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A Randomised Cross-Over Study With Two 1-Piece Urostomy Bags. (DK188OS)
This study is currently recruiting participants.
Verified by Coloplast A/S, December 2008
Sponsored by: Coloplast A/S
Information provided by: Coloplast A/S
ClinicalTrials.gov Identifier: NCT00765388
  Purpose

Background Urostomy is a surgical procedure that detours or diverts urine away form a diseased or defective bladder. The bladder can be removed and the urine is passed out of the body through an opening (stoma) in the stomach. People with urostomy will not be able to start and stop urine coming out through the stoma, so a urostomy bag will be fitted to collect the urine as it comes out.

A urostomy bag consists of an adhesive, which is attached to the skin around the stoma and a bag connected to the adhesive to collect the urine.

It is very important the standard is high on these products; otherwise the user (urostomy-patient) will experience lots of problems with the skin around the stoma.

In this trial we a comparing two types of urostomy bags - the SenSura 1-piece and Hollisters Moderma Flex.

Both products are CE-marked, meaning that they are safe and approved in use for people with an urostomy.

Population 30 urostomy operated people from UK will participate in the trial. Only participants who normally use a flat 1-piece urostomy bag can participate. It is very important that the participants keep their normal use- and change pattern. Furthermore they need to be over 18 years old, have had the urostomy for more than 3 months, the size of the urostomy shall be between 15-55 mm, otherwise the bag will not fit them and then they should be able to handle the bags themselves and be willing to use the two products tested in the trial.


Condition Intervention Phase
Urologic Surgical Procedures
Device: SenSura Uro
Device: Hollister
Phase IV

MedlinePlus related topics: Urine and Urination
U.S. FDA Resources
Study Type: Interventional
Study Design: Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study
Official Title: A Comparative, Randomised, Crossover Study With 2 Urostomy Bags Among 30 Urostomy-Operated Persons in UK

Further study details as provided by Coloplast A/S:

Primary Outcome Measures:
  • Preference [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Awareness [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: October 2008
Estimated Study Completion Date: January 2009
Estimated Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
SenSura Uro: Experimental
The test product is a CE-marked non-sterile one-piece urostomy multi-chamber bag with the SenSura adhesive.
Device: SenSura Uro
The test product is a CE-marked non-sterile one-piece urostomy multi-chamber bag with the SenSura adhesive.
hollister Uro: Active Comparator
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
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

In order to be enrolled in the clinical investigation, the subject must:

  • Be at least 18 years old,
  • Be mentally and physically capable of signing the written consent form
  • Be able to fill in the Case Report Form (questionnaire)
  • Have an urostomy with a size between 15-55 mm.
  • Have had the urostomy for 3 months or more,
  • Use a 1-piece bag normally.
  • Be able to handle the bag themselves (application and removal)
  • Be willing to use Coloplast SenSura 1-piece bag
  • Be willing to use Hollisters Moderma Flex, 1-piece bag

Exclusion Criteria:

  • In order to be enrolled in the clinical investigation, the subjects must not:

    • Be a convex base plate user (i.e. a bowl-shaped adhesive which pushes the stoma forward)
    • Need to use an ostomy belt
    • Be currently suffering from any dermatologiacal problems, needing special treatment, in the peristomal area (investigator will evaluate skin according to a newly developed ostomy skin tool from Coloplast A/S)
    • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00765388

Contacts
Contact: Seema . Wrisberg, M. Sc. Human Nutrition +4549113519 dkssw@coloplast.com
Contact: Daniel Carter, M.Sc.Biology +4549112523 dkdac@coloplast.com

Locations
United Kingdom
Michael Lynch Recruiting
Colchester, United Kingdom, CO45JL
Contact: Frances Horan, Nurse     00441206742009        
Maureen Bridgland Recruiting
Brighton, United Kingdom
United Kingdom, Surrey
St. Peters Hospital Not yet recruiting
Chertsey, Surrey, United Kingdom, KT16OPZ
Principal Investigator: Carol Katte, Senior Stoma Nurse            
United Kingdom, Tooting
Caroline Rudoni Recruiting
London, Tooting, United Kingdom, SW17OQT
Contact: Caroline Rudino, Stoma Nurse     00442087253916        
Sponsors and Collaborators
Coloplast A/S
Investigators
Principal Investigator: Carol Katte, Stoma Nurse Ashford and St. Peters Hospital
Principal Investigator: Maureen Bridgland, Stoma Nurse Royal Sussex County Hospital
Principal Investigator: Caroline Rudoni, Stoma Nurse St. Georges Hospital
Principal Investigator: Theresa Bowles, Stoma Nurse Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
Principal Investigator: Michael Lynch, Surgeon Colchester General Hospital
  More Information

Responsible Party: Coloplast A/S ( Seema Suchdev Wrisberg/Clinical Trial Manager )
Study ID Numbers: DK188OS
Study First Received: October 1, 2008
Last Updated: December 8, 2008
ClinicalTrials.gov Identifier: NCT00765388  
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Coloplast A/S:
urostomy, 1-piece, cross-over, randomised, preference

ClinicalTrials.gov processed this record on January 13, 2009