The American Society of Colon and Rectal Surgeons’ Clinical Practice Guideline for the Treatment of Fecal Incontinence

The American Society of Colon and Rectal Surgeons is dedicated to assuring high-quality patient care by advancing the science, prevention, and management of disorders and diseases of the colon, rectum, and anus. The Clinical Practice Guidelines Committee is composed of Society members who are chosen because they have demonstrated expertise in the specialty of colon and rectal surgery. This Committee was created to lead international efforts in defining quality care for conditions related to the colon, rectum, and anus. This is accompanied by developing Clinical Practice Guidelines based on the best available evidence. These guidelines are inclusive and not prescriptive. Their purpose is to provide information based on which decisions can be made, rather than to dictate a specific form of treatment. These guidelines are intended for the use of all practitioners, health care workers, and patients who desire information about the management of the conditions addressed by the topics covered in these guidelines. It should be recognized that these guidelines should not be deemed inclusive of all proper methods of care or exclusive of methods of care reasonably directed to obtaining the same results. The ultimate judgment regarding the propriety of any specific procedure must be made by the physician in light of all of the circumstances presented by the individual patient. STATEMENT OF THE PROBLEM Fecal incontinence is a frequent and debilitating condition that may result from a multitude of different causes. It is defined as the uncontrolled passage of feces or gas over at least 1 month’s duration, in an individual of at least 4 years of age, who had previously achieved control.1–4 In a large survey of female patients, the term “accidental bowel leakage” was preferred.5 Incontinence has a negative impact on self-esteem and quality of life and may result in significant secondary morbidity, disability, and cost.6 Reported prevalence rates vary widely depending on the method used and the target population examined but, in general, range between 1.4% and 18%. In institutionalized patients, however, incontinence may affect up to 50%, and it is a frequent reason for transfer to nursing homes.7–11 The Mature Woman’s Health Study used Neilson data to survey nearly 6000 women aged ≥45 (86% response rate), and indicated that nearly 20% of women have fecal incontinence at least once per year, whereas 9.5% have at least 1 episode per month.5 Treatment is challenging and needs to be individualized.2,4,12 Apart from conservative and supportive measures, a number of interventions are available that vary in efficacy and morbidity. Over the past several years, new technologies have been developed, and others are emerging from clinical trials to commercialization. Their specific roles in the management of fecal incontinence have not yet been completely defined. The scope of this updated practice parameter (last version 2007)2 is to address the evaluation and management of patients with fecal incontinence based on a thorough review of the published evidence. METHODS An organized search of MEDLINE, PubMed, EMBASE, and the Cochrane Database of Collected Reviews was performed through March 2014. Key word combinations included “fecal incontinence” AND “fecal OR anal OR stool”, AND “physical therapy OR rehabilitation OR biofeedback”, AND “sphincteroplasty” OR “implants” OR “bowel sphincter” OR “artificial sphincter” OR “radiofrequency” OR “sacral nerve stimulation” OR “injectable”. Directed searches of the embedded references from the primary articles were also performed in selected circumstances. The primary authors reviewed all English language manuscripts and studies in adults, systematic reviews, and meta-analyses. In selected instances where a full manuscript was not yet available, reports of conference proceedings were reviewed. Recommendations were formulated by the primary authors and reviewed by the entire Clinical Practice Guidelines Committee. The final grade of recommendation was performed by using the Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) system13 (Table 1) and approved by the entire Clinical Practice Guidelines Committee.Table 1: The GRADE system-grading recommendationsEVALUATION AND RISK ASSESSMENT 1. A thorough disease history should be obtained to define the etiology and specific risk factors for incontinence, characterize the duration and severity of primary symptoms, and capture secondary problems and associated pathologies. Grade of Recommendation: Strong recommendation based on low- or very low-quality evidence, 1C. Continence depends on the complex relationships between the anal sphincter and pelvic floor musculature, rectal reservoir function (capacity, compliance), stool consistency, and neurologic function. Conditions or defects that alter any of these factors may result in fecal incontinence. On an individual basis, however, the etiology of fecal incontinence may be multifactorial and the relative contribution of each factor may not be determined with certainty. A full discussion of contributing factors is beyond the scope of a clinical practice guideline. However, pregnancy, chronic diarrhea, diabetes mellitus, previous anorectal surgery, urinary incontinence, smoking, obesity, limited physical activity, white race, and neurologic disease have all been found to be risk factors for fecal incontinence in large population-based studies.7,14 Sphincter disruption from obstetric injury is clinically recognized in approximately 10% of all vaginal deliveries, but occult sphincter damage that does not cause immediate postpartum incontinence may be identified in up to 21% to 35% of vaginal deliveries.9,15 A higher incidence was seen in those who were multiparous or had instrument-assisted deliveries.1,16 Forceps delivery, occipito-posterior presentation of the child, and prolonged labor are independent risk factors.1 An estimated one-third of these occult defects may result in symptoms of incontinence or urgency at a later date. The extent of a sphincter defect does not necessarily correlate with the degree of fecal incontinence. Furthermore, those with ultrasound evidence of a sphincter defect without clinical signs of incontinence postpartum do not appear to have deterioration of continence in the first decade.17 Evolution of other factors (eg, menopause) and a decompensation of coping mechanisms may be responsible for what may be a long delay between the time of injury and onset of symptoms. A history of anorectal procedures (eg, hemorrhoidectomy, sphincterotomy, fistula surgery) may frequently be identified in patients with symptoms of incontinence, particularly in men.4,18 This finding contrasts with low percentages of incontinence reported for these procedures,19 reflecting the fact that short-term follow-up may fail to capture the delayed onset of symptoms and determine the true incidence of this long-term complication. The purpose of a detailed medical history goes beyond accounting for obstetric injury, anorectal surgery, or perineal trauma; rather, it aims to recognize contributing or exacerbating factors, such as hygiene habits, diet, medications, GI, or neurologic disorders. The information can direct and prompt a more focused examination.1,3,4 2. Validated measures that assess the nature, severity and impact of incontinence on quality of life should be utilized as a part of the medical assessment for fecal incontinence. Grade of Recommendation: Strong recommendation based on moderate-quality evidence, 1B. A number of scoring or grading instruments have been developed to describe and measure the type, frequency, and amount of incontinence and its impact on quality of life. Fecal incontinence severity has been assessed most commonly with the Fecal Incontinence Severity Index,20 St. Marks Incontinence Score,21 and Cleveland Clinic Florida Fecal Incontinence Score (CCF),22 although other measures of fecal incontinence (FI) such as the Revised Fecal Incontinence Scale,23 Comprehensive Fecal Incontinence Questionnaire, and International Consultation on Incontinence Questionnaire-Bowels module have been developed and validated with improved psychometric properties.24–26 Many of the instruments cited above include lifestyle and quality-of-life questions as part of scoring, which can impact overall scores in patients with similar symptoms. However, there is an incontinence-specific quality-of-life measure, Fecal Incontinence Quality of Life scale27 that is commonly used in conjunction with more general quality-of-life measures such as the SF-36.28 All of these instruments are based on patients’ subjective experience of FI, and none correlate well with objective parameters and/or coping mechanisms. There is also no perfect correlation between any of the instruments and prediction of outcomes for various management options. Nevertheless, the use of these instruments is recommended because a validated measure of severity is helpful in selecting patients for therapies and for measuring response to treatment over time. Patients with more severe symptoms or for whom symptoms severely affect quality of life are appropriate for more aggressive therapies up to and including colostomy. Furthermore, validated assessments facilitate comparison of study outcomes. 3. A detailed physical examination is an essential component of the evaluation of patients with fecal incontinence. Grade of Recommendation: Strong recommendation based on low- or very low-quality evidence, 1C. Elements of a thorough clinical evaluation include external inspection, digital examination, and basic instrumentation.1,4,29 The perianal skin is checked for the presence of stool, skin irritation or excoriation, surgical scars, thickness of the perineal body, the presence of a patulous anus upon spreading the buttocks, or other pathologies such as an external fistula opening or rectal prolapse. Perineal sensation should also be assessed. Triggering a mucosal or full-thickness prolapse may require a Valsalva maneuver, or straining on the commode. Digital examination may provide a rough estimate of anal resting and squeeze pressures, muscle coordination including the use of accessory gluteal muscles, and sphincter integrity. Furthermore, it is important to exclude the presence of a rectal mass, stricture, or fecal impaction, which would suggest other mechanisms for incontinence. Anoscopy and proctoscopy can be useful for identifying anal canal pathology that can contribute to incontinence such as hemorrhoids, IBD, or neoplasms. 