Fecal Incontinence
Number: 0611
Table Of Contents
PolicyApplicable CPT / HCPCS / ICD-10 Codes
Background
References
Policy
Scope of Policy
This Clinical Policy Bulletin addresses fecal incontinence.
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Medical Necessity
Aetna considers the following diagnostic tests, treatments and procedures medically necessary for fecal incontinence:
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Diagnostic tests
- Anorectal manometry (see CPB 0616 - Gastrointestinal Manometry)
- Anorectal ultrasonography
- Rectal sensory testing;
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Conservative treatments
- Biofeedback (see CPB 0132 - Biofeedback)
- Bowel training
- Defecation programs
- Diet modification
- Pharmacotherapy;
- An anal sphincter repair for members with severeFootnote1* fecal incontinence who have failed, or are not candidates for, medical interventions (e.g., biofeedback, dietary management, pharmacotherapy, strengthening exercises);
- Colostomy for members with severeFootnote1* fecal incontinence who have failed, or are not candidates for, medical interventions (e.g., biofeedback, dietary management, pharmacotherapy, strengthening exercises) or surgical sphincter repair (e.g., post-anal repair, sphincteroplasty, or total pelvic floor repair);
- The Acticon Neosphincter artificial bowel sphincter for members 18 years of age or older with severeFootnote1* fecal incontinence (i.e., when there is involuntary loss of solid stool or liquid stool on a weekly or more frequent basis) who have failed, or are not candidates for, medical interventions (e.g., biofeedback, dietary management, pharmacotherapy, strengthening exercises) or surgical sphincter repair (e.g., post-anal repair, sphincteroplasty, or total pelvic floor repair);
- Sacral nerve stimulation (sacral neuromodulation) for the treatment of members with chronic fecal incontinence, who have had an inadequate response to conservative treatments (e.g., biofeedback, dietary management, pharmacotherapy, strengthening exercises), and who have a weak but structurally intact anal sphincter:
- Initially, a temporary percutaneous peripheral nerve electrode is considered medically necessary for testing over a 2- to 3-week period;
- Implantation of a permanent implantable pulse generator is considered medically necessary for members who have a 50 percent or greater improvement in incontinence symptoms from the temporary percutaneous peripheral nerve stimulation. Note: Sacral nerve stimulation can be administered via InterStim.
Aetna considers sacral nerve stimulation experimental and investigational when these criteria are not met.
Footnote1* For purposes of this policy, fecal incontinence is considered severe when it results in the involuntary loss of solid stool or liquid stool on a weekly or more frequent basis.
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Experimental and Investigational
Aetna considers the following procedures and interventions experimental and investigational because the effectiveness of these approaches has not been established:
- Acticon Neosphincter artificial bowel sphincter when criteria are not met in Section I;
- Acticon Neosphincter artificial bowel sphincter for persons with any of the following contraindications to its use:
- Individuals with incontinence complicated by an irreversibly obstructed proximal segment of bowel; or
- Individuals who are poor candidates for surgery or anesthesia due to physical or mental conditions;
- Anal sling, pubo-rectal sling, and the Fenix Continence Restoration System for the treatment of fecal incontinence;
- Graciloplasty for the treatment of fecal incontinence;
- Injectable bulking agents for the treatment of fecal incontinence;
- Measurement of pudendal nerve terminal motor latency for evaluation and guidance of therapy of fecal incontinence;
- Perianal electrical stimulation for the treatment of fecal incontinence;
- Posterior tibial nerve stimulation for the treatment of fecal incontinence;
- Regenerative medicine (e.g., biocompatible materials, with or without the use of trophic factors; injection of autologous myoblast cells, mesenchymal stem cells, or stem cells for the treatment of fecal incontinence;
- Renew anal insert for the treatment of fecal incontinence;
- Topical estrogen for the treatment of fecal incontinence;
- Topical oxymetazoline for the treatment of fecal incontinence;
- Trans-anal radiofrequency therapy for the treatment of fecal incontinence (also known as the Secca procedure);
- Vaginal bowel control (eg, Eclipse system) for fecal incontinence.
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Related Policies
Background
Fecal incontinence is the involuntary loss of flatus, liquid, or stool. Fecal incontinence may be caused by damage to the anal sphincter (eg, childbirth, surgery), diarrhea, fecal impaction, illnesses that cause the inability to expand and store fecal matter (eg, inflammatory bowel disease [IBD], Crohn’s disease or injury). Although it is considered a benign disorder, severe fecal incontinence is a distressing and socially isolating medical condition. Individuals who suffer from this condition often alter their lifestyle to minimize the likelihood of bowel accidents in public places. Over time, this can result in progressive social isolation and work incapacity.
Prior to treatment for fecal incontinence, an evaluation must be performed. The initial assessment includes basic office tests, a history and physical, and laboratory tests. Anorectal manometry is a test that uses a pressure sensitive tube to check the sensitivity and function of the rectum. It also measures the ability of the anal sphincter muscles to respond to signals. Anorectal ultrasonography is an ultrasound that is specific to the anus and rectum. This is utilized to evaluate the structure of the anal sphincter muscles. Rectal sensory testing is utilized to detect abnormal rectal sensation. When rectal sensation is reduced, stool may leak before the external sphincter contracts.
The majority of cases of fecal incontinence are mild-to-moderate, and can be managed with medical interventions including anti-diarrheal medications (loperimide, codeine, diphenoxylate, atropine), treatment of underlying infections or inflammatory disorders as indicated, pelvic floor biofeedback, and dietary management (increase dietary fiber with psyllium products or synthetic analogues).
Biofeedback is therapy that utilizes sensors to help the individual identify and contract the anal sphincter muscles which help maintain continence.
Defecation programs (bowel training) are designed to help individuals with disabilities or mental health issues by setting a schedule for sitting on the toilet at a regular time every day after a meal which purportedly may help with incontinence if the bowels are emptied regularly.
Vaginal bowel control (eg, Eclipse system) is a device that includes an inflatable balloon, which is placed in the vagina, which upon inflation exerts pressure on the vaginal wall supposedly closing off the rectum. Reportedly, bowel evacuation is completed by deflating the device and re‐inflating using an external pump.
For some patients with a sphincter defect, surgical procedures such as direct sphincter repair (sphincteroplasty), post-anal repair, or total pelvic floor repair may be attempted. Sphincteroplasty is utilized to repair a defect in the sphincter muscle in which the two ends of the muscle are cut and overlapped onto one another and then sewn into place to restore the complete circle of muscle.
For individuals with severe fecal incontinence who have failed medical interventions and who are not candidates for sphincter repair, the choices are limited. An alternative surgical procedure, a dynamic muscle transposition, may be used in patients where the anal sphincter is either denervated or anatomically absent. It involves the transposition of muscle, usually the gracilis (gracilisplasty) or gluteus maximus, to create a barrier to the passage of stool.
Another alternative is a permanent ostomy that would allow bodily wastes to be expelled through the abdominal wall. A colostomy involves the construction of an artificial opening from the colon through the abdominal wall, which bypasses a diseased portion of the lower intestine and permits the passage of stool to a bag outside of the body; typically used as the last attempt to correct fecal incontinence. However, neither a dynamic muscle transposition nor permanent ostomy provides normal bowel function and fecal continence.
Acticon Neosphincter
Artificial anal sphincter (eg, Acticon Neosphincter) is an implantable, fluid filled device that consists of an inflatable silicon cuff, a pressure‐regulating balloon and a control pump, which reportedly maintains continence by using the pressure of the fluid filled cuff to occlude the anal canal. When there is a need to defecate (bowel movement), the individual squeezes and releases the pump mechanism, which releases the compressive force around the anal canal. The Acticon Neosphincter simulates normal anal sphincter function by allowing the anal canal to open at the control of the patient.
The device consists of 3 interconnected components:- an occlusive cuff,
- a pressure-regulating balloon and
- a control pump.
The occlusive cuff is implanted around a segment of the anal canal. The device maintains continence in the patient by using the pressure of the fluid-filled cuff to occlude the anal canal. To evacuate the bowel, the patient squeezes and releases the pump mechanism, located in the labium or scrotum, several times to move fluid from the cuff to the pressure-regulating balloon implanted in the abdomen. This movement of fluid empties and collapses the cuff, resulting in the release of the compressive force around the anal canal. Residual pressure within the balloon allows fluid to flow back into the cuff, automatically refilling the cuff within a few minutes.
Because of implantation of a silicone device in the perianal area, the peri-operative infection rate is high, and device removal due to infection may be necessary. Additionally, the sphincter may need replacement as often as every 5 years because of device wear.
Results from clinical trials submitted to the Food and Drug Administration (FDA) for approval indicated slightly more than half (51.3 %) of all patients who were implanted with the Acticon Neosphincter had resolution or clinically significant reduction in their symptoms after one year. For the subset of patients who were able to maintain a functional device for 12 months, approximately 85 % had meaningful improvements in their incontinence.
A majority of the patients implanted experienced at least one device-related adverse event. Besides pain, the two most common adverse events were infection (31 % of implanted patients) and device erosion (21 %). Surgical intervention was required to address 36 % of these adverse events. Half of the implanted patients required at least 1 additional surgical device revision after the original implantation procedure and 30 % required total device explantation due to adverse events.
In approving the device, the FDA took into account the adverse event rates for other colorectal surgeries. The FDA cited a study examining the overall mortality and morbidity for patients undergoing resection of the colon or rectum, where 361 out of 971 patients undergoing elective surgery experienced at least 1 post-operative complication. In another study, 36 to 39 % of patients who had elective surgery for colorectal disease suffered from complications.
The FDA concluded that the Acticon Neosphincter is indicated "to treat fecal incontinence in males and females eighteen years and older who have failed, or are not candidates for, less invasive forms of therapy."
Investigators from Adelaide Health Technology Assessment conducted a systematic review of literature on implantation of the Acticon Neosphincter in the management of fecal incontinence (Buckley et al, 2007). The investigators compared the safety, effectiveness, and cost-effectiveness of the Acticon to colostomy, dynamic graciloplasty, and conservative management. An advisory panel with expertise in this area then evaluated the evidence and provided advice to the Australian Medicare Services Advisory Committee (MSAC). The MSAC found no evidence comparing the Acticon with colostomy and limited evidence comparing it with conservative management and dynamic graciloplasty. The MSAC found that the evidence suggested that Acticon implantation is not as safe as conservative management and that it is likely to be at least as safe as dynamic graciloplasty. The MSAC found that the Acticon is more clinically effective than both conservative management and dynamic graciloplasty. The MSAC found that relative cost-effectiveness of the Acticon and the comparators could not be assessed due to lack of data. The comparison of the estimated total costs indicates that the cost to the Australian health system of the Acticon is less than for dynamic graciloplasty.
Transanal Radiofrequency Therapy (The Secca Procedure)
Radiofrequency ablation (eg, Secca System) is a minimally invasive procedure that uses alternating electrical current to cause controlled heating of the tissue in the anal sphincter which supposedly remodels the treated tissue by stimulating the formation of connective tissue
The Secca procedure received FDA clearance through Investigational Device Exemption in March 2002. The Secca procedure entails delivery of temperature controlled radiofrequency (RF) energy to the sphincteric complex of the anal canal. It offers a less-invasive option for treatment of fecal incontinence, as compared to surgery, and is performed on an outpatient basis using conscious sedation. Although the Secca procedure is cleared by the FDA, its clinical effectiveness has not been established.
In a small non-randomized study (n = 10), Takahashi et al (2002) examined the durability and long-term safety of the Secca procedure for the treatment of fecal incontinence. These investigators reported that significant improvements in symptoms of fecal incontinence and quality of life persisted 24 months after RF delivery to the anal canal. While the findings of this study are promising, it does not provide adequate evidence to allow conclusions regarding long-term outcomes. The authors noted that an additional randomized, sham-controlled, double-blind clinical trial is underway to further evaluate the procedure.
Takahashi-Monroy et al (2007) reported an extension of the follow-up from their original study. The Cleveland Clinic Florida Fecal Incontinence Scale (CCF-FI) (0 to 20), fecal incontinence-related quality of life (QOL) score, and Medical Outcomes Study Short-Form 36 were administered to 5 years. Differences between baseline and follow-up were analyzed by using paired t-test. A total of 19 patients were treated and followed for 5 years, including 18 females (aged 57.1 years; range of 44 to 77). The mean duration for fecal incontinence was 7.1 years (range of 1 to 21). At 5-year follow-up, the mean fecal incontinence score had improved from 14.37 to 8.26 (p < 0.00025) with 16 patients (84.2 %) demonstrating greater than 50 % improvement. All fecal incontinence-related QOL scores improved, including lifestyle (2.43 to 3.15; p < 0.00075), coping (1.73 to 2.6; p < 0.00083), depression (2.24 to 3.15; p < 0.0002), and embarrassment (1.56 to 2.51; p < 0.0003). The social function component of the Short-Form 36 improved from 38.3 to 60 (p < 0.05). There was a trend toward improvement in the mental component summary of the Short-Form 36 (SF-36) from 38.1 to 48.14. There were no long-term complications. The authors concluded that significant and sustained improvements in fecal incontinence symptoms and QOL are seen at 5 years after treatment with the Secca procedure.
In an open-label, single arm, non-randomized, multi-center study, Efron et al (2003) evaluated the safety and effectiveness of the Secca procedure. A total of 43 women and 7 men (average age 61 years, range of 29 to 80) were enrolled, treated, and followed for 6 months. Mean duration of fecal incontinence prior to treatment was 15.6 years. At 6 months, the mean CCF-FI score improved significantly from 14.5 to 11.1 (p < 0.0001). Parameters in the fecal incontinence QOL were improved, including lifestyle (from 2.5 to 3.1; p = 0.0001), coping (from 1.9 to 2.3; p = 0.005), depression (from 2.8 to 3.1; p = 0.0008), and embarrassment (from 1.9 to 2.5; p < 0.0001)]. The mean SF-36 mental composite score improved from 45.3 to 48.3 (p = 0.06), and the mean SF-36 social function sub-score improved from 64.0 to 77.3 (p = 0.003). Patient diaries showed that there was a significant reduction in days with any fecal incontinence (p < 0.0001). A clinical response (greater than 10 % improvement) was noted by visual analogue scale in 60 % of patients.
It is interesting to note that the study by Efron et al (2003) did not report the same level of improvements as reported in the study by Takahashi et al (2002). The overall reduction in scores based on CCF-FI was 8.5 points in the study by Takahashi and colleagues and 3.5 points in the study by Efron and co-workers. Furthermore, the overall response rate was 80 % in the study by Takahashi et al and 60 % in the study by Efron et al. The findings of these studies need to be validated by prospective, randomized controlled studies with large sample sizes and long-term follow-up.
Felt-Bersma and colleagues (2007) examined the effectiveness of RF and possible changes in the anal sphincter with 3D-ultrasound in patients with fecal incontinence. A total of 11 women, mean age 61 years (range of 49 to 73) with long-standing fecal incontinence were included in this study. Patients with large sphincter defects and anal stenosis were excluded. The Secca procedure was carried out under conscious sedation and local anesthesia. Oral antibiotics were given. In 4 quadrants on 4 or 5 levels (depending upon length of the anus) RF was delivered with multiple needle electrodes. Patients were evaluated at 0, 6 weeks, 3 and 6 months and 1 year. Three-dimensional anal ultrasound was performed at 0 (before and after the procedure), 6 weeks and 3 months. Anal manometry and rectal compliance measurement were performed at 0 and 3 months. At 3 months, 6 of 11 patients improved, which persisted during follow-up of 1 year. The Vaizey score changed from 18.8 to 15.0 (p = 0.03) and in those improved from 18.3 to 11.5 (p = 0.03). Anal manometry and rectal compliance showed no significant changes, there was a tendency to increased rectal sensitivity concerning urge and maximal tolerated volume (both p = 0.3). Responders compared with non-responders showed no difference in test results. Side effects were local hematoma (n = 2), bleeding 3 days (n = 1), pain persisting 1 to 3 weeks (n = 4) and laxatives-related diarrhea during 1 to 3 weeks (n = 4). The authors concluded that the Secca procedure seems to be promising for patients with fecal incontinence with a persisting effect after 1 year. No significant changes in tests were found.
Kim and associates (2009) evaluated the safety and effectiveness of the Secca procedure (n = 8). The Fecal Incontinence Severity Index (FISI) score and the Fecal Incontinence-related Quality of Life (FIQL) scale were completed at baseline and after the procedure. Anorectal manometry and endoanal ultrasound also were conducted. Seven of the 8 patients were women, and the median age of the patients was 59 years (range of 28 to 73). The mean FISI score and all of the parameters in the FIQL scale with the exception of the embarrassment scale measured at 6 months after the procedure was not improved significantly. No changes in the anal manometry and endoanal ultrasound parameters were observed. Complications associated with the procedure developed in 7 of the 8 patients, including anal bleeding, anal pain, and anal mucosal discharge. The authors concluded that the FISI score and FIQL scale were not improved significantly after the Secca procedure, and considerable complications were associated with the procedure.
The National Institute for Health and Clinical Excellence's guideline on endoscopic radiofrequency therapy of the anal sphincter for fecal incontinenc (2011) stated that "[t]he evidence on endoscopic radiofrequency therapy of the anal sphincter for fecal incontinence raises no major safety concerns. There is evidence of efficacy in the short-term, but in a limited number of patients. Therefore, this procedure should only be used with special arrangements for clinical governance, consent and audit or research. . . . Further research into endoscopic radiofrequency therapy of the anal sphincter for fecal incontinence should clearly define the patient groups being treated. It should also report the clinical impact in terms of quality of life and long-term outcomes".
Abbas et al (2012) evaluated the short- and long-term outcome of the radiofrequency treatment for moderate-to-severe FI. Patients who underwent the radiofrequency procedure were included. The primary outcomes measured were the complication rate, short- and long-term response, and the rate of subsequent intervention for incontinence. A total of 27 patients underwent 31 radiofrequency procedures (81 % women; mean age of 64 years). Median length of symptoms was 3 years. Biofeedback had failed for 52 % of patients, and 23 % of patients had previous surgical intervention. Thirty-eight percent of patients had a sphincter defect. Minor complications were observed in 19 % of the patients. A treatment response was noted in 78 % of the patients (mean Cleveland Clinic Florida Fecal Incontinence Score: 16 (baseline) and 10.9 (3 months post-operatively)). However, a sustained long-term response without any additional intervention was noted in 22 % of the patients, and 52 % of the patients underwent or are awaiting additional intervention for persistent or recurrent incontinence (mean follow-up of 40 months). The authors concluded that the radiofrequency procedure was safe, but a long-term benefit was noted in a minority of patients with moderate-to-severe FI; additional interventions were needed in more than 50 % the patients. Moreover, they stated that larger studies are needed to determine the impact of various patient-related factors on the outcome of the radiofrequency treatment to identify the ideal patient for this therapy. This study is limited by its retrospective nature and the limited number of subjects.
Felt-Bersma (2014) evaluated the clinical response and sustainability of Secca for patients with anal incontinence (AI). Only original clinical studies retrieved from PubMed and Medline were included. The outcome measures, FI scores, definition of response, clinical results and anorectal evaluation were analyzed. A total of 10 studies were included, which involved 150 original patients; 3 studies reported a long-term follow-up. The 1-year follow-up showed a moderate effect, which declined somewhat over time. Only minor temporary side-effects were reported and none of the patients declined treatment. The authors concluded that Secca is a safe and well-tolerated procedure that is easy to perform without any serious short- or long-term complications, but with only a moderate clinical effect that declines over time. They stated that results of randomized, sham-controlled controlled trials are awaited.
In a prospective cohort study, Lam and colleagues (2014) evaluated clinical response and sustainability of Secca for FI. This study involved patients who had failed full conservative management for FI, and performed between 2005 and 2010. Fecal incontinence was scored using the Vaizey score (VS). A clinically significant response to Secca was defined as greater than or equal to 50 % reduction in incontinence score. Impact of FI on QOL was measured using the FIQL. Data were obtained at baseline, at 6 months and at 1 and 3 years. Anal endosonography as well as anal manometry were performed at 3 months and compared to baseline. A total of 31 patients received Secca. During follow-up, 5/31 (16 %), 3/31 (10 %) and 2/31 (6 %) of patients maintained a clinically significant response after the Secca procedure. Mean VS of all patients was 18 (SD 3), 14 (SD 4), 14 (SD 4) and 15 (SD 4), at baseline, 6 months and 1 and 3 years, respectively. No increases in anorectal pressures or improvements in rectal compliance were found. Coping improved between baseline and t = 6 months. No predictive factors for success were found. The authors concluded that the findings of this prospective non-randomized trial showed disappointing outcomes of the Secca procedure for the treatment of FI. The far minority of patients reported a clinically significant response of seemingly temporary nature. They stated that Secca might be valuable in combination with other interventions for FI, but this should be tested in strictly controlled randomized trials.
In a randomized, sham-controlled, clinical trial, Visscher and colleagues (2017) examined if the clinical response to the RF energy procedure is superior to sham in patients with FI. This study was conducted in an out-patient clinic. A total of 40 patients with FI in whom maximal conservative management had failed were randomly assigned to receiving either RF energy or sham procedure; FI was measured using the Vaizey incontinence score (range of 0 to 24). The impact of FI on QOL was measured by using the FI QOL score (range of 1 to 4). Measurements were performed at baseline and at 6 months. Anorectal function was evaluated using anal manometry and anorectal endosonography at baseline and at 3 months. At baseline, Vaizey incontinence score was 16.8 (SD 2.9). At t = 6 months, the RF energy group improved by 2.5 points on the Vaizey incontinence score compared with the sham group (13.2 (SD 3.1), 15.6 (SD 3.3), p = 0.02). The FI QOL score at t = 6 months was not statistically different. Anorectal function did not show any alteration. The authors concluded that both RF energy and sham procedure improved the FI score, the RF energy procedure more than sham. They stated that although statistically significant, the clinical impact for most of the patients was negligible. Thus, the RF energy procedure should not be recommended for patients with FI until patient-related factors associated with treatment success are known.
Sacral Nerve Stimulation (Sacral Neuromodulation)
Sacral nerve stimulation (eg, InterStim) involves the implantation of electrodes at the sacral nerve to improve muscle control of the anal sphincter and improve rectal sensation.
Sacral nerve stimulation, also known as sacral neuromodulation, has been used successfully to treat urinary incontinence as well as non-obstructive urinary retention. However, its mechanism of action remains unclear. Sacral neuromodulation is also a novel treatment for fecal incontinence. It appears to be a promising procedure because of its relative simplicity and low morbidity. However, experience with sacral nerve stimulation for this indication is limited. Studies with longer follow-up are needed to better evaluate this procedure. In a review on sacral nerve stimulation for the treatment of female pelvic floor dysfunction including fecal incontinence, Pettit et al (2002) stated that while the data are encouraging in these new arenas of pelvic floor disorders, investigators acknowledge the need for multicenter, statistically powered studies to assess the validity of these findings. An evidence review prepared for the National Institute for Clinical Excellence (2004) stated that sacral nerve stimulation has shown good results in patients with fecal incontinence due to a functional deficit; however, longer-term follow-up is needed. The National Institute for Clinical Excellence (2004) concluded that "[c]urrent evidence of the safety and efficacy of sacral nerve stimulation for faecal incontinence does not appear adequate to support the use of this procedure without special arrangements for consent and for audit or research."
The National Institute of Clinical Excellence (NICE, 2004) concluded that there is adequate evidence to support the use of sacral nerve stimulation for fecal incontinence in persons with a weak but structurally intact anal sphincter who are refractory to conservative measures. This conclusion was based on the results of a systematic evidence review (Fraser et al, 2004) that identified 6 case series studies of sacral nerve stimulation involving 266 persons with chronic refractory fecal incontinence. The systematic review found that complete continence was achieved in 41 to 75 % (19/46 to 12/16) of patients with permanent implants, whereas 75 to 100 % (3/4 to 16/16) of patients with permanent implants experienced a decrease of 50 % or more in the number of incontinence episodes. Commonly, the procedure is tested in each patient over a 2- to 3-week period, with a temporary percutaneous peripheral nerve electrode attached to an external stimulator (NICE, 2004). If significant benefit is achieved, then the permanent implantable pulse generator can be implanted.
The effectiveness of sacral nerve stimulation in treating fecal incontinence has been demonstrated in clinical studies (Kenefick and Christiansen, 2004; Matzel et al, 2004; and Jarrett et al, 2004). Kenefick and Christiansen (2004) noted that sacral nerve stimulation appears to be an alternative treatment that is successful, has low morbidity, is maintained in the medium term and associated with an improved QOL. The technique has the advantage of a minimally invasive test procedure with high predictive value and the surgery is minor. Matzel et al (2004) stated that sacral nerve stimulation greatly improved continence and QOL in selected patients with morphologically intact or repaired sphincter complex offering a treatment for patients in whom treatment options are limited. Jarrette and associates (2004) concluded that sacral nerve stimulation is a safe and effective treatment, in the medium to long term, for fecal incontinence when conservative treatment has failed.
An assessment by the Australian Medical Services Advisory Committee (MSAC, 2005) recommended that "there is evidence of safety for sacral nerve stimulation in adults with faecal incontinence refractory to conservative, non-surgical treatment and who have an anatomically intact but functionally deficient anal sphincter. The total number of patients is small; there is some evidence of effectiveness and cost-effectiveness. MSAC supports public funding in these circumstances."
An assessment by the Ludwig Boltzmann Institute for Health Technology Assessment (Fischer and Zechmeister, 2011) summarized current evidence on the effectiveness and safety of sacral nerve stimulation for fecal incontinence. The authors identified and analyzed 7 publications, including 5 reviews, 1 meta-analysis and 1 randomized controlled clinical study. The authors concluded that sacral nerve stimulation seems to be effective and safe for a selected group of patients. "However, the poor study design means that results are subject to considerable uncertainty and new studies could have an impact on the estimated effect."
Perianal Electrical Stimulation
Transanal electrical stimulation is electrical stimulation that is applied to the anal canal to supposedly stimulate muscle contraction.
Perianal electrical stimulation has also been tried in treating fecal incontinence. A Cochrane review (Hoster et al, 2000) concluded that there are insufficient data to allow reliable conclusions to be drawn on the effects of electrical stimulation in the management of fecal incontinence. The report also concluded that there is a suggestion that electrical stimulation may have a therapeutic effect, but this is not certain; larger, more generalizable trials are needed. Since publication of the Cochrane review, Riedy et al (2000) reported on a study of perianal electrical stimulation of 5 healthy spinal cord injury patients. These researchers reported that 4 of the 5 subjects had strong anal contractions with perianal electrical stimulation. However, this study did not examine the effect of perianal electrical stimulation on fecal incontinence.
Mahoney et al (2004) reported on a randomized controlled clinical trial of intra-anal electromyographic (EMG) biofeedback versus EMG biofeedback augmented with electrical stimulation of the anal sphincter in the treatment of 60 women with post-partum fecal incontinence. These investigators reported that the addition of electrical stimulation of the anal sphincter did not enhance the symptomatic outcome of women with post-partum fecal incontinence.
Vitton and co-workers (2009) examined the usefulness of transcutaneous posterior tibial nerve stimulation to treat fecal incontinence in inflammatory bowel disease (IBD). A total of 12 patients (7 Crohn's disease, 2 undetermined colitis, 3 ulcerative colitis) were treated by applying transcutaneous posterior tibial nerve electrical stimulation daily for 3 months. A clinical evaluation was performed at the end of treatment, with Wexner's score and Harvey-Bradshaw index and analog scales to assess symptoms and QOL. At 3 months, 5 patients (41.6 %) reported a significant symptomatic and QOL improvement, although only 1 reported a significant modification in the Wexner score. The authors concluded that these preliminary results are encouraging, although further studies are necessary.
Leroi et al (2012) showed that although transcutaneous electrical tibial nerve stimulation (TENS) is being increasingly used to treat FI, its efficacy has never been proved using controlled trials. In this randomized, double-blind, sham-controlled trial, a total of 144 patients aged 30 to 82 years from 9 centers were randomly assigned to receive either active or sham stimulations for 3 months. The primary end point was the response to treatment based on the number of incontinence and urgency episodes. Secondary end points were severity scores, quality of life scores, delay to postpone defecation, patient self-assessment of treatment efficacy, physician assessment of TENS efficacy, anorectal manometry, and adverse events. No statistically significant difference was seen between active and sham TENS in terms of an improvement in the median number of FI/urgency episodes per week. Thirty-four patients (47 %) who received the active TENS treatment exhibited a greater than 30 % decrease in the FI severity score compared with 19 patients (27 %) who received the sham treatment (odds ratio [OR]2.4, 95 % confidence interval [CI]: 1.1 to 5.1, p = 0.02). No differences in delay to postpone defecation, patient self-assessment of treatment efficacy, or anorectal manometry were seen between the two groups. The evaluating physicians rated the active stimulations as more effective than the sham stimulations (p = 0.01). One minor therapy-related adverse event was observed (1.5 %). The authors concluded that they failed to demonstrate any benefit of TENS on the primary end-point.
Cruz and colleagues (2022) noted that FI and urinary incontinence are disabling impairments in patients following stroke that can be clinically managed with electrical stimulation (ES). In a systematic review, these researchers examined the effectiveness of non-implanted ES to reduce the severity of post-stroke incontinence. Clinical trials of non-implanted ES applied for the purposes of treating post-stroke incontinence were searched in Medline, Embase, CINAHL, PEDro, and CENTRAL. From a total of 5,043 manuscripts, 10 trials met the eligibility criteria (n = 894 subjects); 9 trials reported urinary incontinence severity outcomes enabling meta-analysis of transcutaneous electrical nerve stimulation (TENS; 5 trials) and electro-acupuncture (4 trials). Studies provided good-to-fair quality evidence that TENS commenced less than 3 months post-stroke has a large effect on urinary continence (SMD = -3.40, 95 % CI: -4.46 to -2.34) and a medium effect when commenced more than 3 months after stroke (SMD = -0.67, 95 % CI: -1.09 to -0.26). Electro-acupuncture had a large effect when administered more than 5 times a week (SMD = -2.32, 95 % CI: -2.96 to -1.68) and a small effect when administered 5 times a week (SMD = -0.44, 95 % CI: -0.69 to -0.18). Only 1 trial reported the effect of non-implanted ES on post-stroke FI. The authors concluded that published trials examining the effect of non-implanted ES on post-stroke incontinence were few and heterogenous. Synthesized trials suggested that early and frequent treatment using ES is probably more effective than sham or no treatment. These researchers stated that further trials measuring incontinence in an objective manner are needed.
Injectable Bulking Agents
Injectable bulking agents (eg, Solesta injectable gel) involves the injection of collagen, autologous fat or other materials into the anal sphincter area in order to increase the surface area, which purportedly provides a better seal for the anal canal.
A dysfunctional internal anal sphincter can result in fecal incontinence. Previous preliminary attempts to restore functional continuity have included a cutaneous flap to fill an anal canal defect, as well as the use of bulking agents (e.g., polytetrafluoroethylene, collagen, or autologous fat). In a pilot study, Malouf et al (2001) evaluated the effectiveness of single or multiple injections of the silicone-based product Bioplastique for the symptoms of passive fecal incontinence caused by an anatomically disrupted or intact but weak internal anal sphincter. A total of 10 patients (4 men and 6 women; median age of 64 years with a range of 41 to 80 years) with passive incontinence secondary to a weak (n = 6) or disrupted (n = 4) internal anal sphincter were injected either circumferentially or at a single site, respectively. Patients were assessed before and 6 weeks after treatment by clinical assessment, 2-week bowel diary card, anorectal physiologic testing, and endoanal ultrasound. Patients failing to show improvement after the first injection were offered a second injection 6 weeks after the first injection. Clinical assessment was further repeated at 6 months, and 5 patients had a further ultrasound examination. At 6 weeks, 6/10 patients showed either marked improvement (n = 3) or complete cessation of leakage (n = 3). Another patient was greatly improved after a second injection. Three patients were not improved. At 6 months, 2/7 patients had maintained marked improvement, and 1 patient had maintained minor improvement; all of these 3 patients had circumferential multiple injections. Maximum resting and squeeze anal pressures did not differ significantly between before versus 6 weeks after versus 6 months after injection. At 6 weeks, endoanal ultrasound (n = 9) confirmed the presence and correct position of the silicone in all but 1 patient who had experienced obvious external leakage of the product. At 6 months the silicone remained in the correct position in the 5 endosonographically assessed patients. Five of the initial patients experienced pain or minor ulceration at the injection site. These researchers concluded that although clinically effective immediately after injection, the benefit of an injectable biomaterial was maintained in only a minority of patients. This occurred despite the continued presence of material in the correct anatomical site. Patients with diffuse weakness treated by circumferential injection seemed to be the most responsive, but further studies are needed to clarify this finding.
Vaizey and Kamm (2005) noted that studies on the use of injectable bulking agents for the treatment of patients with fecal incontinence are mainly confined to a small number of pilot studies. The authors noted that although bulking agents have been used to treat urinary incontinence for more than 4 decades, their use in fecal incontinence has so far been limited. The large choice of products now available and the lack of a defined injection strategy will hamper efforts to produce meaningful prospective, randomized controlled trials.
Maeda et al (2007) examined the long-term effectiveness of silicone biomaterial (PTQ; Uroplasty BV, Geleen, The Netherlands) injection in the treatment of fecal incontinence. Six patients (median age of 53 years at the time of injection with PTQ) were followed-up at 61 months. A validated fecal incontinence score, treatment-specific questionnaire and SF-36 health survey questionnaire were completed. At 61-month follow-up, 1 patient had undergone a colostomy for fecal incontinence. In the remaining 5 patients the incontinence score was little changed: 11 (8 to 20) versus 13 (9 to 19). However, there was a substantial improvement in physical and social function on the SF-36 scores. S atisfaction scores were high at a median 7 of 10 (range of 0 to 8). Subjectively, 3 patients were improved; 1 of them had undergone a further set of injections and 1 improved after a course of biofeedback. After the follow-up period, 1 of the 5 patients had a colostomy for recto-vaginal fistula. The authors concluded that the results of perianal injection of PTQ for passive fecal incontinence are variable in the long-term. They noted that more extensive evaluation in the short-term, and possibly repeated treatment, may be needed.
An assessment of injectable bulking agents for fecal incontinence by the National Institute for Health and Clinical Excellence (2007) concluded: "Current evidence on the safety and efficacy of injectable bulking agents for faecal incontinence does not appear adequate for this procedure to be used without special arrangements for consent and for audit or research, which should take place in the context of a clinical trial or formal audit protocol that includes information on well-defined patient groups."
In a pilot study, Dehli and co-workers (2007) reported the findings of a new bulking agent (hyaluronic acid and dextranomere) and a new injection technique for the treatment of fecal incontinence. An anascope was used to inject Zuidex (4 x 1. 4 ml) submucosally (proximal to the dentate line and distally to the puborectal muscle) in 4 patients with severe fecal incontinence, who were deemed unfit for other treatment. No anesthesia or antibiotic-prophylaxis was used. All patients tolerated the treatment well, and there were no adverse events. The treatment had an effect in 3 of 4 patients; there was a median fall in St. Mark's score of 3.5 points. The injection technique was well-tolerated, easy to perform within an outpatient setting and with promising short-term results. The method has been implemented in a randomized controlled trial.
Altomare and colleagues (2008) assessed the safety and effectiveness of carbon-coated microbeads (Durasphere) anal injection for the treatment of fecal incontinence. A total of 33 unselected patients with incontinence (24 females; mean age of 61.5 +/- 14 years; range of 22 to 83) underwent anal bulking agent submucosal injection with Durasphere in the outpatient regimen. The causes of incontinence were obstetric lesions in 18.2 %, iatrogenic in 36.4 %, rectal surgery in 12.1 %, and idiopathic in 33.3 %. Previous unsuccessful treatments for fecal incontinence included diet and drugs in 16 patients, biofeedback training in 7 patients, sacral nerve modulation in 6 patients, sphincteroplasty in 2 patients, artificial bowel sphincter in 1 patient, and PTQ macroplastique bulking agent in 1 patient. Under local anesthesia and antibiotic prophylaxis, a mean of 8.8 (range of 2 to 19) ml of Durasphere were injected into the submucosa by using a 1.5-inch, angled, 18-gauge needle. After a median follow-up of 20.8 months (range of 10 to 22), the median Cleveland Clinic continence score decreased significantly from 12 to 8 (p < 0.001) and the median American Medical System score from 89 to 73 (p = 0.0074), but the FIQL did not change significantly (74 to 76, p = not significant). Anal manometry significantly improved (resting pressure increasing from 34 to 42 mm Hg; p = 0.008) and squeezing pressure from 66 to 79 mm Hg (p = 0.04). Two patients complained of moderate anal pain for a few days after the implant, 1 patient had asymptomatic leakage of the injected material through a mucosa perforation, and 2 had distal migration of the Durasphere along the dentate line. The authors concluded that anal bulking agent injection is a safe treatment and can mitigate the severity of fecal incontinence by increasing anal pressure but does not significantly improve the QOL.
Ganio et al (2008) evaluated prospectively the effects of calcium hydroxylaptatite ceramic microspheres (Coaptite) as a bulking agent to treat patients with passive fecal incontinence (n = 10). All patients were assessed by clinical examination, anal ultrasonography and anal manometry. The severity of incontinence and QOL were assessed using the Fecal Incontinence Scoring System (FISS) and FIQL questionnaire at baseline and at 3, 6 and 12 months after the Coaptite injection. Eight patients (80 %) had a marked improvement in continence, with a significant reduction in FISS from 85.6 +/- 9.4 to 28.0 +/- 29.0 (p = 0.008) at 12 months. There was an improvement in global QOL scores, which was significant in 3 subscales (lifestyle, coping/behavior and embarrassment). Manometry showed a significant improvement from baseline in the mean resting anal canal pressure after the Coaptite injection (p= 0.018). The authors concluded that Coaptite is a promising and safe bulking agent for the treatment of passive fecal incontinence.
Soerensen et al (2009) assessed the functional efficacy of inter-sphincteric injected silicone biomaterial (PTQ) in patients with fecal incontinence. A total of 33 patients (male-female ratio: 9:24); median age of 53 years (range of 21 to 75 years) with fecal incontinence of varied etiology were included in this study. The PTQ was injected under general anesthesia with antibiotic cover. All patients had anorectal manometry, endoanal ultrasonography and responded to fecal incontinence severity questionnaire (Wexner score) and SF-36 short-form health survey questionnaire before and 3 months post-operatively. At time of final follow-up, the continence status and QOL questionnaire were re-assessed. The mean follow-up was 12.9 months (range of 3 to 22 months). The Wexner Continence Score was significantly reduced short-term from 12.7 to 11.0 (p = 0.03) and long-term to 10.4 (p = 0.02). The long-term effect on liquid stool incontinence continued to improve significantly (p < 0.01). Six patients (18 %) reported major improvement in Wexner Continence Score at the time of final follow-up. Anorectal manometry was not affected except for the maximum tolerable rectal volume, which was significantly reduced (p < 0.05). The SF-36 short-form questionnaire showed no significant improvement in QOL after treatment with PTQ. The authors concluded that treatment with inter-sphincteric injection of PTQ implants can provide improvement in patients with fecal incontinence of varied etiology. However, the improvement is mainly limited to soiling and minor leakage; and a majority of patients still have severe incontinence, both short-term and long-term.
In a preliminary study, Aigner and associates (2009) evaluated if the injection of carbon beads can significantly improve anal continence. Consecutive patients presenting with fecal incontinence were evaluated with standardized incontinence grading and QOL grading scores, by anoproctoscopy, endoanal ultrasound, and anomanometry before, 3, 6, 12, and 24 months after injection. Injection therapy was carried out in patients with anatomically intact anal sphincters. Patients kept a 2-week incontinence diary. Data were obtained from a 2-year follow-up period. A total of 11 women with a mean age of 66 years (range of 56 to 74) met the inclusion criteria. Mean incontinence score was 12.27 +/- 0.97 at baseline, 6.82 +/- 1.64 at 3-month, 6.73 +/- 1.47 at 6-month, 5.91 +/- 0.95 at 1-year, and 4.91 +/- 0.87 at 2-year follow-up (p = 0.003). Quality-of-life items like coping and embarrassment improved significantly from baseline 2.3 to 3.0 at 3 months and 2.8 at 6 months (p < 0.05). Anomanometry showed a trend toward increase in measured pressures. No major complications occurred. The authors concluded that the injection of carbon beads via an inter-sphincteric approach is a promising new treatment option for old patients with idiopathic fecal incontinence.
In a Cochrane review, Maeda and colleagues (2010) examined the effectiveness of perianal injection of bulking agents for the treatment of fecal incontinence in adults. All randomized or quasi-randomized controlled trials comparing use of injectable bulking agents for fecal incontinence with any alternative treatments or placebo were reviewed to evaluate the therapeutic effects. Case-control and cohort studies were also reviewed to assess risks and complications associated with the treatment. Two reviewers assessed the methodological quality of eligible trials and independently extracted data from included trials using a range of pre-specified outcome measures. Four eligible randomized trials were identified with a total of 176 patients. All trials but 1 were at an uncertain or high risk of bias. Most trials reported a short-term benefit from injections regardless of the material used as outcome measures improved over time. A silicone biomaterial (PTQ), was shown to provide some advantages and was safer in treating fecal incontinence than carbon-coated beads (Durasphere) in the short-term. Similarly, there were short-term benefits from injections delivered under ultrasound guidance compared with digital guidance. However, PTQ did not demonstrate obvious clinical benefit compared to control injection of normal saline. No long-term evidence on outcomes was available and further conclusions were not warranted from the available data. The authors concluded that a definitive conclusion can not be drawn regarding the effectiveness of perianal injection of bulking agents for fecal incontinence due to the limited number of identified trials together with methodological weaknesses. Within the available data, however, these investigators found no reliable evidence for effectiveness of one treatment over another in improving fecal incontinence. They stated that larger well-designed trials with adequate numbers of subjects using reliable validated outcome measures are needed to allow definitive assessment of the treatment for both safety and effectiveness.
Graf et al (2011) stated that injection of a bulking agent in the anal canal is an increasingly used treatment for fecal incontinence, but effectiveness has not been shown in a controlled trial. These researchers evaluated the effectiveness of injection of dextranomer in stabilized hyaluronic acid (NASHA Dx) for treatment of fecal incontinence. In this randomized, double-blind, sham-controlled trial, patients aged 18 to 75 years from centers in United States and Europe were randomly assigned (2:1) to receive either transanal submucosal injections of NASHA Dx or sham injections. Randomization was stratified by sex and region in blocks of 6, and managed with a computer generated, real-time, web-based system. Patients and investigators were masked to assignment for 6 months when the effect on severity of fecal incontinence and quality of life was assessed with a 2-week diary and clinical assessments. The primary endpoint was response to treatment based on the number of incontinence episodes. A response to treatment was defined as a reduction in number of episodes by 50 % or more. Patients in the active treatment group are still being followed-up. A total of 278 patients were screened for inclusion, of whom 206 were randomized to receive NASHA Dx (n = 136) or sham treatment (n = 70). A total of 71 patients who received NASHA Dx (52 %) had a 50 % or more reduction in the number of incontinence episode, compared with 22 patients who received sham treatment (31 %; OR 2·36, 95 % CI: 1·24 to 4·47, p = 0·0089). These investigators recorded 128 treatment-related adverse events, of which 2 were serious (1 rectal abscess and 1 prostatic abscess). The authors concluded that the role of injectable agents in the treatment algorithm for fecal incontinence is not established. They stated that a refinement of selection criteria for patients, optimum injected dose, ideal site of injection, and long-term results might further increase the acceptance of this minimally invasive treatment.
Commenting on the study by Graf et al (2011), Norton (2011) stated that "Graf and colleagues' study as published, would be difficult to replicate because there is little detailed information about characterisation of patients' symptoms (did the patients report passive, urge, or both symptoms of faecal incontinence?). Other data not reported include changes in objective criteria such as anal pressures, ultrasound appearance, or sensation, which might give clues about the mechanism of action. How many patients had functional or structural impairment of the internal anal sphincter was not reported, nor how many faecal incontinence secondary to loose stool. If the treatment's presumed mechanism of action is sphincter occlusion, some categories of faecal incontinence would have little potential for benefit. So, although Graf and colleagues' study might change the conclusion of an updated Cochrane review on the subject, should it change clinical practice? maybe, but until we ask patients what they think, we cannot be sure whether a statistically significant result will actually change peoples' lives".
On May 27, 2011, the FDA approved Solesta, a sterile, injectable dextranomer hyaluronic acid gel to treat fecal incontinence (FI). The Solesta gel is injected into a layer of tissue beneath the anus lining and may help build tissue in that area. By growing the surrounding tissue, the opening of the anus narrows and the patient may be able to better control those muscles. The FDA based its approval on results from a clinical study of 206 patients. In the primary study, most patients received 2 treatments, consisting of 4 injections each, for a total of 8 injections. After 6 months, more than half of the patients injected with Solesta experienced a 50 % reduction in the number of FI episodes. However, one-third of patients who received no Solesta in the study also experienced a similar reduction. Overall, a greater proportion of patients treated with Solesta experienced improvements, indicating the gel provides benefit. Solesta is approved for use in patients aged 18 years and older who have failed conservative therapies (e.g., diet change, fiber therapy or anti-motility medications) failed. It should not be used in patients who have active inflammatory bowel disease, immunodeficiency disorders, previous radiation treatment to the pelvic area, significant rectal prolapse, active infections, bleeding, tumors or malformations in the anorectal area, rectal distended veins, an existing implant in the anorectal region, or allergy to hyaluronic acid based products. The most common side effects associated with Solesta include injection area pain and bleeding. Infection and inflammation of anal tissue are more serious risks, but are less common.
In a systematic review, Luo et al (2010) examined the safety and effectiveness of injectable bulking agents for passive FI in adults. Electronic searches were performed for MEDLINE, EMBASE, ISI Web of Knowledge and other relevant databases. Hand searching of relevant conference proceedings was undertaken. Studies were considered if they met the pre-defined inclusion criteria of more than 10 adult patients and receiving an injectable bulking agent for passive FI with a validated means of assessing pre-operative and post-operative incontinence. A total of 13 case series studies and 1 randomized controlled trial (RCT) were included with a total of 420 patients. Two completed RCTs with placebo control were identified but results were unobtainable. Coaptite, Contigen, Durasphere (carbon-coated beads), EVOH and PTQ (silicone biomaterial) injections were assessed with 24, 73, 83, 21 and 208 patients respectively. Most studies reported a statistically significant improvement in incontinence scores and quality of life. No statistically significant difference was found between the treatment and placebo arms in the RCT. No serious adverse events were reported. The authors concluded that currently there is little evidence for the effectiveness of injectable bulking agents in managing passive FI. The inability to obtain results from 2 further RCTs concerned the reviewers and hindered their ability to make strong recommendations. The identified injectable bulking agents appear to be safe with only minor complications reported.
Schwandner et al (2011) analyzed safety and functional outcome of transanal submucosal injection of dextranomer hyaluronic acid ("bulking agents therapy") in patients with passive FI. All patients who underwent transanal injection therapy were prospectively enrolled in this study. Inclusion criteria included FI (internal anal sphincter dysfunction) after failed conservative treatment. The procedure was performed in a standardized technique, including submucosal injection of 4 × 1 mL dextranomer hyaluronic acid 5 mm above the dentate line. The primary endpoint focused on symptom improvement provided as the change in incontinence status and quality of life using validated scores (Wexner incontinence score, symptom-specific Fecal Incontinence Quality of Life [FIQoL] scale, and generic EQ-5D-Visual Analogue Scale [EQ-5D-VAS]). Within the observation period (July 2007 to May 2009), a total of 21 patients (17 women) with passive FI were treated. Neither morbidity nor adverse events were documented. Three months post-operatively, 61.1 % (11/18) showed significant improvement of symptoms (reduction of incontinence episodes and soiling), which was sustained after 20 months in 55.6 % (10/18). Wexner incontinence score decreased from 16.8 to 12.3 (p > 0.05). Significant improvement was documented for FIQoL and EQ-5D-VAS (p < 0.05). The authors concluded that these findings indicated that injection therapy using hyaluronic acid is an innovative and minimally invasive procedure with no morbidity. Although Wexner incontinence score is not significantly influenced, a significant improvement in quality of life was observed in more than 50 % of patients.
Leung (2011) stated that novel treatments are needed to augment medical therapy for fecal incontinence. The author reviewed observational studies (OS) and RCTs related to injection of bulking agent for the treatment of FI. A total of 22 observational studies and 4 RCTs were identified. OS mostly with limited sample sizes reported promising results. Repeated injection was necessary in some patients. Effect on anal sphincter pressures was highly variable. Significant improvements in the length of anal high-pressure zone, asymmetry index and maximum tolerable rectal volume were suggested. Four RCTs (n = 176) revealed:- Short-term benefits from injection of Bioplastique under ultrasound guidance compared with digital guidance;
- Silicone biomaterial (PTQ) provided some advantages and was safer than carbon-coated beads (Durasphere);
- PTQ did not demonstrate clinical benefit compared to control injection of saline; and
- There was significant improvement at 6 weeks post-injection, but no difference between Bulkamid and Permacol.
A 2010 Cochrane review, however, noted that these data were inconclusive due to limited number and methodological weaknesses. The author concluded that further studies are needed to assess patient-centered outcomes (e.g., adequate relief) in addition to the attenuation of severity of incontinence symptoms in ambulatory patients. In nursing home residents, cost-effectiveness studies combining injection treatment and prompted voiding (to mitigate constraints of immobility and dementia) in preventing peri-anal skin complications deserves to be considered.
Ullah et al (2011) examined the safety and effectiveness of injectable bulking agents for the management of FI. A total of 13 procedures were performed on 11 patients with FI during 2002 to 2007. Patients with internal anal sphincter defect and low incontinence score (Cleveland score less than 10) revealed improvement. Patients with higher incontinence score and external sphincter defect secondary to obstetric damage required further intervention. At a median follow-up of 43 months, 7 (63 %) patients showed improvement in incontinence score and 4 (32 %) showed marked improvement in their symptoms. Fifty six percent of the patients described this as an effective procedure, though the level of effectiveness varied from person to person. Anal injectable collagen was found safe and effective in the management of FI. The authors concluded that long-term follow-ups are needed to re assess and consider definitive procedure in failed cases.
An UpToDate review on "Treatment of chronic functional constipation and fecal incontinence in infants and children" (Ferry, 2012) does not mention the use of bulking agents in the treatment of FI. Moreover, an UpToDate review on "Fecal incontinence in adults" (Robson and Lembo, 2012) states that "Injection of dextranomer/hyaluronic acid (Solesta™) is used for the treatment of urinary incontinence and has been studied in patients with fecal incontinence. Studies suggest dextranomer/hyaluronic acid is effective for the treatment of fecal incontinence". However, the authors did not include injectable bulking agents in the "Summary and Recommendations" of this review.
Furthermore, the National Association For Continence (NAFC, 2012) lists injectable bulking agents (Solesta) as one of the less invasive surgical options that offer promise for selected patients. The NAFC also lists phenylephrine gel (for improvement in resting tone of anal muscles) as one of the treatments undergoing testing.
Hoy and colleagues (2012) noted that dextranomer in stabilized sodium hyaluronate (Solesta), hereafter referred to as dextranomer/hyaluronic acid, is a biocompatible bulking agent administered by submucosal injection. It is hypothesized to expand the submucosal layer of the proximal anal canal, thereby augmenting bowel control. Treatment with dextranomer/hyaluronic acid was associated with symptomatic improvements in adult patients with fecal incontinence participating in a randomized, double-blind, sham-controlled, multi-national study as well as a non-comparative, multinational study. In the double-blind study, patients in the dextranomer/hyaluronic acid group met the primary efficacy objective in that a significantly higher proportion of patients responded to treatment (greater than or equal to 50 % reduction from baseline in the number of incontinence episodes) at the 6-month post-treatment time-point than in the sham group (2 of 3 primary response criteria), with the durability of the treatment response (greater than or equal to 25 % reduction from baseline in the number of incontinence episodes) confirmed at the 12-month post-treatment time-point (3rd primary response criterion). For the most part, dextranomer/hyaluronic acid did not significantly differ from the sham treatment in terms of quality of life and various other symptomatic endpoints at 6 months post-treatment in the double-blind study, although there were significant improvements from baseline in various parameters, such as the mean number of incontinence-free days, the median number of incontinence episodes and mean Fecal Incontinence Quality of Life domain scores, at 12 months post-treatment. In general, dextranomer/hyaluronic acid was well-tolerated for up to 18 months post-treatment, with the majority of treatment-related adverse events considered mild or moderate in intensity.
In an Agency for Healthcare Research and Quality’s report (AHRQ, 2012), a total of 7 experts, with clinical, research, and health systems backgrounds, offered perspectives on the use of Solesta for the treatment of FI. The experts generally agreed that an important unmet need exists for effective fecal incontinence treatment for this patient population, based on the current lack of effective therapies and their associated cost and risk of adverse events. One clinical expert opined that few patients seek proper care for fecal incontinence and that those patients who seek treatment often receive conservative treatment or no treatment at all. However, one expert opined that effective alternative therapies and "protective garments" are available for fecal incontinence management and that the need for improved options was incremental. Most experts stated this intervention has potential to improve health outcomes. Basing their opinions on preliminary results, they thought the tissue-bulking agent would not always completely resolve fecal incontinence. Most experts wanted to see additional trial results. One expert with a clinical perspective found it difficult to determine this intervention’s potential to improve health outcomes, stating that "This will not work for everyone. Those with muscle disruptions will probably need surgery. Even ‘perfect’ candidates will sometimes not be successful". Experts generally agreed that this intervention has the potential to affect the current care model and patient management and to shift care setting from inpatient surgery to office visits. One clinical expert opined that if this treatment is proven effective, it has the potential to dramatically shift the staff needed to treat the condition, because colorectal surgeons who perform the surgical procedures would be supplanted by gastroenterologists delivering minimally invasive injections during an office visit. Another clinical expert commented on this intervention’s potential to "reduce the number of individuals needed to care for incontinent patients (decreased number of aides, LPNs [licensed practical nurses], etc.). It would also decrease the individual’s costs for cleaning materials and local treatments (e.g., creams and ointments)". One research expert added that this intervention would reduce the number of procedures performed in operating rooms.
In a Cochrane review, Maeda et al (2013) examined the effectiveness of perianal injection of bulking agents for the treatment of fecal incontinence in adults. These investigators searched the Cochrane Incontinence Group Specialised Register of trials (May 25, 2012), ZETOC (May3, 2012), clinical trials registries (May 3, 2012) and the reference lists of relevant articles. All randomized or quasi-randomized controlled trials comparing the use of injectable bulking agents for fecal incontinence with any alternative treatments or placebo were reviewed to evaluate the therapeutic effects. Case-control and cohort studies were also reviewed to assess risks and complications associated with the treatments. Two review authors assessed the methodological quality of eligible trials and independently extracted data from the included trials using a range of pre-specified outcome measures. A total of 5 eligible randomized trials with a total of 382 patients were identified; 4 of the trials were at an uncertain or high- risk of bias. Most trials reported a short-term benefit from injections regardless of the material used, including placebo saline injection. One study demonstrated dextranomer in stabilized hyaluronic acid (NASHA Dx) to be more effective than sham injection but with more adverse effects. Dextranomer in stabilized hyaluronic acid (NASHA Dx) was better than sham injections at 6 months (65/136, 48 % versus 48/70, 69 % participants not improved, defined as less than 50 % reduction in incontinence episodes, RR 0.70, 95 % CI: 0.55 to 0.88; with more incontinence free days (3.1 days compared with 1.7 in the sham treatment group, MD 1.40 days, 95 % CI: 0.33 to 2.47). Another study comparing silicone material (PTQ™) to saline injections was too small to demonstrate a clinical benefit compared to the control injection of normal saline. A silicone biomaterial (PTQ™) was shown to provide some advantages and was safer in treating fecal incontinence than carbon-coated beads (Durasphere®) in the short-term. Similarly, there were short-term benefits from injections delivered under ultrasound guidance compared with digital guidance. No long-term evidence on outcomes was available and further conclusions were not warranted from the available data. None of the studies reported patient evaluation of outcomes and thus it is difficult to gauge whether the improvement in incontinence scores matched practical symptom improvements that mattered to the patients. The authors concluded that 1 large randomized controlled trial has shown that this form of treatment using dextranomer in stabilized hyaluronic acid (NASHA Dx) improves continence for a little over 50 % of patients in the short-term. However, the number of identified trials was limited and most had methodological weaknesses.
Nandivada and Nagle (2014) reviewed the most recent surgical options for the treatment of FI within the context of established therapies. Overlapping sphincteroplasty is an established therapy that improves continence and QOL, although results deteriorate over time. Implanted artificial bowel sphincter has a 100 % complication rate and 80 % are explanted over time. Sacral nerve stimulation has minimal risk and more durable long-term improvement in continence. Less invasive versions of nerve stimulation are being researched. Injectable biomaterials have shown some promise, although durability of results is not clear. Novel therapies, including muscle cell transfer and pelvic slings are currently being investigated. The authors concluded that surgical therapies for FI continue to evolve and show promise in improving QOL with a lower risk profile. Effective valuation of these therapies is currently limited by heterogeneous studies, short duration of follow-up, and inconsistent outcome measures.
An UpToDate review on "Fecal incontinence in adults: Management" (Robson and Lembo, 2015a) stated that "Injectable anal bulking agents – It is hypothesized that injection of anal bulking agents may enhance resting anal pressures and thereby improve fecal continence, especially in patients with passive fecal incontinence. Studies suggest that dextranomer stabilized in hyaluronic acid has limited efficacy in the treatment of fecal incontinence in the short term. Long-term follow-up data are lacking".
In a systematic review and meta-analysis, Hong and colleagues (2017) examined the mid-term outcomes of treatment with injectable bulking agents and identified predictive factors for improvement in FI. PubMed, Embase, Web of Science, and Cochrane Library databases were searched using the terms injection, bulking agents, and fecal incontinence. Studies with a minimum follow-up of 1 year were included. The improvement rate in FI was calculated by percent change in validated FIS following injection treatment. To explore the impact of predictive factors on improvement in incontinence, univariate meta-regressions were conducted using the random-effect model. A total of 889 patients in 23 articles were included. The weighted mean follow-up duration was 23.7 months (95 % CI: 19.3 to 28.2); 11 different bulking agents were used and 4 validated FISs were used. The Cleveland Clinic Fecal Incontinence score (CC-FIS) was used in 19 studies. Most studies reported a statistically significant improvement in FIS. The pooled mean pre-operative CC-FIS (n = 637) was 12.4 (95 % CI: 11.4 to 13.3). The pooled mean CC-FIS at last follow-up (n = 590) was 7.7 (95 % CI: 6.1 to 9.3). The weighted mean difference in CC-FIS between pre-operative visit and last follow-up was 4.9 (95 % CI: 4.0-5.8). Hence, the rate of improvement in FI was 39.5 % based on CC-FIS. Meta-regression revealed that the peri-anal injection route and implants intact on endo-anal ultrasonography were predictive of greater improvement in incontinence. The manometric data revealed that the initial increase in the mean resting pressure following injection was attenuated over time. The pooled rate of adverse events (AEs) was 18.0 % (95 % CI: 10.0 to 30.1). In most cases, AEs were minor and resolved within a couple of weeks. The authors concluded that administration of injectable bulking agents resulted in significant mid-term improvement in FIS. They stated that peri-anal injection route and implants intact on endo-anal ultrasound (EAUS) were predictive of higher improvement in FI; however, given the paucity of RCTs in the literature, further research is needed to improve the quality of the evidence.
In a review on "Modern strategies for the treatment of fecal incontinence", Brunner and colleagues (2019) noted that bulking agents are an alternative – predominantly in passive FI, although the evidence is limited due to the use of different substances and techniques, lack of long-term results and sub-optimal study designs.
Regenerative Medicine (e.g., Biocompatible Materials, With or Without the Use of Trophic Factors, Injection of Autologous Myoblast Cells / Mesenchymal Stem Cells / Stem Cells)
In a pilot study, Frudinger and colleagues (2010) examined the effectiveness of injection of autologous myoblast cells in the treatment of anal incontinence as a result of obstetric trauma. A total of 10 women suffering from anal incontinence due to obstetric anal sphincter injury, refractory to conventional non-surgical therapy were included in this study. Autologous myoblasts were cultured from a pectoralis muscle biopsy, harvested, and injected into the external anal sphincter defect using direct ultrasound guidance. Main outcome measures included Wexner incontinence score, anal squeeze pressures, and QOL 12 months after injection. The procedure was well-tolerated and no adverse events were observed. At 12 months the Wexner incontince score had decreased by a mean of 13.7 units (95 % CI: -16.3 to -11.2), anal squeeze pressures were unchanged, and overall QOL scores improved by a median of 30 points (95 % CI: 25 to 42). Anal squeeze pressures rose significantly at 1 month and 6 months post-injection (p = 0.03). The authors concluded that injection of autologous myoblasts is safe, well-tolerated, and significantly improves symptoms of anal incontinence due to obstetric anal sphincter trauma. The findings of this small pilot study need to be validated by well-designed studies.
Park et al (2016) examined the safety and effectiveness of using allogeneic-adipose-derived mesenchymal stem cells in the treatment of the anal sphincter of patients with FI. This study is a randomized, prospective, dose escalation, placebo-controlled, single-blinded, single-center trial with 2 parallel groups. The safety test is performed by an injection of allogeneic-adipose-derived mesenchymal stem cells (ALLO-ASCs) into the anal sphincter with dose escalation (3 × 10(7), 6 × 10(7) and 9 × 10(7) cells, sequentially). After confirming the safety of the stem cells, an effectiveness test is performed by this dose in the experimental group. The experimental group will receive ALLO-ASCs mixed with fibrin glue into the anal sphincter, and the placebo group will receive 0.9 % normal saline injection mixed with fibrin glue. The primary end-point is to evaluate the safety of ALLO-ASCs after the injection into the anal sphincter, and the secondary end-point is to compare the efficacy of ALLO-ASC injection with fibrin glue in patients with FI. The study protocol was approved by the Ministry of Food and Drug Safety and the Ministry of Health & Welfare, in the Republic of Korea. The informed consent form was approved by the institutional review board of Gangnam Severance Hospital (IRB approval number 3-2014-0271). Dissemination of the results will be presented at a conference and in peer-reviewed publications.
De Ligny and colleagues (2019) carried out a quality assessment and provided a critical overview of the current research available on regenerative medicine as a treatment for FI. These researchers performed a systematic search strategy in PubMed, Cochrane Library, Embase, Medline, Web of Science, and Cinahl from inception until March of 2018. Studies were found relevant when the animals or patients in the studied group had objectively determined or induced FI, and the intervention must have used any kind of cells, stem cells, or biocompatible material, with or without the use of trophic factors. Studies were screened on title and consecutively on abstract for relevance by 2 independent investigators. The risk of bias of pre-clinical studies was assessed using the SYstematic Review Centre for Laboratory animal Experimentation risk of bias tool for animal studies, and for clinical studies the Cochrane risk of bias tool for randomized trials was used. A total of 34 pre-clinical studies and 5 clinical studies were included. Animal species, type of anal sphincter injury, intervention, and outcome parameters were heterogenous. Thus, a meta-analysis could not be performed; the overall risk of bias of the included studies was high. The authors concluded that the efficacy of regenerative medicine to treat FI could not be determined due to the high risk of bias and heterogenicity of the available pre-clinical and clinical studies. These researchers stated that the findings of this systematic review may result in improved study design of future studies, which could help the translation of regenerative medicine to the clinic as an alternative to current treatments for FI.
In a commentary regarding the afore-mentioned study, El-Said and Emile (2019) stated that "Because regenerative medicine is still evolving, several concepts about tissue healing and the role of stem cells in healing are still not clear. The current concept in regenerative medicine is based on the stem-cell paradigm that suggests that stem cells can differentiate into any type of parenchymal cell and are responsible for healing by regeneration. In light of this theory, local injection of stem cells at the site of injury, with or without adjunct stimulation or scaffolding, results in healing of injured tissue by regeneration. Although this concept seems ideal and simple, previous studies failed to prove the validity of this hypothesis. An alternative paradigm of healing by regeneration may exist. Bone marrow-derived progenitor cells may initiate the first step in the regeneration process by the formation of connective tissue stroma that subsequently is infiltrated by parenchymal cells from the surrounding tissues. It is suitable to assume that, if stroma formation by the bone marrow-derived progenitor cells was deficient and took a prolonged duration, then the parenchymal stem/progenitor cells that were stimulated by injury will not find a suitable stroma to proliferate within which will impair the process of regeneration. Healing of injured skeletal muscles is a vivid example of this regenerative healing process because it entails healing of tissues composed of parenchyma and stroma. Experimental studies have suggested that healing of injured skeletal muscles can occur by regeneration even without the injection of stem cells. By critically studying the results of different and apparently conflicting experimental studies, stem-cell injection seems to accelerate the regenerative healing of injured skeletal muscles".
Topical Estrogen
In a prospective, randomized, double-blind study, Pinedo and co-workers (2009) evaluated the effect of topical estrogens (TE) in controlling symptoms of fecal incontinence in post-menopausal women. Patients were randomized into 2 groups:- topical estriol, and
- placebo.
In both groups, the ointment was applied 3 times daily for a period of 6 weeks. Wexner's fecal incontinence score and the fecal incontinence QOL scale were compared before commencing and after 6 weeks of TE application. A total of 36 patients were evaluated (average age of 67 years; range of 48 to 84). Group (i): 18 patients and group (ii): 18 patients, 1 patient was excluded. Wexner's fecal incontinence score in group (i) was 11 (5 to 18) and 7 (0 to 19) with pre- and post-application, respectively (p = 0.002). Wexner's fecal incontinence score in group (ii) was 12 and 9 with pre- and post-application, respectively (p = 0.013). When results between both groups were compared, these were not statistically significant (p = 0.521). The authors concluded that there is improvement of continence in both groups that had the ointment applied; nonetheless this study could not show that TE improves fecal incontinence more than a placebo does.
Posterior Tibial Nerve Stimulation
In percutaneous posterior tibial nerve stimulation (PTNS) (e.g., Urgent PC, Nuro Neuromodulation System) a nonimplanted electrode is utilized to produce tibial nerve stimulation that purportedly travels to the sacral nerve plexus to control incontinence
Findlay and Maxwell-Armstrong (2011) stated that fecal incontinence is a common and important multi-factorial disorder with a range of treatment options. Over the last 2 decades, neuromodulation via sacral nerve stimulators has been shown to be effective for both fecal and urinary incontinence, although associated with complications. Peripheral neuromodulation, via the posterior tibial nerve, is widely used in urinary incontinence; however, its use in fecal incontinence, while evolving is limited to 8 small heterogeneous studies. These 8 studies were discussed in the context of the methodology and underlying neurophysiology of peripheral neuromodulation, as are thus far unanswered questions. The 8 studies include a total of 129 patients with fecal incontinence (of variable etiology), all of whom had failed conservative management. One study was prospective and controlled, 6 were uncontrolled and 1 was retrospective and uncontrolled. Five different neuromodulatory protocols were used over 6 different study periods. Outcome measures varied, but short-term primary end point success ranged from 30.0 % to 83.3 %. The limitations to this early evidence, while encouraging, are significant, and it remains to be seen whether this novel treatment modality represents the minimally invasive, well-tolerated, cost-effective and flexible panacea hoped for this common and debilitating disease. The authors noted that 3 upcoming multi-center, placebo-controlled trials will better be able to delineate its role.
