A Randomised Cross-over Study With Two 1-piece Urostomy Bags. (DK188OS)

Coloplast

Status and phase: Completed; Phase 4

Conditions: Urostomy

Treatments: Device: SenSura Uro; Device: Hollister

Study type: Interventional

Funder types: Industry

Identifiers

NCT00765388

DK188OS

Details and patient eligibility

About

Background Urostomy is a surgical procedure that detours or diverts urine away form a diseased or defective bladder. The bladder can be removed and the urine is passed out of the body through an opening (stoma) in the stomach. People with urostomy will not be able to start and stop urine coming out through the stoma, so a urostomy bag will be fitted to collect the urine as it comes out.

A urostomy bag consists of an adhesive, which is attached to the skin around the stoma and a bag connected to the adhesive to collect the urine.

It is very important the standard is high on these products; otherwise the user (urostomy-patient) will experience lots of problems with the skin around the stoma.

Full description

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.

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

27 participants in 2 patient groups

SenSura Uro

Experimental group

Description:

The test product is a CE-marked non-sterile one-piece urostomy multi-chamber bag with the SenSura adhesive.

Treatment:

Device: SenSura Uro

hollister Uro

Active Comparator group

Description:

The comparator product is CE-marked and non-sterile and produced for urostomy operated. It is a flat one-piece urostomy product, Hollister Moderma Flex Urostomy beige, Cut-to-Fit Bag, flat adhesive

Treatment:

Device: Hollister