A Feasibility Study of a Fecal Incontinence Management System for Medical Use

• Sponsor: Coloplast A/S (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00556972
• Collaborator: (none)
• Enrollment: 4
• Location: 1
• Arm: 1
• Duration (Months): 3
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fecal Incontinence	Device: Fecal Incontinence Management System	Phase 1/Phase 2

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 4 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: A Feasibility Study of a Fecal Incontinence Management System for Medical Use
• Study Start Date: Jan 1, 2008
• Actual Primary Completion Date: Apr 1, 2008
• Actual Study Completion Date: Apr 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Fecal Incontinence management system Fecal Incontinence Management System is based on the same principle as fecal pouches. A barrier around anus to ensure adhesion and prevent leakage.	Device: Fecal Incontinence Management System; The device is intended to remedy fecal incontinence.

Outcome Measures

Primary Outcome Measures

1. The Primary Outcome Measure is Device Wear Time (Time From the Device is Applied Until it is Removed) [5 days]

Secondary Outcome Measures

1. 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

2. 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.

3. What is Your Assessment of the Ease of Correct Application of the Anal Adhesive? [After application of product]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beth Israel Deaconess Medical Center, Inc.	Boston	Massachusetts	United States	02215

Sponsors and Collaborators

• Coloplast A/S

Investigators

• Study Chair: Thais Benjamin N. Christensen, M.Sc. (BME), Coloplast A/S

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Coloplast A/S
• ClinicalTrials.gov Identifier: NCT00556972
• Other Study ID Numbers: DK172OS
• First Posted: Nov 12, 2007
• Last Update Posted: Jan 1, 2013
• Last Verified: Nov 1, 2012

• Additional relevant MeSH terms: Fecal Incontinence

Study Results

Participant Flow

Arm/Group Title	Fecal Incontinence Management System
Arm/Group Description	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.
Period Title: Overall Study
STARTED	4
COMPLETED	4
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Fecal Incontinence Management System
Arm/Group Description	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 Participants	4
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	2 50%
>=65 years	2 50%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	62.0 (14.2)
Sex: Female, Male (Count of Participants)
Female	3 75%
Male	1 25%
Region of Enrollment (participants) [Number]
United States	4 100%

Outcome Measures

1. Primary Outcome

Title	The Primary Outcome Measure is Device Wear Time (Time From the Device is Applied Until it is Removed)
Time Frame	5 days

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	Fecal Incontinence Management System
Arm/Group Description	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.
Measure Participants	4
Mean (Standard Deviation) [Hours]	23.1 (0.7)

2. Secondary Outcome

Title	Is the Barrier Size and Shape Satisfactory
Description	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

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	Fecal Incontinence Management System
Arm/Group Description	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.
Measure Participants	4
Number [Percentage of subjects]	100

3. Secondary Outcome

Title	Assessment of Skin 0-2 Inches From the Edge of the Anus
Description	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

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	Fecal Incontinence Management System
Arm/Group Description	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.
Measure Participants	4
Before test	2.25 (1.89297)
After test	3.25 (2.62996)

4. Secondary Outcome

Title	What is Your Assessment of the Ease of Correct Application of the Anal Adhesive?
Time Frame	After application of product

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fecal Incontinence Management System
Arm/Group Description	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.
Measure Participants	4
Measure Pouch and bag	7
Very difficult	0
Difficult	1
Reasonable	0
Easy	6
Very Easy	0

Adverse Events

Arm/Group Title	Fecal Incontinence Management System
Arm/Group Description	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.
All Cause Mortality
	Fecal Incontinence Management System
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Fecal Incontinence Management System
	Affected / at Risk (%)	# Events
Total	0/4 (0%)
Other (Not Including Serious) Adverse Events
	Fecal Incontinence Management System
	Affected / at Risk (%)	# Events
Total	0/4 (0%)

Limitations/Caveats

No overall conclusions could be drawn, due to the limited amount of data (N=4 due to delays and low recruitment rate). A new study, with a higher sample size needs to be executed, if the objectives set in this study are to be investigated thoroughly.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.