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.

Study Overview

• Status: Completed
• Conditions: Urostomy Patent
• Intervention / Treatment: Device: SenSura Uro 2-piece; Device: Convatec Uro 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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 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

How is the study designed?

Design Details

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

Number of Arms

2

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	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

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

Study record dates

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: Urostomy,; 2-piece,; preference,
• Other Study ID Numbers: DK189OS