Clinical trial NCT00765388: A Randomised Cross-over Study With Two 1-piece Urostomy Bags.
Official title: A Comparative, Randomised, Crossover Study With 2 Urostomy Bags Among 30 Urostomy-operated Persons in UK
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Urostomy
Keywords: urostomy, 1-piece, cross-over, randomised, preference
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2008-10-02
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Preference of Sensura vs Moderma
timeFrame: 4 weeks
Secondary outcomes:
measure: Immediate Adhesion
timeFrame: 4 weeks
measure: Removal of the Bag
timeFrame: 4 weeks
measure: Adhesion of the Bag During Use
timeFrame: 4 weeks
measure: Adhesives Ability to Absorb Perspiration
timeFrame: 4 weeks
measure: Flexibility of the Product
timeFrame: 4 weeks
measure: Awareness of the Presence of the Product
timeFrame: 4 weeks
measure: Feeling of Security During the Day
timeFrame: 4 weeks
measure: Feeling of Security During the Night
timeFrame: 4 weeks
measure: Problems With Splashing Sounds During Use
timeFrame: 4 weeks
measure: Bag Twisting During Night
timeFrame: 4 weeks
measure: Changes in Skin Compared to Before Study
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Chertsey
country: United Kingdom
facility: St. Peters Hospital
state: Surrey
city: London
country: United Kingdom
facility: Caroline Rudoni
state: Tooting
city: Brighton
country: United Kingdom
facility: Maureen Bridgland
city: Colchester
country: United Kingdom
facility: Michael Lynch
city: London
country: United Kingdom
facility: University of London Hospital
city: Norwich
country: United Kingdom
facility: Theresa Bowles
Study officials:
affiliation: Ashford and St. Peters Hospital
name: Carol Katte, Stoma Nurse
role: STUDY_CHAIR
affiliation: Royal Sussex County Hospital
name: Maureen Bridgland, Stoma Nurse
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Georges Hospital
name: Caroline Rudoni, Stoma Nurse
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
name: Theresa Bowles, Stoma Nurse
role: PRINCIPAL_INVESTIGATOR
affiliation: Colchester General Hospital
name: Michael Lynch, Surgeon
role: PRINCIPAL_INVESTIGATOR
affiliation: UCLH
name: Sharon Fillingham, Nurse
role: PRINCIPAL_INVESTIGATOR
References: