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

Phase 4

Completed

Brief Summary: 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.

Detailed 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.

Recruitment & Eligibility

Inclusion Criteria

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

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.

Arm && Interventions

Group	Intervention	Description
SenSura Uro	SenSura Uro	The test product is a CE-marked non-sterile one-piece urostomy multi-chamber bag with the SenSura adhesive.
hollister Uro	Hollister	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

Primary Outcome Measures

Name	Time	Method
Preference of Sensura vs Moderma	4 weeks	Subjects were asked which of the tested products they preferred; SenSura or Moderma.

Secondary Outcome Measures

Name	Time	Method
Immediate Adhesion	4 weeks	Evaluation of immediate adhesion after each period
Removal of the Bag	4 weeks	How easy/difficult it was to remove the bag
Adhesion of the Bag During Use	4 weeks	Evaluation of the adhesion of the base plate around the stoma during use
Adhesives Ability to Absorb Perspiration	4 weeks	Evaluation of the adhesives ability to absorb perspiration from the skin
Flexibility of the Product	4 weeks	Evaluation of the ability of the bag to conform with the patients movements (flexibility)
Awareness of the Presence of the Product	4 weeks	Evaluates the patients awareness of the presence of the product during use.
Feeling of Security During the Day	4 weeks	The patients feeling of security with the bag during the day
Feeling of Security During the Night	4 weeks	The patients feeling of security with the product during the night
Problems With Splashing Sounds During Use	4 weeks	The patient was asked whether he/she noticed any splashinh sounds during use
Bag Twisting During Night	4 weeks	The patient was asked if he/she noticed whether the bag twisted during night
Changes in Skin Compared to Before Study	4 weeks	The patient was asked whether he/she experienced changes in the skin condition after testing the blue/red product

Locations (6): St. Peters Hospital
🇬🇧
Chertsey, Surrey, United Kingdom
University of London Hospital
🇬🇧
London, United Kingdom
Caroline Rudoni
🇬🇧
London, Tooting, United Kingdom
Maureen Bridgland
🇬🇧
Brighton, United Kingdom
Theresa Bowles
🇬🇧
Norwich, United Kingdom
Michael Lynch
🇬🇧
Colchester, United Kingdom