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Biomedical subjects

M Fader

Publications and source records attributed to M Fader.

13 recordsLinked to original sources
PubMed2001

Sheaths for urinary incontinence: a randomized crossover trial.

OBJECTIVE: To evaluate the full range of self-adhesive continence sheaths for men available in the UK and thus provide clinicians and consumers with a basis for product selection. PATIENTS AND METHODS: Fifty-eight volunteers (aged 30-89 years) tested each of six different self-adhesive sheaths available in the UK in September 1998 for 1 week each. Thirty subjects applied the sheaths themselves and 28 subjects relied on a carer to do so. During each week subjects completed a diary recording sheath changes and the result of skin inspection, to note any unscheduled sheath changes (because of sheath detachment) and any skin problems. At the end of each week an 11-item questionnaire was completed using a three-point rating scale ('good', 'acceptable', 'unacceptable') to assess the key aspects of product performance. RESULTS: A significantly higher proportion of subjects scored the 'Aquadry Clear Advantage' sheath as 'good' than four of the other sheaths (P < 0.01) and a significantly higher proportion found the 'Incare' sheath to be 'unacceptable' than all of the other sheaths (P < 0.001) for the 'overall opinion' question. Sheath detachments (sheath falling off or blowing off) for the 'Incare' were significantly more common than for four of the other products (P < 0.01). Sheath detachments for the 'Aquadry Clear Advantage' were significantly less common than for two of the other products (P < 0.01). A significantly higher proportion of subjects found sheaths with an applicator to be 'unacceptable' than sheaths with no applicator (P < 0.001) for the 'ease of putting on' and 'overall opinion' questions (when adjusted for previous product use and person applying the sheath). CONCLUSIONS: There were substantial differences between products in their general performance and ergonomics, and for the frequency of detachment as recorded in the diary. The 'Aquadry Clear Advantage' was particularly successful and the 'Incare' particularly unsuccessful when compared with the other sheaths. Sheaths with no applicators were preferred to those with applicators. Applicators are mainly designed to make sheaths easier to put on, especially for carers, but there was no evidence that carers preferred applicators. This may have implications for manufacturers.

Adult↗
PubMed2001

Coated catheters for intermittent catheterization: smooth or sticky?

OBJECTIVE: To evaluate the current range of hydrophilic-coated catheters for intermittent self-catheterization, focusing on the adherence of the catheter to the urethral mucosa at the end of catheterization. PATIENTS AND METHODS: In a prospective randomized study, 61 community-based men tested each of four different hydrophilic-coated catheters available in the UK at the time. Subjects used each of the four test catheters for 1 week in a random order, and were provided with the number and size of catheter they normally used. To assess the products, the subjects: (i) timed seven catheterizations using a stop-watch to determine the time taken from extracting the catheter from the water-filled package, to removing the catheter from the penis, having emptied the bladder; (ii) recorded the severity of 'sticking' on catheter removal on a three-point scale (not at all, a little, a lot); and (iii) completed a product-performance questionnaire. RESULTS: There were no significant differences in ratings of 'sticking' between the 'Easicath' and 'Lofric' (P > 0.05), but there were significant differences between these two products and the 'Aquacath' and the 'Silky', which were found to 'stick' more (P < 0.001). The 'Silky' was reported to stick significantly more than the 'Aquacath' (P < 0.001). CONCLUSIONS: Adherence to the urethral mucosa on catheter removal was a common problem, occurring with all catheters, but two products were significantly more likely to stick than the other two. The clinical importance of 'sticking' and the long-term implications are currently unknown. The relative 'sticking' of uncoated catheters has also not been established.

Adult↗
PubMed2001

The CPE network: creating an evidence base for continence product selection.

Selecting continence products for an individual patient or hospital contract is often a daunting task. This article describes the evaluation process developed for a program of government-funded multicenter evaluations of continence products established in the United Kingdom to provide an evidence base for product selection. The essential requirements of an evaluation are discussed, together with the methodologic and statistical issues that such evaluations present. The strengths and limitations of multicenter trials are examined and suggestions are made regarding other areas of nursing in which this approach could be usefully adopted.

Catheterization↗
PubMed1997

Improving the performance of small incontinence pads: a study of "wet comfort".

PURPOSE: The wet comfort of small, disposable incontinence pads has been found to correlate strongly with overall acceptability. This study examined the relationship between pad properties (absorption capacity, strike-through, and wetback) and wet comfort. DESIGN: A group of women with light incontinence were asked to report on the wet comfort of a series of experimental pads made up to the same design geometry but in different combinations of materials. METHODS: Three different pad variants were selected, and two experiments were conducted. Experiment 1 used a single-blind design in which 20 testers were supplied with a random mix of the three unlabeled pad variants. All pads were saved for weighing and scored for overall performance, wet comfort, and absorbency. In experiment 2, subjects used each pad variant in turn for 1 week and at the end of each week compared that pad with the one used the previous week. MAIN OUTCOME MEASURES: Absorption capacity, wetback, and strike-through properties for each pad variant were measured in the laboratory setting, and wet comfort was measured by a written tool completed by participants during clinical trials. RESULTS: Data analysis from experiment 1 revealed statistically significant differences among pad variants, particularly when assessed for absorbency. Differences for wet comfort were less marked and only achieved significance when those with ratings of good or OK for wet comfort were compared with those with a score of poor. In experiment 2, no statistically significant differences were found for wet comfort. CONCLUSIONS: Overall, the improvement in wet comfort achieved by a substantial increase in absorption capacity and reduction in wetback were disappointing. The relatively small sample and the design specifications of the pad may have masked differences. Cost considerations mean that more evidence is needed to justify the inclusion of more expensive materials and production stages in the manufacture of small pads.

Adult↗
PubMedDate not supplied

A multicentre comparative evaluation of catheter valves.

Catheter valves are an alternative to leg bags for urine drainage, but no studies have yet been published which have compared the performance of different valves. This study was undertaken to evaluate the performance of the seven catheter valves available on the UK market in April 1996. The study was carried out by the Continence Products Evaluation (CPE) Network funded by the Medical Devices Agency (Department of Health). Each valve type was tested for 1 week by 19-36 cognitively unimpaired and manually dextrous subjects recruited from 11 test centres. At the end of each week, subjects completed an evaluation form (based on a three-point rating scale) to record product performance. The same catheter valves were also tested for ease of opening/closing by 33 subjects (mostly catheter users) who had some manual impairment. Performance scores varied widely between products. It was found that, to be successful, a valve needs to be easy to manipulate, leak-free, comfortable and inconspicuous. Prescribers need to be aware of the strengths and limitations of different valves for appropriate product selection.

Attitude to Health↗
PubMedDate not supplied

The selection of female urinals: results of a multicentre evaluation.

Female urinals are designed to enable women to empty their bladders while not on the toilet and are therefore potentially useful in preventing incontinence. However, there is little published information to guide product selection. Therefore, an evaluation of these products was undertaken by the Continence Products Evaluation Network (funded by the Medical Devices Agency). All 13 reusable female urinals available in the UK in March 1997 were evaluated. Each urinal was evaluated by 28-32 community-based women. Preliminarily, each subject tested all urinals by trying to place them in one or two of their preferred positions, to establish if the urinals were suitable for full testing. Each of the urinals that were selected for full testing were then used for 1 week each. During this week the subjects kept a diary to record leakage or spillage when using the urinal. At the end of the week a product evaluation form was filled in to record product performance. The results from full testing indicate that all urinals were successful for some subjects. However, some urinals were found to be successful for all four main positions (e.g. Petal Female Urinal) while others were successful mainly in one or two positions (e.g. Bridge Saddle Pan and Subaseal). Many urinals were successful in the standing/crouching and sitting on the edge (of chair or bed) positions, while comparatively few urinals were successful in the lying position. It was found that the chances of finding a suitable urinal increased with levels of independence. This means that subjects with higher levels of dependency found fewer urinals to be suitable for their needs when used without assistance. The results of this evaluation provide guidance for product selection. However, it is recommended that continence specialists keep samples of the full range of female urinals to enable women to experiment with urinals in order to find one that best suits their needs.

Activities of Daily Living↗