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

• Sponsor: Shaare Zedek Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT02989545
• Collaborator: (none)
• Enrollment: 20
• Arms: 2
• Duration (Months): 24

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Fecal Incontinence	Device: Anal Tape	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Non-Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Use of an "Anal-Tape" in Patients With Fecal Incontinence
• Study Start Date: Dec 1, 2016
• Actual Primary Completion Date: Dec 1, 2018
• Actual Study Completion Date: Dec 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Off treatment 2 week period without intervention
Experimental: Treatment period 2 week period with intervention	Device: Anal Tape

Outcome Measures

Primary Outcome Measures

1. Any Improvment in the Fecal Incontince Quality of Life Scale (FIQoLs) [2 weeks]

   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.

Secondary Outcome Measures

1. A 50% Reduction in the Number of Episodes of FI Per Week [4 weeks]

   Number of pateints with reduction of more than 50% in the absolute number of FI events during each week of the study

2. Mean Wexner Score [2 weeks]

   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.

3. Mean Redction in Wexner Scale Compared to Baseline [2 weeks]

   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.

4. General Satisfaction [2 weeks]

   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.

5. Willingness of the Patient to Continue Using the Anal Tape After the Study. [4 weeks]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Shaare Zedek Medical Center

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 25, 2019

More Information

Publications

None provided.

• Responsible Party: Dan Livovsky, Dr. Dan M. Livovsky and Dr. Joseph Lysy, Shaare Zedek Medical Center
• ClinicalTrials.gov Identifier: NCT02989545
• Other Study ID Numbers: Shaare Zedek Medical Center FI
• First Posted: Dec 12, 2016
• Last Update Posted: Apr 2, 2020
• Last Verified: Apr 1, 2020

• Additional relevant MeSH terms: Fecal Incontinence

Study Results

Participant Flow

Arm/Group Title	Per Sequence
Arm/Group Description	Off treatment first for 14 days Treatment period second for 14 days
Period Title: Control Period - no Intervention
STARTED	20
COMPLETED	20
NOT COMPLETED	0
Period Title: Control Period - no Intervention
STARTED	20
COMPLETED	20
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	All Patients
Arm/Group Description	2 week period without intervention then 2 week period with anal tape intervention
Overall Participants	20
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	64
Sex: Female, Male (Count of Participants)
Female	20 100%
Male	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	0 0%
More than one race	0 0%
Unknown or Not Reported	20 100%

Outcome Measures

1. Primary Outcome

Title	Any Improvment in the Fecal Incontince Quality of Life Scale (FIQoLs)
Description	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.
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Off Treatment	Treatment Period
Arm/Group Description	2 week period without intervention	2 week period with intervention - Anal tape
Measure Participants	20	20
Lifestyle	2.8 (0.69)	3.3 (0.68)
Coping/Behaivoir	1.9 (0.64)	2.5 (0.73)
Depression/Self-Perception	3.1 (0.75)	3.5 (0.74)
Embarrassment	2.13 (0.67)	2.65 (0.76)

2. Secondary Outcome

Title	A 50% Reduction in the Number of Episodes of FI Per Week
Description	Number of pateints with reduction of more than 50% in the absolute number of FI events during each week of the study
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

Note that this outcome was obtained by free text stool diaries that patients had to keep at home. Only 15 patient out of 20 provided full diaries, therefore the analysis is limited to 15 instead of all 20.

Arm/Group Title	Off Treatment	Treatment Period
Arm/Group Description	2 week period without intervention	2 week period with intervention Anal Tape
Measure Participants	15	15
Count of Participants [Participants]	0 0%	5 NaN

3. Secondary Outcome

Title	Mean Wexner Score
Description	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.
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Off Treatment	Treatment Period
Arm/Group Description	2 week period without intervention	2 week period with intervention Anal Tape
Measure Participants	20	20
Mean (Standard Deviation) [score on a scale]	11.9 (3.5)	10.3 (4.8)

4. Secondary Outcome

Title	Mean Redction in Wexner Scale Compared to Baseline
Description	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.
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Off Treatment	Treatment Period
Arm/Group Description	2 week period without intervention	2 week period with intervention Anal Tape
Measure Participants	20	20
Mean (Standard Deviation) [score on a scale]	0.6 (1.7)	1.95 (4.2)

5. Secondary Outcome

Title	General Satisfaction
Description	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.
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

Note that in 3 patients these data were missing, therefore the analysis if for 17 out of 20 participants.

Arm/Group Title	Treatment Period
Arm/Group Description	2 week period with intervention Anal Tape
Measure Participants	17
Median (Inter-Quartile Range) [mm in VAS scale]	80

6. Secondary Outcome

Title	Willingness of the Patient to Continue Using the Anal Tape After the Study.
Description	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.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

Note that in 3 patients these data were missing, therefore the analysis if for 17 out of 20 participants.

Arm/Group Title	Treatment Period
Arm/Group Description	2 week period with intervention Anal Tape
Measure Participants	17
Median (Inter-Quartile Range) [mm in VAS scale]	90

Adverse Events

Time Frame	4 weeks study period
Arm/Group Title	Control Period - No Intervention		Treatment Period - Anal Tape Provided
Arm/Group Description	Consiting of the first 14 days of the study during which patients were off treatment and baseline and safety data was collected		Consiting of the second 14 days of the study (day 15 to 28) during which patients were provided with the "anal tape" device and during this period efficacy and safety data was collected.
All Cause Mortality
	Control Period - No Intervention		Treatment Period - Anal Tape Provided
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)
Serious Adverse Events
	Control Period - No Intervention		Treatment Period - Anal Tape Provided
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)
Other (Not Including Serious) Adverse Events
	Control Period - No Intervention		Treatment Period - Anal Tape Provided
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		3/20 (15%)
Gastrointestinal disorders
Mild difficulty to remove the device	0/20 (0%)	0	3/20 (15%)	3

Limitations/Caveats

Short term, single center, open label

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.