Trial Outcomes & Findings for A Feasibility Study of a Fecal Incontinence Management System for Medical Use (NCT NCT00556972)
NCT ID: NCT00556972
Last Updated: 2022-12-06
Results Overview
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
4 participants
Primary outcome timeframe
5 days
Results posted on
2022-12-06
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
4
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Feasibility Study of a Fecal Incontinence Management System for Medical Use
Baseline characteristics by cohort
| Measure |
Fecal Incontinence Management System
n=4 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
|
Age, Continuous
|
62.0 years
STANDARD_DEVIATION 14.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5 daysPopulation: ITT
Outcome measures
| Measure |
Fecal Incontinence Management System
n=4 Participants
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.
|
|---|---|
|
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 outcome
Timeframe: Subjects were followed for the duration of the study, an average of 23 hoursPopulation: ITT
Percentage of subjects who answered yes to the question: is the barrier size and shape satisfactory
Outcome measures
| Measure |
Fecal Incontinence Management System
n=4 Participants
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.
|
|---|---|
|
Is the Barrier Size and Shape Satisfactory
|
100 Percentage of subjects
|
SECONDARY outcome
Timeframe: Subjects were evaluated before and after testPopulation: ITT
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.
Outcome measures
| Measure |
Fecal Incontinence Management System
n=4 Participants
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.
|
|---|---|
|
Assessment of Skin 0-2 Inches From the Edge of the Anus
Before test
|
2.25 Scores on a scale
Standard Deviation 1.89297
|
|
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 outcome
Timeframe: After application of productOutcome measures
| Measure |
Fecal Incontinence Management System
n=7 Pouch and bag
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.
|
|---|---|
|
What is Your Assessment of the Ease of Correct Application of the Anal Adhesive?
Very difficult
|
0 Pouche and Bag
|
|
What is Your Assessment of the Ease of Correct Application of the Anal Adhesive?
Difficult
|
1 Pouche and Bag
|
|
What is Your Assessment of the Ease of Correct Application of the Anal Adhesive?
Reasonable
|
0 Pouche and Bag
|
|
What is Your Assessment of the Ease of Correct Application of the Anal Adhesive?
Easy
|
6 Pouche and Bag
|
|
What is Your Assessment of the Ease of Correct Application of the Anal Adhesive?
Very Easy
|
0 Pouche and Bag
|
Adverse Events
Fecal Incontinence Management System
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Thais Benjamin N. Christensen, Senior Clinical Project Manager
Coloplast A/S
Phone: +4549112668
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60