Comparison of Two Urostomy Bags (2-piece).

NCT00761748 | Completed Phase 3 Results

• 1 other identifier: DK189OS
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Urostomy Patent

Keywords

Urostomy,; 2-piece,; preference,

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

SenSura

EXPERIMENTAL

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

Convatec

ACTIVE COMPARATOR

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

Interventions

Convatec Uro 2-piece DEVICE

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.

Also known as: ConvaTec 2-piece

Convatec

SenSura Uro 2-piece DEVICE

SenSura URO 2-piece Extended Wear, convex light, 50 mm coupling, cuttable (15-33 mm)

Also known as: SenSura

SenSura

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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),

You may not qualify if:

• 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.

Sponsors & Collaborators

• Coloplast A/S: lead

Study Sites (1)

Visé Mitteldeutschland GmbH

Magdeburg, 39114, Germany

Location

Results Point of Contact

• Title: Director of Medical Outcome
• Organization: Coloplast A/S

dkbir@coloplast.com

Study Officials

• Daniel Carter, M.Sc

  Coloplast A/S

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2008
• First Posted: September 29, 2008
• Study Start: September 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: February 1, 2009
• Last Updated: January 1, 2013
• Results First Posted: January 1, 2013

Record last verified: 2012-11

Locations

DE (1)