A Randomised Cross-over Study With Two 1-piece Urostomy Bags. (DK188OS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Coloplast A/S
ClinicalTrials.gov Identifier:
NCT00765388
First received: October 1, 2008
Last updated: January 27, 2014
Last verified: August 2012
  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.


Condition Intervention Phase
Urostomy
Device: SenSura Uro
Device: Hollister
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: A Comparative, Randomised, Crossover Study With 2 Urostomy Bags Among 30 Urostomy-operated Persons in UK

Resource links provided by NLM:


Further study details as provided by Coloplast A/S:

Primary Outcome Measures:
  • Preference of Sensura vs Moderma [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Subjects were asked which of the tested products they preferred; SenSura or Moderma.


Secondary Outcome Measures:
  • Immediate Adhesion [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Evaluation of immediate adhesion after each period

  • Removal of the Bag [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    How easy/difficult it was to remove the bag

  • Adhesion of the Bag During Use [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Evaluation of the adhesion of the base plate around the stoma during use

  • Adhesives Ability to Absorb Perspiration [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Evaluation of the adhesives ability to absorb perspiration from the skin

  • Flexibility of the Product [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Evaluation of the ability of the bag to conform with the patients movements (flexibility)

  • Awareness of the Presence of the Product [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Evaluates the patients awareness of the presence of the product during use.

  • Feeling of Security During the Day [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    The patients feeling of security with the bag during the day

  • Feeling of Security During the Night [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    The patients feeling of security with the product during the night

  • Problems With Splashing Sounds During Use [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    The patient was asked whether he/she noticed any splashinh sounds during use

  • Bag Twisting During Night [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    The patient was asked if he/she noticed whether the bag twisted during night

  • Changes in Skin Compared to Before Study [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    The patient was asked whether he/she experienced changes in the skin condition after testing the blue/red product


Enrollment: 27
Study Start Date: October 2008
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SenSura Uro
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.
Other Names:
  • SenSura URO Standard Wear 1-piece bag
  • Product number:1438298
Active Comparator: hollister Uro
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.
Other Names:
  • Moderma Flex Urostomy, Cut-to-fit bag, flat adhesive.
  • product id : 29100

Detailed Description:

In this trial we are 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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00765388

Locations
United Kingdom
St. Peters Hospital
Chertsey, Surrey, United Kingdom, KT16OPZ
Caroline Rudoni
London, Tooting, United Kingdom, SW17OQT
Maureen Bridgland
Brighton, United Kingdom
Michael Lynch
Colchester, United Kingdom, CO45JL
University of London Hospital
London, United Kingdom, WC1E 5DB
Theresa Bowles
Norwich, United Kingdom
Sponsors and Collaborators
Coloplast A/S
Investigators
Study Chair: 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
Principal Investigator: Sharon Fillingham, Nurse UCLH
  More Information

No publications provided

Responsible Party: Coloplast A/S
ClinicalTrials.gov Identifier: NCT00765388     History of Changes
Other Study ID Numbers: DK188OS
Study First Received: October 1, 2008
Results First Received: September 19, 2011
Last Updated: January 27, 2014
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 August 26, 2014