Stoma
Conditions
Keywords
Stoma, Ostomy
Brief summary
The main purpose of the study is to document real life experience on SenSura with focus on skin condition and quality of life.
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.
Interventions
DEVICESenSura
Real life assessment of SenSura
Sponsors
Coloplast A/S
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life (Scale 0(Worst)-100(Best)) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SenSura Test of SenSura for 6-8 weeks | 3,017 |
| Total | 3,017 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 44 |
| Overall Study | other/unknown reason | 104 |
| Overall Study | Physician Decision | 9 |
| Overall Study | Product dysfunction | 21 |
| Overall Study | Protocol Violation | 33 |
| Overall Study | Withdrawal by Subject | 10 |
Baseline characteristics
| Characteristic | SenSura |
|---|---|
| Age Continuous | 63.2 years STANDARD_DEVIATION 14.3 |
| Gender Female | 1541 participants |
| Gender Male | 1474 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 58 / 3,017 |
| serious Total, serious adverse events | 17 / 3,017 |
Outcome results
Primary
Quality of Life (Scale 0(Worst)-100(Best))
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.
Time frame: 6-8 weeks
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SenSura | Quality of Life (Scale 0(Worst)-100(Best)) | 1.8 units on a scale | Standard Deviation 6.9 |
p-value: <0.000195% CI: [1.553, 2.073]Mixed Models Analysis