A Randomised Cross-over Study With Two 1-piece Urostomy Bags.

In this trial we are comparing two types of urostomy bags - the SenSura 1-piece and Hollisters Moderma Flex.

Both products are CE-marked, meaning that they are safe and approved in use for people with an urostomy.

Population 30 urostomy operated people from UK will participate in the trial. Only participants who normally use a flat 1-piece urostomy bag can participate. It is very important that the participants keep their normal use- and change pattern. Furthermore they need to be over 18 years old, have had the urostomy for more than 3 months, the size of the urostomy shall be between 15-55 mm, otherwise the bag will not fit them and then they should be able to handle the bags themselves and be willing to use the two products tested in the trial.

Inclusion criteria

In order to be enrolled in the clinical investigation, the subject must:

• Be at least 18 years old,
• Be mentally and physically capable of signing the written consent form
• Be able to fill in the Case Report Form (questionnaire)
• Have an urostomy with a size between 15-55 mm.
• Have had the urostomy for 3 months or more,
• Use a 1-piece bag normally.
• Be able to handle the bag themselves (application and removal)
• Be willing to use Coloplast SenSura 1-piece bag
• Be willing to use Hollisters Moderma Flex, 1-piece bag

Exclusion criteria

In order to be enrolled in the clinical investigation, the subjects must not:

• Be a convex base plate user (i.e. a bowl-shaped adhesive which pushes the stoma forward)
• Need to use an ostomy belt
• Be currently suffering from any dermatologiacal problems, needing special treatment, in the peristomal area (investigator will evaluate skin according to a newly developed ostomy skin tool from Coloplast A/S)
• Being treated with chemo- or radiation therapy,
• Be hospitalized during study enrollment, or have a hospitalization or significant surgery planned during the 4-week study period, or
• Be pregnant or breast-feeding.