- Top of page
- PATIENTS AND METHODS
- CONFLICT OF INTEREST
- TRIAL REGISTRATION
Urinary incontinence (UI) is a common disorder which has a substantial impact on quality of life (QoL) [1–6]. Perceived as truly debilitating from a physical, psychological and social point of view, it may cause both isolation and loss of independence, and eventually result in some elderly patients being admitted to an institution [1,2]. UI affects up to 11% of men aged 60–64 years and 30% of men ≥85 years [4,7]. Most have urge UI. Despite the development of new therapies, a large proportion of patients do not respond to conventional treatments [8,9]. For incontinent men not cured completely, or whilst waiting for surgery, and for men who may not be candidates for treatment, or who may choose management over attempted cure, urisheaths (also called condom catheters, external catheters, penile or urinary sheaths) are one of the most appropriate palliative options for restoring normal social life [1,8]. Urisheaths were developed to meet the specific needs of incontinent patients in terms of: comfort, particularly when used for a whole day; hygiene, in allowing patients to stay dry; and clothing protection, sparing patients from potentially embarrassing situations.
Despite the theoretical advantages of urisheaths, the use of pads or absorbent products (APs) is still widespread in the incontinent male population, and the use of urisheaths still limited. Several factors may be responsible for the restricted use of urisheaths: prescribers may have misconceptions about their uses, patients may refuse to use them, and urisheaths may be considered as not having any advantages over conventional APs. A literature review does not provide answers to these questions, as no published articles have compared urisheaths with APs. In its recommendations for the use of continence products, the International Consultation on Incontinence (ICI) committee in 2005 drew attention to the lack of such studies and strongly recommended that such studies be performed according to strict methodological principles .
In view of the lack of existing evidence this randomized, prospective controlled trial was initiated. Its aim was to determine whether urisheaths are comparable with or superior to APs. Two validated QoL questionnaires were used, the validated UI-specific King’s Health Questionnaire (KHQ)  and the short form–12 (SF-12) acute questionnaire [11,12]. Patients’ preference and product efficacy and safety were also evaluated.
- Top of page
- PATIENTS AND METHODS
- CONFLICT OF INTEREST
- TRIAL REGISTRATION
This randomized, controlled, prospective, crossover study is the first to have been performed to date, measuring the impact on QoL of using a urisheath with a urine collecting bag vs the patient’s usual AP in men with stable, moderate to severe UI. The methodology complies with ICI recommendations [1,13]. According to the ICI, the outcome measures must include instruments for QoL measurement and a patient questionnaire assessing patient overall preference, which should be the primary outcome variable, as well as the product impact on such dimensions as daily activities, hygiene, odour management, urinary infections and skin health. The present study showed that the Conveen Optima urisheath provides better results than the AP in terms of QoL (Fig. 3) and patient preference (Fig. 4).Patients also reported a significant improvement in efficacy, self image, odour management, discretion and skin integrity (Fig. 5). The incidence of UTIs appears comparable, but a larger sample size would be necessary for confirmatory conclusions.
The study was conducted in two periods of 2 weeks each. One can speculate that longer use would give similar findings in favour of urisheaths, since patients need to be trained in urisheath use and there is a decreased difficulty in use over time, especially if patient training and close follow-up by healthcare professionals is done in compliance with the ICI recommendations [1,13].
While urisheaths are most often used for men with spinal cord injuries , the population in this study mainly consisted of men with stable moderate to severe UI of urological origin, with no concomitant faecal incontinence, who were able to use urisheaths without assistance. The choice of comparator in this study was represented by the palliative system generally used by the patient. This was done to measure the impact of urisheaths on QoL under real-life conditions. Recent studies have shown that the preferred AP varied greatly from patient to patient, that the skin protection offered by different AP models was much the same, and that using different types of AP for different situations (day or night, at home or out) was more efficient and economical than wearing a standard AP [15,16].
This study confirmed an excellent safety profile of Conveen Optima urisheaths in the majority of patients (91.7%). Product-related adverse events, mainly skin irritations, were reported in only five patients (8.3%). In most cases (three of five), these irritations could have been avoided by the patients’ following simple hygiene measures.
It should be noted that urisheaths come in a variety of sizes to fit different penis lengths and diameters. If the urisheath is too small for the patient, urine collection problems may arise and blood supply to the penis may be reduced. Conversely, if the urisheath is too big, wrinkles may appear in the device, leakage may occur, and the device may slip off .
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 , 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).
This study did not explore the health-economic aspects of urisheath vs AP use, although this was recommended by the ICI [1,13]. In incontinent male patients, product selection is strongly influenced by the patient’s financial means and health reimbursement policies (for both urisheaths and APs) which vary considerably among countries. In France, urisheaths but not APs are reimbursed by Social Security; APs are paid for by the patient or, in a few cases, through private insurance and elderly people allowance. This could be an additional argument for wider use of urisheaths in France.
Male continence products must be reliable and must allow patients to deal with incontinence simply, discreetly and independently. In addition, they must provide a high standard of hygiene and odour management and protect both skin and clothing . An inappropriate choice may force users to restrict their social and professional activities, may place undue stress on relationships, and may be detrimental to QoL . 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].
In conclusion, compared with APs, Conveen Optima urisheaths showed a positive impact on QoL (according to the KHQ results) in moderate to severely incontinent men, without concomitant faecal incontinence, who were long-term users of APs. Participants largely preferred the urisheath over APs, listing its many advantages offered in real-life conditions. We believe that the results of the present study support a wider use of Conveen Optima urisheaths in preference to APs in moderate to severely incontinent men. We believe that healthcare professionals should make effective and informed decisions as they help their patients to choose between continence product categories and recommend the promotion of patient education related to urisheath use.