Keywords

These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

FormalPara Key Points
  • The history is the most important aspect in planning treatment for fecal incontinence, which includes the patient’s perception of the problem.

  • Health-care providers and patients many times have divergent views as to the definition and severity of fecal incontinence.

  • Quantitative tools of evaluation such as incontinence scores and quality of life scales are helpful when looking for improvement or change after a treatment intervention, but do not replace a thorough history and physical examination.

  • The goal is to improve quality of life—a cure with “perfect” bowel control is usually not realistic. You should emphasize improvement and improvement in quality of life as the goals.

  • There is no one treatment for fecal incontinence. Rather, therapy must be individualized, perhaps combining several methods for optimal improvement.

  • Successful outcomes revolve around you having a clear understanding of the pathophysiology and any associated underlying conditions.

  • While several operative and nonoperative options exist, ultimately a stoma may be the best option for certain patients who fail or are not candidates for these treatment strategies.

Evaluation

Fecal continence is a complex disorder. Controlled elimination of fecal matter and gas relies on a coordination of many facets of physiology to work in concert, automatically, and dependently until it reaches the distal rectum. At that time, human volition intervenes until the circumstances are socially acceptable to expel gas, liquid, or solid waste. Problems at any level of this process can lead to fecal incontinence. This can range from soiling of the anal skin to inability to control flatus to loss of an entire bowel motion—all either with or without knowledge that this horrifying event is occurring. Health-care providers and patients many times have divergent views as to the definition and severity of fecal incontinence. This is highlighted when considering the fecal incontinence severity index, as there are two formulas for determining scores based on whether the surgeon or the patient is completing the form [1]. When the tool was being developed, it was discovered that patients and colorectal surgeons rate and view the severity of accidental loss of solid stool differently. Therefore, all treatment of fecal incontinence begins with a comprehensive history, which must include the patient’s perception of the problem.

History

Key Concept: A critical aspect to accurately determining the origin of fecal incontinence involves a thorough review of the patient’s entire history. This includes evaluating for concomitant pelvic floor disorders that may change your treatment.

A comprehensive history starts with discovering exactly what the patient defines as loss of stool, the frequency, the urgency associated with defecation, and how it affects them. Precise questioning clarifies someone who plans their daily life around their bowels (i.e., does not eat for a day before they go to the grocery store or will not travel due to concerns of stool control) such that they have few incontinent episodes but at the cost of an extremely poor quality of life. It is also helpful to clarify the stool character. Using an aid such as the Bristol stool scale provides an easy visual method (Fig. 13.1; see also Table 20.2) [2]. Questions regarding changes in bowel habits over time (i.e., bowel habits when a teen and then changes during each decade of their life) provide clues to “normal” changes in women’s bowels with aging [3]. Men can also have changes with their bowels as they age, but it many times is not as pronounced as in women. Many women may also experience typical changes during their hormonal menstrual cycle that stress a fragile balance in defecation and lead to gas/stool control issues.

Fig. 13.1
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Bristol stool scale (From Lewis and Heaton [52]. Reproduced with permission of Informa Healthcare © 1997)

Defining exactly when the problem with fecal control occurs is another important clue. For instance, do they feel like they fully empty their rectum (as may be seen when stool is trapped in a rectocele and may leak out after they leave the bathroom)? Do they have soilage or leakage in the first several hours after defecation (again stool trapped in a rectocele or stool retained in the rectum after evacuation)? Do they have loss of stool while sleeping (very unusual)?

Obstetrical history is also crucial, including number/weight of children, unusual presentation at delivery, prolonged labor, episiotomy, or tears of the perineum. Basic language helps to delineate some of these issues, such as asking if the doctor needed to use sutures in the vaginal area. Also most women remember if they had changes in bowel or bladder control after a delivery and if this had fully resolved.

Dietary choices can greatly affect stool quality, and a review of what, how much, when, and changes may elucidate a culprit that can be modified.

Many systemic diseases affect defecation and stool evacuation, especially diabetes, scleroderma, and multiple sclerosis. Also other central nervous system problems, which include back surgery or back injury, may lead to alterations in nerve signals to the intestine and the pelvis and should be investigated. Medications, including some herbal/health food store brands, change stool character, and ascertaining exactly when they were started and the relationship to any perceived changes in stool consistency should be sought. Many patients do not link the two, so careful questioning can assist in this endeavor.

Anal, pelvic, or abdominal surgery may also influence defecation, along with any anal trauma or injury. This would include anal intercourse or sexual abuse—both areas that surgeons typically are uncomfortable to investigate, though are crucial to ask about. Additionally, prior radiation treatment to the pelvis or a congenital malformation in the pelvis should be noted.

A large percentage of women may be experiencing other pelvic floor problems such as urinary incontinence, dysfunctional uterine bleeding, or vaginal prolapse. While these may not directly affect fecal control, your treatment options may be influenced by other pelvic disorders.

As a general rule, questions about alcohol, tobacco, illegal drug use, family history of bowel problems, and general health care (including colonoscopy) are important as they may provide clues that tailor which treatment options would be optimal for an individual patient.

Although not often as publicized, men experience problems with fecal control as well. Life-changing events such as loss of a spouse or divorce (i.e., diet may then have changed after spouse no longer cooks for them) or change in job (additional stress leads to a change in stool character) are particularly important to note along with all other points outlined above that would pertain to men. One study that specifically examined 43 males with fecal incontinence found that 77 % were classified as having fecal leakage and 23 % fecal incontinence [4]. Forty percent of those with leakage had a sphincter defect compared with 70 % in the fecal incontinent group. All patients with leakage improved with lifestyle changes and biofeedback, while 6/10 in the fecal incontinent groups required surgical intervention such as sacral nerve stimulation or other involved treatments. The authors concluded that males with fecal incontinence (versus leakage) had some type of sphincter weakening that typically requires surgical treatment. Table 13.1 summarizes the key elements that need to be discussed during the history.

Table 13.1 Key concepts to be covered when obtaining the history

Physical Examination

Key Concept: A thorough examination involves evaluation of everything from the undergarments and perineal skin to the perineum, including both rectal and vaginal examinations, and abdomen. Validated scoring systems will assist in quantifying and tracking progress.

The physical examination focuses generally on the abdomen and perineum. The abdominal exam generally keys on scars, masses, distension, and tenderness. When looking at the perineum, I first note the underclothes and perianal skin for any signs of soilage, along with any skin irritation (Fig. 13.2) or anal scars over the perineal body or over the anal skin. I typically examine patients in the left lateral position. In women I look in the vagina and note, with strain, any descent of the vaginal wall. I may also digitize the vagina again to clarify vaginal descent or simultaneously digitate the anus and vagina to again clarify descent. I ask them to strain and also note anal descent. When I see that the anal area move 4–5 cm and take on the shape of a bowel, this may be associated with damaged support structures, straining, and defecation problems. While there are patients that have descent and no defecation issues, it is something to keep in mind in combination with the history as clues to the etiology of the fecal incontinence. These patients may not be totally emptying their rectum or have an element of internal prolapse that may be adding to their symptoms. The anal and perianal skin requires close inspection first looking at the length of the perineal body. I ask them to squeeze and look for anal muscle movement. Many times there is excessive buttock movement as patients have gotten into the habit of squeezing all muscles in that region in an effort to avoid the horrifying aftermath of fecal leakage. To determine if they can contract their anal muscle, touching the skin over the anal muscle and asking them to pull only that muscle toward their umbilical area will clarify for them the muscle to contract and allow you to detect anal sphincter movement. On digital anal exam, differentiating between movement of the levator muscle and anal sphincter when squeezing should be noted, as you may be falsely believe the patient has sphincter tone when in fact is coming from higher in the canal. Again asking them to pull the muscle to their umbilical area may assist in detecting anal sphincter movement. Also important is anal muscle fatigue, which may be detected after several prolonged (about 15 s) anal sphincter contractions. For patients with significant fatigue, anal muscle retraining and strengthening is strongly considered as part of the treatment plan. On digital anal exam, a mass, the stool content (and character), presence of a rectocele, and abdominal contents that impinge on the rectum with strain should also be considered. An anoproctoscopy is helpful if there is suspicion of a mass or proctitis.

Fig. 13.2
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This patient has severe anal excoriation from leakage of mucus and liquid stool at her anal verge. The other marks across her skin and buttocks are classic from continuous sitting on a heating pad in an unsuccessful attempt to alleviate the discomfort (Reproduced with permission from Tracy Hull, MD The Cleveland Clinic Foundation Cleveland, Ohio)

Quantitative tools of evaluation such as incontinence scores and quality of life scales may be employed. They are helpful when looking for improvement or change after a treatment intervention. However, they should never replace a comprehensive history. Some form of incontinence tool is mandatory to determine using sacral nerve stimulation, which will be discussed in more detail below. As there are many acceptable tools used for the purpose of fecal incontinence, choosing one that works for you and your office staff and administering the questionnaires before seeing the patient and after treatment interventions will allow familiarity with its nuances and use. One study looked at the current popular tools to score fecal incontinence (Rothenberger, Wexner, Vaizey, and Fecal Incontinence Severity Index) and found the Wexner scale correlated most closely with subjective perception of severity of symptoms by patients [5]. Another study looked at “responsiveness and interpretability” of the Vaizey score, Wexner score, and Fecal Incontinence Quality of Life scale [6]. These researchers felt none of these popular tools attain the high levels of psychometric soundness needed to be recommended as the best tool to use. They also echo the notion previously stated, that what a patient views as important may be different from the physician. While the Wexner score was felt to be the most suitable for severity assessment, they recommended that several tools should be used for evaluation in an attempt to circumvent these issues. An overview of each tool and its pros and cons are beyond the scope of this paper, but an excellent overview was written by Wang and Varma [7], which outlines some of the commonly used tools.

Testing

Key Concept: Testing is meant to augment or clarify findings on history and physical examination. Ultrasonography is my preferential test to help guide therapy.

Testing is individualized based on the history and physical exam. In appropriate patients, a colonoscopy would be ordered. In some patients where I question their ability to control stool, a fiber enema is administered (Fig. 13.3). This consists of fiber (i.e., a packet or large tablespoon of MetamucilR, Citrucel) that is poured into an empty container and mixed with about 50 cc of water and quickly instilled in the rectum before it has time to gel. Then the patient walks around, bends over, and generally has sustained non-strenuous activity for 5 min to determine if they have leakage of this mixture from their anus.

Fig. 13.3
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Fiber enema: a packet of fiber or a large tablespoon is placed in an empty enema dispensing container. An empty Fleet EnemaR container works well. Then about 50 cc of tap water is added, and the mixture is quickly shook and then inserted into the rectum. The goal is to insert the mixture before the fiber has a chance to gel making insertion impossible (Reproduced with permission from Tracy Hull, MD The Cleveland Clinic Foundation Cleveland, Ohio)

The utility of anorectal physiology testing was questioned by our center and found not to correlate with incontinence scores [8]. Also ultrasound findings did not correlate with manometry results. We felt that preoperative anal manometry and endoanal ultrasound should be used to guide treatment, but improvement after an overlapping sphincter repair should not be assessed by changes in manometry pressures. This somewhat contradicts data from another unit; however, their aim was somewhat different. They looked at whether anal manometry could separate those patients with fecal incontinence from healthy individuals [9]. They found that patients with fecal incontinence had lower rest and squeeze pressures and lower urge sensation along with a higher volume of first sensation pressures. Overall they found that single studies were not helpful, but the entire panel of anal physiology studies had excellent sensitivity, moderate specificity, and convincing accuracy.

My feeling is that overall anal physiology testing may guide therapy, but I am not sure it is always needed. We rarely order needle EMG looking for neurological damage as it has not proved useful in guiding treatment. Perhaps looking for a sacral reflex before considering sacral nerve stimulation may be a consideration. I am also not sure that pudendal nerve terminal motor latency offers much assistance. Previously we used nerve prolongation, particularly bilaterally, to counsel patients that results after sphincter repair most likely would be poor. However, I have seen patients without prolongation of their pudendal nerves when tested, where absolutely no anal muscle moves when I ask them to squeeze on physical exam. Anal endosonography on the other hand provides a useful road map when considering treatment, and I usually rely on this test (making sure I perform it myself or know that the endosonographer is experienced in accurately depicting sphincter defects). Our unit still typically orders anorectal physiology on most patients because we maintain extensive databases that we may use in future studies; however, we only use the data to selectively counsel patients. For instance, a patient with a low maximal tolerated volume and low anal pressures may not achieve the expected short-term benefit from an overlapping sphincter repair. We would use this information to preoperatively discuss expected outcomes with the patient and aid in navigating the treatment plan. While pelvic magnetic resonance imaging is a consideration instead of or with anal endosonography, I am not convinced it adds enough information to justify the expense. I do not routinely order a defecating proctogram unless there is an accompanying problem with stool expulsion during defecation. Dudding and Vaizey wrote an excellent overview of testing for fecal incontinence and other pelvic floor disorders, and the reader is directed to this review for more in-depth descriptions of the various tests [10].

Treatment Options

Key Concept: From the very beginning, set realistic expectations with your patient and ensure they understand this may involve several different treatment modalities.

The next step in management involves an individual treatment plan for the patient. This does not encompass only one intervention, but could involve several combined modalities customized for the patient and revolves around a clear understanding of the pathophysiology and underlying conditions. Fecal incontinence should be viewed as a chronic disease like diabetes or hypertension. Similarly, in these chronic diseases, several treatment modalities may be needed for optimal control of the disease process and optimization of the patient’s quality of life. Similarly management of fecal incontinence is a long-term notion, and adjustment in the treatment plan will be necessary as needed. This also involves setting realistic expectations for the patient and the surgeon (i.e., some health-care provider must be prepared to assist and manage this patient long term). Society typically views defecation issues as voluntary (i.e., mind over matter) which adds to unrealistic goals determined by the patient. Therefore, attaining “perfect” bowel function may not be a realistic goal, and the health-care provider should emphasize improvement and improvement in quality of life as the goals.

Conservative Management

Key Concept: Almost every patient will require medical management, which typically involves dietary supplements and one (or more) of several classes of medications.

Most treatment plans include some element of conservative management. Any issues with loose or soft stool can contribute to problems with control. Evaluation and treatment alone of diarrhea (or just loose stool) can sometimes greatly improve the patient’s situation. These include fiber supplementation (taken with the least amount of water) pectin, and medication. Loperamide is a typical medication used, and instructions for use must be carefully discussed as the instructions on the package may not be appropriate for each patient’s problem. Depending on the pattern of defecation, perhaps starting with one pill/capsule (2 mg) each morning could be the initial recommendation for this medication. The goal is titration to avoid fecal incontinence but not too much that produces constipation; however, this may not be possible. If one pill is too much, the liquid form administered to children can be used so the dose can be decreased. Also if constipation is an issue, using the medication every other day or every 3 days per week may allow therapeutic benefit for the incontinence without precipitating constipation.

Skin irritation frequently accompanies fecal incontinence or may even be the true reason a patient seeks medical assistance. Counseling regarding skin care therefore is also part of conservative treatment. Barrier creams that typically employ zinc (such as CalmoseptineR, Calmoseptine, Inc., Huntington Beach, California) and lanolin (make sure they are not allergic to wool) may be lathered onto the anal skin like frosting (i.e., a thick layer). Patients should place these creams up to the dentate line for complete protection. They may stain underclothes, so patients should be warned of this possibility. Antibiotic ointments are rarely required, and occasionally an antifungal powder may need to be dusted on the skin if Candida is detected. This can be applied using a cotton ball (dusted over the barrier cream) and then leaving the cotton ball by the anus to wick away moisture (similar to cotton socks used in athletic activity). Since anal irritation may lead some patients to feel that their anal area is unclean, they may wipe that region excessively (similar to polishing furniture but instead polishing their anus). Advising them to wipe with unscented baby wipes or wet paper towel and avoid using soap and a washcloth in the shower along with minimal wiping after defecation can aid in improving anal irritation from excessive wiping.

Dietary manipulation may be advised if certain foods lead to loose, urgent, or uncontrolled stools. A food diary that corresponds to incontinent episodes may clarify offending foods. Fresh fruit and vegetables can make stools loose and add to urgency. Many patients have concerns with excessive or uncontrollable flatus. A low carbohydrate diet may reduce flatus. While many anti-gas (over-the-counter) medications can be recommended, many patients find these unhelpful with flatal incontinence. For severe problems with excessive flatus, an intermittent short course of antibiotics (rifaximin [XifaxanR] is a popular choice) can be prescribed, but many effective agents are very expensive. Metronidazole is another choice that is less expensive, but side effects such as an Antabuse effect, tin taste in the mouth, or peripheral neuropathy must be considered before prescribing. These agents will change the flora and decrease intestinal gas temporarily. Therefore, the medication must be repeated with the goal of the least days per month possible to attain relief. One way I advise taking antibiotics for this purpose is 1 week out of every month, which in my experience seems to adequately reduce issues with excessive flatus. Probiotics also are helpful for some patients with excessive gas issues.

Since a lot of information may be recommended regarding conservative therapy, it is extremely helpful to give precise written instructions for skin care and bowel-altering medication so the patient has exact instructions to follow and does not need to rely on memory to implement suggested changes or treatment. Since it is important to individualize the treatment, we do not use standardized forms and actually type out the instructions that are also filed in their chart.

For some patients with leakage, especially when it seems to occur directly after they leave the bathroom, a tap water or rinsing enema after defecation will eliminate any retained material and alleviate the problem. While many patients do not prefer this approach, if explained in a positive light and the patient successfully uses this treatment, they may change their mind. I typically recommend that an empty phosphate soda enema container be used (they can use the actual phosphate enema for irrigation rather than discarding it, then the container can be filled with water and used five to eight times again before the material cracks). Alternatively, a large catheter can be used to instill 50–200 cc of tepid tap water. I emphasize it is like “rinsing” out the rectum.

For some, a large volume water enema may be needed if they are using this treatment for more than minor leakage. For those patients, my nurse will discuss using a large volume enema consisting of 500–1,000 cc or water. This is delivered via a 28-Fr Foley catheter (as this has a 30-cc balloon that can be inflated if necessary) (Fig. 13.4). The fluid is placed in a tube feeding administration bag as this has a valve to regulate the inflow of fluid rather than straight tubing which otherwise allows the liquid to run in quickly. The catheter must be well lubricated and this is emphasized. We ask them to start with 500 cc and increase the amount weekly over 4–6 weeks. They are also counseled to allow 45–60 min to perform the irrigation and evacuation daily. It also tends to be more successful if performed at the same time daily (typically in the early morning). Encouragement and patience is provided by my nurse, and this seems to enhance success with this treatment. An extension of this thought process is the antegrade continence enema. A surgical procedure is performed where the appendix or a tapered segment of terminal ileum is brought to the surface to form a flush stoma about the size of a 10-French catheter. Water is instilled via the small stoma, which then flushes out the entire colon via the antegrade approach. While this therapy tends to be more popular in the pediatric population, selected adults are quite satisfied doing irrigation by this method.

Fig. 13.4
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For a large volume enema, a 28-Fr Foley is lubricated and inserted into the anus. For patients who cannot retain fluid, the balloon can be inflated with up to 30 cc and pulled back to rest against the pelvic floor. Then 500–1,000 cc of water is placed in the bag. Tubing connects the bag to the Foley. There is a control valve on the tubing. Fluid can be instilled under direct control of the patient via the control valve into the rectum and left colon (Reproduced with permission from Tracy Hull, MD The Cleveland Clinic Foundation Cleveland, Ohio)

Other Therapies

Key Concept: Progressively invasive treatment options are available. Each has its own strength and weaknesses, depending on the severity of incontinence and underlying pathology.

Physical Retraining (Biofeedback)

Physical retraining of the pelvic floor is also a treatment that may improve the patient’s situation (and does not worsen) and should be considered. It is important to be alert to the fact that some insurance companies will not reimburse for this treatment. Also a therapist (whether a physical therapist, nurse, or other interested health-care provider) may not have specialized specific training for pelvic floor issues and may not provide the most optimal teaching. The Cochrane review done by Norton and Cody identified 21 studies with a total of 1,525 patients [11]. They found severe methodological weaknesses in nearly all studies reviewed but concluded that perhaps some portions of biofeedback and sphincter exercises may have therapeutic effect. The authors emphasized that this was not definitely shown in their review and larger well-designed trials were needed.

Anal Plug

For minor leakage, the anal plug may be considered. The recent Cochrane review looked at four studies of 136 patients [12]. They noted that the rate of intolerance or ineffectiveness from reviewed studies was 35 %. In the short-term (not considering any long-term results), anal plugs, when tolerated, could provide continence. They also noted that overall satisfaction was better when polyurethane plugs were used versus polyvinyl-alcohol plugs. Experience worldwide with plugs is limited. This device should be considered in patients with minor leakage, but dislodgement or intolerance is an issue. They can be obtained in various types, designs, and sizes. Insurance coverage may be limited. They also may be considered as part of a larger treatment plan for a patient.

Radiofrequency Energy (RFE)

Radiofrequency treatment of the anal sphincter has been available for over a decade and is administered per the SECCAR machine and protocol (Figs. 13.5 and 13.6). Two recent studies have looked at its effectiveness. One study looked at pre-procedure and 1-year changes in the Wexner score [13]. Mean improvement from 15.6 to 12.9 (p = 0.035) and mean improvement in 3 of 4 Fecal Incontinence Quality of Life subsets were found. There were minimal complications, with 3 limited episodes of post-procedure bleeding. Another study of 27 patients found a sustained long-term response in 22 %, but 52 % of patients required additional treatment interventions at a mean follow-up of 40 months [14]. We have offered this treatment to select patients with mild-to-moderate fecal incontinence and an intact sphincter. How this will fit into our algorithm with the approval of new therapies will need to be determined. We have had minimal complications, and reimbursement, overall, has not been an issue; therefore, it can be considered when few options exist. One note of caution, use of RFE after a patient has been treated with an injectable agent has been discouraged. The theoretical concerns are that the needles would be deployed into the injected implant and have no effect on stimulation and heating of the connective tissue in the anal region. Also the potential for infection of the injected implant has also been raised as a possible complication. I am not aware of any studies definitively reporting this as happening, but this possibility has been raised and should be acknowledged. Therefore, if the use of RFE is being contemplated, its use should be considered before treating with an injectable agent.

Fig. 13.5
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The handpiece for the SECCA® procedure shown with the needles deployed. The handpiece is inserted in the anal canal starting at the dentate line and the four needles deployed into the tissue. Radiofrequency is then delivered for 90 s. The needles are retracted and the probe is rotated 90° and the process repeated until all four quadrants are treated. Then the probe is moved 5 mm proximal, and those four quadrants are treated. The process starts at the dentate line, and typically, there are 4 rows of treatment (Reproduced with permission from Tracy Hull, MD The Cleveland Clinic Foundation Cleveland, Ohio)

Fig. 13.6
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Shown is the handpiece inserted in the anal canal with the attachments (Reproduced with permission from Tracy Hull, MD The Cleveland Clinic Foundation Cleveland, Ohio)

Injectables

Key Concept: While preliminary results have shown success in small studies, several questions remain regarding the ideal substance, technique, and population. I prefer to use it in mild-to-moderate incontinent patients with a thinning or fibrotic internal sphincter complex.

There are over ten different materials that have been reported as injectables into the anal region for fecal incontinence. The Cochrane review of this subject highlights the diversity of this material, along with the lack of well-designed studies, prohibiting these authors from making definitive conclusions [15]. This was echoed in a review of 13 case series and one randomized controlled trial, in total involving 420 patients, by Luo and Samaranayake [16]. These authors also concluded that future appropriately designed randomized controlled trials with large study populations and longer follow-up are needed to truly evaluate injectables.

The only injectable that has been Food and Drug Administration (FDA) approved in the United States is dextranomer in stabilized hyaluronic acid (NASA DxR). In the randomized monitored study for FDA approval, 52 % of patients being injected had >50 % reduction in fecal incontinence episodes compared to 31 % of those receiving a sham injection who reported the same degree of improvement [17]. The high degree of improvement in the sham group is curious, but placebo treatments for fecal incontinence for unclear reasons seem to have up to a 30 % improvement rate. These results were sustained at 36 months, and all of the quality of life scores showed significant improvement at 36 months [18]. This is a safe procedure with minor bleeding being the most common complication although 2/278 patients in the FDA-monitored study developed an abscess (one rectal, one prostatic) [17].

Besides the lack of sufficient data to guide treatment, other controversies surrounding injectable agents involve technique. Currently, there are seven different techniques found in the literature to administer the agent. The procedure typically involves one cc of this material injected into the submucosal space in four areas at the top of the anal canal. While many inject in the submucosal space, the intersphincteric space may be better. Yet, there are several additional questions that remain unanswered. Would the use of ultrasound to guide injection be superior to blinded injection? This procedure is typically done in the outpatient setting, but would the results improve if done in the OR? Additionally should the needle go through the anal mucosa or be inserted from the perianal skin to the target location? The size of the needle is typically 21 gauge, which seems necessary as the material is quite viscous and difficult to push through the needle. However, is this size of needle correct, as some of the material can be seen oozing out of the injection site at times after the treatment? The exact optimal patient who will benefit from this treatment is also unclear. Some of the patients in the FDA-monitored trial had severe fecal incontinence [17], but would patients with mild-to-moderate incontinence or leakage be better candidates? Also can injectable material be used to augment a defect in the internal sphincter (such as after a lateral sphincterotomy that has leakage) or a divot in the smooth contour of the anal canal, which is leading to leakage? All these questions surround using this material.

Our practice continues to be performing this procedure in the outpatient setting. We target patients with mild-to-moderate fecal incontinence. Also we would offer this to a patient with internal sphincter thinning or fibrosis as seen on anal endosonography. The patient receives a phosphate enema before and then is typically positioned in the left lateral position. Using a long beveled anoscope, Betadine is swabbed in the anal canal (a plain wet swab is used if the patient reports an iodine sensitivity that is concerning). The nurse steadies the anoscope after it is placed in position. The physician steadies the needle with one hand and injects with the other. The material is injected about 1 cm cephalad to the dentate line. We use digital guidance to inject in the submucosal space in four quadrants and turn the needle a quarter turn before withdrawal in attempt to prevent material leakage. Postoperatively, we do not issue any restrictions in activity and give advice on keeping stools soft. We ask patients to call immediately if they have pain, bleeding, or fever.

Sphincter Repair

Key Concept: Sphincter repair still plays a role in the management of incontinence, though long-term results remain disappointing. Preoperative biofeedback may be considered to improve results.

For patients with an anterior sphincter defect, typically from childbirth trauma, an overlapping sphincter repair has been advocated. The initial enthusiasm for this operation has been tempered with the realization that long-term results tend to be abysmal [19]. A systematic review of 16 studies with nearly 900 patients concluded worsening results over time with no predictive factors identified [20]. Technical factors have been blamed for these poor results, but even with verification of an intact overlap, the long-term results remain poor. Even when pudendal nerve terminal motor latency is not affected, the results tend to be disappointing. The exact reason remains elusive. Since some women have no issues with fecal control until years after the delivery trauma, there may be intrinsic damage to the sphincter besides the structural damage. Hence, when a sphincter is damaged during childbirth, the scar and fibrosis may eventually interfere with optimal function even if the sphincter has been repaired and the repair remains intact.

In many countries sphincter defects are not repaired in favor of sacral nerve stimulation. However, there may still be a place for this procedure. It is a relatively easy procedure, requiring no extra equipment, lower cost than many other procedures for fecal incontinence, and can be performed globally in any OR. In a young woman who has a significant symptomatic childbirth injury, our unit prefers a sphincter repair as the initial recommended treatment. Additionally, many women may be averse to having a permanent device implanted (sacral nerve stimulation or artificial bowel sphincter) at a young age. Full disclosure regarding the possibility of poor long-term results is also part of the preoperative discussion. Another consideration is that many women who have had fecal control issues for any length of time have forgotten how to contract their anal sphincter muscles. They may pull their buttocks together to avoid stool loss. Therefore, planning some lessons regarding anal sphincter movement (physical therapy retraining) before the repair and then after the surgery has healed may be beneficial.

In an attempt to improve long-term results, our center proposed using a biological graft to reinforce the two overlapped ends [21]. In a pilot study of ten women, there were no complications. These patients were compared to ten matched patients who had undergone a traditional overlapping repair. At 1 year, significant improvement in continence and quality of life was seen over baseline and compared to results from traditional repair. The question is whether these improvements will be sustained as these patients age and that will require long-term studies.

For young women who have an obstetrical injury, timing is frequently questioned. If we see them within weeks of the injury, it is important for the tissue to fully heal before any repair is attempted. This typically takes 3–6 months for the scar to become soft and pliable. For women who desire more children, the questions comes up regarding repair now versus waiting until after they have finished having all their children. This is discussed extensively with the patient along with the infringement that the fecal incontinence has on their quality of life. It is unclear if waiting versus immediate repair makes a difference, so it is a decision that the patient will make. However, if they have more children, they should still have a C-section to avoid further injury to their anal muscles. I have seen women with a sphincter injury who defer repair and then have another vaginal delivery. On many occasions they return with worse problems such as no muscle movement in their entire perineal area or further injury of the muscle complex.

I prefer a full bowel preparation before this procedure and the prone position. However, successful results have been accomplished without a bowel prep or in the lithotomy position. A Foley catheter is inserted. For the procedure, typically a transverse incision is made across the perineal body. The ends of the muscle must be dissected out to allow overlap. There is some literature that end-to-end repair may be superior [22, 23], but I still prefer a careful overlap using 2-0 polydioxanone. While the internal and external muscle can be separated and repaired individually, I prefer to overlap them together in bulk. Another unanswered question is if a levatorplasty will improve the longevity of a repair. A word of caution regarding the levatorplasty is that it may lead to a bridge of tissue across the vagina and dyspareunia. Therefore, I will add a levatorplasty if it does not narrow the vagina, lead to a bridge of tissue that feels like a tight band across the posterior vagina, and not require extensive further dissection of tissue. I take special precaution when raising the flap of anorectal skin and mucosa to avoid making the flap too thin (or it will become ischemic) and also avoid using excessive trauma with pickups, which would pinch this fragile area. Irrigation with antibiotic solution is used throughout. The horizontal incision is closed transversely over the anal sphincter and vagina. I typically will leave the central portion open for drainage. Invariably the wound rarely heals in a straightforward manner when the skin is closed. The most important thing is to make sure there is an outlet for drainage of any fluid that may be trapped or is a transudate into the deep wound area. The goal is to avoid drainage into the anal area that could lead to a fistula or destroy the muscle repair. I try to make the environment such that the fluid drains out the perineal area or closer to the vagina. Drains are used selectively (by me, although one of my partners always uses a drain) particularly if there is a lot of dead space. In the postoperative period up to about 3 weeks, if fluid becomes trapped beneath the repair, it is crucial that it is evacuated to avoid an abscess. To this end the wound is examined if possible on a weekly or 2-week basis in the outpatient clinic to ensure fluid does not become trapped. After the surgery, if possible I admit the patient for 1–2 days. Many insurance companies will only approve 23-h stay, so adjustment to this time frame is needed.

There is no clear evidence as to postoperative care, so experience- versus evidence-based approach is taken. I administer IV antibiotics while the patient is hospitalized and then oral antibiotics for 5 more days. Women prone to vaginal yeast infections also are given an oral antifungal agent during this time. Postoperative bowel management is crucial and often neglected. Besides exogenous fiber and a regular diet, I ask patients to ingest 30 cc of mineral oil daily, warning them that they will have an orange discharge on their underclothes. If they do not have a stool by 3 days after starting an oral diet, then they are advised to take milk of magnesia, one ounce twice daily until they stool. I prefer very soft stools versus a hard stool bolus that is difficult to pass. They can take a shower, but no baths or sitz baths to avoid excessive skin maceration for 2–3 weeks. Leaving the anal skin incision open over part of the perineal body infers that it will heal by secondary intention from the bottom up. Warning patients that the wound may be open for 4 weeks and they may note blood with wiping or on their underclothes avoids alarming calls by patients. I allow them to walk and sit on the first postoperative day and also ask them to avoid lifting over 20–25 lb for 4–6 weeks as lifting or excessive exercise inadvertently will bear down on the pelvic floor and may put pressure on the repair. I also ask them not to sit on a doughnut to avoid pulling the buttock cheeks apart and hence pull on the repair.

Artificial Bowel Sphincter

Key Concept: While still plagued by increased complication rates, ABS may be an option for select, motivated patients. Several technical tips are useful to minimize the morbidity associated with ABS implantation.

There is still a place in the surgical armamentarium for the artificial bowel sphincter. This treatment may be offered to patients born without a functioning anal muscle, those that have traumatic loss of the anal muscle, or those that fail or are not candidates for other treatments. Even after the learning curve, this procedure has a significant infection rate, reported to be around 40 % in two single-institution studies [24, 25]. One unit that divided their cases by experience reported a 50 % failure rate for the first 12 cases but 80 % success in the last 25 [26]. Most recently this center reported implantation via the vaginal approach and a 22 % rate of adverse septic events in 32 patients. Of note, these were in women with severe damage and scarring of the perineum, and a vaginal approach was chosen due to concern regarding the feasibility of implantation via the perineal route [27]. Whether routine transvaginal implantation in women will improve results will need further study. Even with the high complication rate, up to 50–70 % can achieve success—defined as an activated working device and improved continence [25, 28] in centers with experience in implantation. Additionally, all studies report significantly reduced fecal incontinent episodes and improved quality of life in those with an activated device [2528]. One further issue noted in patients with an activated device may be empting difficulties reported in 28–57 % [26, 29]. This may be due to a new “dam” on the rectum where it was freely open to evacuate before or overall congenital problems affecting rectal function.

I continue to offer this treatment to appropriate patients. I discuss in depth the issues of infection, complications, and explantation. While these are serious issues, they are almost never life-threatening. I also discuss the problems with evacuation that require considerable counseling and typically laxatives or enemas to ensure adequate evacuation. The device initially is not activated after implantation to allow all wounds to heal. During this time, I still recommend 30 cc of oral mineral oil to prevent impaction as the device itself coupled with postoperative swelling and use of narcotic pain medication may lead to new evacuation problems. If a patient has uncontrollable diarrhea, the mineral oil is discontinued, but otherwise I recommend that it be continued for two more weeks beyond the 6-week mark when I activate the device. I find in patients with severe fecal incontinence, especially when a stoma is their only alternative, the high failure rate does not deter them regarding this device.

Some technical tips that I have found helpful include, during the procedure, employing two teams for implantation, one for the perineal portion to implant the cuff and the other team for the abdominal portion to implant the pump and balloon. There has been speculation that this will reduce rates of infection, and while I do not know if this is true, it does reduce the operative time. I make sure the cuff around the anus when in the open position is just barely snug when buttoned, but not too tight to help lessen evacuation problems. I also insist on an experienced company representative being present with entirely new inventory in every size of each part of the device for several reasons. Since limited numbers are done in a year, I do not like to use inventory that has been on our hospital shelf for an extended period of time. At one point in my past experience, I had difficulty activating the pump on three consecutive cases, and it was theorized that shelf stock, which was up-to-date but not new, may have been the culprit. I additionally want an experienced company representative present to answer the multiple questions that nurses usually have about preparation of the device. This is a complex procedure with many steps, and even the experienced nurses will not be involved in many cases per year. I use a full bowel prep before the surgery, as one study showed that an independent risk factor for infection was short time from implant to first bowel motion [24]. Patients receive IV antibiotics before the implant that cover gram-negative, gram-positive, and anaerobic bacteria. They continue these antibiotics until discharge, which can be up to 5 days in the hospital. They then go home on oral antibiotic to total 10 days IV plus oral. The night before the procedure, they also wash with antiseptic soap. Women are cautioned not to shave their pubic hair for 5 days prior, and in the OR, hair is clipped and not shaved over the suprapubic region. Ice packs are used on the perineal wound for 24 h postoperatively, and bacitracin topical ointment is applied to the perineal wound directly after surgery and for the first week.

If an inadvertent opening is made in the rectum while developing the plane anterior to the rectum for cuff placement, then the insertion is abandoned. To attempt to avoid this situation, the rectovaginal septum in women or anterior anal area in men must be developed deeply enough (I prefer ~6 cm) to allow subcutaneous tissue to easily cover the device and be closed in layers prior to skin closure. If a vaginotomy occurs, in selected situations if I can place the device well cephalad to the vaginal opening, and the vaginotomy is repaired and then the anal cuff inserted. All skin incisions are closed in layers with polyglactin suture. I also irrigate the perineal wound with antibiotic irrigation during the procedure. Placement of the cuff from the abdominal incision into the labia or scrotum can be difficult. It is crucial to develop the tract via the abdominal incision with a large Kelley clamp and make it large enough to allow the device to easily slide to the desired level of the scrotum or labia. The activation button should be turned to face laterally, and the tissue just cephalad to the pump is snugged down with a suture to ensure the pump does not migrate toward the abdominal incision or change orientation. Care is taken when placing this suture to avoid needle penetration of the tubing. Which side to place the pump is chosen in the office preoperatively with the patient’s input to ensure ease of manipulation of the pump with their preferred hand. Morbidly obese patients that cannot reach their labia or scrotum or patients with debility in hand coordination should be cautioned against an ABS.

Long-term activity restrictions are controversial. I ask them to avoid riding a bike but otherwise have not been restrictive. Avoidance of anal intercourse is also discussed.

Sacral Nerve Stimulation (SNS)

Key Concept: SNS has an evolving role in these patients. The ability to observe improvement during a test phase makes this is an attractive alternative.

While considerable experience has been reported since 1995 with sacral nerve stimulation (SNS) for fecal incontinence, it is one of the newer modalities available in the United States being FDA approved in 2011. The exact therapy has been used for urinary incontinence for the past two decades, and there is extensive data published in that arena. A unique aspect to SNS is that the device can be tested as stage 1 of a two-stage procedure to assess improvement before a permanent device is implanted (Video 13.1). Stage 1 can be done in two ways. Currently in the United States, a tined lead is inserted (typically in the S3 sacral foramina under fluoroscopic assistance) and connected to a temporary neurostimulator device. If there is a reduction in 50 % of incontinent episodes, then this lead is disconnected from the external neurostimulator device and a new connection is performed to a permanent neurostimulator device that is implanted in the subcutaneous fat of the upper buttock region. If there is no improvement, the lead can be removed. In many centers outside the United States, and gaining in popularity with urologists worldwide, is the alternative stage 1 method called percutaneous nerve evaluation (PNE). For PNE a temporary thin wire is threaded into the S3 foramen and secured at the exit site with tape onto the skin. It is connected to the same temporary neurostimulator device, and the patient is monitored for improvement in fecal incontinent episodes. If therapeutic success is reached, the temporary wire is removed and the permanent lead and permanent neurostimulator is implanted as the second stage of the procedure. This can occur at a later date after the PNE wire is removed.

At this point, I do not find the latter method as attractive because the PNE wire can easily become dislodged and the therapy deemed unsuccessful. Also the implanted tined lead may not be exactly in the same position as a successful PNE wire and that also can lead to failure when the permanent device is inserted. The popularity of PNE is related to the fact that it costs less to insert and can be removed easily. If successful, the plans for placement of the permanent device can be readily scheduled or delayed to the far future. With the permanent implantation of the tined lead during stage 1, the lead should be internalized or removed within 2–3 weeks to avoid infection. Compared to the ABS, the infection rate overall is less and reported to be 11 % in the monitored study for FDA approval in the United States [30].

Recently, success for therapies involving fecal incontinence has been defined as 50 % reduction in fecal incontinent episodes, which concurs with FDA requirements for approval in the United States. It is debated whether this truly improves a patient’s suffering with fecal incontinence, but most results are reported in this fashion. In the multicentered prospective study conducted under a strict protocol for FDA approval mentioned above, 285 patients were screened and 133 met criteria for stage 1. Of those, 120 were successfully implanted during stage 2. At 1 year, 83 % had >50 % reduction in incontinent episodes [31], at 3 years 86 % [32], and at 5 years 89 % (p < 0.0001) [33]. Overall, approximately 40 % were totally continent at these time points. Looking at the data another way, the number of incontinent episodes per week at baseline before this treatment was 9.1. At 1 year it dropped to 1.9 [31] and 1.7 at 5 years (p < 0.0001) [33]. At 5 years, 44 patients had left the study, but only 15 exited due to lack of efficacy or patient-related issues with the device [33]. Quality of life was also found to significantly improve and remained sustained over the study period [34]. Overall, these results mirror other reports from centers outside the United States regarding the improvement in continence and quality of life [3538].

Improvement is also seen when studies are done that include patients with an anterior sphincter defect [39]. Based on relevant studies, a consensus panel felt SNS could be offered to patients with 120° external sphincter defect [40]. Additionally this panel felt SNS was a good option to treat patients with combined fecal and urinary incontinence.

Unsolved issues in implantation include use of antibiotics. There are many protocols used by various centers. After an informal poll of urologists at our institution and various centers implanting SNS, we have elected to use cefazolin (AncefR) for stage 1 and vancomycin and gentamicin for stage 2. Another unsolved issue is whether or not to impose activity restrictions in the immediate postoperative period and long term. While we do not advise any long-term restrictions, after stage 1 we ask them not to shower, reduce physical activity to avoid pulling on the wire or dislodging it, and keep the device beneath clothing.

Controversies in Fecal Incontinence Management

Does Age Influence Choice of Treatment?

All treatment for fecal incontinence should be individualized and tailored to the patient. Generally, as stated above, we have advised young women with an obstetrical injury to have their sphincter repaired as the initial procedure. However, this may not be the recommendation at other centers—particularly outside the United States. When compared to younger patients with a median age of 38 years, older patients (median age 56) reported subjectively worse outcomes and tended to have worse incontinence scores and quality of life measures [41]. This study was based on a postal survey, which had a 55 % useable response rate and no preoperative scoring tool as a comparison. The introduction of injectables and SNS may change the algorithm, but anecdotally I have performed a sphincter repair on a woman in her late 80s with a satisfactory result. I prefer to look at their physiologic status and their stool and bowel consistency. In a woman with no muscle movement and typically loose stool that cannot be improved, I feel will fare poorly with a sphincter repair—particularly if older. Alternatively, whether SNS will be offered to older patients (older perhaps meaning in their 80s) remains to be defined. For an active patient, I believe age will not be the limiting issue.

Repeat Overlapping Sphincter Repair

Repeat overlapping sphincter repair is a feasible option when a defect is identified on anal endosonography. With US approval of SNS and injectable agents—combined with the realization that a sphincter defect does not preclude “success”—a repeat repair does not look as attractive. If they are eligible for SNS, I would favor that treatment.

Managing Expectations of Outcome

Perhaps one of the most important aspects of working with patients who experience fecal incontinence is setting realistic expectations. The notion of perfect continence like they probably experienced in their youth is rarely obtained. The goal should be improvement, particularly in their quality of life. Attempting to fully explain in layman terms the advantages and disadvantages of each procedure is challenging; therefore, most patients will rely on our assessment of their individual problem and our recommendation for improvement. Again, the concept that a combination of procedures may be necessary for improvement, and viewing incontinence as a chronic disease requiring lifelong adjustments, should be introduced.

What Findings on Testing Influence Certain Choices?

The history and physical exam is usually the most important determinant in providing a tailored treatment option. The most important test is usually anal endosonography because a defect in the muscle may influence what is recommended.

I may be hesitant to recommend SNS for a patient who has had a traumatic pelvic injury and hence no spinal reflex, but that again is not definite, as the first stage can be done to look for a response when the sacral foramina are stimulated.

For patients that seem to have a component of irritable bowel syndrome and fecal incontinence, SNS may be the preferred recommendation. We do not know how SNS truly works, but an intriguing study showed that chronic stimulation seems to affect the learning and reward center of the brain [42]. This potentially could have a positive effect on the mechanism of irritable bowel syndrome, but definitely more studies are required to confirm these thoughts.

Is a Stoma Ever the Best Option?

Absolutely! For some patients a permanent stoma is their best option—they may simply not want to hear or believe that. This includes patients who fail all therapy or are not candidates for lesser therapies for various reasons. While a stoma is usually my treatment of last resort, this allows patients to function outside their home. Additionally patients who want the most reliable “fix” may opt for a stoma since it involves one procedure with the most predictable outcome. Consultation with an enterostomal therapist is also helpful to answer questions and to mark the patient before surgery. After surgery, as equipment requires adjustment, these nurses can continue to answer questions and provide specialized advice. I try to steer wheelchair-dependent patients toward this option, and marking in the wheelchair is crucial for the correct position.

When patients choose this option, it is paramount that the best stoma be constructed. If this requires an open procedure, the approach (laparoscopic versus open) should not compromise the end result. I typically attempt to perform an end colostomy in the left colon making sure the bowel used is soft and pliable, or distal transverse colon if necessary, to attain the best stoma.

Defects in the Internal Sphincter Only or Other Types of Lateral Sphincter Defects

Select patients have defects in the internal sphincter only that lead typically to debilitating fecal leakage. Most commonly I see these patients after an internal sphincterotomy that changes the contour of their oval anus, leading to a deep crevice that allows escape of typically liquid stool or mucus. While I have no data to support this approach, I favor trying to re-approximate the internal sphincter in order to change the topography of that area.

The exact approach to address the lateral internal sphincter defect is a separate dilemma, as I have found that there is usually a thick scar over the area. I have tried a semicircular incision at the anal verge and creating a flap to the sphincter and repairing via this approach, but I have almost abandoned this, as the scar over the area of repair typically will become ischemic and necrotic. Therefore, when faced with these patients, I presently will incise longitudinally over the scar and dissect until each limb of the internal sphincter is identified. I try to limit the amount of dissection because the goal is to change the contour and eliminate the divot while trying to limit the amount of dead space created.

A similar type of topography issue can be seen in select cases after a fistulotomy or traumatic (slice/stab type) injury of the anus. This type of injury is not located anteriorly, and repair is not as straightforward as the typical anterior overlapping sphincter repair done for an obstetrical injury. Again this is typically a contour problem, and the goal is usually to create a smooth contour that will not allow liquid stool or mucus to seep through. Anal endosonography is crucial in providing a road map prior to surgery. A linear incision is made over the scar and the muscle ends are identified. In specific cases, especially if the defect in the sphincter is close to 180°, the scar (rather than the retracted muscle) can be used as one end of the circular repair, which is sewn to other end of muscle to improve function. I attempt to bring muscle across the anterior or posterior aspect of the anal circle where the sphincter would be and thus try to orient the scarred portion on the lateral sides. This seems to provide a more oval contour.

If optimal improvement is not seen, injectable therapy may be a consideration, although I have not used it in this type of patient as of yet. Also SNS or ABS may be a consideration if all other forms of therapy are unsuccessful.

How to Manage Concomitant Pelvic Floor Disorders (i.e., Rectal Prolapse, Rectocele) if Repairing the Sphincter

Typically I favor repair of associated pelvic floor disorders when a sphincter repair is planned in most instances. Over 10 years ago when our results were examined, there was no difference in outcome improvement if a sphincter repair was done at the same operation combined with an anterior pelvic procedure (with the urologist or urogynecologist) versus a sphincteroplasty alone [43, 44]. Combined surgery with the anterior pelvic surgeons requires a team approach and may involve a position change if you prefer to repair the anal sphincter in the prone position. Therefore, the anesthesiologist must also be agreeable to the position change.

I have performed several sphincter repairs when an abdominal procedure was done at the same setting for rectal prolapse repair. These were typically more difficult and very bloody repairs, such that I currently hesitate to perform simultaneous repairs in this setting as rule. Most women have improvement in their anal sphincter when their rectal prolapse no longer chronically stretches the muscle, so I wait and reassess at about 6 months.

Future Treatments

Key Concept: Several treatments have been reported that are currently not available in the United States.

Magnetic Ring

One described treatment involves a titanium wire containing magnetic beads threaded around the anus. When the pressure in the rectum during straining reaches a certain threshold, the magnetic beads spring open allowing defecation. Currently one company (Torax Shoreview, Minn) makes the device, which they have called FenixTM. They have conducted a feasibility study with this device [45] demonstrating ease of implantation and no requirement for adjustments by the physician or patient. Of 14 implanted devices, 3 were removed. Short-term results showed a decrease of the mean number of weekly incontinent episodes from 7.2 to 0.7. One group outside the United States that participated in this study compared their results in 10 patients implanted with the magnetic ring matched to 10 with an ABS [46] and 12 with the magnetic ring matched to 16 with SNS [47]. They found that the magnetic ring was as effective as SNS in improving continence scores and quality of life with similar morbidity. Regarding ABS, the magnetic ring patients had similar quality of life and less constipation versus ABS. It did show that the ABS patients tended to have better incontinence scores (p = 0.0625). This device certainly looks promising with a relatively simple method of implantation and acceptable and comparable results compared to other treatments [48]. Further studies are needed to define its role and gain FDA approval in the United States.

Anal Sling

For urinary incontinence, slings have been used extensively to improve control. Similarly a U-shaped sling has been devised that goes behind the lowest part of the anorectum with the ends being brought out through small incisions lateral to the vagina at the medial notch of the obturator foramen. The tension is adjusted on the posterior anorectum and the excess “arms” clipped at the skin and the skin closed over them, to create a sling like support of the anus (Patents/US20110046436). A multicenter study has been completed and is awaiting adequate follow-up prior to publication of results.

Posterior Tibial Stimulation

Posterior tibial stimulation of the posterior tibial nerve at the medial ankle either by needle or surface electrode has been proposed to treat fecal incontinence. It is currently being studied for urinary incontinence in the United States and not approved or trialed as of this writing for fecal issues in the United States. There are eight studies from outside the United States, and all vary regarding treatment protocol (i.e., frequency of stimulation (20–30 Hz), timing (daily, alternate days, weekly, every other week), and duration (20–30 min)), but all use external portable pulse generators [49, 50]. Five studies had 60 % of patients reach the primary endpoint they set before starting and defined these patients as having a successful outcome. Again, all of these published studies all had varied protocols for treatment. A recent randomized, blinded, sham-controlled study of 144 patients from nine centers failed to show any benefit versus sham particularly in median number of fecal incontinent episodes per week [50]. This well-conducted study does cast some doubt toward its usefulness in individuals with fecal incontinence.

Summary Pearls

Fecal incontinence is a complex chronic disease. Many treatments are available, and individualization typically based on history and sphincter integrity currently aids in making treatment choices. Treatment choices revolve around conservative, nonsurgical, and surgical treatments (see Table 13.2). The surgical procedures aim to correct a defect, augment the sphincter, or change the “wiring” of the pelvic area. There is no panacea for treatment—which is a key concept. The Cochrane review for fecal incontinence in adults seemed to compare all treatments together, which proved to be unhelpful for providing guidance due to many reasons including the poor design of most trials [51]. But more importantly, the authors did not recognize that a crucial part of the question is which patient characteristics should steer health-care providers toward which treatments. More importantly, it failed to identify the reality that a combination of treatments may provide the best outcome. With all these unknown variables, future study should include discovering which patient characteristics are important to give optimal results for each individual therapy. A more difficult aspect for future study is what combination of treatments will provide the best outcome for individual patients. In the meantime, providers treating these patients must be familiar with all treatments and prepared to offer various treatments, perhaps in combination, to optimize quality of life with the caveat that this is a lifelong problem and adjustments in treatment approaches will be necessary (Fig. 13.7).

Table 13.2 Treatment options for fecal incontinence
Fig. 13.7
figure 7figure 7

My current algorithm when considering treating patients with fecal incontinence. ABS artificial bowel sphincter, SNS sacral nerve stimulation, Tx treatment, FI fecal incontinence