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

ABSTRACT

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.