Sheaths for urinary incontinence: a randomized crossover trial

Objective To evaluate the full range of self-adhesive continence sheaths fo r men available in the UK and thus provide clinicians and consumers with a basis for product selection. Subjects and methods Fifty-eight volunteers (aged 30-89 years) tested each of six different self-adhesive sheaths available in the UK in September 199 8 for 1 week each. Thirty subjects applied the sheaths themselves and 28 su bjects relied on a carer to do so. During each week subjects completed a di ary recording sheath changes and the result of skin inspection, to note any unscheduled sheath changes (because of sheath detachment) and any skin pro blems. At the end of each week an 11-item questionnaire was completed using a three-point rating scale ('good', 'acceptable', 'unacceptable') to asses s the key aspects of product performance, Results A significantly higher proportion of subjects scored the 'Aquadry C lear Advantage' sheath as 'good' than four of the other sheaths (P < 0.01) and a significantly higher proportion found the 'Incare' sheath to be 'unac ceptable' than all of the other sheaths (P < 0.001) for the 'overall opinio n' question. Sheath detachments (sheath falling off or blowing off) for the 'Incare' were significantly more common than for four of the other product s (P < 0.01). Sheath detachments for the 'Aquadry Clear Advantage' were sig nificantly less common than for two of the other products (P < 0.01). A sig nificantly higher proportion of subjects found sheaths with an applicator t o be 'unacceptable' than sheaths with no applicator (P < 0.001) for the 'ea se of putting on' and 'overall opinion' questions (when adjusted for previo us product use and person applying the sheath). Conclusions There were substantial differences between products in their ge neral performance and ergonomics. and for the frequency of detachment as re corded in the diary. The 'Aquadry Clear Advantage' was particularly success ful and the 'Incare' particularly unsuccessful when compared with the other sheaths. Sheaths with no applicators were preferred to those with applicat ors. Applicators are mainly designed to make sheaths easier to put on, espe cially for carers, but there was no evidence that carers preferred applicat ors. This may have implications for manufacturers.