Comparison of Two Urostomy Bags (2-piece).

Coloplast

Status and phase: Completed; Phase 3

Conditions: Urostomy Patent

Treatments: Device: SenSura Uro 2-piece; Device: Convatec Uro 2-piece

Study type: Interventional

Funder types: Industry

Identifiers

NCT00761748

DK189OS

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

30 participants in 2 patient groups

SenSura

Experimental group

Description:

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.

Treatment:

Device: SenSura Uro 2-piece

Convatec

Active Comparator group

Description:

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.

Treatment:

Device: Convatec Uro 2-piece