Sheaths for urinary incontinence: a randomized crossover trial

Abstract

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. Subjects 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 signi®cantly higher proportion of subjects scored the`Aquadry Clear Advantage' sheath as good' than four of the other sheaths (P<0.01) and a signi®cantly 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 signi®cantly more common than for four of the other products (P<0.01). Sheath detachments for the`Aquadry Clear Advantage' were signi®cantly less common than for two of the other products (P<0.01). A signi®cantly higher proportion of subjects found sheaths with an applicator to bè 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.

Randomized, crossover study evaluating patient preference and the impact on quality of life of urisheaths vs absorbent products in incontinent men

“…As it has been shown previously that the performance and acceptability of different urisheaths may vary [15,18,19] and that leg bag design has a considerable influence on urisheath performance [20], and considering the fact that this is the first study comparing urisheaths with APs, the observed results can apply only to the collecting device studied here (the Conveen Optima urisheath).…”

“…Patients are influenced by several factors when selecting a continence product, including personal preference and needs, the patients’ degree of independence, their activities and the time of day they are performed (day or night, at home or out), the nature of their UI, and the information given to them about the different methods available for managing UI [23–25]. Urisheaths are used as an alternative to an AP, and most specialists agree that their use enhances the physical and psychological well‐being of incontinent patients [18,19,26]. According to ICI recommendations, improving patient QoL must be considered first and foremost before making any decisions [1,13].…”

Continence products: Research priorities to improve the lives of people with urinary and/or fecal leakage

“…4 In addition to absorbent pads and long-term catheters there are three main devices available to men, compression devices (penile clamps), sheaths (similar to condoms), which attach to drainage bags, and pubic-pressure devices (usually a ring fitted over the penis onto which a drainage bag or system is fixed, held in place with close-fitting straps). There has been one small trial of penile compression devices 19 and several studies comparing different sheaths 20,21 and one comparing a sheath with a long-term catheter, 22 but no trials of pubic pressure devices.…”

A trial of devices for urinary incontinence after treatment for prostate cancer

“… Product performance questionnaires were based on a previously tested tool used in a study of sheath use and were piloted by seven men (five using sheath or BWU; two using clamp) to ensure questions captured all relevant aspects of product performance. These were administered at the end of each product testing (Data S1). QoL measured by the KHQ.…”