The Use of an "Anal-Tape" in Patients With Fecal Incontinence
Phase: NA
Conditions: Fecal Incontinence
Sponsor: Shaare Zedek Medical Center

Cover Page: 
Date of last modification of this document: December 25, 2019 
Original Protocol was written : In mid 2016 
Title: The use of an "Anal-Tape" in patients with fecal incontinence 
ClinicalTrials.gov ID: NCT02989545 
Authors: 
Dan M. Livovsky MD, Primary Investigator  
Benjamin Koslowsky MD, 
Joseph Lysy MD 
The Neurogastroenterolgy & Motility and the Pelvic Floor Unit, Digestive Diseases 
Institute, Shaare Zedek Medical Center, Jerusalem, Israel 
 
 
 

The use of an "Anal-Tape" in patients with fecal incontinence 
Dan M. Livovsky MD, Joseph Lysy MD 
The Neurogastroenterolgy & Motility and the Pelvic Floor Unit, Digestive Diseases 
Institute, Shaare Zedek Medical Center, Jerusalem, Israel 
Introduction: 
 
Fecal incontinence (FI), defined as the involuntary passage of stool for more 
than 3 months[1] and is a devastating disease. The negative impact on quality of life 
has been consistently demonstrated[2-4]. Moreover many patients with FI avoid 
leaving their homes do to fear of being exposed episodes of FI in public and thus 
restrict their social life[1]. In the elderly FI may be associated with  
institutionalization and mortality[5, 6].  
 
The prevalence of FI is probably underestimated in most studies duo to 
unawareness of physicians and patients reluctance to report it to the associated 
social stigma[7]. Nevertheless  the estimated prevalence vary depending on the 
population studied and the definition of FI [7-11]. In community settings the 
prevalence of FI increases with age an varies between 2.2 and 25%[12, 13]. In 
hospitals the prevalence is 18 to 33% and in nursing homes it rises up to 50 to 
70%[1]  
FI may be secondary to intestinal diseases, pelvic floor disorders, anal weakness, 
neurological and psychiatric diseases. Often the etiology of FI is multifactorial[1, 13]: 
• Anal sphincter weakness 
o Traumatic: obstetric, surgical, others. 
▪ Obstetric anal sphincter injury can cause immediate FI, but 
more typically begins 2–3 decades after the injury. 
o Nontraumatic: scleroderma, internal sphincter degeneration of 
unknown etiology 
o Neuropathy: peripheral (e.g., pudendal) or generalized (e.g., diabetes 
mellitus( 
• Disturbances of pelvic floor: rectal prolapse, descending perineum syndrome 
• Disorders affecting rectal capacity or sensation:  
o Inflammatory conditions: IBD, post radiation 
o Rectal surgery: Pouch, low anterior resection 
• Central nervous system disorders: dementia, stroke, brain tumors, multiple 
sclerosis, spinal cord lesions 
• Psychiatric diseases, behavioral disorders 
• Bowel Disturbances: 
o Diarrhea: irritable bowel syndrome, post-cholecystectomy diarrhea 
o Constipation and fecal retention with overflow. 

 
The management of FI start with reassurance, explaining patients that the 
disorder is not uncommon. Dietary modifications, skin care, and medications to 
improve stool consistency and delivery to the rectum may suffice. Anti-diarrheal 
drugs should provided if diarrhea is present. Pelvic floor training and biofeedback 
training have been found effective as well[13]. 
 
Scheduled defecations (e.g. every morning) with or without water enemas to 
clean the left colon can benefit some patients.  
 
Minimally invasive procedures such as injection of bulking agents to the anal 
sphincter and muscle augmentation with radiofrequency ablation (SECCA) as well as 
surgical interventions and sacral nerve stimulation may be of use to some patients 
but are complex, expensive and associated with adverse effects. 
 
Consequently local mechanical devices, that can be applied externally are 
very attractive, some of them are already commercially available.  
 
