first flow-stop between the two catheters. Catheterisations with the MHZC were significantly more likely to achieve zero flow-stops and a residual urine volume of <10 ml at first flow-stop. The women had a significantly more positive perception of the MHZC than the CEC in areas including handling, confidence, sensation and satisfaction. Conclusion: The MHZC enabled effective bladder emptying without catheters needing to be repositioned, supporting the women by simplifying the procedure and making them feel confident that their bladders were empty.