A study of a new 2-piece multi-chamber pouching system for urostomy in Germany

BACKGROUND
Urostomy pouching systems are currently being improved to give better safety, discretion and comfort, so daily life is eased for the users. Higher standards are required with skin friendliness and adhesion for 2-piece systems, as they are worn longer than 1-piece systems and are exposed to urine for a longer period of time.

PURPOSE
To compare the performance of a new 2-piece multi-chamber urostomy pouching system (system A) to an established 2-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 Germany at 5 home care centers, from September 2008 to February 2009. The participants tested system A for three weeks (±3 days) and system B for three 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. After using each pouching system, the participants evaluated the performance of system A and B as well as their own peristomal skin. Data were collected in a questionnaire.
Statistics: Statistical analyses included logistic regression, chi-square test and parametric general linear models, using an overall significance level of 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.