Comparison of Two Urostomy Bags (2-piece).

Coloplast A/S30 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

Conditions

Urostomy Patent

Interventions

Convatec Uro 2-pieceDEVICE

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.

SenSura Uro 2-pieceDEVICE

SenSura URO 2-piece Extended Wear, convex light, 50 mm coupling, cuttable (15-33 mm)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Visé Mitteldeutschland GmbH

Magdeburg, Germany

Outcomes

Primary Outcomes

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.

Time frame: 6 weeks

Data from ClinicalTrials.gov

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