Comparison of Two Urostomy Bags (2-piece).

November 29, 2012 updated by: Coloplast A/S

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Magdeburg, Germany, 39114
        • Visé Mitteldeutschland GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • ConvaTec 2-piece

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preference of the Two Urostomy Products
Time Frame: 6 weeks

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.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Coloplast A/S

Investigators

  • Study Chair: Daniel Carter, M.Sc, Coloplast A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

September 26, 2008

First Submitted That Met QC Criteria

September 26, 2008

First Posted (Estimate)

September 29, 2008

Study Record Updates

Last Update Posted (Estimate)

January 1, 2013

Last Update Submitted That Met QC Criteria

November 29, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DK189OS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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