Status:
COMPLETED
A Randomised Cross-over Study With Two 1-piece Urostomy Bags.
Lead Sponsor:
Coloplast A/S
Conditions:
Urostomy
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 openi...
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 wit...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00765388
Start Date
October 1 2008
End Date
May 1 2009
Last Update
March 11 2014
Active Locations (6)
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1
St. Peters Hospital
Chertsey, Surrey, United Kingdom, KT16OPZ
2
Caroline Rudoni
London, Tooting, United Kingdom, SW17OQT
3
Maureen Bridgland
Brighton, United Kingdom
4
Michael Lynch
Colchester, United Kingdom, CO45JL