The Use of an "Anal-Tape" in Patients With Fecal Incontinence

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2018-12-31

Brief Summary

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Fecal incontinence (FI), defined as the involuntary passage of stool for more than 3 months and is a devastating disease. The negative impact on quality of life has been consistently demonstrated. The prevalence of FI is probably underestimated in most studies. Currently conservative treatment is only modestly effective and surgical treatment is complex and expensive with less than optimal efficacy.

The investigators developed an "anal tape" using a commercially available elastic band with a special adhesive that is approved for use in the skin. A special design of the tape can be applied to the skin surrounding the anus providing support and additional pressure forces to the anal sphincter.

This is a 4 week, prospective, non blinded, cross-over study to explore the efficacy and safety of this device in patients with FI. The primary endpoint will be improvement in quality of life.

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Detailed Description

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Conditions

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Fecal Incontinence

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Off treatment

2 week period without intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Treatment period

2 week period with intervention

Group Type EXPERIMENTAL

Anal Tape

Intervention Type DEVICE

Interventions

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Anal Tape

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* \>18 years old
* Fecal incontinence for more than 6 months
* Willing to participate
* Understand the study procedures
* Is able to apply and remove the "anal tape" without significant assistance of others.
* Have done sigmoidsocopy or colonoscopy and anal manometry within five year of screening visit

Exclusion Criteria

* Advanced full thickness rectal prolapse.
* Injured, inflamed or any significant disease in the peri-anal skin.
* Allergy to any component of the device, either known or developed during testing in the screening visit.
* Moderate to severe proctitis of any etiology.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No