Thomas et al (2013) evaluated the published results of posterior tibial nerve stimulation for FI. A search was performed of PubMed, MEDLINE and Embase to identify studies describing the clinical outcome of posterior tibial nerve stimulation for FI. A total of 13 studies were identified. These described the outcome of posterior tibial nerve stimulation for FI in 273 patients; 4 described transcutaneous posterior tibial nerve stimulation (TTNS), 8 percutaneous posterior tibial nerve stimulation (PTNS) and 1 compared both methods of posterior tibial nerve stimulation with a sham transcutaneous group. One investigated patients with FI and spinal cord injury and another with inflammatory bowel disease. There was marked heterogeneity of the treatment regimens and of the end-points used. All reported that posterior tibial nerve stimulation improved FI. A greater than 50 % improvement was reported in episodes of FI in 63 to 82 % of patients. An improvement was seen in urgency (1 to 5 mins). Improvement was also described in the Cleveland Clinic fecal incontinence score in 8 studies. Patients with urge and mixed incontinence appear to benefit more than those with passive incontinence. Treatment regimens ranged in duration from 1 to 3 months. A residual therapeutic effect is seen after completion of treatment. Follow-up ranged from 1 to 30 months. The authors concluded that posterior tibial nerve stimulation is effective for FI. However, many of the published studies are of poor quality. Comparison between studies was difficult owing to differences in the outcome measures used, technique of posterior tibial nerve stimulation and the timing and duration of treatment.
Horrocks and colleagues (2014) noted that 2 forms of posterior tibial nerve stimulation are used to treat FI:- PTNS, and
- TTNS.
These investigators appraised the literature on both procedures. A systematic review was performed adhering to the PRISMA framework. A comprehensive literature search was conducted, with systematic methodological quality assessment and data extraction. Summary measures for individual outcome variables were reported. A total of 12 articles met eligibility criteria; 6 related to PTNS, 5 to TTNS, and 1 to both procedures. These included 10 case series and 2 RCTs. Case series were evaluated using the National Institute for Health and Care Excellence quality assessment for case series, scoring 3 to 6 of 8. Randomized controlled trials were evaluated using the Jadad score, scoring 4 of a possible 5 marks, and the Cochrane Collaboration bias assessment tool. From 1 RCT and case series reports, the success rate of PTNS, based on the proportion of patients who achieved a reduction in weekly FI episodes of at least 50 %, was 63 to 82 %, and that of TTNS was 0 to 45 %. In a RCT of TTNS versus sham, no patient had a reduction in weekly FI episodes of 50 % or more, whereas in a RCT of PTNS versus TTNS versus sham, 82 % of patients undergoing PTNS, 45 % of those having TTNS, and 13 % of patients in the sham group had treatment success. The authors concluded that PTNS and TTNS resulted in significant improvements in some outcome measures; however, TTNS was not superior to sham stimulation in a large, adequately powered, RCT. Moreover, they stated that as no adequate RCT of PTNS versus sham has been conducted, conclusions cannot be drawn regarding this treatment.
Edenfield et al (2015) systematically reviewed the literature regarding the effectiveness of PTNS as a treatment of FI. These investigators searched MEDLINE/PubMed, EMBASE, and Cochrane databases from inception through November 2013. They included English-language full-text articles reporting outcomes for FI with either percutaneous PTNS or transcutaneous techniques (TENS). They used the Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) system to assess study quality. The search yielded 1,154 citations; 129 abstracts and 17 articles were included for full-text review. There were 13 case series and 4 RCTs; 15 studies were of low quality, none was of fair quality, and 2 studies were of good quality based on the GRADE system. In total, 745 subjects were studied, and of those, 90 % were women and 10 % were men. Studies involved percutaneous PTNS in 57 % (428/745) of the subjects, TENS in 30 % (223/745), and sham technique in 13 % (94/745). Therapy frequency, maintenance therapy, and follow-up time varied across studies. A total of 11 studies assessed FI episodes and bowel movement deferment time; all but 1 showed statistical improvement after therapy; 10 of the 11 studies that used the Cleveland Clinic Florida Fecal Incontinence score reported statistically significantly improved scores after treatment. The authors concluded that multiple low-quality studies showed improvement in FI after PTNS. They stated that high-quality studies with comparison groups and clinically meaningful outcome measures would further establish the utility of PTNS for FI.
In a multi-center, parallel-arm, double-blind, RCT, Horrocks et al (2015) evaluated the effectiveness of PTNS compared with sham electrical stimulation in the treatment of patients with FI in whom initial conservative strategies have failed. Participants aged greater than 18 years with FI who have failed conservative treatments and whose symptoms were sufficiently severe to merit further intervention were included in this study; PTNS was delivered via the Urgent® PC device (Uroplasty Limited, Manchester, UK), a hand-held pulse generator unit, with single-use leads and fine-needle electrodes. The needle was inserted near the tibial nerve on the right leg adhering to the manufacturer's protocol (and specialist training). Treatment was for 30 minutes weekly for a duration of 12 treatments. Validated sham stimulation involved insertion of the Urgent PC needle subcutaneously at the same site with electrical stimulation delivered to the distal foot using transcutaneous electrical nerve stimulation. Outcome measures were assessed at baseline and 2 weeks following treatment. Clinical outcomes were derived from bowel diaries and validated, investigator-administered questionnaires. The primary outcome classified patients as responders or non-responders, with a responder defined as someone having achieved greater than or equal to 50 % reduction in weekly FI episodes (FIEs). A total of 227 patients were randomized from 373 screened: 115 received PTNS and 112 received sham stimulation. There were 12 trial withdrawals: 7 from the PTNS arm and 5 from the sham arm. Missing data were multiply imputed. For the primary outcome, the proportion of patients achieving a greater than or equal to 50 % reduction in weekly FIEs was similar in both arms: 39 in the PTNS arm (38 %) compared with 32 in the sham arm (31 %) [odds ratio 1.28, 95 % CI: 0.72 to 2.28; p = 0.396]. For the secondary outcomes, significantly greater decreases in weekly FIEs were observed in the PTNS arm than in the sham arm (beta -2.3, 95 % CI: -4.2 to -0.3; p = 0.02), comprising a reduction in urge FIEs (p = 0.02) rather than passive FIEs (p = 0.23). No significant differences were found in the St Mark's Continence Score or any QOL measures. No serious adverse events related to treatment were reported. The authors concluded that PTNS did not show significant clinical benefit over sham electrical stimulation in the treatment of FI based on number of patients who received at least a 50 % reduction in weekly FIE. It would be difficult to recommend this therapy for the patient population studied.
Horrocks and associates (2017) stated that a recent randomized, multi-center, phase-III clinical trial, performed in the United Kingdom (Control of Fecal Incontinence using Distal Neuromodulation Trial), demonstrated no significant clinical benefit of PTNS compared to sham stimulation in patients with FI. However, this study did not analyze predictors of response. These researchers used data from this trial to identify factors that predict the efficacy of PTNS in adults with FI. The study population comprised 205 patients from the CONtrol of Fecal Incontinence using Distal NeuromodulaTion Trial. The primary outcome was a binary indicator of success (greater than or equal to 50 % reduction in weekly FI episodes after 12 weeks of treatment) or failure, as per the original trial characteristics including baseline FI symptom type, defecatory urgency, and co-existent symptoms of baseline liquid stool consistency and obstructive defecation (OD) were defined a priori. Uni-variable and multi-variable analyses were performed to explore these factors as predictors of response to PTNS and sham. In both uni-variable and multi-variable analysis, the presence of OD symptoms negatively predicted outcome in patients who received PTNS (OR, 0.38; 95 % CI: 0.16 to 0.91; p = 0.029), and positively predicted sham response (OR, 3.45; 95 % CI: 1.31 to 9.21; p = 0.012). No other tested variable affected outcome. Re-analysis of the primary outcome excluding patients with OD symptoms (n = 112) resulted in a significant clinical effect of PTNS compared to sham (48.9 % versus 18.2 % response, p = 0.002; multi-variable OR, 4.71; 95 % CI: 1.71 to 12.93; p = 0.003). The authors concluded that concomitant OD symptoms negatively affected the clinical outcome of PTNS versus sham in a major RCT. They stated that future appropriately designed studies could further explore this observation with potential for future stratified patient selection.
In a pilot study, Sanagapalli and colleagues (2018) evaluated the efficacy of PTNS in treating multiple sclerosis-related FI. Consecutive multiple sclerosis patients with FI that had failed conservative therapy received PTNS between 2012 and 2015. All patients had previously undergone anorectal physiology tests and EAUS. Patients whose Wexner incontinence score reduced below 10 post-therapy or halved from baseline were deemed responders. A total of 33 patients (25 women, median age of 43 years) were included; 23 (70 %) had urge, 4 (12 %) passive, and 9 (27 %) mixed FI; 26 (79 %) were classified as responders. The majority of subjects had relapsing-remitting multiple sclerosis (67 %); those had a significantly higher response rate (95 % versus 67 % and 50 % in primary and secondary progressive respectively, p < 0.05). Responders tended to be more symptomatic at baseline and had greater improvements in bowel symptom scores and QOL scores with therapy. The authors concluded that PTNS demonstrated potential as an effective therapy for FI in multiple sclerosis. They stated that these findings provided the basis for more definitive controlled studies.
In a systematic review and meta-analysis, Simillis and colleagues (2018) compared the clinical outcomes and effectiveness of sacral nerve stimulation (SNS) versus PTNS for the treatment of FI in adults. These investigators carried out a literature search of Medline, Embase, Science Citation Index Expanded and Cochrane to identify studies comparing SNS and PTNS for treating FI. A risk of bias assessment was performed using the Cochrane Collaboration's risk of bias tool. A random effects model was used for the meta-analysis. A total of 4 studies (1 RCT and 3 non-randomized prospective studies) reported on 302 patients: 109 underwent SNS and 193 underwent PTNS. All included studies noted an improvement in symptoms after treatment, without any significant difference in efficacy between SNS and PTNS. Meta-analysis demonstrated that the Wexner score improved significantly with SNS compared to PTNS (weighted mean difference [WMD] 2.27; 95 % CI: 3.42 to 1.12; p < 0.01). Moreover, SNS was also associated with a significant reduction in FI episodes per week and a greater improvement in the fecal incontinence QOL coping and depression domains, compared to PTNS on short-term follow-up. Only 2 studies reported on AEs, reporting no serious AEs with neither SNS nor PTNS. The authors concluded that current evidence suggested that SNS resulted in significantly improved functional outcomes and QOL compared to PTNS. No serious AEs were identified with either treatment. These researchers stated that further, high-quality, multi-center RCTs with standardized outcome measures and long-term follow-up are needed in this field.