We developed an "anal tape" using a commercially available elastic band 
with a special adhesive that is approved for  use in the skin. This adhesive band is 
available worldwide and is used by numerous people, especially athletes. The band 
can be fashioned in any form and taped to any area of the body with a healthy skin 
and is for single use. Thus  a square of the band with a small opening in the center 
can be applied to the skin surrounding the anus providing support and additional 
pressure forces to the anal sphincter. 
 
This study will explore the efficacy and safety of this device in patients with 
FI, importantly the tape is commercially available; thus we have no commercial 
interest in the success of the device.     
Aims of study:  
 
To determine the efficacy and safety of the "anal tape" device in patients 
with fecal insentience that match with the inclusion and exclusion criteria of this 
study. 
Study design: 
 
This is a 4 week open-label, non-blinded, non randomized study in patients 
with fecal incontinence.  
The study will consist of two periods of two weeks: 
• First two weeks - control period: Patients will be asked to continue his / her 
normal life and to answer to validated questionnaires of fecal incontinence, 
quality of life and to fill a stool diary. 
o The first week will be considered as the baseline period 
o The second week as the control period. 

• Second two weeks - treatment period:  Patients will be provided with the 
device, and ask to answer to the same questionnaires, stool diary and an 
additional usability questionnaire. 
 
Study population 
 
Male and female patients above the age of 18 suffering from fecal 
incontinence of any etiology and that match the inclusion and exclusion criteria.   
 
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 
o If there is clinical suspicion of proctitis a new sigmoidoscopy will be 
required as part of the regular clinical evaluation of patient with 
suspected proctitis.   
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 of developed during 
testing in the screening visit (see below).  
• Moderate to severe proctitis of any etiology. 
 
Outcome variables: 
Primary outcomes:  
▪ Any improvement in any of the domain explored by the Fecal Incontinence 
quality of life questionnaire[14]. 
Secondary outcomes: 
▪  

▪ A 50% reduction in the number of episodes of FI or days per week, evaluated 
with the bowel diary and the weekly Wexner questionnaire. 
▪ Any improvement in Wexner score, both total score and any of its 
components. 
▪ Any improvement in quality of life score, and in any of its component. 
▪ Usability score 
▪ General satisfaction using a VAS score. 
▪ Willingness of the patient to continue using the anal tape after the study. 
Safety outcome: 
• Any adverse effect that can be related to the device. 
Number of patients: 
 
In this study each patient will be his own control before and after the 
intervention. We expected minimal change (if any) during the control period. We 
calculated that 20 patients in each group are required to have a 80% chance of 
detecting, (with a significant 5% level), an increase in 5 points in the quality of life 
questionnaire from 20%  in the control period to 60% in the treatment period. 
Study procedures: 
The study includes 3 office visits: 
• Screening day 0:  
o Obtain informed consent for participation. 
o Personal information and demography: Age, medications, medical 
history, obstetric history (e.g. number of vaginal deliveries, obstetric 
anal sphincter injury)  etc. 
o Obtain detailed FI related history: 
▪ Possible etiology 
▪ Review sigmoidoscopy and manometric data. 
▪ Type of FI: 
• Stool consistency 
o Gas 
o Liquid 
o Solid 
• Urge incontinence 
• Passive incontinence  
 
o Physical examination including digital rectal examination.  
o Overview of inclusion and exclusion criteria. 
o Obtain informed consent 
o Explain the use of the "anal tape" 

o Apply the "anal tape" to the arm or leg for 30 minutes in order to 
examine unexpected skin reaction to the device. 
o Provide the patient with the questionnaires: 
▪ To fill immediately: 
• Quality of life 
• Wexner 
▪ To fill in day 7 of study 
• Quality of life 
• Wexner 
▪ Bowel / stool diary 
o Insert all data into the database. 
 
• Follow up day 14: 
o Retrieve questionnaires from day 7 and stool diary. 
o Explain again the use of the "Anal Tape" 
o Provide the patient with 28 (two for every day of the intervention 
period) single use "Anal Tapes". 
o Provide the patient with additional questionnaires: 
▪ To fill immediately: 
• Quality of life 
• Wexner 
▪ To fill in day 21 of study 
• Quality of life 
• Wexner 
▪ Bowel / stool diary 
o Insert all data into the database. 
 
