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 preferences.

Design: The multi center, comparative, randomized, open, cross-over was conducted in the United States in the fall/winter of 2004-2005. Pouches with outlet A and outlet B were tested for one week each. 36 subjects were included - main selection criteria: minimum 18 years old, having an colostomy, using a 2-piece open ended/drainable pouch, using a “standard-wear” adhesive, not currently/previously using an integrated outlet closure, not pregnant/breastfeeding. The investigation was approved by the appropriate IRBs.

Results: Outlet A was evaluated significantly better than outlet B regarding “handling in general“ (p-value: 0.010). Furthermore opening the outlet, opening the outlet with one hand only, emptying through the outlet, cleaning the outlet, hygiene of the outlet and preference among outlets were evaluated in significantly favour of the outlet A (p-values all below 0.05). No significant differences were found in favour of 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, hygiene and preference.

Pouch with outlet A: Assura^® EasiClose^TM Wide Outlet Pouch with outlet B: New Image Lock ‘n Roll^TM

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