Comparison of Two Urostomy Bags (2-piece).

NCT ID: NCT00761748

Last Updated: 2013-01-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2009-02-28

Brief Summary

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

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.

Conditions

Urostomy Patent

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

SenSura Uro 2-piece

Intervention Type: DEVICE

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

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.

Group Type: ACTIVE_COMPARATOR

Convatec Uro 2-piece

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

SenSura Uro 2-piece

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

Intervention Type: DEVICE

Other Intervention Names

ConvaTec 2-piece; SenSura

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Coloplast A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel Carter, M.Sc

Role: STUDY_CHAIR

Coloplast A/S

Locations

Visé Mitteldeutschland GmbH

Magdeburg, , Germany

Countries

Germany

Other Identifiers

DK189OS

Identifier Type: -

Identifier Source: org_study_id