Coloplast DialogueStudy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00626821
Recruitment Status : Completed
First Posted : February 29, 2008
Results First Posted : March 12, 2012
Last Update Posted : March 12, 2012
Information provided by (Responsible Party):
Coloplast A/S

February 21, 2008
February 29, 2008
October 6, 2011
March 12, 2012
March 12, 2012
February 2008
April 2010   (Final data collection date for primary outcome measure)
Quality of Life (Scale 0(Worst)-100(Best)) [ Time Frame: 6-8 weeks ]
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.
Quality of Life [ Time Frame: week 0 and week 6 ]
Complete list of historical versions of study NCT00626821 on Archive Site
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Coloplast DialogueStudy
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
The main purpose of the study is to document real life experience on SenSura with focus on skin condition and quality of life.
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.
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Device: SenSura
Real life assessment of SenSura
Experimental: 1
Intervention: Device: SenSura
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2010
April 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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Coloplast A/S
Coloplast A/S
Not Provided
Principal Investigator: Birgitte D Andersen, RN Herlev Hospital, Dep of colorectal surgery
Coloplast A/S
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP