Fader, M., Cottenden, A., Geliffe, K., Gage, H., Clarke-O'Neill, S., Jamieson, K., Green, N., Williams, P., Brooks, R. and Malone-Lee, J. (2008) Absorbent products for urinary/faecal incontinence: a comparative evaluation of key product designs. Health Technology Assessment, 12 (29), 1-208. (doi:10.3310/hta12290). (PMID:18547500)
Abstract
Background: The UK health service, nursing homes and public spend around £94 million per year on incontinence pads (absorbent products) to contain urine and/or faeces, but the research base for making informed choices between different product designs is very weak.
Objectives: The aim of this trial was to compare the performance and cost-effectiveness of the key absorbent product designs to provide a more solid basis for guiding selection and purchase.
A further aim was to carry out the first stage in the development of a quality of life instrument for measuring the impact of absorbent product use on users' lives.
Design: The work involved three clinical trials focusing on the three biggest market sectors. Each trial had a similar crossover design in which each participant tested all products within their group in random order.
Settings, participants and methods: In Trial 1, 85 women with light urinary incontinence living in the community tested three products from each of the four design categories available (total of 12 test products): disposable inserts (pads); menstrual pads; washable pants with integral pad; and washable inserts. In Trial 2a, 85 moderate/heavily incontinent adults (urinary or urinary/faecal) living in the community (49 men and 36 women) tested three (or two) products from each of the five design categories available (total of 14 test products): disposable inserts (with mesh pants); disposable diapers (nappies); disposable pull-ups (similar to toddlers' trainer pants); disposable T-shaped diapers (nappies with waist-band); and washable diapers. All products were provided in a daytime and a (mostly more absorbent) night-time variant. In these first two trials, the test products were selected on the basis of data from pilot studies. In Trial 2b, 100 moderate/heavily incontinent adults (urinary or urinary/faecal) living in 10 nursing homes (27 men and 73 women) evaluated one product from each of the four disposable design categories from Trial 2a. Products were selected on the basis of product performance in Trial 2a and, again, daytime and night-time variants were provided. The first phase of work to develop a quality of life tool for measuring the impact of using different pad designs was carried out by interviewing participants from Trials 1 and 2a.
Outcome measures: Product performance was characterised using validated questionnaires, which asked the participants (in Trials 1 and 2a) or carers (all participants in Trial 2b, except for the few who could report for themselves) to evaluate various aspects of pad performance (leakage, ease of putting on, discreetness, etc.) using a five-point scale (very good–very poor) at the end of the week (or 2 weeks for Trial 2b) of product testing. In addition, participants/carers were asked to save individual used pads in bags for weighing and to indicate the severity of any leakage from them on a three-point scale (none, a little, a lot). These data were used to determine differences in leakage performance. Numbers of laundry items and pads used were recorded to estimate costs, and skin health changes were recorded by the participant or by the researchers (Trial 2b). At the end of testing, participants were interviewed and ranked their preferences (with and without costs), stated the acceptability of each design (highly acceptable–totally unacceptable) and recorded their overall opinion on a visual analogue scale (VAS) of 0–100 points (worst design–best design). This VAS score was used with product costs to estimate cost-effectiveness. In addition, a timed pad changing exercise was conducted with 10 women from Trial 2b to determine any differences between product designs.
Results: Results presented are for statistically and clinically significant findings.
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