Fecal Incontinence
Conditions
Brief summary
The purpose of this feasibility study is to evaluate the performance and skin-friendliness of the barrier of the Fecal Incontinence Management System. The investigator will complete a questionnaire for each of the tested products and the products will be evaluated as regards leakage, wear time, and skin-friendliness.
Detailed description
The purpose of this feasibility study is to evaluate the performance and skin-friendliness of the barrier of the Fecal Incontinence Management System. The investigator will complete a questionnaire for each of the tested products and the products will be evaluated as regards leakage, wear time, and skin-friendliness
Interventions
DEVICEFecal Incontinence Management System
The device is intended to remedy fecal incontinence.
Sponsors
Coloplast A/S
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The subject is at least 18 years of age * The subject has fecal incontinence
Exclusion criteria
* The subject is pregnant and/or breastfeeding * The subject has perianal fistulas and/or hemorrhoids * It's estimated that the subject's perianal skin makes it inappropriate for subject to participate in the study (i.e. in case of damaged skin, very sweaty skin or very sinuous and folded skin)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Primary Outcome Measure is Device Wear Time (Time From the Device is Applied Until it is Removed) | 5 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Is the Barrier Size and Shape Satisfactory | Subjects were followed for the duration of the study, an average of 23 hours | Percentage of subjects who answered yes to the question: is the barrier size and shape satisfactory |
| Assessment of Skin 0-2 Inches From the Edge of the Anus | Subjects were evaluated before and after test | Skin condition scale: 1 = Normal skin without redness, 2 = Normal redness and intact skin, 3 = Abnormal redness but intact skin, 4 = Red and spotted but intact skin, 5 = Red and broken skin, 6 = Broken and bleeding skin Best skin condition score is 1, and worst skin condition score is 6. |
| What is Your Assessment of the Ease of Correct Application of the Anal Adhesive? | After application of product | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fecal Incontinence Management System The product is a management system for use in fecal incontinence. It consists of a barrier with an attached pouch and a Bed Drainage Bag. | 4 |
| Total | 4 |
Baseline characteristics
| Characteristic | Fecal Incontinence Management System |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants |
| Age, Continuous | 62.0 years STANDARD_DEVIATION 14.2 |
| Region of Enrollment United States | 4 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 4 |
| serious Total, serious adverse events | 0 / 4 |
Outcome results
Primary
The Primary Outcome Measure is Device Wear Time (Time From the Device is Applied Until it is Removed)
Time frame: 5 days
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fecal Incontinence Management System | The Primary Outcome Measure is Device Wear Time (Time From the Device is Applied Until it is Removed) | 23.1 Hours | Standard Deviation 0.7 |
Secondary
Assessment of Skin 0-2 Inches From the Edge of the Anus
Skin condition scale: 1 = Normal skin without redness, 2 = Normal redness and intact skin, 3 = Abnormal redness but intact skin, 4 = Red and spotted but intact skin, 5 = Red and broken skin, 6 = Broken and bleeding skin Best skin condition score is 1, and worst skin condition score is 6.
Time frame: Subjects were evaluated before and after test
Population: ITT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fecal Incontinence Management System | Assessment of Skin 0-2 Inches From the Edge of the Anus | Before test | 2.25 Scores on a scale | Standard Deviation 1.89297 |
| Fecal Incontinence Management System | Assessment of Skin 0-2 Inches From the Edge of the Anus | After test | 3.25 Scores on a scale | Standard Deviation 2.62996 |
Secondary
Is the Barrier Size and Shape Satisfactory
Percentage of subjects who answered yes to the question: is the barrier size and shape satisfactory
Time frame: Subjects were followed for the duration of the study, an average of 23 hours
Population: ITT
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fecal Incontinence Management System | Is the Barrier Size and Shape Satisfactory | 100 Percentage of subjects |
Secondary
What is Your Assessment of the Ease of Correct Application of the Anal Adhesive?
Time frame: After application of product
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fecal Incontinence Management System | What is Your Assessment of the Ease of Correct Application of the Anal Adhesive? | Very difficult | 0 Pouche and Bag |
| Fecal Incontinence Management System | What is Your Assessment of the Ease of Correct Application of the Anal Adhesive? | Difficult | 1 Pouche and Bag |
| Fecal Incontinence Management System | What is Your Assessment of the Ease of Correct Application of the Anal Adhesive? | Reasonable | 0 Pouche and Bag |
| Fecal Incontinence Management System | What is Your Assessment of the Ease of Correct Application of the Anal Adhesive? | Easy | 6 Pouche and Bag |
| Fecal Incontinence Management System | What is Your Assessment of the Ease of Correct Application of the Anal Adhesive? | Very Easy | 0 Pouche and Bag |