Sheaths for urinary incontinence: a randomized crossover trial

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.

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.

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).

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.