Comparison of Two Urostomy Bags (2-piece).
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Purpose
Coloplast A/S has developed a new, improved 2-piece product for people with urostomies.
| Condition | Intervention | Phase |
|---|---|---|
|
Urostomy Patent |
Device: Convatec Uro 2-piece Device: SenSura Uro 2-piece |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: 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 ] [ Designated as safety issue: No ]
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.
| Enrollment: | 30 |
| Study Start Date: | September 2008 |
| Study Completion Date: | February 2009 |
| Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: SenSura
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
|
Detailed Description:
The 2-piece product is a part of a new product family, under the brand name SenSura. The aim of this investigation is to see how the urology product is perceived and how it performs against another 2-piece product from ConvaTec. The device 'ConvaTec 2-piece combihesive Natura' is selected as the comparative product because of its similarity to SenSura 2-piece product.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Be at least 18 years old,
- Be able to complete a written consent form
- Be able to fill in the Case Report Form
- Have a urostomy with a diameter of 33 mm. or less.
- Have had the urostomy for 3 months or more.
- Use a 2-piece convex (or convex light) normally.
- Be able to use SenSura URO 2-piece product
- Be able to use ConvaTec, 2-piece product
- Be able to handle the product themselves (application, removal and emptying),
Exclusion Criteria:
In order to be enrolled in the clinical investigation, the subjects must not:
- Need to use an ostomy belt
- Be currently suffering from any dermatological problems, needing special treatment, on the peristomal skin
- 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 More Information
No publications provided
| Responsible Party: | Coloplast A/S |
| ClinicalTrials.gov Identifier: | NCT00761748 History of Changes |
| Other Study ID Numbers: | DK189OS |
| Study First Received: | September 26, 2008 |
| Results First Received: | March 8, 2010 |
| Last Updated: | November 29, 2012 |
| Health Authority: | Germany: Ethics Commission |
Keywords provided by Coloplast A/S:
|
Urostomy, 2-piece, preference, |
ClinicalTrials.gov processed this record on May 16, 2013