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Sponsored by: |
Coloplast A/S |
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Information provided by: | Coloplast A/S |
ClinicalTrials.gov Identifier: | NCT00765388 |
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.
In this trial we a 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.
Condition | Intervention | Phase |
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Urologic Surgical Procedures |
Device: SenSura Uro Device: Hollister |
Phase IV |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | A Comparative, Randomised, Crossover Study With 2 Urostomy Bags Among 30 Urostomy-Operated Persons in UK |
Estimated Enrollment: | 30 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | January 2009 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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SenSura Uro: Experimental
The test product is a CE-marked non-sterile one-piece urostomy multi-chamber bag with the SenSura adhesive.
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Device: SenSura Uro
The test product is a CE-marked non-sterile one-piece urostomy multi-chamber bag with the SenSura adhesive.
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hollister Uro: Active Comparator
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
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Device: 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.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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:
Contact: Seema . Wrisberg, M. Sc. Human Nutrition | +4549113519 | dkssw@coloplast.com |
Contact: Daniel Carter, M.Sc.Biology | +4549112523 | dkdac@coloplast.com |
United Kingdom | |
Michael Lynch | Recruiting |
Colchester, United Kingdom, CO45JL | |
Contact: Frances Horan, Nurse 00441206742009 | |
Maureen Bridgland | Recruiting |
Brighton, United Kingdom | |
United Kingdom, Surrey | |
St. Peters Hospital | Not yet recruiting |
Chertsey, Surrey, United Kingdom, KT16OPZ | |
Principal Investigator: Carol Katte, Senior Stoma Nurse | |
United Kingdom, Tooting | |
Caroline Rudoni | Recruiting |
London, Tooting, United Kingdom, SW17OQT | |
Contact: Caroline Rudino, Stoma Nurse 00442087253916 |
Principal Investigator: | Carol Katte, Stoma Nurse | Ashford and St. Peters Hospital |
Principal Investigator: | Maureen Bridgland, Stoma Nurse | Royal Sussex County Hospital |
Principal Investigator: | Caroline Rudoni, Stoma Nurse | St. Georges Hospital |
Principal Investigator: | Theresa Bowles, Stoma Nurse | Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK) |
Principal Investigator: | Michael Lynch, Surgeon | Colchester General Hospital |
Responsible Party: | Coloplast A/S ( Seema Suchdev Wrisberg/Clinical Trial Manager ) |
Study ID Numbers: | DK188OS |
Study First Received: | October 1, 2008 |
Last Updated: | December 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00765388 |
Health Authority: | United Kingdom: Research Ethics Committee |
urostomy, 1-piece, cross-over, randomised, preference |