A Randomised Cross-over Study With Two 1-piece Urostomy Bags.

PHASE4CompletedINTERVENTIONAL
Enrollment

27

Participants

Timeline

Start Date

October 31, 2008

Primary Completion Date

May 31, 2009

Study Completion Date

May 31, 2009

Conditions
Urostomy
Interventions
DEVICE

SenSura Uro

The test product is a CE-marked non-sterile one-piece urostomy multi-chamber bag with the SenSura adhesive.

DEVICE

Hollister

The comparator product is CE-marked and non-sterile and produced for urostomy operated. It is a flat one-piece urostomy product, Hollister Moderma Flex Urostomy beige, Cut-to-Fit Bag, flat adhesive.

Trial Locations (6)

KT16OPZ

St. Peters Hospital, Chertsey

SW17OQT

Caroline Rudoni, London

Unknown

Maureen Bridgland, Brighton

Theresa Bowles, Norwich

CO45JL

Michael Lynch, Colchester

WC1E 5DB

University of London Hospital, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Coloplast A/S

INDUSTRY