Comparison of Two Urostomy Bags (2-piece).

PHASE3CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

September 30, 2008

Primary Completion Date

January 31, 2009

Study Completion Date

February 28, 2009

Conditions
Urostomy Patent
Interventions
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)

Trial Locations (1)

39114

Visé Mitteldeutschland GmbH, Magdeburg

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Coloplast A/S

INDUSTRY