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

Fecal Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02989545
• Other study ID #: Shaare Zedek Medical Center FI
• Status: Completed
• Phase: N/A
• Start date: December 2016
• Est. completion date: December 2018

Study information

• Verified date: April 2020
• Source: Shaare Zedek Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fecal Incontinence

Intervention

Device:
• Anal Tape

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shaare Zedek Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Any Improvment in the Fecal Incontince Quality of Life Scale (FIQoLs)	The FIQoL is a validated, condition-specific tool that evaluates quality of life (QoL) in patients with fecal incontinence (FI) it consisting of 29 questions, subdivided into four domains: Lifestyle, Coping/Behavior, Depression/Self-perception, and Embarrassment. Item 1, general health, is graded from 1 "excellent" to 5 "poor" and is reversely scored. Items 2 to 28 are graded on a 4-point Likert-scale (1 = lower QoL). Item 29, FI specific depression, is graded from 1 "extremely so" to 6 "not at all." The average score for each domain is calculated separately and is calculated only if half or more of the items in the particular domain have been answered. Scales range from 1 to 5, with a 1 indicating a lower quality of life. Each domain or subscale is reported separately (Range 1 to 5), a total score including all four domains is not calculated.	2 weeks
Secondary	A 50% Reduction in the Number of Episodes of FI Per Week	Number of pateints with reduction of more than 50% in the absolute number of FI events during each week of the study	4 weeks
Secondary	Mean Wexner Score	The Wexner Scale is a measure of frequency and severity of anal incontinence. It comprises five items, three regarding frequency of involuntary passage of gas, liquid, or solid stool, frequency of pad wearing, and frequency of lifestyle alteration, scored in a 5-point Likert-scale (never=0, rarely=1, sometimes=2, usually=3, always=4). A sum of all scores from 0 to 20 is calculated with higher scores meaning more severe incontince.	2 weeks
Secondary	Mean Redction in Wexner Scale Compared to Baseline	The Wexner Scale is a measure of frequency and severity of anal incontinence. It comprises five items, three regarding frequency of involuntary passage of gas, liquid, or solid stool, frequency of pad wearing, and frequency of lifestyle alteration, scored in a 5-point Likert-scale (never=0, rarely=1, sometimes=2, usually=3, always=4). A sum of all scores from 0 to 20 is calculated with higher scores meaning more severe incontince.	2 weeks
Secondary	General Satisfaction	General satisfaction with the device was assessed using a standard 100 mm visual analog scale. Patients were asked to grade their satisfaction with the device between 0 and 100 by drawing a perpendicular line in the 100 mm visual analog scale. Then the distance in mm was measured in mm from 0 to the perpendicular line and the score was calculated. Higher scores meaning better satisfaction.	2 weeks
Secondary	Willingness of the Patient to Continue Using the Anal Tape After the Study.	Willingness of the patient to continue using the device was assessed using a standard 100 mm visual analog scale. Patients were asked to grade their willingness to use the device in the future between 0 and 100 by drawing a perpendicular line in the 100 mm visual analog scale. Then the distance in mm was measured in mm from 0 to the perpendicular line and the score was calculated. Higher scores meaning better satisfaction.	4 weeks