Coloplast DialogueStudy

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

3017 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2010-12-31

Brief Summary

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The main purpose of the study is to document real life experience on SenSura with focus on skin condition and quality of life.

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Detailed Description

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It is important to continuously develop and test ostomy products in order to prevent peristomal skin disorders and to enhance the quality of life for people with a stoma. Furthermore, it is essential to create awareness about the importance of healthy peristomal skin as many of these conditions are preventable.

Conditions

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Stoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

SenSura

Intervention Type DEVICE

Real life assessment of SenSura

Interventions

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SenSura

Real life assessment of SenSura

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Signed informed consent before any study related activities
* Subjects with a colostomy, ileostomy or urostomy
* Subjects must have had their ostomy for at least 6 months
* Subjects must have mental capacity to understand the study and questionnaires
* Subjects must be at least 18 years of age.

Exclusion Criteria

* Women who are pregnant or breast-feeding
* Subjects who have more than one ostomy
* Subjects with an ostomy who use plug
* Participation in other studies at the same time
* Previous participation in this study

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No