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

Urostomy Clinical Trial

— DK188OS  

Official title:

A Comparative, Randomised, Crossover Study With 2 Urostomy Bags Among 30 Urostomy-operated Persons in UK

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00765388
• Other study ID #: DK188OS
• Status: Completed
• Phase: Phase 4
• First received: October 1, 2008
• Last updated: January 27, 2014
• Start date: October 2008
• Est. completion date: May 2009

Study information

• Verified date: August 2012
• Source: Coloplast A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Urostomy

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Maureen Bridgland	Brighton
United Kingdom	St. Peters Hospital	Chertsey	Surrey
United Kingdom	Michael Lynch	Colchester
United Kingdom	Caroline Rudoni	London	Tooting
United Kingdom	University of London Hospital	London
United Kingdom	Theresa Bowles	Norwich

Sponsors (1)

Lead Sponsor	Collaborator
Coloplast A/S

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preference of Sensura vs Moderma	Subjects were asked which of the tested products they preferred; SenSura or Moderma.	4 weeks	No
Secondary	Immediate Adhesion	Evaluation of immediate adhesion after each period	4 weeks	No
Secondary	Removal of the Bag	How easy/difficult it was to remove the bag	4 weeks	No
Secondary	Adhesion of the Bag During Use	Evaluation of the adhesion of the base plate around the stoma during use	4 weeks	No
Secondary	Adhesives Ability to Absorb Perspiration	Evaluation of the adhesives ability to absorb perspiration from the skin	4 weeks	No
Secondary	Flexibility of the Product	Evaluation of the ability of the bag to conform with the patients movements (flexibility)	4 weeks	No
Secondary	Awareness of the Presence of the Product	Evaluates the patients awareness of the presence of the product during use.	4 weeks	No
Secondary	Feeling of Security During the Day	The patients feeling of security with the bag during the day	4 weeks	No
Secondary	Feeling of Security During the Night	The patients feeling of security with the product during the night	4 weeks	No
Secondary	Problems With Splashing Sounds During Use	The patient was asked whether he/she noticed any splashinh sounds during use	4 weeks	No
Secondary	Bag Twisting During Night	The patient was asked if he/she noticed whether the bag twisted during night	4 weeks	No
Secondary	Changes in Skin Compared to Before Study	The patient was asked whether he/she experienced changes in the skin condition after testing the blue/red product	4 weeks	No