Coloplast DialogueStudy

This study has been completed.
Information provided by (Responsible Party):
Coloplast A/S Identifier:
First received: February 21, 2008
Last updated: February 9, 2012
Last verified: January 2012

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

Condition Intervention Phase
Device: SenSura
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label, Non-comparative, Multi-national Post-Market Study to Document Real Life Experience on SenSura With Focus on Skin Condition and Quality of Life

Resource links provided by NLM:

Further study details as provided by Coloplast A/S:

Primary Outcome Measures:
  • Quality of Life (Scale 0(Worst)-100(Best)) [ Time Frame: 6-8 weeks ] [ Designated as safety issue: No ]
    The mean change in quality of life (Stoma-QoL value) from visit 1 to visit 2. An increase in Stoma-QoL is an improvement, a decrease in Stoma-QoL is a worsening.

Enrollment: 3017
Study Start Date: February 2008
Study Completion Date: December 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Device: SenSura
Real life assessment of SenSura
Other Name: SenSura

Detailed Description:

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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Please refer to this study by its identifier: NCT00626821

United States, Missouri
Restored Images
Kansas City, Missouri, United States, 64119
Sponsors and Collaborators
Coloplast A/S
Principal Investigator: Birgitte D Andersen, RN Herlev Hospital, Dep of colorectal surgery
  More Information

No publications provided

Responsible Party: Coloplast A/S Identifier: NCT00626821     History of Changes
Other Study ID Numbers: DK175OS
Study First Received: February 21, 2008
Results First Received: October 6, 2011
Last Updated: February 9, 2012
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Ethics Committee
United States: Institutional Review Board
Slovakia: Ethics Committee
The Netherlands: Ethics Committee
Australia: Ethics Committee
Iceland: Ethics Committee
Poland: Ethics Committee
Spain: Ethics Committee
Japan: Ethics Committee

Keywords provided by Coloplast A/S:
Ostomy processed this record on April 17, 2014