Department of Urology, NHS Foundation Trust, Addenbrooke's Hospital, Cambridge University Hospital, Cambridge, UK.
Coloplast A/S, Humlebaek, Denmark.
Neurourol Urodyn. 2024 Feb;43(2):464-478. doi: 10.1002/nau.25383. Epub 2024 Jan 9.
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).
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.
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.
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.
证实与传统的导眼导管（CEC）相比，微孔区域导管（MHZC）在清洁间歇性导尿（CIC）的男性使用者中的性能得到改善。
使用亲水套管软/柔性 CIC 作为唯一排空膀胱方法的男性自我导尿受试者被纳入这项在六个欧洲地点进行的多中心、随机、交叉研究。受试者测试了具有 120 个微孔的引流区域的 MHZC 和带有两个导眼的 CEC。该研究包括 4 次研究访问（V0-V3），在此期间测量了与导管性能相关的终点（尿流停止、膀胱排空和导管内压力），并在家中进行了两次为期 4 周的测试期（T1 和 T2），评估了两种导管之间的尿潜血和用户感知。
纳入了 73 名患有非神经源性和神经源性膀胱功能障碍的男性受试者（3:2）。平均而言，与 CEC 相比，MHZC 导尿导致接近平均零尿流停止，而与 CEC 相比，在 HCP 和自我导尿时均有≥1 次尿流停止（均 p<0.001）。与 CEC 相比，MHZC 时首次尿流停止时的残余尿量明显减少（分别为 p=0.001 和 p=0.004，对于 HCP 和自我导尿）。这是由于首次尿流停止时的压力峰值显著降低，这是最小化黏膜抽吸的指标（HCP 和自我导尿，均 p<0.001）。在家用导管后，两种导管之间的尿潜血相当，而导管与膀胱排空、阻塞感减少和与 CEC 相比改善的卫生导管化有关的感知显著改善。
这项研究证实了与 CEC 相比，MHZC 可改善膀胱排空，而无需重新定位导管。因此，MHZC 为依赖 CIC 的使用者提供了增强的益处，确保在不间断的自由流动中完全排空膀胱，并减少排空期间重新定位导管的需要。
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