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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00765388
Recruitment Status : Completed
First Posted : October 2, 2008
Results First Posted : March 11, 2014
Last Update Posted : March 11, 2014
Sponsor:
Information provided by (Responsible Party):
Coloplast A/S

Tracking Information
First Submitted Date  ICMJE October 1, 2008
First Posted Date  ICMJE October 2, 2008
Results First Submitted Date  ICMJE September 19, 2011
Results First Posted Date  ICMJE March 11, 2014
Last Update Posted Date March 11, 2014
Study Start Date  ICMJE October 2008
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 27, 2014)
Preference of Sensura vs Moderma [ Time Frame: 4 weeks ]
Subjects were asked which of the tested products they preferred; SenSura or Moderma.
Original Primary Outcome Measures  ICMJE
 (submitted: October 1, 2008)
Preference [ Time Frame: 4 weeks ]
Change History Complete list of historical versions of study NCT00765388 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 27, 2014)
  • Immediate Adhesion [ Time Frame: 4 weeks ]
    Evaluation of immediate adhesion after each period
  • Removal of the Bag [ Time Frame: 4 weeks ]
    How easy/difficult it was to remove the bag
  • Adhesion of the Bag During Use [ Time Frame: 4 weeks ]
    Evaluation of the adhesion of the base plate around the stoma during use
  • Adhesives Ability to Absorb Perspiration [ Time Frame: 4 weeks ]
    Evaluation of the adhesives ability to absorb perspiration from the skin
  • Flexibility of the Product [ Time Frame: 4 weeks ]
    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 ]
    Evaluates the patients awareness of the presence of the product during use.
  • Feeling of Security During the Day [ Time Frame: 4 weeks ]
    The patients feeling of security with the bag during the day
  • Feeling of Security During the Night [ Time Frame: 4 weeks ]
    The patients feeling of security with the product during the night
  • Problems With Splashing Sounds During Use [ Time Frame: 4 weeks ]
    The patient was asked whether he/she noticed any splashinh sounds during use
  • Bag Twisting During Night [ Time Frame: 4 weeks ]
    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 ]
    The patient was asked whether he/she experienced changes in the skin condition after testing the blue/red product
Original Secondary Outcome Measures  ICMJE
 (submitted: October 1, 2008)
Awareness [ Time Frame: 4 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Randomised Cross-over Study With Two 1-piece Urostomy Bags.
Official Title  ICMJE A Comparative, Randomised, Crossover Study With 2 Urostomy Bags Among 30 Urostomy-operated Persons in UK
Brief Summary

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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Condition  ICMJE Urostomy
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: SenSura Uro
    The test product is a CE-marked non-sterile one-piece urostomy multi-chamber bag with the SenSura adhesive.
    Intervention: Device: SenSura Uro
  • 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
    Intervention: Device: Hollister
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 27, 2014)
27
Original Estimated Enrollment  ICMJE
 (submitted: October 1, 2008)
30
Actual Study Completion Date  ICMJE May 2009
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00765388
Other Study ID Numbers  ICMJE DK188OS
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Coloplast A/S
Study Sponsor  ICMJE Coloplast A/S
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Coloplast A/S
Verification Date August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP