Comparison of Two Urostomy Bags (2-piece).

Study Overview
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Brief Summary
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Coloplast A/S has developed a new, improved 2-piece product for people with urostomies.

Detailed Description
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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.

Official Title
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A Comparative, Randomised, Crossover Study With SenSura Uro 2-piece Versus ConvaTec 2-piece Among 30 Urostomy-operated Persons in Germany

Conditions
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Urostomy Patent

Intervention / Treatment
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* Device: Convatec Uro 2-piece
* Device: SenSura Uro 2-piece


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SenSura<br>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<br>* SenSura URO 2-piece Extended Wear, convex light, 50 mm coupling, cuttable (15-33 mm)<br>* Other names: SenSura;|
| Active Comparator: Convatec<br>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<br>* 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.<br>* Other names: ConvaTec 2-piece;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preference of the Two Urostomy Products | 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. | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Urostomy,, 2-piece,, preference,