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Comparison of Two Urostomy Bags (2-piece).

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Coloplast A/S
ClinicalTrials.gov Identifier:
NCT00761748
First received: September 26, 2008
Last updated: November 29, 2012
Last verified: November 2012
History of Changes

September 26, 2008
November 29, 2012
September 2008
January 2009   (final data collection date for primary outcome measure)
Preference of the Two Urostomy Products [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Number of participants preferring the SenSura Uro 2 piece product or the reference Convatec 2 piece product.

The subjects are asked via the case report form (questionnaire) at the end of the second cross over period, which of the two products they preferred.
preference of the two urostomy products [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00761748 on ClinicalTrials.gov Archive Site
Not Provided
Reason for change of product [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Comparison of Two Urostomy Bags (2-piece).
A Comparative, Randomised, Crossover Study With SenSura Uro 2-piece Versus ConvaTec 2-piece Among 30 Urostomy-operated Persons in Germany

Coloplast A/S has developed a new, improved 2-piece product for people with urostomies.

The 2-piece product is a part of a new product family, under the brand name SenSura. The aim of this investigation is to see how the urology product is perceived and how it performs against another 2-piece product from ConvaTec. The device 'ConvaTec 2-piece combihesive Natura' is selected as the comparative product because of its similarity to SenSura 2-piece product.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Urostomy Patent
  • 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.

    Other Name: ConvaTec 2-piece
  • Device: SenSura Uro 2-piece
    SenSura URO 2-piece Extended Wear, convex light, 50 mm coupling, cuttable (15-33 mm)
    Other Name: SenSura
  • Experimental: SenSura
    SenSura Uro 2-piece. Is a urostomy bag with the intended use of collecting urine from a stoma. Consist of a base plate and a bag that is attached to the base plate.
    Intervention: Device: SenSura Uro 2-piece
  • Active Comparator: Convatec
    Convatec Uro 2-piece Is a urostomy bag with the intended use of collecting urine from a stoma. Consist of a base plate and a bag that is attached to the base plate.
    Intervention: Device: Convatec Uro 2-piece
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
February 2009
January 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Be at least 18 years old,
  • Be able to complete a written consent form
  • Be able to fill in the Case Report Form
  • Have a urostomy with a diameter of 33 mm. or less.
  • Have had the urostomy for 3 months or more.
  • Use a 2-piece convex (or convex light) normally.
  • Be able to use SenSura URO 2-piece product
  • Be able to use ConvaTec, 2-piece product
  • Be able to handle the product themselves (application, removal and emptying),

Exclusion Criteria:

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

    • Need to use an ostomy belt
    • Be currently suffering from any dermatological problems, needing special treatment, on the peristomal skin
    • 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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00761748
DK189OS
No
Coloplast A/S
Coloplast A/S
Not Provided
Study Chair: Daniel Carter, M.Sc Coloplast A/S
Coloplast A/S
November 2012

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