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A MULTI-CENTRE
EVALUATION OF SELF-ADHESIVE SHEATHS
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Authors:
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L. Pettersson, M. Fader,
A. Cottenden, G. Dean, J. Malone-Lee
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Institution:
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University College London
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AIMS OF STUDY:
Sheaths are widely used by men with intractable urinary incontinence. Self-adhesive
sheaths (with integral internal adhesive strip) have been found to be more acceptable
than the two-piece system (with separate adhesive strip)(1). But, no recent
evaluation to compare the performance of different self-adhesive sheaths has
been carried out and an evaluation was therefore timely.
METHODS:
58 male volunteers between the ages of 30 and 89 tested each of the 6 different
self-adhesive sheaths available in the UK in November 1998 for one week each.
Thirty subjects applied the sheaths themselves and 28 subjects relied on a carer
to do so. During each week subjects filled in a sheath change and skin inspection
diary to note any non-routine sheath changes (due to 'fall-off' or 'blow-off')
and any skin problems. At the end of each week a performance questionnaire was
completed using a three point rating scale (good, acceptable, unacceptable).
RESULTS:
A significantly higher proportion of subjects found sheaths with an applicator
to be unacceptable than sheaths without an applicator (p<0.0001) for the 'ease
of putting on' and 'overall opinion' questions (when adjusted for previous product
use and person applying the sheath). A significantly higher proportion of subjects
found the Aquadry Clear Advantage sheath to be good than four of the other sheaths
(p<0.01), for the same questions and a significantly higher proportion of subjects
found the Incare sheath to be unacceptable than all of the other sheaths (p<0.001)
for the overall opinion question (see table below).
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Product
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Overall
opinion
(%
‘good’)
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Ease
of putting on
(%
‘good’)
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No fall off/blow off
(%)
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Integrity
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25
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29
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64
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Incare
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9
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22
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28
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Conveen
Security+
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40
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21
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71
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Aquadry
Clear Advantage
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74
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78
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75
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Conveen
Urisheath
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46
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48
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48
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Aquadry
Freedom (+)
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58
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56
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72
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CONCLUSIONS:
We found substantial differences between products for the 'overall opinion'
and 'ease of putting on' questions and for the frequency of falling off or blowing
off recorded in the diary data. Sheaths with applicators were preferred to those
without. Applicators are mainly designed to make sheaths easier to put on, especially
for carers, however we found no evidence that carers preferred applicators.
This may have implications for manufacturers.1 Medical Devices Agency, A15 -
Penile sheaths, 1995