The American Society of Colon and Rectal Surgeons Clinical Practice Guidelines for the Management of Fecal Incontinence

Abstract

The American Society of Colon and Rectal Surgeons (ASCRS) is dedicated to ensuring high-quality patient care by advancing the science and 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 and develop clinical practice guidelines based on the best available evidence. Although not proscriptive, these guidelines provide information on which decisions can be made and do not dictate a specific form of treatment. These guidelines are intended for the use of all practitioners, health care workers, and patients who desire information on the management of the conditions addressed by the topics covered in these guidelines. These guidelines should not be deemed inclusive of all proper methods of care nor exclusive of methods of care reasonably directed toward obtaining the same results. The ultimate judgment regarding the propriety of any specific procedure must be made by the physician considering all the circumstances presented by the individual patient. STATEMENT OF THE PROBLEM Fecal incontinence (FI) is generally defined as the uncontrolled passage of feces for a duration of at least 3 months in an individual who previously had control.1,2 The prevalence of FI varies widely depending on the specific definition used and the population surveyed, ranging between 1.4% and 18% in women.3–8 A study of bowel function in a primary care network found the incidence of FI to be 12.5%, with many patients reporting moderate to severe FI (Vaizey score more than 8).9 The Mature Women’s Health Study administered an online survey to 5817 women aged >45 years with an 86% response rate and found that nearly 20% of women reported FI.10 Although many women with FI have coexisting pelvic floor disorders, the most bothersome symptoms are most often related to their FI.11 FI in men is not as common and is most commonly because of evacuatory dysfunction and rectal hyposensitivity.12 The highest incidence of incontinence is reported in nursing home populations, in which rates of FI can reach as high as 50%; FI is the second leading cause of nursing home placement in the United States.5 The management of FI is challenging and needs to be individualized according to the severity of symptoms, cause, and coexisting pathology.2,13–17 Aside from conservative and supportive measures, several surgical interventions are available to treat FI with variable efficacy. This practice guideline reviews the medical and surgical options currently available for the management of patients with FI. Treatments for FI that are not currently approved for use in the United States by the Food and Drug Administration (FDA), have become unavailable in the United States, or lack clinical data to support their use are beyond the scope of this guideline. METHODOLOGY These guidelines are based on the previous ASCRS Clinical Practice Guidelines for the Treatment of Fecal Incontinence published in 2015.18 An organized search of MEDLINE, PubMed, Scopus, Cochrane Database of Collected Reviews, Embase, and Web of Science was performed from January 1, 2014, through September 22, 2022. 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”). The 2289 screened articles were evaluated for their level of evidence, favoring clinical trials, meta-analyses/systematic reviews, comparative studies, and large registry retrospective studies over single institutional series, retrospective reviews, and peer-reviewed observational studies. Additional references identified through embedded references and other sources as well as practice guidelines or consensus statements from relevant societies were also reviewed. A final list of 182 sources was evaluated for methodological quality, the evidence base was analyzed, and a treatment guideline was formulated by the subcommittee for this guideline (Fig. 1).FIGURE 1.: PRISMA literature search flow chart. PRISMA = Preferred Reporting Item for Systematic Reviews and Meta-Analysis.Certainty of Evidence The final grade of recommendation and level of evidence for each statement were determined using the Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) system.19 The certainty of evidence reflects the extent of our confidence in the estimates of effect. Evidence from randomized controlled trials (RCTs) start as high certainty, and evidence derived from observational studies start as low certainty. For each outcome, the evidence is graded as high, moderate, low, or very low (Table 1). The evidence can be rated down for risk of bias, inconsistency, indirectness, imprecision, and publication bias. The certainty of evidence originating from observational studies can be rated up when there is a large magnitude of effect or dose–response relationship. As per GRADE methodology, recommendations are labeled as “strong” or “conditional” (Table 2). When agreement was incomplete regarding the evidence base or treatment guideline, consensus from the committee chair, vice chair, and 2 assigned reviewers determined the outcome. Recommendations formulated by the subcommittee were reviewed by the entire Clinical Practice Guidelines Committee. The submission was then approved by the ASCRS Executive Council and peer-reviewed in Diseases of the Colon and Rectum. In general, each ASCRS Clinical Practice Guideline is updated approximately every 5 years. No funding was received for preparing this guideline and the authors have declared no competing interests related to this material. This guideline conforms to the Appraisal of Guidelines for Research and Evaluation checklist. TABLE 1. - Summary and strength of GRADE recommendations Summary Recommendation strength GRADE quality of evidence 1 A history should be obtained to help determine the cause of incontinence and should include specific risk factors for incontinence and characterize the duration and severity of symptoms. Strong Expert opinion 2 Measures that assess the nature and severity of incontinence and the impact of incontinence on quality of life should be used as a part of the assessment of FI. Conditional Low 3 A physical examination is an essential component of the evaluation of patients with FI. Strong Expert opinion 4 Anorectal physiology testing (manometry, anorectal sensation, volume tolerance, and compliance) can be considered to help define the elements of dysfunction and guide management. Conditional Very low 5 Endoanal ultrasound may be useful to evaluate sphincter anatomy when planning a sphincter repair. Conditional Very low 6 Pudendal nerve terminal motor latency testing is not routinely recommended. Strong Very low 7 Endoscopy should be performed according to established screening guidelines and in patients presenting with symptoms that warrant further evaluation (ie, changes in bowel habits, bleeding). Strong Moderate 8 Dietary and medical management are recommended as first-line therapy for patients with FI. Strong Low 9 Bowel training programs can improve rectal evacuation in selected patients. Conditional Very low 10 Biofeedback may be considered for patients with FI. Conditional Low 11 Vaginal mechanical inserts are not routinely recommended for FI. Conditional Very low 12 Anal mechanical insert devices are not routinely recommended for FI. Conditional Very low 13 Anal sphincteroplasty may be considered in patients with a defect in the external anal sphincter, but clinical results often deteriorate over time. Conditional Low 14 Repeat anal sphincter reconstruction after a failed overlapping sphincteroplasty should generally be avoided. Conditional Very low 15 Sacral neuromodulation may be considered as a first-line surgical option for incontinent patients with or without sphincter defects. Conditional Low 16 Injection of biocompatible bulking agents into the anal canal is not routinely recommended for the treatment of FI. Conditional Low 17 Application of temperature-controlled radiofrequency energy to the sphincter complex is not recommended to treat FI. Conditional Very low 18 Antegrade colonic enemas can be considered in highly motivated patients who are seeking an alternative to a stoma. Conditional Very low 19 Colostomy is an option for patients who have failed or do not wish to pursue other therapies for FI. Conditional Very low FI = fecal incontinence. EVALUATION A History Should Be Obtained to Help Determine the Cause of Incontinence and Should Include Specific Risk Factors for Incontinence and Characterize the Duration and Severity of Symptoms Maintaining continence depends on the complex interplay of multiple factors, including anal sphincter and pelvic floor musculature, rectal reservoir function (eg, capacity and compliance), stool consistency, and neurologic function (eg, colonic transit and motility, mental cognition, and sensorimotor function). Although conditions that alter these factors may result in FI, the cause of FI may be multifactorial, and the relative contribution of each factor may be difficult to ascertain. Independent risk factors for FI identified in population-based studies include physical neurologic and and multiple FI is more with bowel or sphincter is in approximately to of all but sphincter may be in up to to of women after patients with a relevant FI is more commonly in women and in patients who had women develop FI, which can difficult to determine the FI is with sphincter or with other factors as pelvic or Additional of FI include sphincter from anorectal (eg, pelvic or or after surgical or treatment for rectal TABLE - of and recommendations using the GRADE Recommendation Strong should the are not to be to help decisions with their and Conditional be for individual patients with their and may be useful in patients decisions with their individual and GRADE certainty The authors are that the effect is to the effect. Moderate The authors that the effect is to the effect. Low The effect be from the effect. Very low The effect is from the effect. GRADE = Grades of Recommendation, Assessment, Development, and with FI have coexisting pelvic floor disorders and may from a For patients with a specific of FI that may be related to pelvic or rectal the FI in this may not improve quality of A history beyond for anorectal or For changes in stool and factors, changes in and and may help the cause of FI. as and can alter stool and and should also be considered when Measures the and Severity of Incontinence and the of Incontinence on of Should Be as a of the of FI A of have to the and of incontinence as well as the impact of FI on quality of FI severity most commonly with the Fecal Incontinence Severity the Fecal Incontinence (Vaizey and the Fecal Incontinence other of FI also have of severity can help for a response to treatment over and of patients with A score of 9 or a of quality of life and is the at which patients commonly medical The Fecal Incontinence is an commonly used in with more as the and is more commonly used in the A by the ASCRS that be in clinical care and regarding patients with FI and recommended the use of a labeled of that the and the the of patients are of these are based on of FI. A bowel that the and severity of FI may help severity and after A of or more in the of per used in FI studies as an of clinical after an Although this is the most commonly used of in trials, not other A an of the Evaluation of FI of a clinical examination include external and rectal The should be evaluated for stool or surgical the of a anus on the or other as an external or rectal The of the should be as patients a or when on the may a or examination may provide estimates of anal the use of and sphincter is to the of a rectal or fecal which other of incontinence. and can be useful for including or that may be to incontinence. Anorectal Anorectal and Be to Help the of and An evaluation of pelvic floor function can be considered in patients who to to conservative anorectal physiology testing not routinely management and as to which are considered Anorectal can provide information regarding anal sphincter and motor function as well as rectal Anorectal physiology testing of a of elements that the and of the anal sphincter, determine the of the and the of the anal and assess anorectal sensation, rectal and rectal statements have recommended for to clinical care and A of 13 studies, including patients with FI and that the of controlled studies anorectal is and that the risk of the literature was Although provide to guide evidence the clinical of is generally For patients who from neuromodulation therapy or or The of may be in by the lack of of the of FI in clinical A to the regarding testing is that may be useful to guide therapy in patients with with and FI may from as as Endoanal Be to When a Endoanal ultrasound is a useful and to a sphincter defect in the of FI, when there is a history of or when a a sphincter repair. Although ultrasound can and external sphincter the of a sphincter defect is not to studies using ultrasound a between sphincter on ultrasound and on anal a study of patients using ultrasound demonstrated = in patients with external sphincter on ultrasound but no in incontinence with FI years after are found to have evidence of a sphincter but the of these not with the severity of their The of ultrasound and pelvic floor ultrasound can of FI, which can with anal sphincter including and rectal but these are not widely as and should be considered when ultrasound is not available or when an ultrasound a sphincter complex in selected Pudendal Pudendal nerve terminal motor latency testing is no routinely Although a of have clinical symptoms or testing with the of the or of not after a sphincter or severe and nerve have reported in patients who incontinent after an sphincter is as to this is relevant or the nerve is a for other conditions related to pelvic floor including or or the lack of clinical testing is not routinely recommended in patients with FI. No studies have published in support of this testing and the 2 more studies not support this for clinical Endoscopy Should Be to Guidelines and in Symptoms Evaluation (ie, in Bowel Although to the and management of FI, is commonly in women with and evaluation may be these circumstances to other symptoms of include and that may be because of or other screening recommendations should be for all other patients to that Dietary and as for FI management is considered first-line therapy because to of patients with FI symptoms after regarding and management and changes to An evaluation of with information a bowel regarding the of bowel the of incontinent and the of incontinent may be when medical management The of this is to and factors in Specific should be directed toward the use and of and or that may fecal or in a patient. medical management of FI on colonic and stool have used to colonic and sphincter of the in stool may be addressed by which and stool A patients who were with or that patients in the their of incontinent to than of that in the and had an in stool medical for FI are by evidence and on the management of and A Cochrane 16 randomized trials that used other than to FI and that as or may of FI in patients with used in these circumstances include (eg, and which in the A of may be in patients with from after or management of FI should also include supportive that provide on (eg, and Bowel Rectal in Bowel management programs from training patients to by using enemas or to more complex the of of or into the and the colon to as or colonic specific devices (eg, and on to is a available for and this most in the population and patients with Although most commonly in evaluated in studies in patients with FI by low or The rate of is evaluated as the of patients because they a reported in of patients with who to may pursue alternative interventions as Biofeedback Be for FI Biofeedback also pelvic floor is a treatment option for patients with FI who have not to and other supportive The of a are to improve sensation, and strength and to provide supportive and regarding bowel habits, and The reported of in the of FI and to be by the of presenting symptoms, cause, and patient Although and retrospective to in FI related to many of the studies have methodological that difficult to regarding the of randomized trials have to treatment as pelvic floor and but there are no to treatment and studies are to determine the of this treatment Vaginal for FI The is a that can be in the in a as to the and provide a to the fecal to improve FI symptoms. In a including patients a and were for FI. 1 of of patients or more in FI In a of the clinical of or more in FI was in of patients at 3 months of 12 months of FI per 2 from a of to and from to Although these results are the available clinical evidence that to of patients are to a clinical with this and clinical evidence is to further evaluate there have no clinical studies of this published Anal for FI Anal inserts for the treatment of FI have in that reported in the most common reported were and The study this reported that of patients a or more in FI This study had no and not any A study assigned patients to treatment with an anal insert = or with neuromodulation and reported a or more in FI in 19 patients with an anal insert to 12 patients with nerve = Although these data provide studies of a of anal insert devices the years have reported or beyond 3 the of these devices for FI Anal Be in a in the Anal but Clinical Anal sphincteroplasty is performed to treat to the anal sphincter because of a Although sphincteroplasty of have with to results in up to of many studies not use to define difficult to and The of anal sphincter reconstruction is that the clinical results often over time. 5 as as to of patients have a in that FI after is have in in the after but these results to by 3 the authors have the of in women who develop incontinence after their and have recommended considering other as data a in the of anal sphincteroplasty performed in the United States from to In a retrospective that patients with an external sphincter defect who sphincteroplasty = neuromodulation = patients who had had a in their score at 3 months = patients who sphincteroplasty not a in score at 3 months = Repeat Anal a Should Be in function after overlapping sphincteroplasty over In patients without a specific factor for of their as sphincter because of sphincteroplasty is to be studies sphincteroplasty reported without A retrospective of patients who sphincteroplasty for FI Although the score from to after is to that patients with a score more than 9 are considered to have severe FI, and patients with this of medical of the patients in this study further for FI and after months of of patients reported a Sacral Be as a for or was approved by the in for fecal and this patients a evaluation after a lead in the or a evaluation with in the patients with at least a in FI their evaluation are In a of studies, a of of patients or more in FI in the (ie, and a of of patients or more at months In a study of patients with at 14 the United States, and of the patients who were for at least 5 at least 1 or the for patient devices and devices with up to 15 years of life are available and may the of because of life but clinical studies to determine this to in the study of 15 patients with the in a single or more in FI in 13 patients at 4 This response was at 6 The best of with is a of clinical factors as the of a sphincter defect or or a history of a previous sphincter do not of For in a retrospective study of patients for FI with the patients who had a sphincter on ultrasound demonstrated to to the patients with an retrospective study the impact of a sphincter on the of patients with external sphincter defect defect = to patients without a sphincter In this patients with an external sphincter defect from a Fecal Incontinence score of 15 to at which was to the patients without a sphincter defect who from a score of 14 to 3 at 12 a of 10 studies including patients with a sphincter demonstrated a in the Fecal Incontinence score from to of reported in patients with sphincter of up to may also improve FI symptoms in patients with A of 10 studies in patients with found a in FI after score a single retrospective study from that for to treat FI was in of patients with on and in 86% of patients without Although these data have not The of for FI may be in women than In a retrospective study men and the and treatment rates were and in men and and in study of patients with at 7 reported that at 10 patients because of a of as of = or = and of = The in men may be because of in of FI as men with FI in these studies were more to have had previous anorectal or low women with FI were more to have had Although there is evidence of there are a studies to other or other surgical randomized that used = with a = and reported continence in of patients and that of patients had at least a there was no in the Injection of the Anal for the Treatment of FI In the approved a for in patients with FI. The this at the was a of patients from and the United In this at of patients in the reported or more in FI to of patients in the = A that of study patients had or more in FI to but in this of patients from 14 at to 11 at months most patients function in this had 2 of the bulking In a retrospective study with of 19 patients with an for FI, ultrasound evaluation that than of the was after 5 and the of these patients had to the over and bulking agents are not considered first-line treatment for FI. Application of to the to FI The of radiofrequency energy for FI was from the treatment for and was approved for this in the evidence this for the management of FI is and relevant studies regarding this without reported in considered to of patients at 12 months based on had in but most not a of or more in incontinence A of patients with radiofrequency energy or a procedure reported that the from to in the treatment and from to in the and there was no in quality of life at 6 retrospective study of 10 patients with radiofrequency energy with 15 years of no in the from = or to on the available radiofrequency energy is not recommended for the treatment of FI. no studies this have published Antegrade Be in an to a data regarding the use of enemas an or a have to the A by published in several therapy for the treatment of or incontinence in In this most of the patients had FI because of anorectal or anorectal the primary was the of patients with enemas at the of the the patients with FI included in the study with to were using enemas at to months of 1 retrospective survey of patients used a and found a in the score at a of Colostomy an for or to for FI When alternative therapies are not or have a may patients with FI to and may improve their quality of In a study patients with FI with a to patients with FI without who had a reported in Fecal Incontinence as = = and = and had to the = in survey of patients with FI with of patients reported a in and of patients that they to have the created who because of their reported to be of the of or and the of or anal

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