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

Nikesh Thiruchelvam, Hashim Hashim, Christian Riis Forman, Lotte Jacobsen, Trine Sperup, Karin Andersen
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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.

新型紧凑型微孔区导尿管可使女性实现有效的膀胱排空,而无需停流。
背景:使用传统孔导尿管(CEC)进行清洁间歇性自我导尿(CISC)时会出现尿流停止的情况,这就需要重新定位导尿管,以便恢复尿流。出现尿流停止的原因通常是膀胱粘膜被吸入了尿眼。目的:本研究旨在比较微孔区导尿管(MHZC)与 CEC 的膀胱排空性能:这是一项多中心、随机、开放标签、对照交叉研究,共有 82 名女性参加,对 MHZC 和 CEC 进行了比较。与膀胱排空性能有关的终点包括首次停流时的残余容量、停流次数和成功治疗的比例。此外,还对妇女对导尿管的感知以及装置的不适感进行了评估:使用 MHZC 进行导管治疗可显著降低停流风险,相对风险结果显示,由医护人员主导的导管治疗可将停流风险降低 2.74 倍,而自行导管治疗可将停流风险降低 2.52 倍。两种导管在首次停流时的残余尿量没有统计学差异。使用MHZC导尿管进行导尿时,更有可能实现零停流和残余尿量达标:MHZC 能够有效排空膀胱,而无需重新定位导尿管,简化了手术过程,使妇女对膀胱排空充满信心。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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