Comparison of Two Urostomy Bags (2-piece).

Phase 3

Completed

• Conditions: Urostomy Patent
• Interventions: Device: Convatec Uro 2-piece; Device: SenSura Uro 2-piece

• Registration Number: NCT00761748
• Lead Sponsor: Coloplast A/S

Brief Summary

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

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 Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-09-26
• Study First Submitted QC: 2008-09-26
• Study First Posted: 2008-09-29
• Primary Completion: 2009-01
• Study Completion: 2009-02
• Results First Submitted: 2010-03-08
• Status Verified: 2012-11
• Results First Submitted QC: 2012-11-29
• Last Update Submitted: 2012-11-29
• Results First Posted: 2013-01-01
• Last Update Posted: 2013-01-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Convatec	Convatec Uro 2-piece	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.
SenSura	SenSura Uro 2-piece	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.

Primary Outcome Measures

Name	Time	Method
Preference of the Two Urostomy Products	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.

Trial Locations

Locations (1)

Visé Mitteldeutschland GmbH; 🇩🇪 Magdeburg, Germany