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

Not Applicable

Terminated

• Conditions: Fecal Incontinence
• Interventions: Device: Fecal Incontinence Management System

• Registration Number: NCT00556972
• Lead Sponsor: Coloplast A/S

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

Study Timeline

• Study First Submitted: 2007-11-09
• Study First Submitted QC: 2007-11-09
• Study First Posted: 2007-11-12
• Study Start: 2008-01
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Results First Submitted: 2011-08-02
• Results First Submitted QC: 2012-11-29
• Results First Posted: 2013-01-01
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-15
• Last Update Posted: 2022-12-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fecal Incontinence management system	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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
What is Your Assessment of the Ease of Correct Application of the Anal Adhesive?	After application of product
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.

Trial Locations

Locations (1)

Beth Israel Deaconess Medical Center, Inc.; 🇺🇸 Boston, Massachusetts, United States