NCT00761748

Comparison of Two Urostomy Bags (2-piece).

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Coloplast A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.
DEVICE	SenSura Uro 2-piece	SenSura URO 2-piece Extended Wear, convex light, 50 mm coupling, cuttable (15-33 mm)

Timeline

• Start date: 2008-09-01
• Primary completion: 2009-01-01
• Completion: 2009-02-01
• First posted: 2008-09-29
• Last updated: 2013-01-01
• Results posted: 2013-01-01

Locations

1 site across 1 country: Germany