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
  Purpose

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


Condition Intervention Phase
Urostomy Patent
Device: Convatec Uro 2-piece
Device: SenSura Uro 2-piece
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: A Comparative, Randomised, Crossover Study With SenSura Uro 2-piece Versus ConvaTec 2-piece Among 30 Urostomy-operated Persons in Germany

Further study details as provided by Coloplast A/S:

Primary Outcome Measures:
  • 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.



Enrollment: 30
Study Start Date: September 2008
Study Completion Date: February 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Device: SenSura Uro 2-piece
SenSura URO 2-piece Extended Wear, convex light, 50 mm coupling, cuttable (15-33 mm)
Other Name: SenSura
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.
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

Detailed Description:

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.

  Eligibility

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

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.
  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: NCT00761748

Locations
Germany
Visé Mitteldeutschland GmbH
Magdeburg, Germany, 39114
Sponsors and Collaborators
Coloplast A/S
Investigators
Study Chair: Daniel Carter, M.Sc Coloplast A/S
  More Information

No publications provided

Responsible Party: Coloplast A/S
ClinicalTrials.gov Identifier: NCT00761748     History of Changes
Other Study ID Numbers: DK189OS
Study First Received: September 26, 2008
Results First Received: March 8, 2010
Last Updated: November 29, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by Coloplast A/S:
Urostomy,
2-piece,
preference,

ClinicalTrials.gov processed this record on July 29, 2014