Incontinence


Type of incontinence

Never

Rarely

Sometimes

Usually

Always

Solid

0

1

2

3

4

Liquid

0

1

2

3

4

Gas

0

1

2

3

4

Wears pad

0

1

2

3

4

Lifestyle alteration

0

1

2

3

4


Never 0. Rarely <1/month. Sometimes <1/week, ≥1/month. Usually <1/day, ≥1/week. Always ≥1/day

Score Range 0 (perfect)–20 (complete incontinence)

Adapted from Jorge and Wexner [5]





Etiology and Evaluation of Fecal Incontinence


The pathogenesis and etiology of fecal incontinence may be multifactorial. It may be due to anal sphincter or pelvic floor muscle weakness (e.g., childbirth, operative, trauma), neuropathy (e.g., stretch injury of pudendal nerve, diabetes mellitus), abnormalities of the pelvic floor (e.g., fistula, rectal prolapse), anorectal inflammation (e.g., inflammatory bowel disease, radiation proctitis), central nervous system disease (e.g., cerebellar vascular accident, spinal cord lesion, multiple sclerosis), or bowel disturbances (e.g., irritable bowel syndrome, overflow diarrhea) [2]. Treatment should be directed by a detailed history and physical examination. It is important to ascertain the frequency of FI episodes, clarify symptoms of partial (involuntary leakage or flatus) or complete incontinence, determine stool characteristics (liquid, solid, mucous), and determine if there are symptoms of urgency. Dietary habits, history of congenital abnormalities, childbirth history, previous anorectal procedures, or low colon anastomosis should also be discussed.

Physical examination of the anorectum should include inspection, digital examination, and endoscopic assessment. Normally, the presence of soiled undergarments, anal fissures, prolapsing hemorrhoids, scars from previous surgeries, perineal length (decreased length is often associated with external anal sphincter defects), sphincter tone, a palpable defect, sensation to pinprick and the presence of an anocutaneous reflex should be noted [7].

There are several investigative tools available for assessment of fecal incontinence [7]. Endoanal ultrasound can define the presence and extent of an anatomical sphincter (internal or external) injury. Pelvic floor ultrasound can delineate other injuries and abnormalities of the pelvic floor and the pelvis. Anorectal manometry can objectively document anal resting and squeeze pressures and assess anorectal compliance and the anorectal inhibitory reflex. Pudendal nerve terminal motor latency (PNTML), although its utility is controversial, may be used to assess possible nerve damage such as pudendal neuropathy. Defecography may be used to visualize the function of the rectum and document functional abnormalities, such as rectal intussusception, rectocele, enterocele, etc. It can be performed using fluoroscopic or MRI techniques.


Treatment of Fecal Incontinence


After a thorough assessment of FI symptoms, treatment usually starts with conservative measures: patient education, normalization of stool consistency, behavioral techniques, and pelvic floor exercises [8]. Dietary modifications with avoidance of food triggers (e.g., caffeine, spicy foods, and alcohol), supplemental fiber and antidiarrheal agents (e.g., loperamide) are usually recommended for diarrhea-associated FI. On the other hand, laxatives are recommended in individuals with FI-associated fecal impaction. Topical treatments that increase smooth muscle tone (e.g., phenylephrine, valproate) have also been trialed in patients with FI and have shown mild, statistically significant, improvement in bowel control [8]. Behavioral training includes scheduled toileting attempts and preventive techniques such as squeezing prior to increased intraabdominal pressure activity such as bending, coughing, or lifting.

Pelvic floor exercises to strengthen the pelvic floor musculature are frequently recommended. Although there is no consensus on how to perform pelvic floor exercises, patients are usually taught methods to increase self-awareness of contraction and relaxation of the pelvic musculature. Biofeedback therapy, an instrument-assisted training strategy, allows patients to visually assess the character and quality of their pelvic strengthening exercises [7]. Biofeedback implementation for FI has success rates between 40 and 100% in different studies [9]. Heymen and coworkers [9] sought to determine the effectiveness of biofeedback training compared to pelvic floor exercises for FI in a clinical, randomized-controlled trial. In their study, prior to treatment, patients received educational training on anatomy and physiology of the pelvic floor muscles, a review of their anorectal manometry results, and instructions on fiber supplements and antidiarrheal medications. After four weeks of conservative measures, 21% of patients experienced adequate relief from FI, and there was an overall decrease of 41% in FI days. Three months after initiation of either biofeedback training or pelvic floor exercises, 67% of patients treated with biofeedback reported adequate relief from FI compared to 41% of patients treated with pelvic floor exercises. Moreover, biofeedback patients had fewer days with FI (not statistically significant), greater reduction in their Fecal Incontinence Severity Index Scores anal canal squeeze pressures, as well as less abdominal tension during squeeze [10]. These results were sustained at 12-month follow-up.

Conservative and nonsurgical treatment options are usually risk free and significant complications are usually not reported.


Surgical Anal Sphincter Repair


If conservative and nonsurgical treatment do not yield satisfactory improvement, surgical anal sphincter repair can be pursued if there is a localized sphincter injury. The repair usually involves repair of defects of the anal sphincters and the most common repair is performed in the anterior aspect (after obstetric injuries). The sphincteroplasty is usually performed with an overlapping technique. A curvilinear incision (200°–240° arc) is made parallel to the outer edge of the external sphincter and the anoderm is mobilized from the underlying sphincter and scar tissue. Dissection is continued cephalad to the sphincter injury. Two rows of interrupted absorbable sutures are used to overlap the ends of the severed sphincter and the anal aperture should permit a snugly fit index finger.

Fecal diversion after sphincter repair was previously common, with the assumption it would improve primary wound healing and functional outcome. Over time, the use of diversion has decreased, and today the repair is routinely performed without diversion. A randomized-controlled study of 27 patients by Hasegawa et al. [11] concluded fecal diversion in sphincter repair is not necessary. The authors assert diversion adds no benefit to wound healing or functional outcomes, but rather contributes to morbidity from stoma-related complications. Currently, fecal diversion is reserved for technically difficult sphincter repair operations, repeat sphincter repair, or if patients develops a postoperative infection.


Outcomes


Most reported literature on outcomes after sphincteroplasty for FI is based upon patient-reported satisfaction, grading scales such (i.e., modified-Parks Continence Score [12]), severity scales (i.e., CCFIS), and/or quality of life scores (i.e., FIQoL). Failure is usually defined as lack of improvement in FI symptoms, the need for reoperation for FI, and/or patient dissatisfaction. Overall, the short-term (<5 years) outcomes of sphincteroplasty have been considered favorable with excellent (no incontinence) or good (continence to flatus, some stain or urgency) in the range of 50–80%) [1320]. Likewise, functional outcomes graded by the CCFIS have shown improvement in the short term [21, 22]. Unfortunately, long-term studies demonstrate that success rates deteriorate over time (>5 years) [13, 1820, 23].

There are several studies reporting data after sphincteroplasty. In a retrospective study, Lamblin and coworkers [24] demonstrated in 23 patients that the CCFIS decreased from 12.7 preoperatively to 7.5 postoperatively. Overall, 17 patients reported being satisfied with their results, three (13%) expressed unsatisfactory or dissatisfactory outcomes, and three (13%) patients demonstrated early recurrence of FI symptoms. Both Maslekar et al. [14] and Lehto et al. [23] conducted prospective, observational studies in >50 individuals and they found patients experiencing deterioration in efficacy with time at term follow-up. For example, Maslekar et al. evaluated a group of patients with a CCFIS of 16 preoperatively. Postoperatively, the CCFIS score improved to five at 12-months of follow-up and subsequently seven at 84 months of follow-up. The authors reported an overall 80% surgical success rate. On the other hand, Lehto et al. [23] reported FI improved in 67% of their patients at short-term follow-up but after a longer follow-up the severity of FI was about the same as preoperatively. Barisic et al. [13] prospectively studied 56 patients with a preoperative CCFIS of 17.8. They found a significant improvement in CCFIS scores, four at 3-months of follow-up and six at 80-months of follow-up. Using the modified Parks grading system, 48% of patients had successful results and 42% experienced recurrent or continuing FI symptoms at the latest follow-up. Finally, Oom et al. and Bravo Gutierrez et al. conducted retrospective reviews of >120 patients with 10-year follow-up. In both studies, approximately 40% of patients reported satisfactory fecal continence (excellent or good results) and about 60% had continued FI symptoms or needed additional surgery for their symptoms. Interestingly, about 60% of patients were satisfied with their results due to patient-perceived improvement in FI episodes compared to preoperative baseline.

Anal manometry has not routinely been included in assessments of the efficacy of anterior sphincteroplasty. In most studies including manometric evaluations, no significant change in resting pressures has been reported [17, 18, 25]. Some studies also fail to demonstrate a significant change in squeeze pressures or sphincter length [18, 25], while another study found a postoperative increase in squeeze pressures and anal sphincter length [17]. A separate study demonstrated that preoperative anal manometry and PNTML measurements are not predictive of postoperative success [26].


Complications


The incidence of postoperative complications after sphincteroplasty is difficult to ascertain, as this has rarely been the primary study outcome when reported. Based on available data, it appears that the overall immediate postoperative complication rate ranges between 5 and 30%. The most common complication is postoperative wound infection, reported between 1 and 20% in different studies. In clinical practice, however, superficial infection that leads to opening up of the wound is rather common and these infections typically heal without further intervention [24, 27, 28]. The patient should be informed about this risk, however, since this will extend the healing time. Despite a fairly high rate of superficial infections that leads to the wounds to open up, the incidence of breakdown of the sphincteroplasty is rather uncommon. Some authors use a perineal drain, because of the infection risk, but there is not a proven benefit in the literature [29].

Perioperative events, such as deep venous thrombosis, pulmonary embolism and ileus, are rare [30]. Other reported complications include postoperative hematoma, prolonged perineal pain, UTI, and fecal impaction. Adverse functional events such as temporary urinary retention [21, 26, 31] and impairment in fecal evacuation requiring long-term use of laxatives and suppositories have been occasionally reported [21]. Some women report problems with dyspareunia [3235].


Sacral Nerve Stimulation


In 1981, Tanago and Schmidt [36] reported on symptom improvement in urinary urge incontinence and non-obstructive urinary retention using an implanted stimulator for stimulation of the sacral nerve roots. A simultaneous improvement was observed in bowel symptoms in some patients and studies were soon undertaken to assess this effect.

Sacral nerve stimulation (SNS) is usually performed in two stages. The first stage confirms that there is a proper neuromuscular response (contraction of the pelvic floor and plantar flexion of the big toe) with stimulation of the third sacral nerve [37]. Thereafter, a lead is placed and connected to an external stimulator. The patient thereafter undergoes a test-stimulation phase for 2 weeks. Greater than 50% reduction in incontinence episodes is considered a significant response and the patient then becomes eligible for permanent electrode placement.


Outcomes


SNS works by electrical stimulation of sacral nerve roots. Its exact mechanism of action is not clear. Studies indicate that FI may be improved by improved colorectal motility, improved rectoanal sensitivity, and spinal or supraspinal afferent inputs [38]. SNS therapy has demonstrated improved outcomes in a wide array of patient types. FI symptoms are improved in patient with or without sphincter injuries, patients with neuropathic fecal incontinence, cauda equina syndrome, and patients with low anterior resection syndrome [3941].

According to a meta-analysis conducted by Tan et al. [42], SNS therapy has shown a statistically significant change in CCFIS and a significant increase in FIQoL scores subcategories. Success rates range between 55 and 80% with patients reporting improved decreased FI symptoms. About 30–40% report complete resolution of FI symptoms, while about 20% may have diminished efficacy of the treatment within 5 years [4351].


Complications


SNS is associated with overall adverse event rate of 5–33%, but serious complications are rare [39, 48, 5258]. Pain is the most common postoperative complication. Pain usually occurs at the site of implantation, but can also be experienced as extremity pain [46, 47]. To distinguish pain from sacral nerve stimulation versus pain from the device location under the skin, the device can be switched off. Resolution of symptoms indicates sacral nerve stimulation as the culprit of the patient’s discomfort. This pain can usually be alleviated by reducing the pulse width, changing the electrode configuration, or reducing the stimulation amplitude. Rarely, has the device been explanted for pain, although resitting the device may be necessary [47].

Wound infection may occur in up to 8–10% of patients [46, 47, 58]. An infection of the device or the lead, usually necessitates explant of the lead and stimulator and treatment with antibiotics. Patients can then usually be reimplanted about 3 months later when the infection has healed. Another local colication is hematoma, but this is quite rare.

There are some technical problems that may occur with SNS. Dislodgement of the unipolar test lead can happen, but this is less common with the tined lead electrode [59]. The neurostimulator generator is battery-operated and has a lifespan of 3–6 years if used for chronic stimulation [48].

Detailed instructions for troubleshooting have been well described by Dudding and coworkers [60]. A measurement of impedence provides valuable insight into a malfunctioning neurostimulator. An impedence of >4000 Ω indicates a technical failure of the implant or lead fracture, where as <15 Ω suggests a short circuit. In either situation, it is best to pursue surgical exploration to replace faulty components as a sacral radiograph is often nondiagnostic. At times, patients may complain of decreased or absent sensation of stimulation or require high-amplitude stimulation for sensation. If impedence measurements are normal, these findings suggest suboptimal lead placement or migration and significant lead migration will require replacement.

Maeda and colleagues [45] reported on 101 patients undergoing SNS in an observational study. They reported a total of 521 reportable events in 94 patients. The most commonly reported events were loss of efficacy (193 events, 37%) and lack of efficacy (141 events, 27%). A total of 422 events required reprogramming, such as changing electrode pole combinations, and/or stimulation amplitudes and switching the device on/off. Eight patients were lost to follow-up, 20 patients had their device removed (eight for loss of efficacy, six for lack of efficacy in which two also had pain, two for pain and discomfort, two for infection, one for a required MRI scan for an unrelated condition, and one was removed per patient request after a new colostomy formation for an unrelated condition. Four patients had their device permanently switched off because of loss of efficacy (two), lack of efficacy (one) and spontaneous improvement in FI symptoms (one).


Magnetic Anal Sphincter


There have been several interventions to improve the function of the anal sphincter, including the artificial bowel sphincter and dynamic graciloplasty. The artificial bowel sphincter has been discontinued and dynamic graciloplasty is not approved in the United States and is rarely performed. These procedures will therefore not be discussed.

Magnetic anal sphincter augmentation has been recently approved by the United States Food and Drug Administration (FDA), through the humanitarian device exemption process, for patients with FI who failed other surgical interventions or are poor surgical candidates [61]. For any institution in the United States to be able to offer magnetic anal sphincter augmentation, approval is required by an institutional review board [62]. The FENIX™ Magnetic Sphincter Augmentation Continence Restoration System (MSA) is a dynamic, annular band of 14–20 interlinked, titanium beads with a magnetic core that is surgically placed around the anal sphincter complex. At rest, the band maintains the anus closed, simulating anal sphincter tone. To defecate, increased rectal pressure from normal Valsalva maneuver overcomes the attractive force of the beads. They then separate, opening the anal canal for fecal egress, and self-retract afterwards.

To implant the device, an anterior incision is made in the perineal body. Careful dissection along the rectovaginal septum is performed to 3–5 cm depth. A tunnel is circumferentially created around the anal canal to implant the device. The correct size is estimated and the device is implanted. The perineal incision is subsequently closed.


Outcomes


To date, there are four clinical studies on magnetic anal sphincter. Two are single center, prospective observational studies [63, 64], one is a prospective comparison study with SNS [65] and one is a multicenter feasibility study [61]. Study results demonstrate an encouraging short-term benefit of ≥50% improvement in incontinence in approximately 70% of patients and there were improvements in both CCFIS and FIQoL.


Complications


Between the four studies, a total of 67 patients were selected for implantation of the MSA device, and there were 26 device-related adverse events reported. Two patients experienced intraoperative rectal perforation and had no device placed and one device was accidently cut during a separate procedure for rectal prolapse repair [63, 64]. The most common complication was wound infection (seven events; 15%) [61, 63, 64]. Four of the infections were accompanied with wound dehiscence and resolved with antibiotics. Two patients had the device explanted due to abscess or chronic infection. In one patient, although the infection resolved with antibiotics, the device was explanted per patient request for lack of efficacy. Perianal and gluteal swelling with erythema were reported in five patients in one study and resolved with conservative treatment [63]. Straining during defecation seems to risk cracking and self-expulsion of the MSA device and was observed in three patients [64, 65]. Three patients experienced fecal impaction which resolved with enemas and three patients experienced rectal bleeding which resolved spontaneously [61, 65]. Pain related to the device has been reported in two patients and resolved with medications [61].


Ventral Rectopexy for Fecal Incontinence


Both internal rectal intussusception and external rectal prolapse are associated with FI [6668]. These conditions are, in addition, frequently associated with difficulties in rectal emptying. Internal and external prolapse may be treated with ventral rectopexy, which involves an anterior mobilization of the rectum after which a mesh is placed between the rectum and the posterior vaginal wall and secured to the sacrum.


Outcomes


In a systematic review of ventral rectopexy procedure for overt rectal prolapse, the authors report preoperative incontinence ranging between 23 and 93% in 191 patients [69]. Postoperatively, there was a statistically significant decrease in symptoms (FI ranging between 0 and 29%). This improvement corresponded to a significant decrease in CCFIS in two of the studies (the other four studies did not report pre-and postoperative CCFIS) [68, 70].


Complications


According to a systematic review by Gouvas et al. [69], the recurrent rate of rectal prolapse after ventral rectopexy is about 2–4% with an overall complication rate of 8.9%. In the studies reviewed, pelvic sepsis, pelvic hematoma, visceral erosion, mesh dislocation and infection occurred in up to 3% of patients. Port site infection or hematoma (1–6%) and port site hernias (0–7%) were observed. Other complications included urinary dysfunction and or infection, chronic abdominal pain, ileus, and cardiopulmonary complications.

The authors of a separate, retrospective review [71] of the safety of ventral rectopexy performed at five institutions reported their results on 2203 patients who underwent ventral rectopexy for rectal prolapse. Their most serious adverse event related to ventral rectopexy was mesh-related. Two percent developed mesh erosion and a majority of these patients presented within 36 months of the operation. Treatment of mesh complications varied from minor (51% had local excision of stitch/exposed mesh) to major (40% had either laparoscopic removal, removal with colostomy, or anterior resection) procedures. Eleven percent of patients developed non-mesh complications (e.g., port site hernias, urinary retention, or urinary tract infection, postoperative pain) with postoperative pain as the most common complaint. Conservative treatment was appropriate for most non-mesh complications. Four patients required pudendal nerve blocks for perianal pain and four patients were treated for anal fissures. Six patents required a diagnostic laparoscopy for pain symptoms.


Vaginal Bowel-Control System for Fecal Incontinence


The vaginal bowel-control system (Eclipse System) was approved by the FDA in 2015 as a nonsurgical treatment option for fecal incontinence. The system consists of a silicone-coated device with a stainless steel base and a posteriorly directed balloon, both of which are available in different sizes. It is inserted into the vagina and the air-filled balloon compresses the rectum to improve continence [72]. The device can be placed in the clinic setting and five preset pressure settings are available for a comfortable fitting. The device can be deflated to enable/facilitate defecation. The device is cleaned daily with menstruation or otherwise once weekly.


Outcomes


To date, there is only one clinical study reporting results of for the vaginal bowel-control system [72]. All patients had ≥4 FI episodes over two weeks. Of the 100 patients fitted with the device, 56 patients entered treatment and completed follow-up after one month. 86% of patients experienced treatment success (≥50% reduction in FI episodes) at 1 month. At 3 months, 86% of 44 patients had >50% reduction in FI episodes and 72.7% had ≥75% reduction in FI episodes according to the last 2 weeks of their bowel diaries.


Complications


In the published study [72], there were no major adverse events associated with the vaginal bowel-control system. Minor complications amongst the 110 patients fitted for the device included pelvic cramping (15%), urinary incontinence/urgency (10%), vaginal symptoms (9%), pelvic pain (8%) and spotting (7%). At one month, the two most common symptoms were pelvic cramping (10%) and vaginal findings (5%). At 3 months, the only complaints were pelvic cramping (9%) and pelvic pain (3%).


Rectal Sling for the Treatment of Fecal Incontinence


The TOPAS pelvic floor repair system (American Medical Systems, INC [AMS], Minnetonka, MI) was first described in 2014 by Rosenblatt et al. [73]. The device includes a monofilament mesh that is placed about the anal canal using a tension-free, transobturator approach. Using a curved insertion needle, the mesh is tunneled between two small buttock incisions posterior to the rectum. The sling is then passed lateral to the rectum and vagina, around the ischiopubic ramus, and out through the obturator foramen on each side. The mesh and sheath arms are then gently pulled upward for tension adjustment of the mesh [73, 74]. Currently, the TOPAS system is not commercially available.

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Oct 18, 2017 | Posted by in GASTROENTEROLOGY | Comments Off on Incontinence
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