Predicting the leakage performance of bodyworn disposable incontinence pads using laboratory tests

A.M. Cottenden, D.J. Ledger
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引用次数: 8

Abstract

An international multi-centre project (The ISO Pad Leakage Project) was conducted to study the leakage performance of large bodyworn incontinence pads for heavily incontinent users and to create international standards for measuring their absorption capacities in the laboratory. This was achieved by recruiting 13 user test centres through which over 100 incontinent subjects tested each of six different products (each in three different sizes) for a period of about a week to a common protocol. Over 10 000 used pads were collected and weighed and the severity of leakage from each of them recorded. Correlations were sought between these data and the results from some 50 technical tests performed in a total of 16 technical test centres in order to discover the impact of different technical parameters on clinical pad performance. It was found that at low urine weights (less than 50 g, say) pad shaping was the most important predictor of pad leakage performance: shaped pads leaked less. With increasing urine weight, absorption capacity and absorption time increased in importance until at 350 g of urine these two parameters and shaping were of about equal significance: shaped pads with high absorption capacity and fast absorption time leaked least. A second series of analyses identified two absorption capacity tests which produced data correlating well with the overall leakage performance of pads, considering all urine weights together. Both tests were checked for repeatability (precision within laboratories) and reproducibility (precision between laboratories) and have been written up as working draft standards. In due course, either or both of them should be adopted as International Standards for measuring the absorption capacity of pads for heavily incontinent users. A second, similar project (ISO Pad Leakage Project 2) has begun. It focuses on small pads for lightly incontinent ambulatory women.

使用实验室测试预测一次性尿失禁垫的泄漏性能
开展了一项国际多中心项目(ISO尿垫泄漏项目),研究严重尿失禁用户使用的大型人体尿失禁垫的泄漏性能,并制定了在实验室测量其吸收能力的国际标准。这是通过招募13个用户测试中心来实现的,通过该中心,100多名失禁受试者根据一项共同协议测试了六种不同产品(每种产品有三种不同的尺寸)中的每一种,为期约一周。收集并称重了超过1万个使用过的卫生巾,并记录了每个卫生巾的泄漏严重程度。为了发现不同技术参数对临床垫性能的影响,在这些数据与总共16个技术测试中心进行的约50项技术测试的结果之间寻找相关性。研究发现,在尿重较轻的情况下(比如小于50克),尿垫形状是尿垫泄漏性能最重要的预测指标:形状的尿垫泄漏较少。随着尿重的增加,吸收容量和吸收时间的重要性增加,直到350g时,这两个参数与塑形的重要性基本相等:吸收容量高、吸收时间快的塑形垫漏出的最少。第二个系列分析确定了两个吸收能力测试,考虑到所有尿液重量,这两个测试产生的数据与尿垫的整体泄漏性能很好地相关。对这两项测试的重复性(实验室内的精度)和再现性(实验室间的精度)进行了检查,并编写为工作标准草案。在适当的时候,应采用其中一种或两种方法作为测量严重失禁使用者的护垫吸收能力的国际标准。第二个类似的项目(ISO衬垫泄漏项目2)已经开始。它的重点是小垫轻度失禁的流动妇女。
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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