微孔区域间歇导尿管性能提升：对 3 项比较新型导尿管技术与传统网眼导尿管的随机对照研究的综合分析

Improved Performance With the Micro-Hole Zone Intermittent Catheter: A Combined Analysis of 3 Randomized Controlled Studies Comparing the New Catheter Technology With a Conventional Eyelet Catheter.

机构信息

Malene Hornbak Landauro, PhD , Coloplast A/S, Humlebæk, Denmark.

Fabio Tentor, PhD , Coloplast A/S, Humlebæk, Denmark.

出版信息

J Wound Ostomy Continence Nurs. 2023;50(6):504-511. doi: 10.1097/WON.0000000000001029.

DOI:10.1097/WON.0000000000001029

PMID:37966080

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10681284/

Abstract

PURPOSE

To assess the performance of a new urinary intermittent catheter (IC) prototype designed with a micro-hole drainage zone compared to a conventional eyelet catheter (CEC) in terms of flow-stop, bladder emptying, and hematuria.

DESIGN

Randomized controlled crossover studies.

SUBJECT AND SETTING

The sample comprised 15 male healthy volunteers (HV) and 15 IC users, along with 15 female HV and 15 IC users. The age range was lower for HV participants than for IC users (range: 20-57 years for HV vs 21-82 years for IC users). The study setting was the Department of Urology, located in Rigshospitalet, Copenhagen.

METHODS

Number of flow-stop incidents, residual urine volume at first flow-stop (RV1), and dipstick hematuria were measured during and after catheterization by a health care professional (HV) and by self-catheterisation (IC-users). Results from the 3 studies were combined for HV and IC users on RV1 and number of flow-stop incidents but separated on sex. For incidents of hematuria, an effect of underlying condition was assumed, and a combined analysis on sex was performed, separating HV and IC users.

RESULTS

When compared to the micro-hole drainage zone design, catheterizations with CEC resulted in a significantly higher mean RV1 (mean difference: 49 mL in males and 32 mL in females, both P < .001) and average number of flow-stop incidents (8 and 21 times more frequent for males and females, respectively, both P < .001). The likelihood for hematuria was 5.84 higher with CEC than with micro-hole drainage hole design, P = .053, during normal micturition in HV postcatheterization. No serious adverse events were reported.

CONCLUSION

The micro-hole drainage zone catheter provides IC users fewer premature flow-stops. This design feature reduces modifiable urinary tract infection risk factors, such as residual urine and micro-trauma; additional research is needed to determine its effects on bladder health.

摘要

目的

评估一种新的间歇导尿管（IC）原型在流量停止、膀胱排空和血尿方面的性能，该原型设计有微孔引流区，与传统的导尿管（CEC）相比。

设计

随机对照交叉研究。

研究对象和地点

样本包括 15 名男性健康志愿者（HV）和 15 名 IC 用户，以及 15 名女性 HV 和 15 名 IC 用户。HV 参与者的年龄范围低于 IC 用户（HV 参与者的年龄范围为 20-57 岁，而 IC 用户的年龄范围为 21-82 岁）。研究地点是位于哥本哈根 Rigshospitalet 的泌尿科。

方法

由医疗保健专业人员（HV）和自我导尿（IC 用户）在导尿过程中和导尿后测量流量停止次数、第一次流量停止时的残余尿量（RV1）和尿潜血。HV 和 IC 用户的 3 项研究结果合并用于 RV1 和流量停止次数，但按性别分开。对于血尿事件，假设存在潜在疾病的影响，并对男女进行了综合分析，将 HV 和 IC 用户分开。

结果

与微孔引流区设计相比，CEC 导尿导致平均 RV1 显著增加（男性平均差异为 49 毫升，女性为 32 毫升，均 P<.001），平均流量停止次数也显著增加（男性和女性分别增加 8 倍和 21 倍，均 P<.001）。在 HV 导尿后正常排尿时，CEC 发生血尿的可能性比微孔引流孔设计高 5.84 倍，P =.053。未报告严重不良事件。