RESUMEN
AIMS: To confirm the improved performance of the micro-hole zone catheter (MHZC) compared to a conventional eyelet catheter (CEC) in male users of clean intermittent catheterizations (CICs). METHODS: Male self-catheterizing subjects, who used hydrophilic sleeved soft/flexible CIC as the only bladder emptying method, were enrolled into a multi-center, randomized, cross-over study performed across six European sites. Subjects tested the MHZC, featuring a drainage zone with 120 micro-holes and a CEC with two eyelets. The study consisted of four study visits (V0-V3), during which endpoints related to catheter performance (urinary flow-stops, bladder emptying, and intra-catheter pressure) were measured and two 4-week test periods at home (T1 and T2) where dipstick hematuria and user perception between catheters were evaluated. RESULTS: Seventy-three male subjects with non-neurogenic and neurogenic bladder dysfunction (3:2) were enrolled. On average, catheterizations with the MHZC led to close to mean zero flow-stops compared to ≥1 flow-stops with the CEC, during both HCP- and self-led catheterizations (both p < 0.001). Residual urine at first flow-stop was significantly reduced for the MHZC compared to CEC (p = 0.001 and p = 0.004, for HCP- and self-led catheterizations, respectively). This was substantiated by a significantly smaller pressure peak at first flow-stop, a proxy for minimized mucosal suction (both HCP- and self-led catheterizations, p < 0.001). After home-use catheterizations, dipstick hematuria was comparable between catheters, whereas catheterizations were associated with significantly improved perception in favor of MHZC regarding bladder emptying, less blocking sensation, and improved hygienic catheterization compared to the CEC. CONCLUSION: This study confirmed the evidence of improved bladder emptying with the MHZC compared to a CEC without the need to reposition the catheter. The MHZC therefore offers an enhanced benefit for the dependent CIC user securing complete bladder emptying in an uninterrupted free flow and reducing the need to reposition the catheter during emptying.
