Background: The frequency of problems related to using an ostomy pouching system may be relatively high¹. This may affect the quality of life of a person with an ostomy ² and there is a need to improve existing systems.

Purpose: To evaluate the performance and safety of a new one-piece drainable ostomy pouching system (system A) and to compare it to a reference system already known to the market (system B).

Methodology: The investigation was a comparative, open, randomized, crossover investigation and included 9 centers in the United States (2006-2007). Forty-one participants with a mean age of 63 years ± 16 (SD) and with a colostomy (³ 3 months since creation) were enrolled. Each participant evaluated one of the pouching systems for two weeks and the other system for another two weeks in random order. The participants and the investigators completed a questionnaire with 29 comparative and two non-comparative parameters. They were evaluated on a 5 or 6-point scale (e.g.: 1-very poor; 2-poor; 3-reasonable; 4-good; 5-very good). Ordinal logistic regression was used to analyze the data (a=0.05).

Key outcomes:

The mean wear time was around 3 days for both systems, p=0.6. Two thirds of the participants rated the overall performance of the new pouching system as being “good/very good” versus 1/3

for the reference system, p=0.003. The feeling of security with the new system was significantly higher than with the reference system, p=0.002. The outlet on the new pouch was superior to the reference on all outcomes including handling, hygiene and security p<0.05. The new system was preferred by 86% of the participants over the reference system, p<0.001.

Conclusion:

The new pouching system as a whole was perceived as being better and more secure than the reference system. Both systems had an adequate wear time and were safe in use.