A study of a new 1-piece multi-chamber pouching system for urostomy in the United Kingdom

BACKGROUND
Urostomy pouching systems are currently being improved to give better safety, discretion and comfort, so daily life is eased for the users. A new pouch is divided into chambers to prevent the pouch from bulging and to minimize sounds from splashing urine. The chambers disperse the urine evenly in the pouch.

PURPOSE
To compare performance of a new 1-piece multi-chamber urostomy pouching system (system A) to an established 1-piece system for urostomy with one chamber (system B).

METHODOLOGY
Study population: The study included 30 participants (≥ 18 years of age) with a urostomy. Participants were excluded if they had peristomal skin problems that required treatment.
Design: The study was conducted in the United Kingdom at 5 hospital centers, from September 2008 to February 2009. It was approved by the Joint RNOH/IOMS Research Ethics Committee, London.  The participants tested system A for two weeks (±3 days) and system B for two weeks (±3 days) in randomized order (crossover design). Each participant met with the investigator at the start and end of the testing.

Study outcome: Outcomes included safety (peristomal skin conditions and unplanned changes) and performance (adhesive parameters, splashing sounds, wear time, product awareness and product preference). The investigator collected baseline data and evaluated the peristomal skin at baseline, using the Ostomy Skin Tool. The participants evaluated the performance of system A and B and after using each pouching system, the participants then evaluated their own peristomal skin. Data was collected in a questionnaire.

Statistics: Statistical analyses included logistic regression, chi-square test and parametric general linear models. Overall significance level: 0.05.

RESULTS
Baseline characteristics and differences in skin conditions after using system A and B will be presented. Performance and safety parameters will be compared for System A and B.