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Objective

To evaluate the impact of urisheaths versus absorbent products on quality of life (QoL) in incontinent men.

 

Study design

  • A randomised, controlled, crossover trial in 61 outpatient adult men with stable, moderate to severe urinary incontinence with no concomitant faecal incontinence.
  • Conducted from June 2007 to February 2009 in 14 urology centres
  • Participants tested Conveen Optima urisheaths (Coloplast A/S, Denmark) with collecting bags and their usual absorbent product for 2 week periods each in random order (Figure 1)
Figure 1. Study design. V=visit, D=day, Pt quest=10-item patient questionnaire

Outcome measures

  • Impact on QoL was measured with the King’s Health Questionnaire (KHQ) and the SF-12 Acute questionnaire
  • Patient's product preference was recorded using a 10-item patient questionnaire
  • A 72-hour 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 scored lower with urisheaths, indicating an improvement in QoL, especially for “limitations of daily activities”
  • (-10.24 ± 3.99, p=0.01) and “impact of incontinence” (-7.05 ± 3.45, p<0.05) (Figure 2)
  • The majority (69%) of patients preferred Conveen Optima urisheaths to their usual absorbent product (p=0.002)
  • Urisheaths scored significantly higher for all categories (efficacy, self-image, odour management, discretion, skin integrity) other than ease of use  
Figure 2. KHQ scores. The lower the score the higher the quality of life. *Significant difference (p<0.05)>

Safety

  • Safety was considered to be good
  • Adverse events that were possibly related to the urisheaths were reported in 5 patients (8.3%); 4 cases of skin irritation (3 cases resolved with improved hygiene over 1-3 days) and 1 case of maculopapular rash (resulted in discontinuation)
  • 3 urinary tract infections (2 on absorbent product, 1 on urisheath) were reported for 2 patients but were not considered product related  

 

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 absorbent products
  • Participants largely preferred the Conveen Optima urisheaths
  • In view of these results, urisheaths (Conveen Optima) may be recommended in preference to absorbent products in incontinent men