A Randomised Cross-over Study With Two 1-piece Urostomy Bags. (DK188OS)
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Purpose
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 |
|---|---|---|
|
Urologic Surgical Procedures |
Device: SenSura Uro Device: Hollister |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label |
| Official Title: | A Comparative, Randomised, Crossover Study With 2 Urostomy Bags Among 30 Urostomy-operated Persons in UK |
- Preference [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Awareness [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 30 |
| Study Start Date: | October 2008 |
| Study Completion Date: | May 2009 |
| Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: SenSura Uro
The test product is a CE-marked non-sterile one-piece urostomy multi-chamber bag with the SenSura adhesive.
|
Device: SenSura Uro
The test product is a CE-marked non-sterile one-piece urostomy multi-chamber bag with the SenSura adhesive.
Other Names:
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|
Active Comparator: hollister Uro
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
|
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.
Other Names:
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Eligibility| 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:
- 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.
Contacts and Locations| United Kingdom | |
| St. Peters Hospital | |
| Chertsey, Surrey, United Kingdom, KT16OPZ | |
| Caroline Rudoni | |
| London, Tooting, United Kingdom, SW17OQT | |
| Maureen Bridgland | |
| Brighton, United Kingdom | |
| Michael Lynch | |
| Colchester, United Kingdom, CO45JL | |
| University of London Hospital | |
| London, United Kingdom, WC1E 5DB | |
| Theresa Bowles | |
| Norwich, United Kingdom | |
| Study Chair: | 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 |
| Principal Investigator: | Sharon Fillingham, Nurse | UCLH |
More Information
No publications provided
| Responsible Party: | Seema Suchdev Wrisberg/Clinical Trial Manager, Coloplast A/S |
| ClinicalTrials.gov Identifier: | NCT00765388 History of Changes |
| Other Study ID Numbers: | DK188OS |
| Study First Received: | October 1, 2008 |
| Last Updated: | November 27, 2009 |
| Health Authority: | United Kingdom: Research Ethics Committee |
Keywords provided by Coloplast A/S:
|
urostomy, 1-piece, cross-over, randomised, preference |
ClinicalTrials.gov processed this record on June 17, 2013