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

Shaare Zedek Medical Center

Status

Completed

Conditions

Fecal Incontinence

Treatments

Device: Anal Tape

Study type

Interventional

Funder types

Other

Identifiers

NCT02989545

Shaare Zedek Medical Center FI

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.