Phase 4
N=3,017
Coloplast DialogueStudy
Stoma
Bottom Line
View on ClinicalTrials.gov: NCT00626821 ↗Enrolled (actual)
3,017
Serious AEs
0.6%
Results posted
Mar 2012
Primary outcome: Primary: Quality of Life (Scale 0(Worst)-100(Best)) — 1.8 units on a scale — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- SenSura (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Coloplast A/S
- Primary completion
- Apr 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Quality of Life (Scale 0(Worst)-100(Best)) |
1.8 | <0.0001 sig |
Summary
The main purpose of the study is to document real life experience on SenSura with focus on skin condition and quality of life.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00626821). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.