4. Anorectal anorectal can be to define the of and Grade of Recommendation: Strong recommendation based on low- or very low-quality evidence, 1C. Anorectal of a number of to 1) measure the resting and squeeze of the anal determine the of the and of the anal and assess the anorectal rectal and rectal the ultimate would be to correlate objective with the of and response to various treatment published reports have a significant of data in as well as patients by FI, regarding anal the do not correlate with the severity of or prediction of they may the management decisions to the individual treatment ultrasound is useful to sphincter defects in patients with sphincter Grade of Recommendation: Strong recommendation based on moderate-quality evidence, 1B. ultrasound is a useful and in the evaluation of patients with FI, there is a history of vaginal or anorectal surgery. can and external sphincter defects that may be associated with sphincter The presence of a sphincter defect is not to a because it may be identified in and However, it has been that assessment and scoring of the of the anal sphincter can correlate with symptoms and (eg, have at this are to ultrasound but they may provide information where ultrasound is nerve may be but has limited impact in the and management of patients with fecal incontinence, and is not Grade of Recommendation: Strong recommendation based on moderate-quality evidence, 1B. The of nerve studies for the management of patients with at best A number of reports have clinical symptoms or with the degree of However, the presence or of be used to outcomes a sphincter and are not found to correlate with outcomes of and nerve damage are in patients who a sphincter evaluation should be performed in patients who the general guidelines or with specific symptoms diarrhea, that Grade of Recommendation: Strong recommendation based on moderate-quality evidence, 1B. a evaluation to the and management of incontinence, is commonly seen in women with incontinence, and evaluation may be to assess the symptoms of include and that may contribute to incontinence and be of or more should be for all other patients to exclude pathology that require 1. and medical management are recommended as therapy for patients with fecal incontinence. Grade of Recommendation: Strong recommendation based on low- or very low-quality evidence, 1C. A evaluation of the patients’ by using a or can and or factors in These may be to the of an a physician The patients should be and to use and to management that for of the impact of these on bowel function and should be directed to the of and other that may result in fecal urgency or have also that to of patients can have in with from a regarding habits, bowel and to of of stool may be addressed by the use of to stool However, in patients with sphincter the of can result in incontinence to and of measures include skin (eg, and as well as and all of these measures are used in these efforts have to be stool and roles in can and sphincter such as by in the particularly in patients with a history of or such as and affect and may the anal sphincter an on and sphincter result in and The risk of and from the use of and may have to be the on an individual A Cochrane review examined trials that used to address by sphincter with or using skin The review that most medical were at diarrhea, no be regarding any of these which is used in bowel was used for because it rectal sensation and It can patients by stool and frequency, although the are not 2. management to in rectal are useful in Grade of Recommendation: recommendation based on low- or very low-quality evidence, the by using or at in a of rectal stool and may the risk of incontinence This measure may be particularly helpful in patients with primary with incontinence, or in patients because of the use of 1. should be as an treatment for patients with incontinence and sphincter Grade of Recommendation: Strong recommendation based on moderate-quality evidence, 1B. or pelvic floor rehabilitation is and a treatment for patients with that have not to medications, and other supportive The is to and although supportive and regarding diet, bowel habits, and skin care important of The objective reported in the has or to in incontinence trials have different of pelvic floor and as well as but there are no trials of to of the studies of using to FI, the and of the studies it to any studies are to the of this