Background: The following issues have been identified as being related to quality of life when using a pouching system: peristomal skin disorders; concerns about leakage, odour and sleep interruptions; noise from and indiscreetness of the pouching system¹.

Purpose: To evaluate the performance of a new 2-piece ostomy pouching system with closed-end pouches (system A) and to compare it to a reference system already known to the market (system B).

Methodology: 73 participants with a colostomy aged 63 ± 13 years (mean ± SD) participated in a study conducted in Germany at 8 home care centres.  Each participant evaluated 4-6 barriers of one pouching system and then evaluated 4-6 barriers of the other system in randomized order. Investigators visited the subjects three times during the study and filled in parts of a questionnaire (baseline characteristics, user patterns and skin evaluation). Participants filled in parts about product performance and safety. Answers were collected in terms of 3 or 5-point scales, e.g. from 1 (very poor) to 5 (very good). Statistical analyses included Wilcoxon, Sign and students t-test (all paired) and Binomial test. The significance level was 5%.

Results: The new pouching system barrier was significantly more flexible (p<0.0005) and easier to remove (p=0.0005).  The outlet on the new pouch was significantly easier to clean and more secure than the reference pouch (p<0.0005). Significantly fewer participants were bothered about the pressure needed to apply the new pouch to the new barrier (p<0.0005).  There were less ballooning (p<0.0005) and decreased odour problems (p<0.0005) with the new pouch. The new system was preferred by 98% of the participants over the reference system (p<0.0005).

Conclusion: In this study the new 2-piece closed-end pouching system performed significantly better than the reference pouching system on all parameters relating the use of ostomy pouching systems to quality of life.