• Follow up day 28 and end of study: 
o Retrieve questionnaires from day 21 and stool diary. 
o Provide the patient with additional questionnaires: 
▪ To fill immediately: 
• Quality of life 
• Wexner 
• Usability score 
o Ask the patient about general satisfaction using a VAS score. 
o Ask the patient about willingness to continue using the anal tape after 
the study (yes or no answer). 
o Insert all data into the database. 
Anorectal manometry: 

• If there is clinical indication to perform anorectal manometry (according to 
one of the investigators), a new anorectal manometry will be required as part 
of the regular clinical evaluation, but in these cases we will measure anal 
pressure with and without the "anal tape" in situ. 
o We expect that up to 10 patients will require this additional 
evaluation. 
Statistical Analysis Plan (SAP): 
Descriptive statistics will be used to define baseline demographic characteristics of 
patients. Patients’ data and clinical parameters will be given as means with standard 
deviation (SD), for normally distributed variables; and as median with range or 
interquartile range (IQR) in parenthesis as indicated, for non-normally distributed 
variables. Differences between the continuous variables during the control and the 
intervention period will be analyzed by t-test or the Mann-Whitney U test for 
normally or non-normally distributed variables respectively. Paired, Two-tailed tests 
with a significance level of 5% will be used in all analyses. All calculations will be 
performed using IBM statistics SPSS v25. 
 
 
 
 
 

 
References 
1.  
Rao, S.S., et al., Functional Anorectal Disorders. Gastroenterology, 2016. 
2.  
Mundet, L., et al., Quality of Life Differences in Female and Male Patients with Fecal 
Incontinence. J Neurogastroenterol Motil, 2016. 22(1): p. 94-101. 
3.  
Rothbarth, J., et al., What is the impact of fecal incontinence on quality of life? Dis 
Colon Rectum, 2001. 44(1): p. 67-71. 
4.  
Bharucha, A.E., et al., Symptoms and quality of life in community women with fecal 
incontinence. Clin Gastroenterol Hepatol, 2006. 4(8): p. 1004 -
9.  
5.  
AlAmeel, T., M.K. Andrew, and C. MacKnight, The association of fecal incontinence 
with institutionalization and mortality in older adults. Am J Gastroenterol, 2010. 
105(8): p. 1830-4. 
6.  
Grover, M. and W.E. Whitehead, Is fecal incontinence a risk factor for 
institutionalization in the elderly? Am J Gastroenterol, 2011. 106(2): p. 366-7; author 
reply 367. 
7.  
Johanson, J.F. and J. Lafferty, Epidemiology of fecal incontinence: the silent affliction. 
Am J Gastroenterol, 1996. 91(1): p. 33-6. 
8.  
Macmillan, A.K., et al., The prevalence of fecal incontinence in community-dwelling 
adults: a systematic review of the literature. Dis Colon Rectum, 2004. 47(8): p. 1341-
9. 
9.  
Nelson, R., et al., Community-based prevalence of anal incontinence. JAMA, 1995. 
274
(
7
 :)
p. 559-61. 
10
.
 
Perry, S., et al., Prevalence of faecal incontinence in adults aged 40 years or more 
living in the community. Gut, 2002. 50(4): p. 480-4. 
11
.
 
Whitehead, W.E., et al., Fecal incontinence in US adults: epidemiology and risk 
factors. Gastroenterology, 2009. 137(2): p. 512-7, 517 e1-2. 
12
.
 
Norton, C., et al., Management of fecal incontinence in adults. Neurourol Urodyn, 
2010. 29(1): p. 199-206. 
13
.
 
Wald, A., et al., ACG clinical guideline: management of benign anorectal disorders. 
Am J Gastroenterol, 2014. 109(8): p. 1141-57; (Quiz) 1058. 
14
.
 
Rockwood, T.H., et al., Fecal Incontinence Quality of Life Scale: quality of life 
instrument for patients with fecal incontinence. Dis Colon Rectum, 2000. 43(1): p. 9-
16; discussion 16-7.