Cottenden A M, Ledger D J
St Pancras Hospital, London, UK.
J Biomed Eng. 1993 May;15(3):212-20. doi: 10.1016/0141-5425(93)90117-h.
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.(ABSTRACT TRUNCATED AT 250 WORDS)
开展了一项国际多中心项目（ISO 尿垫渗漏项目），以研究供重度失禁患者使用的大型贴身失禁尿垫的渗漏性能，并制定在实验室测量其吸收能力的国际标准。通过招募13个用户测试中心来实现这一目标，100多名失禁受试者按照通用方案，对六种不同产品（每种产品有三种不同尺寸）中的每一种进行了为期约一周的测试。收集并称重了10000多个用过的尿垫，并记录了每个尿垫的渗漏严重程度。为了发现不同技术参数对临床尿垫性能的影响，研究人员在总共16个技术测试中心进行了约50项技术测试，并将这些测试数据与上述数据进行相关性分析。结果发现，在低尿量（比如少于50克）时，尿垫形状是尿垫渗漏性能的最重要预测因素：形状合适的尿垫渗漏较少。随着尿量增加，吸收能力和吸收时间的重要性不断提高，直到尿量达到350克时，这两个参数和尿垫形状的重要性大致相当：吸收能力高且吸收时间快的形状合适的尿垫渗漏最少。第二项分析系列确定了两项吸收能力测试，将所有尿量综合考虑时，这两项测试得出的数据与尿垫的整体渗漏性能相关性良好。对这两项测试都进行了重复性（实验室内部精度）和再现性（实验室之间精度）检查，并已编写成工作标准草案。（摘要截短为250字）