treatment of 1. defects such as rectal or fistula in or should be as part of the treatment of fecal incontinence. Grade of Recommendation: Strong recommendation based on low- or very low-quality evidence, 1C. Patients who experience in conjunction or as a result of defects (eg, rectal or fistula in should have those defects because this may frequently or the Sphincter 1. Sphincter may be to patients with a defined defect of the external anal Grade of Recommendation: Strong recommendation based on moderate-quality evidence, 1B. of the of the anal sphincter muscle may the of its because the of the muscle not an of the anal sphincter would result in a However, continence is a complex between muscle rectal rectal and nerve function. A may be than but a in and at least the incontinence symptoms. for defects by obstetric injury have been associated with short-term in up to of have not used to define between different It is however, that the with long-term years, as as 10% to of patients had in most In of these an number of authors have the of in women who incontinence any obstetric and have other treatment such a comparison between these has been reported to date. reports have to factors of outcomes with and results. the of no anorectal be with or was associated with in but not all There has been as to the of measures (eg, or of with in a and function and quality of life over However, studies are to assess this and determine what impact it may have upon treatment outcomes. 2. anal sphincter a should be other treatment are not or have Grade of Recommendation: Strong recommendation based on low- or very low-quality evidence, 1C. of is particularly with an time from surgery. In the of a of factors responsible for sphincter injury from vaginal delivery, are to be more authors have reported that up to patients a result an external sphincter defect can be demonstrated by ultrasound and These are with significant for because the patients for whom the a were sphincter no with are It may be more to and more treatment which can be used in the of sphincter such as nerve 3. of the external anal sphincter is not Grade of Recommendation: Strong recommendation based on moderate-quality evidence, 1B. the number of of a external sphincter muscle is not because it has not any or of 1. of the anal to of fecal incontinence. Grade of Recommendation: recommendation based on moderate-quality evidence, may a for patients with incontinence. 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Grade of Recommendation: Strong recommendation based on low- or very low-quality evidence, 1C. The a and of a The of reported are and a limited number of studies have been very the studies the degree of of the the be and without However, all studies a of which included and anorectal secondary to of from the and A systematic review found that of were at in the or in the later problems such as which has an incidence in is for outcomes. of the rates and of other such as is for patients in whom all other have or those with sphincter incontinence from injury, or significant bowel with anal canal of a 1. of a is an surgical for patients who have or do not to other therapies for fecal incontinence. Grade of Recommendation, 1C. of a at an appropriate is very in the with the primary the of an therapies are not appropriate or have a the patient to and quality of In a of patients with who had a created reported a significant in and of the patients would to have the created are not approved for use in the by the but they are used that a discussion of evidence is 1. nerve may be because it short-term in of fecal incontinence. Grade of Recommendation: recommendation based on low- or very low-quality evidence, nerve is a treatment that of the of to the nerve in The best treatment has not been defined. A limited number of have demonstrated a of 4 from scores and a of 4 per in short-term The overall are with 1 study a significant in at This treatment is not approved for use in the although a has been and are long-term to determine its ultimate in Sphincter 1. data are to the use of the sphincter for fecal incontinence. Grade of Recommendation: recommendation based on low- or very low-quality evidence, A anal is the which of a of with a that is to the anus. The the the to and the anal canal to the use of an or a is created to the external A is used to the proper number of The on this is from studies suggest a efficacy but a rates were not included in these studies and patients were it to determine the efficacy and of this include severe the presence of or of the anus or the This is not available in the but an for use has been and to be it is as a for long-term to determine its ultimate in other have been including of that are not available in the nerve nerve perineal is not available in the and muscle These are not in and a discussion is beyond the scope of this practice or have also been but the use in the These and data are in a review by The American Society of Colon and Rectal A of the Clinical Practice Committee