Fecal Incontinence Treatment & Management

Updated: Mar 05, 2021
  • Author: Tanaz R Ferzandi, MD, MA; Chief Editor: Kris Strohbehn, MD  more...
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Medical Therapy

Conservative treatment options for fecal incontinence include bulking agents and biofeedback. After history and physical examination findings have helped exclude systemic disease and local anal pathology as the source of the patient's problem, the provider can initiate treatment.

The goal of medical therapy is to reduce stool frequency and improve stool consistency. A regular bowel regimen including daily laxatives should be established. If impacted, manual disimpaction and a daily tap-water enema may help prevent reaccumulation. The etiology of diarrhea should be diagnosed and treatment initiated. Mild incontinence can often be improved by initiating simple conservative measures. For patients with infrequent, low volume stools, bulking agents are helpful, as formed stools are easier to control than liquid stools. Methylcellulose (Citrucel) or psyllium (Metamucil, Fiberall, Hydrocil) can be taken daily. Additional firming of the stool can be obtained by restricting fluid with intake of the bulking agent. This may be helpful therapy in the patient who has incontinence of soft stool or liquid stool.

In patients with diarrhea due to noninfectious etiologies or with reduced rectal compliance due to radiation proctitis or inflammatory bowel disease, agents that slow the motility of the gut may be helpful. Loperamide hydrochloride increases gut transit time, allowing for increased absorption of water from the volume of stool. This results in a firmer, more easily controlled stool. The maximum daily dosage is 16 mg. The usual dose regimen is 2-4 mg twice or three times daily to control symptoms. An additional benefit of the opiate derivative loperamide (Imodium) is that it increases internal anal sphincter tone and may improve rectal compliance. [52] Diphenoxylate hydrochloride/atropine (Lomotil) has also been used; however, diphenoxylate hydrochloride can cause dependence and is a schedule V medication under the Controlled Substance Act.

Biofeedback is a safe, minimally invasive behavioral technique that uses auditory or visual feedback to reeducate the pelvic floor musculature. Although many different therapies have been used, several studies that have demonstrated a significant improvement in fecal incontinence by treatment with biofeedback. [53, 54] Other data, including a recent Cochrane review, does not provide clear evidence of therapeutic benefit. [55] The most commonly used techniques are rectal sensitivity training and anal sphincter strength training.

During rectal sensitivity training, a rectal balloon is gradually distended with air or water and the patient is asked to report first sensation of rectal filling. Once this threshold volume is determined, repeated reinflations of the balloon are performed with the objective being to teach the patient to feel the distension at progressively lower volumes. The rationale is that some patients are found to have high threshold volumes and if the patient detects stool arriving sooner, there is more possibility to either find a toilet or use an anal squeeze, or both. Conversely, the same technique has also be used to teach the patient to tolerate progressively larger volumes in those with urgency and a hypersensitive rectum. [55]

Biofeedback techniques have also been used to demonstrate anal sphincter pressures or activity to the patient, thereby enabling teaching of anal sphincter exercises and giving feedback on performance and progress. This can be achieved by using EMG skin electrodes, manometric pressures, intra-anal EMG, or anal ultrasonography. The patient is encouraged, by seeing or hearing the signal, to enhance squeeze strength and endurance. There is no consensus on an optimum exercise regimen for use at home between sessions, nor on the number of squeezes, frequency of exercises, or treatment duration. Different authors may describe very different programs. [55]

Biofeedback requires some rectal sensation and the ability to voluntarily contract the sphincter. It appears to be effective for neurogenic and idiopathic anal incontinence and for incontinence related to disruption of anal sphincters [54] , but a recent Cochrane review did not demonstrate conclusive therapeutic benefits. [55] Biofeedback's success seems to depend on improving rectal sensation, because manometric studies have not shown consistent improved sphincter pressure. Personal units are now available (without prescription) for home use after initial clinical instruction. They use a vaginally placed, air-filled sensor that provides information on force and duration of contractions. Results from biofeedback can diminish over time, but home devices provide the patient the opportunity for a prolonged course of therapy and intermittent reeducation in a private setting.

In a 2012 randomized, double-blind study, 3 months of treatment with transcutaneous electrical tibial nerve stimulation (TENS) was not significantly better than sham treatment in improving the number of incontinence and urgency episodes in 144 patients with fecal incontinence. [56]

A 2015 summary of the treatment of fecal incontinence from the 2013 National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Workshop has been published. [4]


Surgical Therapy

Once medical therapy has been maximized, minimally invasive and surgical therapies may be considered. In select patients, injectable materials may provide improvement in anal sphincter function.

Several reports have described injection of various materials to augment the function of the internal anal sphincter. Injectable silicone has been shown to be effective. In a study of 82 patients with severe fecal incontinence and a low anal resting pressure caused by internal anal sphincter dysfunction, patients were randomized to silicone injection into the intersphincteric space and internal anal sphincter with (Group A, n = 42) or without (Group B, n = 40) guidance by endoanal ultrasonography. Results show that fecal incontinence improved significantly in both groups with up to 12 months of follow-up but to a greater extent in the group in whom injection was ultrasonographically guided. No serious complications occurred. [57]

Results with carbon-coated microbeads have been less promising. In a pilot study of 33 patients, the submucosal injection of carbon-coated microbeads improved minor fecal incontinence by increasing anal pressure but did not significantly improve quality of life. [58] Experience with collagen injections has been more limited.

Several surgical procedures are performed for the treatment of anal incontinence. The type of procedure used is based on the patient history, physical examination findings, and results of diagnostic evaluation. The current philosophy in pelvic reconstructive surgery is restoration of normal anatomy. Usually, sphincter complex defects are secondary to obstetric injury, fistula repair, or lateral internal sphincterotomy. The standard procedure for anal incontinence due to anal sphincter disruption is the anterior overlapping sphincteroplasty. This procedure was first proposed by Parks et al in 1971 and modified by Slade et al in 1977.

Anterior sphincteroplasty consists of dissecting out the external anal sphincter, dividing the scar tissue in the midline, and then overlapping the scar so that muscle is approximated to muscle as closely as possible. The surgery can be performed with the patient in the prone jackknife position or the dorsal lithotomy position. Controversy exists as to the need to identify and plicate the internal anal sphincter. Its value in the continence mechanism has been discussed. Several postoperative studies have demonstrated improvement in resting and squeeze pressures, which suggest that either the internal sphincter was plicated intentionally or that the internal anal sphincter was also unintentionally plicated in the process of overlapping the scar mass. In an older study, Fang and colleagues suggest not separating the internal from the external anal sphincters; however, they do not discuss the reasoning for this. [59]

Several other studies have performed ultrasonography of the sphincters postoperatively, yet few specifically mention the condition of the internal sphincter. Briel et al compared 2 groups of patients who underwent surgical repair. One group had surgical repair of only the external sphincter between 1973 and 1989. The second group underwent surgical repair consisting of restoration of the rectovaginal septum, perineal body, and repair of the external and internal sphincters. These patients had surgical repair between 1989 and 1994. They found that the more complex repair conferred no advantage. The measured outcome focused on anal continence, which was restored or improved in 63% and 68%, respectively. [60]

For the internal anal sphincter repair, the surgical approach requires dissection along the intersphincteric plane and identification of the internal anal sphincter. The sphincter is then dissected free from the rectal mucosa and mobilized. The surgical technique varies depending on the bulk of scar tissue. The scar tissue is either divided or left intact as the sphincter is plicated.

Abou-Zeid performed isolated internal sphincter repair in 8 patients with ultrasonographically proven defects of the internal anal sphincter. All patients had anal incontinence of varying degrees. All had undergone a prior surgical procedure, such as hemorrhoidectomy or sphincterotomy, and had developed symptoms subsequently. All patients underwent preoperative ultrasonography, and 6 patients underwent postoperative endoanal ultrasonography to document internal sphincter anatomy. Continence scores improved in all patients, and 2 patients achieved complete continence. [8] The small numbers of this cases series are encouraging, but do not allow for definitive conclusions.

Most reconstructive surgeons perform colporrhaphy and perineorrhaphy as part of the overall repair. Numerous articles describe the physiologic and supportive role of the rectovaginal septum and perineal body. In a study of 143 women, Weber and colleagues found that defects in the posterior compartment often coexist with bowel symptoms; however, they were unable to show a direct correlation between stage of prolapse and severity of bowel symptoms. This study did not proceed with surgical repair and evaluate for symptoms postoperatively. [61] Wexner and Olivera support the philosophy of repair of all defects and suggest that failure to recognize and repair concomitant injuries of the anal sphincter mechanism is usually accompanied by continued anal incontinence. [62]

Pudendal nerve neuropathy is associated with a higher failure rate after sphincteroplasty. As discussed previously, Gilliland found that the only factor predictive of successful outcome of overlapping sphincteroplasty was bilaterally intact PNTML. [47] Sangwan et al found that patients with unilaterally intact pudendal nerves had a less favorable outcome than those with bilaterally normal latencies. [48] Chen et al evaluated patients who had normal (1), unilateral (7), or bilateral (4) prolongation of PNTML with preoperative and postoperative incontinence scores. They found significant improvement in incontinence scores among all groups. These results were sustained at 20 to 72 month follow-up.

Different studies have demonstrated that anterior overlapping sphincter repair can improve continence scores, resting pressures, and squeeze pressures regardless of pudendal nerve latencies; therefore, if sphincter disruption is present, repair should be offered. Counseling patients regarding surgical outcomes and risks is imperative.

Some researchers perform postanal repair in patients with anal incontinence from a neurogenic or idiopathic cause. This type of anal incontinence is often associated with denervation of the pelvic floor. Patients have a decreased ability to sense impending defecation and may initially become aware of the need for a bowel movement only after they have passed stool and notice the odor or sensation of fecal material around the anus. The internal and external anal sphincters are usually intact. Evaluation often demonstrates an increase in the anorectal angle, which has also been described as a "flattening" of the anorectal angle.

The original theory behind postanal repair was restoration of the anorectal angle and lengthening of the anal canal. The incision is made posterior to the anal canal and carried to the levator plate. The dissection is carried in the intersphincteric plane between the internal and external anal sphincters. Once identified, the ileococcygeus, puborectalis, and pubococcygeus muscles are plicated posterior to the rectum. The internal anal sphincter, external anal sphincter, or both can also be plicated during the procedure. This approach was first described by Sir Alan Parks, whose initial series had an 83% success rate. Many subsequent series by different investigators have been unable to match this original success rate.

In an attempt to better understand the mechanism of postanal repair, several investigators have performed preoperative and postoperative physiologic evaluation of patients. In a review of 30 patients who had undergone postanal repair, Setti Carraro et al found that 19 of the 30 patients had breaks in the internal anal sphincter (6), the external anal sphincter (4), or both (9) on endoanal ultrasonography. [63] Matsuoka and colleagues performed preoperative PNTML, EMG, and manometry and found no predictive factor in the outcome of postanal repair. [64] Scott et al performed manometry prior to postanal repair and were unable to show any correlation between manometry and successful outcome.

Laurberg et al performed extensive preoperative and postoperative evaluation including manometry, perineal descent, PNTML, and single-fiber EMG. They found minimal correlation with preoperative physiologic testing and successful surgical outcome. Of interest in this study is the finding of increased fiber density and prolonged PNTML in those patients who improved with surgery, suggesting damage as a result of postanal surgical repair. [65] Setti Carraro et al also found postoperative prolongation of PNTML, from 2.2 milliseconds to 2.85 milliseconds, in patients with a successful surgical outcome. They found that the only preoperative factor predicting successful outcome was intact PNTML. [63] Others also found that intact PNTML is associated with better surgical outcomes. These findings seem to indicate that the patient with idiopathic fecal incontinence and normal PNTML has a better chance of success compared to a patient with a neurogenic cause of incontinence.

Both Laurberg et al and Setti Carraro et al have found that postanal repair may cause trauma to the pudendal nerves that did not exist preoperatively. The potential consequences of this are not known. Jameson et al evaluated patients 2 years following postanal repair and found a decrease in the number of patients who had some benefit (83% to 53%), with only 28% who were markedly better at 2 years. [66]

The effect of postanal repair on the anorectal angle has also been evaluated. Bartolo et al have shown that restoration of the anorectal angle does not correlate with the success of postanal repair. Failure of postanal repair to restore the anorectal angle has been confirmed by other investigators. Womack et al had improvement in 70% of 16 patients and found no significant change in the anorectal angle when measured radiographically. They recommend that the procedure not be limited to those patients with widening of the anorectal angle. [67]

In a comparison of anterior sphincteroplasty and postanal repair, Orrom et al found no postoperative advantage for either procedure. [68] They found that patients who had undergone postanal repair had no change in anorectal angle, whereas those who had undergone anterior sphincteroplasty with anterior plication of the levators had a more obtuse anorectal angle. They concluded that restoration of the anorectal angle was not important, and their group has abandoned the postanal approach. Matsuoka et al concluded that although the success rate for postanal repair was low (~35%), it is a valid therapeutic approach because of low morbidity and the absence of mortality. [64] The alternative for these patients, in whom other modalities have failed, is to live with this very disabling condition, undergo diverting colostomy, or undergo muscle transfer.

Muscle-wrap techniques have been developed in which striated muscles from the gracilis or gluteus muscles are transposed and wrapped around the anal canal to increase tone. The use of the gluteus muscle has largely been replaced by gracilis transfer. These techniques create a neosphincter when there is not enough muscle present to repair. The procedure may be indicated in patients who have congenital absence of the anal sphincter or in those who have lost the anal sphincter as a result of disease, although some have undertaken this procedure after attempts at sphincter repair have failed.

To perform gracilis transfer, the muscle is mobilized while maintaining the proximal attachments and the neurovascular bundle. Care must be taken to prevent devitalization of the muscle. The muscle is tunneled and then wrapped around the anus. The distal end is sutured to the contralateral ischial tuberosity. Implantation of a nerve stimulator to the transposed muscle to aid in long-term contraction is described. Results have been good, with a success rate of 66% in a series of 139 patients. [69] However, the procedure has a high complication rate and is usually performed in the research setting. [70] In patients with severe anal incontinence or those in whom other procedures have failed, muscle transposition may offer an improvement in quality of life. [71]

The artificial bowel sphincter (Acticon Neosphincter) was designed to act as a patient's own anal sphincter in cases of severe fecal incontinence. This implantable device is produced by American Medical Systems and is available in the United States. The inflatable cuff is placed around the anus, and an inflation reservoir is placed in the space of Retzius. As the patient feels the need to have a bowel movement, a control pump is squeezed and forces water out of the cuff and into the reservoir. This allows the patient to have a bowel movement. The cuff slowly refills over several minutes. Its use in patients with fecal incontinence has been somewhat limited and recent long-term data has been disappointing. In a study of 25 patients who were followed for a median of 50 months, only 3 had good functional results with the system. Complications included infection, erosion, chronic pain, and obstructed defecation; the device removal rate was approximately 50% in this series. [72]

When fecal incontinence persists after medical and surgical therapies have failed, a colostomy may be considered. This converts a perineal stoma into a manageable abdominal stoma and removes the constant fear of public humiliation.

For more recent information, the reader is encouraged to review the 2015 summary of the treatment of fecal incontinence from the 2013 National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Workshop. [4]

Sacral nerve stimulation

Sacral nerve stimulation (SNS) is an established, FDA-approved, minimally invasive procedure for the treatment of fecal incontinence. The neurostimulator device is known as the InterStim® System, manufactured by Medtronics. SNS has been shown to benefit patients with fecal incontinence caused by minor anal sphincter defects or due to neurologic disorders resulting in rectal hyposensitivity, as well as those with intact sphincters who have failed conservative therapies, including low-residue diet, medications, and biofeedback physiotherapy.

Interstim® SNS is a two-step process that begins with the placement of a temporary external electrode into the sacral foramen to provide low-amplitude electrical stimulation of the S3 sacral nerve roots. It likely works at the pelvic afferent and/or central level rather than primarily peripheral motor neurostimulation. [73] SNS then reduces symptoms of fecal incontinence by improving the resting and squeeze pressures of the anal sphincter, rectal sensation, and colonic motility. [73, 74, 75, 76] Patients who respond to a 2-week trial subsequently undergo placement of a permanent electrode connected transcutaneously to an embedded neurostimulator. Both steps are performed in the operating room and require general or local anesthesia. The practice of employing a temporary, percutaneous SNS for a 2- to 3-week period allows practitioners to identify patients who are most likely to respond positively to a permanent implant. [77]  Percutaneous nerve evaluation (PNE) is an alternative, office-based procedure that allows the temporary neuromodulator lead to be placed under local anesthesia. If this initial, temporary phase is successful, the InterStim device is implanted in the operating room. Studies have shown superiority of the 2-staged trial as compared to PNE. [78, 79]

Several clinical studies have shown that SNS achieves greater rate of continence among patients with fecal incontinence compared to placebo or to optimal medical management. Good outcomes were first reported in 1995, and since then, numerous trials in the United States and in Europe have yielded evidence suggesting that SNS can improve continence in a proportion of patients with fecal incontinence. [77, 74]

Several authors have also shown good outcomes among patients with fecal incontinence caused by anterior resection and chemoradiation for rectal cancer, [80, 81] systemic sclerosis, [82, 83] and Crohn’s disease. [84] Studies suggest that after implantation, 41 to 75% of patients achieve complete fecal continence and 75 to 100% experience improvement in incontinence episodes. [85] Importantly, the therapeutic effect and improved quality of life for fecal incontinence is maintained for at least 5 years after SNS implantation, with 89 to 92% having > 50% improvement and 36 to 48% having complete continence. [86] However, 10 to 35% of patients with fecal incontinence do not respond after permanent implantation, either immediately or later, despite initially satisfactory test stimulation for reasons yet unknown. Several cohort studies have not been able to identify specific predictive factors during pre-operative evaluation for successful outcomes with the permanent SNS implant. [87, 88, 89]

A 120-patient prospective multicenter cohort study with an FDA-approved investigational protocol revealed that 83% and 85% of subjects with a permanent neurostimulator achieved therapeutic success (defined as ≥ 50% reductions of incontinent episodes per week) at 12 and 24 months, respectively, and 41% of patients achieved 100% continence at 24 months. Incontinent episodes decreased from a mean of 9.4 per week to 1.9 at 12 months and 2.9 at 24 months. [90]

In a randomized study by Tjandra et al, 120 patients with severe fecal incontinence were randomized to have SNS or best supportive therapy, which involved pelvic floor exercises, bulking agent, and dietary manipulation. During a 12-month follow-up period, full assessment included endo-anal ultrasound, ano-rectal physiology, a 2-week bowel diary, and fecal incontinence quality of life index. Compared to the control group, the SNS group experienced a significant decrease in mean incontinent episodes per week from 9.5 to 3.1 and in mean incontinent days per week from 3.3 to 1, as well as a significant improvement in fecal incontinence quality of life index. Forty-seven patients (39%) achieved perfect continence with SNS. [91]

In a multicenter study comparing SNS to placebo, Leroi et al randomized 27 patients with SNS in a double-blind crossover design to stimulation ON or OFF for 1-month periods for up to 8 months. Patients who received stimulation reported a significant reduction in frequency of fecal incontinence episodes and symptom severity, preference for ON phase, and an improvement in the ability to postpone defecation, the quality of life, anal sphincter function. Continence was fully restored in 5 of the 19 (26%) patients who actually received stimulation. [92]

A 5-year prospective study by Boyle et al was first to report data with intention to treat in an attempt to assess the true efficacy of SNS for fecal incontinence. Among 50 patients with fecal incontinence, 13 patients (26%) did not respond during the first, temporary implantation stage or were dissatisfied with the result. Ten additional patients (20%) did not achieve a > 50% reduction in symptoms following permanent implantation. Nevertheless, 27 patients (54%) experienced > 50% reduction in symptoms, including 13 (26%) who achieved apparent continence. SNS resulted in a significant reduction of fecal incontinence episodes per night from 14 to 2, and in an improvement in the ability to defer defecation. Therefore, while good outcomes were comparable to aforementioned studies, this study revealed that symptoms of fecal incontinence continue in the majority (74%) of patients when analyzed by intention to treat. [93]

Among the abovementioned studies, analyzed in a Cochrane Review, adverse events occurred among 12-25% and included pain, hematoma, and/or seroma at the implant site, lead migration, paresthesia, change in the sensation of stimulation, and infection. There were no septic events. [77] Faucheron et al also investigated reasons for neurostimulator implant revision, thus elucidating SNS-associated morbidity. Among 87 patients who received the transcutaneous neurostimulator implant, 36 (41%) required surgical revision of the device due to site infection, pain or adverse stimulation, electrode displacement, electrode breakage, total or partial loss of clinical efficacy, device dysfunction, and battery depletion. [94]

Dueland-Jakobsen et al explored alternative neurostimulator settings in a randomized double-blind cross-over study with 15 patients who have sustained loss of efficacy. By altering pulse frequencies and pulse widths, the authors found a preferred setting for each individual that ultimately achieved significant improvement in the Fecal Incontinence Quality of Life Scale. They noted a trend toward highest patient satisfaction and improved treatment outcome with high-frequency stimulation, which was preferred by 8 of the patients, which was sustained at 3 month follow-up. [95]

Sacral transcutaneous electrical nerve stimulation (S-TENS) is a non-invasive, cheap, simple and promising alternative to the transcutaneous SNS with Interstim® System. A small prospective study by Chew et al showed optimistic results among 17 patients with idiopathic fecal incontinence who used TENS. Treatment included 2 hours of daily S3 nerve stimulation for 3 months. Sixty-nine percent of the subjects showed improvement in the fecal incontinence severity index, with a decrease in the number of gas and/or stool incontinence episodes per week. All patients reported subjective impression of improvement, and 88% scored > 6/10 for bowel control. The mean rectal volume of first sensation and first urge fell, and the maximum tolerable volume rose. The satisfaction score was > 6/10 in all patients. [96] However, more studies are necessary to evaluate its efficacy.

The InterStim® System neurostimulator manufactured The InterStim® System neurostimulator manufactured by Medtronic shown in place. Courtesy of Medtronic Inc.
The InterStim® System neurostimulator manufactured The InterStim® System neurostimulator manufactured by Medtronic. Courtesy of Medtronic Inc.

Injectable anal bulking agent

Solesta® (Oceana Therapeutics, Inc.) is a bulking agent consisting of a dextranomer stabilized in hyaluronic acid that was approved by the FDA in 2011 for the treatment of passive fecal incontinence in patients who have failed other conservative therapies. In Europe and Canada it is known as NASHA Dx or Zuidex®. Dextranomer/hyaluronic acid is a biocompatible bulking agent injected under the anal submucosa. Four 1 mL injections are administered into the deep submucosa in the proximal part of the high pressure zone of the anal canal, approximately 5 mm above the dentate line. If the response is inadequate after a minimum of 4 weeks, treatment can be repeated a second time. By expanding the anal tissue, the proximal anal canal narrows, thus preventing fecal leakage. Dextranomer/hyaluronic acid injection can be administered in an outpatient setting without anesthesia. [97]

Recent studies suggest that just over one half of patients achieve >= 50% reduction in number of fecal incontinence episodes at 6 months, and this effect is sustained for up to 3 years. Furthermore, patients report significant improvement from baseline in most of the domains of the Fecal Incontinence Quality of Life scale with dextranomer/hyaluronic acid injections. [98] A 3-year cost-effectiveness model comparing dextranomer/hyaluronic acid injection and sacral nerve stimulation following failed conservative management revealed that dextranomer/hyaluronic acid injection is cost-effective and results in more efficient use of resources for the treatment of fecal incontinence than sacral nerve stimulation. [99]

One of the first, and most cited, studies to support the use of dextranomer/hyaluronic acid for the treatment of fecal incontinence was a randomized, double-blind, sham-controlled trial with 206 patients by Graf et al. Of the 136 patients receiving dextranomer/hyaluronic acid injections, 71 (52%) reported > 50% reduction in the number of incontinence episodes at 6-month follow-up, compared to 22 (32%) of the 70 patients receiving sham injections. There was no blinding from 6 to 12 months, and all remaining participants received dextranomer/hyaluronic acid injection, with 57% achieving > 50% reduction in symptoms. The number of incontinence episodes decreased from 15 at baseline to 6.2 at 12 months, and the mean number of incontinence-free days increased from 4.4 at baseline to 7.9 at 12 months. The mean Fecal Incontinence Quality of Life scores for all four items improved significantly between baseline and month 12. [100]

Interestingly, the percentage of subjects achieving at least 50% reduction in fecal incontinence symptoms at 6 and 36 months remained stable (52%), while the percentage of subjects achieving 100% reduction rose from 6% at 6 months to 13% at 36 months. Of note, the majority of patients available for analysis at 36 months had received a second injection 1 month after the initial treatment. Therefore, it appears that the achieved effect of dextranomer/hyaluronic acid injection is sustained for up to 3 years. [101]

An open-label study by La Torre and de la Portilla produced comparable results for efficacy of dextranomer/hyaluronic acid at 24 months. Of the 83 individuals who completed 24-month follow-up, 63% experienced a >= 50% reduction in the total number of episodes of fecal incontinence, with the median number of episodes declining by 69%. The number of incontinence-free days increased from 15 at baseline to 22 at 24 months. [102]

Among these and other studies, most treatment-related adverse events were mild to moderate, self-limited and resolved within 1 month of injection. These include proctalgia, rectal hemorrhage, constipation, injection site bleeding, rectal discharge, anal pruritus, proctitis, painful defecation, and fever. Three serious adverse events were reported, representing a total of 1.3% of all adverse events related to dextranomer/hyaluronic acid injection: Escherichia coli bacteremia and 2 minor abscesses. [103]

Vaginal bowel control device

A new device received FDA approval in 2015.  The Eclipse System offers a conservative, safe, and effective option for the management of fecal incontinence with no reported serious adverse outcomes. It is a vaginal insert that is intended to treat fecal incontinence in women 18 to 75 years old who experience at least 4 incontinence episodes in a 2-week period. The device includes an inflatable balloon, which is placed in the vagina. Upon inflation, the balloon exerts pressure through the vaginal wall onto the rectal area, thereby reducing the number of fecal incontinence episodes. The device is initially fitted and inflated by a clinician (with the use of a pump), and after proper fitting, the patient can inflate and deflate the device at home as needed. The device should be removed periodically for cleaning. 

A study looked at 61 of 110 (56%) participants from 6 clinical sites that were successfully fit and entered treatment. At 1 month, intention-to-treat success was 79% (48/61); per protocol success, 86% (48/56) considered bowel symptoms “very much better” or “much better.” There was significant improvement in all Fecal Incontinence Quality of Life and Modified Manchester subscales. Success rate at 3 months was 86%. [104] Similarly, another multi-center, open-label, prospective trial showed that 62% of the 91 intent-to-treat subjects achieved a > 50% reduction in incontinence frequency. Mean fecal incontinence severity scores improved by 32%, and 78% of completers were “very” or “extremely” satisfied with the device. [105]

Eclipse System (vaginal insert) from Pelvalon. Cou Eclipse System (vaginal insert) from Pelvalon. Courtesy of Pelvalon Inc.

Preoperative Details

Once the decision has been made to proceed with surgical repair, mechanical bowel cleansing is performed. This can be performed with a variety of agents. Full mechanical bowel preparation with large volumes of solution is probably unnecessary, although it has some benefits for postoperative management. Smaller volumes of solution are better tolerated by patients, with some surgeons using only Fleet enemas prior to repair. The value of a more thorough preparation, such as GoLYTELY, is in the postoperative period when most surgeons are concerned about delaying mechanical stretch to the newly repaired sphincter.

Antimicrobial prophylaxis for colorectal operations can consist of an oral antimicrobial bowel preparation, preoperative parenteral antimicrobials, or a combination of both. Oral prophylaxis consists of neomycin plus erythromycin, or neomycin plus metronidazole, started no more than 18-24 hours before surgery along with a mechanical bowel preparation. Current recommendations for parenteral antibiotic prophylaxis include a third generation cephalosporin with metronidazole. A single preoperative parenteral dose of antibiotic is sufficient and should be administered within 1 hour prior to incision. [106]


Intraoperative Details

To minimize the risk of surgical site infections, care should be taken to keep the operative field clean from contamination. Preoperative antibiotics should be administered prior to beginning the procedure.

During overlapping sphincteroplasty, maintaining the scar tissue on the muscle belly and using this to decrease the likelihood of suture pull-through has been one of the most important factors improving surgical outcomes. The adequate mobilization of the existing scar tissue and separation of the scar in the midline to allow for overlap is also important. The judicious use of cautery to prevent devascularization is also wise.


Postoperative Details

Postoperative management after surgical treatment for fecal incontinence varies significantly according to provider. Agreement exists about the use of postoperative stool softeners and dietary fiber, and several products are available (see Medical therapy). Mineral oil may be used for a short period of time postoperatively, but long-term use is associated with absorption problems.

Specific dietary restrictions are commonly used postoperatively. Many surgeons delay feeding and keep patients on clear liquid diets or soft foods for several days. Others allow a more liberal diet and use stool softeners and mineral oil to decrease stool firmness. If a mechanical bowel preparation is used, the time to first bowel movement will be delayed, especially if the patient is kept NPO for the immediate postoperative period. Many encourage patients to use sitz baths as a means of decreasing perianal edema and to assist with cleanliness. However, some believe that osmotic gradients actually allow for more swelling and tissue maceration, and they promote the use of peribottles to wash the perineum and rectum. In these cases, showering is acceptable as the perineum is not submerged in water.

The use of postoperative antibiotics is controversial. Due to the location and nature of the tissues, infection of the surgical site is a risk; however, the blood supply to this area is rich and, unless compromised with extensive electrocautery, the need for postoperative antibiotics is questioned.



Owing to the nature and location of the surgical repair, pain control is an important issue. Patients should have adequate access to their surgeon for additional medications as necessary. Because the rate of separation of superficial tissues is as high as 25% and because of the potential for infection, patient concerns and symptoms must be taken seriously. Evaluation by trained providers, if only to reassure the patient, allows the surgeon to detect serious complications early.

Postoperative evaluation should be scheduled for 4-6 weeks after the procedure. At this time, most postoperative swelling and tissue distortion is usually resolved. A history of the patient's bowel habits should be taken and problems addressed. If modification of the stool softener regimen is required, it can be done at this time. Mineral oil regimens should be stopped if the patient has continued these medications postoperatively. Additional follow up can be scheduled depending on the individual needs of the patient and practice of the surgeon.



The complication rate from surgical repair of the anal sphincter varies based on the series reviewed. The patient population requiring surgical repair may have significant comorbidities that predispose them to postoperative complications. A review of several series for both postanal repair and anterior sphincteroplasty reveals that most patients are in the fifth through seventh decade of life. Underlying medical conditions, such as obesity, diabetes, or heart disease, can increase the postoperative risk of myocardial infarction or deep vein thrombosis.

The most common complication is superficial separation of skin and subcutaneous tissues, and the frequency rate is as high as 25% in some series. Care must be taken to place as little tension as possible on these tissues. Conversion of the curvilinear incision into a Y-shaped incision at the time of closure can place a great deal of tension on the perineal skin and predispose it to separation. Plication of the bulbospongiosus and superficial transverse perineum muscles can remove tension from the overlying skin and serve to restore anatomy. Devascularization of the vaginal or rectal mucosa can result in necrosis of these tissues.

Risk of infection is 3-5%. Opening the wound to allow for drainage and treatment with antibiotics may allow the physician to salvage the surgical repair. Fistula formation occurs in fewer than 1% of the series reviewed, but it is more common in those cases in which infection develops.

Bleeding and hematoma formation are also possible complications. Bleeding can usually be controlled with pressure achieved with packing. Hematoma formation into the perirectal space can go unnoticed and result in the sequestration of large amounts of blood. Treatment requires evacuation of the hematoma and surgical hemostasis.

Other complications include anal stricture, fecal impaction, and pain. Pain may be associated with bowel movements and intercourse, leading to a great deal of frustration for both the provider and patient. Many of these problems improved with time. Most complications that arise do not affect the sphincter repair. Although patients may be distressed, they should be reassured that the risk of failure of the procedure is not increased.


Outcome and Prognosis

Initial outcome after sphincteroplasty is 64-90% with short-term follow-up. [68, 107] The success rate starts to fall after the first few years and continues to fall with longer follow-up. Two long-term studies demonstrate that only half of the patients have satisfactory continence at 69-80 months postoperatively. [108, 109]

A secondary analysis of data from a multicenter study evaluating adaptive behaviors among women with fecal incontinence in the Pelvic Floor Disorders Network revealed significant improvements in symptom severity and condition-specific quality of life at 3 and 12 months following treatment. [110] Treatment was nonsurgical in 78% of the women; 22% underwent anal sphincter repair.


Future and Controversies

The disappointing results of the artificial anal sphincter have led investigators to explore other therapies for severe fecal incontinence.

Sacral spinal nerve stimulation has been used successfully for the treatment of female patients with urinary incontinence associated with overactive bladder and nonobstructive urinary retention. The Medtronic InterStim device (Medtronic, Inc, Minneapolis, MN) is FDA approved in the United States for this indication. In Europe, sacral spinal nerve stimulation has given patients with fecal incontinence an option that is minimally invasive and appears to offer significant improvement. A recent randomized control trial of 120 patients with severe fecal incontinence demonstrated a significant improvement of incontinence symptoms, decreasing from 9.5 to 3.1 mean incontinence episodes per week when compared with optimal medical therapy that comprised bulking agents, pelvic floor exercises, and dietary management. These results are even more encouraging given that half of the patients had evidence of a sphincter defect and two thirds had evidence of pudendal neuropathy.

Interestingly, neither the maximal resting pressure, squeeze anal pressures, or pudendal nerve terminal latency had any association with improvement. In addition to a sustained functional improvement, quality of life was significantly enhanced as measured by fecal incontinence quality of life (FIQL) scores. Medtronic InterStim has been the modality of choice of investigators in this and other studies treating fecal incontinence. [111] Long-term data of greater than 5 years since implantation are reassuring. In 52 patients who had undergone implantation, at least 50% improvement occurred in three quarters of the patients. [112] Successful results have been demonstrated even with significant anal sphincter disruption. [113]