Purpose: The main purpose of this investigation was to evaluate integrated outlet A and integrated outlet B with regard to handling aspects.

Objective: Primary parameter was ease of “handling in general “evaluated on a 5-point scale. Secondary parameters were related to handling, hygiene and preference.

Design: This multi-center, comparative, randomized, open, crossover, investigation was conducted in the United States in 2004-2005. Pouches with outlet A and outlet B were tested for one week each. 32 subjects were included - main selection criteria: minimum 18 years old, having a colostomy, using a 2-piece open-ended/drainable pouch, using a “standard-wear” adhesive, not currently/previously using an integrated outlet closure, and not pregnant/breastfeeding. The investigation was approved by the appropriate IRBs.

Results: No significant difference was found regarding “handling in general” (p-value: 0.078). However, outlet A was evaluated significantly better than outlet B regarding: folding/closing, security, comfort and preference (p-values all below 0.05). Overall, the pouch with outlet A was evaluated significantly better than the pouch with outlet B regarding discretion, comfort and preference (p-values all below 0.05). No significant differences were found in favour of the pouch with outlet B. All assessments were analyzed using ordinal logistic regression models and binomial tests (two sided significance level at 0.05).

Conclusion: Outlet A is concluded to be superior to outlet B regarding handling perspectives, feeling of security, and preference.

Pouch with outlet A: Assura^® EasiClose^TM WIDE Outlet Pouch with outlet B: SUR-FIT Natura^® Invisiclose^®

Financial Assistance/Disclosure: The investigation was initiated and sponsored by Coloplast.