How well does ISO 11948-1 (the Rothwell method) for measuring the absorption capacity of incontinence pads in the laboratory correlate with clinical pad performance.
The ability of ISO 11948-1 (the Rothwell method) to predict the leakage performance of disposable bodyworn pads for heavy urinary incontinence was investigated by measuring correlations between models based on clinical evaluations of 138 diapers and inserts (the two major design categories), and technical models based on their Rothwell absorption capacities and design features. Correlations were poorer than in the original 1993 study for the standard (r < or =0.87 compared with r < or =0.95), but still strong enough to help with purchasing choices. For a given Rothwell capacity, the leakage performance of diapers was far superior to inserts; for example, diapers containing 450 and 300 g of urine performed, as well as inserts containing 300 and 100 g, respectively. No evidence was found for any other design feature having a significant impact on leakage performance. The coefficient of variation for Rothwell capacity (a measure of product consistency) had significant impact on the leakage performance of diapers, but not inserts. The probability of diapers with the poorest consistency leaking exceeded that for the best by about 10 percentage points. Similarly, diapers were about 10 percentage points more likely to leak when used at night than during the day. Differences between day-time and night-time use of inserts were not studied.
Cottenden
A M
AM
Department of Medical Physics and Bioengineering, University College London, Archway Campus, N19 5LW, London, UK. a.cottenden@medphys.ucl.ac.uk
Fader
M J
MJ
Pettersson
L
L
Brooks
R J
RJ
D000042:Absorption; D019544:Equipment Failure Analysis / Q000379:methods* / Q000592:standards* / Q000706:statistics & numerical data; D006801:Humans; D016496:Incontinence Pads / Q000592:standards* / Q000706:statistics & numerical data*; D007391:International Cooperation; D012015:Reference Standards; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013223:Statistics as Topic; D016482:Urinalysis / Q000379:methods* / Q000592:standards*; D014556:Urine / Q000737:chemistry*