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

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Fecal Incontinence

Clinical Trial Details

NCT number	NCT02989545
Study type	Interventional
Source	Shaare Zedek Medical Center
Contact
Status	Completed
Phase	N/A
Start date	December 2016
Completion date	December 2018

View Details

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