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

Abstract

Study Type – Therapy (RCT) Level of Evidence 1b OBJECTIVE To evaluate the impact of urisheaths vs absorbent products (APs) on quality of life (QoL) in men with moderate to severe urinary incontinence (UI). PATIENTS AND METHODS A randomized, controlled, crossover trial in 61 outpatient adult men with stable, moderate to severe UI, with no concomitant faecal incontinence, was conducted from June 2007 to February 2009 in 14 urology centres. Participants tested Conveen Optima urisheaths (Coloplast, Humlebaek, Denmark) with collecting bags and their usual AP in random order for 2 weeks each. The impact of each on QoL was measured using the King’s Health Questionnaire (KHQ) and the short form‐12 acute questionnaire, and each patient’s preference was recorded. A 10‐item patient questionnaire was also used to assess the product main advantages on an 11‐point scale (0: worst; 10: best). A 72‐h leakage diary was used to record the number and severity of leaks and daily product consumption. Safety was measured as the number of local adverse events. RESULTS All dimensions of the KHQ were scored lower with urisheaths, indicating an improvement in QoL. The greatest mean score reductions were in Limitations of Daily Activities (−10.24, P= 0.01) and Incontinence Impact (−7.05, P= 0.045). The majority (69%) of patients preferred Conveen Optima urisheaths to their usual AP (P = 0.002). Urisheaths scored significantly higher for all categories in the patient questionnaire (efficacy, self‐image, odour management, discretion, skin integrity) except ease of use. Safety was considered to be good. CONCLUSIONS Conveen Optima urisheaths showed a positive impact on QoL (according to the KHQ results) in moderate to severe incontinent men, who were long‐term users of APs, and participants largely preferred urisheaths. Conveen Optima urisheaths should be recommended to incontinent men in preference to APs.

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

“…The present population differs from that reported by Chartier‐Kastler et al. who studied men with moderate/heavy UI (any cause) when wearing a sheath drainage system compared with their usual pads. Participants in that study reported significantly better QoL with sheaths and around two‐thirds preferred sheaths to pads.…”

“…This is the first clinical trial comparing performance of three male‐specific devices for continence management and absorbent pads, and the first to examine user preferences immediately after testing and actual use (revealed preferences) several months later. It is also the first published trial of BWUs (there have been clinical trials of urinary sheaths , absorbent pads , and penile clamps , and) thus provides valuable clinical information on the differences between products, their strengths and limitations, and the need for individual support in choice of products for different activities.…”

“…In the UK the latter two are available on NHS prescription. However, their market share is low compared with the use of absorbent products, despite recommendations that men should be offered male devices as well as pads and evidence that men may prefer sheaths to pads . The limited research on the comparative effectiveness, strengths and limitations, is an important barrier to alternate device use.…”

Comprehensive in‐hospital monitoring in acute heart failure: applications for clinical practice and future directions for research. A statement from the Acute Heart Failure Committee of the Heart Failure Association (HFA) of the European Society of Cardiology (ESC)

“…In case of incontinence, weighing an incontinence pad or use of disposable urinary sheaths in males may be a better approach than estimation. Emerging data suggest that urinary characteristics (i.e.…”

The management of urinary incontinence in the male neurological patient

“…However, indwelling catheters are not recommended for routine long-term treatment because of the associated complications such as acute and chronic UTI, stone formation, urinary leakage/incontinence, erosion of meatus and urethra, fistula formation, reduction in bladder capacity, and compliance (with continuous drainage) [20,21,22 && ]. Condom catheters [23] or other external appliances such as drip collectors can help to control urinary incontinence and make it socially more acceptable.…”