Randomized, crossover study evaluating patient preference and the impact on quality of life of urisheaths vs absorbent products in incontinent men
Article first published online: 15 OCT 2010
© 2010 THE AUTHORS. BJU INTERNATIONAL © 2010 BJU INTERNATIONAL
Volume 108, Issue 2, pages 241–247, July 2011
How to Cite
Chartier-Kastler, E., Ballanger, P., Petit, J., Fourmarier, M., Bart, S., Ragni-Ghazarossian, E., Ruffion, A., Le Normand, L. and Costa, P. (2011), Randomized, crossover study evaluating patient preference and the impact on quality of life of urisheaths vs absorbent products in incontinent men. BJU International, 108: 241–247. doi: 10.1111/j.1464-410X.2010.09736.x
- Issue published online: 1 JUL 2011
- Article first published online: 15 OCT 2010
- Accepted for publication 2 July 2010
- evaluation study;
- quality of life;
- urinary incontinence;
- urinary sheath
Study Type – Therapy (RCT)
Level of Evidence 1b
- • 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.
- • 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.
- • 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.