Comparison of Two Urostomy Bags (2-piece).
|Urostomy Patent||Device: Convatec Uro 2-piece Device: SenSura Uro 2-piece||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
|Official Title:||A Comparative, Randomised, Crossover Study With SenSura Uro 2-piece Versus ConvaTec 2-piece Among 30 Urostomy-operated Persons in Germany|
- Preference of the Two Urostomy Products [ Time Frame: 6 weeks ]
Number of participants preferring the SenSura Uro 2 piece product or the reference Convatec 2 piece product.
The subjects are asked via the case report form (questionnaire) at the end of the second cross over period, which of the two products they preferred.
|Study Start Date:||September 2008|
|Study Completion Date:||February 2009|
|Primary Completion Date:||January 2009 (Final data collection date for primary outcome measure)|
SenSura Uro 2-piece. Is a urostomy bag with the intended use of collecting urine from a stoma. Consist of a base plate and a bag that is attached to the base plate.
Device: SenSura Uro 2-piece
SenSura URO 2-piece Extended Wear, convex light, 50 mm coupling, cuttable (15-33 mm)
Other Name: SenSura
Active Comparator: Convatec
Convatec Uro 2-piece Is a urostomy bag with the intended use of collecting urine from a stoma. Consist of a base plate and a bag that is attached to the base plate.
Device: Convatec Uro 2-piece
Specific name of the device: 'Combihesive Natura® with a Durahesive Convex-It® base plate, 45 mm coupling, moldable (13-22 and 22-33 mm) hole size with boarder tape'.
The subjects are asked to test each of the two products for 21 days plus/minus 3 days in a randomised order and in accordance with their normal frequency of change and normal use pattern. The duration of the clinical investigation should be enough time to identify any difference in user-preference. If the subject is in the middle of testing an urostomy base plate when the test period is turning into the next period, the urostomy base plate can be worn until it needs to be changed. It is not possible to blind the investigation as the appearance of the test- and refer-ence products are very different in the look.
Other Name: ConvaTec 2-piece
Please refer to this study by its ClinicalTrials.gov identifier: NCT00761748
|Visé Mitteldeutschland GmbH|
|Magdeburg, Germany, 39114|
|Study Chair:||Daniel Carter, M.Sc||Coloplast A/S|