Iacona and associates (2019) stated that neuromodulation is the application of electrical stimulation on nerve fibers to modulate the neuronal activity. Its use for chronic constipation and FI has increased in popularity over the past few years. Invasive and non-invasive techniques are currently available. These investigators reviewed the current literature on the application of the neuromodulation techniques in the management of chronic constipation and FI in children. They carried out a search of Healthcare Database Advanced Search, Embase, Medline, and Cochrane database in accordance with PRISMA guideline. Terms used in the search included neuromodulation, nerve stimulation, fecal/fecal incontinence, incontinence, constipation, children, and pediatric/pediatric. A total of 241 papers were screened; 14 were included for the systematic review: 7 were selected for the ISNM (implantable sacral nerve modulation) technique, 1 for the transcutaneous tibial nerve stimulation), 1 for the transcutaneous sacral nerve modulation), and 5 for the transcutaneous interferential sacral nerve stimulation. Results showed an overall improvement in constipation symptoms in 79 to 85.7 % of patients, resolution of symptoms in 40 %, reduced use of ACE stoma/trans-anal irrigation system in 12.5 to 38.4 %, and improvement in incontinence symptoms in 75 %. High complication rate was reported (17 to 50 %) in the ISNM group. No complications were reported in the non-invasive group. The authors concluded that neuromodulation is a promising tool in the management of constipation refractory to medical treatment and FI in children. Non-invasive techniques provided good results with no complications. These researchers stated that a longer term follow-up will provide more information regarding patient compliance and sustainability of benefits of these new techniques.
Simillis and co-workers (2019) stated that although numerous treatments exist for FI, no consensus exists on the best treatment strategy. In a systematic review and network meta-analysis, these investigators evaluated the literature and compared the clinical outcomes and effectiveness of treatments available for FI. A systematic literature review was carried out from inception to May 2018, of the following databases: Medline, Embase, Science Citation Index Expanded, Cochrane Library. The search terms used were "faecal incontinence" and "treatment". Only RCTs comparing treatments for FI were considered. A Bayesian network meta-analysis was performed using the Markov chain Monte Carlo method. A total of 47 RCTs were included comparing 37 treatments and reporting on 3,748 subjects. No treatment ranked best or worst with high probability for any outcome of interest. No significant difference was identified between treatments for frequency of FI per week, or in changing the resting pressure, maximum resting pressure, squeeze pressure, and maximum squeeze pressure. Radiofrequency resulted in more AEs compared to placebo. Sacral nerve stimulation (SNS) and zinc-aluminum improved the FIQL lifestyle questionnaire, coping, and embarrassment domains compared to placebo. Transcutaneous PTNS (TPTNS) improved the FIQL embarrassment domain compared to placebo. Autologous myoblasts and zinc-aluminum improved the FIQL depression domain compared to placebo. SNS, artificial bowel sphincter (ABS), and zinc-aluminum significantly improved incontinence scores compared to placebo. Injection of non-animal stabilized hyaluronic acid/dextranomer (NASHA/Dx) resulted in more patients with greater than or equal to 50 % reduction in FI episodes compared to placebo. The authors concluded that SNS, ABS, TPTNS, NASHA/Dx, zinc-aluminum, and autologous myoblasts resulted in isolated improvements in specific outcomes of interest. No difference was identified in incontinence episodes, no treatment ranked best persistently or persistently improved outcomes, and many included treatments did not significantly benefit patients compared to placebo. These researchers stated that large, multi-center RCTs with long-term follow-up and standardized inclusion criteria and outcome measures are needed.
Tan and colleagues (2020) noted that successful treatments following electrical nerve stimulation have been commonly reported in patients with FI and constipation. However, many of these nerve stimulation trials have not implemented sham controls, and were, therefore, unable to differentiate overall treatment responses from placebo. In a systematic review, these researchers quantified placebo effects and responses following sham electrical nerve stimulation in patients with FI and constipation. They carried out a literature search of Ovid Medline, PubMed, Embase, and Cochrane databases from inception to April 2017. Randomized sham-controlled trials examining the effect of lower gastro-intestinal (GI) electrical nerve stimulation in FI and constipation were included; pediatric and non-sham controlled trials were excluded. A total of 10 randomized sham-controlled trials were included. Sham stimulation resulted in improvements in FI episodes by 1.3 episodes per week (95 % CI: -2.53 to -0.01, p = 0.05), fecal urgency by 1.5 episodes per week (CI: -3.32 to 0.25, p = 0.09), and Cleveland Clinic Severity scores by 2.2 points (CI: 1.01 to 3.36, p = 0.0003). Sham also improved symptoms of constipation with improved stool frequency (1.3 episodes per week, CI: 1.16 to 1.42, p < 0.00001), Wexner Constipation scores (5.0 points, CI: -7.45 to -2.54 p < 0.0001), and GI-QOL scores (7.9 points, CI: -0.46 to 16.18, p = 0.06). The authors concluded that sham stimulation was associated with clinical and statistically meaningful improvements in symptoms of FI and constipation, as well as QOL scores, highlighting the importance of sham controls in nerve stimulation trials. These researchers stated that non-controlled studies should be interpreted with caution.
Pudendal Nerve Terminal Motor Latency
Pudendal nerve terminal motor latency (PNTML) measures the neuromuscular integrity between the terminal portion of the terminal nerve and the anal sphincter. This test is utilized to determine if there is weak sphincter muscle.
Pudendal nerve terminal motor latency (PNTML) is determined by measuring the time required after stimulating the pudendal nerves with an electrode as it crosses the ischial spine to induce a contraction of the external anal sphincter. Normal delay is approximately 2.0 msec; prolongation of the PNTML suggests damage to the nerve. However, this technique is operator-dependent and has poor correlation with clinical symptoms and histologic findings. Guidelines from the American Gastroenterological Association (1999) stated "The PNTML cannot be recommended for evaluation of patients with fecal incontinence".
An UpToDate review on "Functional fecal incontinence in infants and children: Definition, clinical manifestations and evaluation" (Sood, 2015) does not mention the use of PNTML measurements. Furthermore, an UpToDate review on "Fecal incontinence in adults: Etiology and evaluation" (Robson and Lembo, 2015b) states that "Pudendal nerve terminal latency (PNTL) and saline infusion test have no role in the evaluation of fecal incontinence".
Weledji (2017) noted that pudendal neuropathy is not a predictor of surgical intervention for FI, but independent predictors include the presence of a prolapse, a functional sphincter length of less than 1 cm, an external anal sphincter defect, and a Cleveland Clinic Incontinence Score greater than or equal to 10. In clinical assessments, pudendal nerve studies are of particular value in patients with FI, but not in those with solitary rectal ulcer syndrome, hemorrhoids or the complexity of obstructive defecation syndrome as many of the associated problems or pathologies may not be immediately apparent. In addition, pudendal nerve motor latency (PNML) is operator-dependent and has a poor correlation with clinical symptoms and histological findings. The investigation only examines the fastest conducting fibers of the pudendal nerve, so PNML can still be normal even in the presence of abnormal sphincter innervation. The authors stated that pudendal nerve testing may not, therefore, contribute to surgical decision-making in patients with FI; and the American Gastroenterology Association does not, therefore, recommend the use of pudendal nerve testing for the evaluation of patients with FI.
Saraidaridis and colleagues (2018) stated that pudendal nerve terminal motor latency (PNTML) testing is a standard recommendation for the evaluation of FI. Its role in guiding therapy for FI has been previously questioned. These researchers examined the relationship between PNTML testing and anorectal dysfunction. This was a retrospective analysis of data collected prospectively from patients who presented to a pelvic floor disorder center from 2007 to 2015. The relationship between PNTML (normal versus delayed) and anorectal manometry, FI severity, and FI-related QOL scores was assessed using the Wilcoxon-Mann-Whitney test. A total of 269 patients underwent PNTML testing, and 91.1 % were women (n = 245) (median age of 62.2 years). Normal PNTML was observed in 234 (87.0 %) patients. Among 268 patients who underwent anorectal manometry, delayed PNTML was only significantly associated with median maximum anal squeeze pressure (p = 0.04). Delayed PNTML was not associated with a decrease in median FI severity or FI-related QOL scores (n = 99). The authors concluded that PNTML was only associated with median maximum anal squeeze pressure, and it was not associated with patient-reported severity of symptoms of FI, changes in QOL attributable to FI, median mean resting anal pressure, or median maximum resting anal pressure. They stated that PNTML testing may not be relevant to current therapeutic algorithms for FI and its routine use should be questioned.
Rectal Banding
An UpToDate review on "Fecal incontinence in adults: Management" (Robson and Lembo, 2015a) does not mention rectal banding as a therapeutic option.
Surgical Treatments
Meyer and Richter (2016) noted that surgical management of FI is considered invasive and provided only short-term success with high complication rates. Recent research has provided additional data on the existing treatments as well as the development of less invasive options and new investigational treatments.
Forte and colleagues (2016) evaluated the effectiveness, comparative effectiveness, and harms of surgical treatments for FI in adults. Ovid Medline, Embase, Physiotherapy Evidence Database, Cumulative Index to Nursing and Allied Health Literature, Allied and Complementary Medicine, and the Cochrane Central Register of Controlled Trials, as well as hand searches of systematic reviews, were used as data sources. Two investigators screened abstracts for eligibility (surgical treatment of FI in adults, published 1980 to 2015, RCT or observational study with comparator; case series were included for AEs). Full-text articles were reviewed for patient-reported outcomes. These researchers extracted data, assessed study risk of bias, and evaluated strength of evidence for each treatment-outcome combination. Main outcome measures were FI episodes/severity, QOL, urgency, and pain were measured. A total of 22 studies met inclusion criteria (13 randomized trials and 9 observational trials); 53 case series were included for harms. Most patients were middle-aged women with mixed FI etiologies. Intervention and outcome heterogeneity precluded meta-analysis. Evidence was insufficient for all of the surgical comparisons. Few studies examined the same comparisons; no studies were high quality. Functional improvements varied; some authors excluded those patients with complications or lost to follow-up from analyses. Complications ranged from minor to major (infection, bowel obstruction, perforation, and fistula) and were most frequent after the artificial bowel sphincter (22 % to 100 %). Major surgical complications often required re-operation; few required permanent colostomy. The authors concluded that available evidence was insufficient to support clinical or policy decisions for any surgical treatments for FI in adults. More invasive surgical procedures had substantial complications. The lack of compliance with study reporting standards is a modifiable impediment in the field. They stated that future studies should focus on longer-term outcomes and attempt to identify subgroups of adults who might benefit from specific procedures. The major drawbacks of this study were:- most evidence was intermediate term,
- small patient samples and
- substantial methodological limitations.
An UpToDate review on "Fecal incontinence in adults: Management" (Robson and Lembo, 2017) states that "Although implantation of an artificial sphincter device has been associated with a clinically significant improvement in fecal continence, its use is limited by complications including explantation in up to 1/3 of patients … Diversion of the fecal stream with a colostomy is the only option in patients with intractable symptoms who are not candidates for any other therapy, or in whom other treatments have failed … Surgical placement of a perianal sling designed to enhance the anorectal angle may be a potential option for patients, but additional studies are needed".
Pubo-Rectal Sling
In a pilot study, Brochard and associates (2017) described the use of a pubo-rectal sling (placed via a trans-obturator approach with a device used for vaginal vault prolapse) for the treatment of FI and reported long-term outcome at 5 years. A total of 6 women with FI for whom usual treatments (including sacral nerve stimulation) have failed were enrolled in this study. Cleveland Clinic Incontinence Score (CCIS) and FIQL were used to evaluate results. The median CCIS was significantly improved at 12 months (18.5 [15 to 20] versus 7.5 [4 to 20] in post-operative assessment; p = 0.037). The median FIQL was improved at 12 months (6.05 [5.6 to 7] versus 10.2 [5.6 to 12.5]; p = 0.0542). No AE was recorded except the distension of the device in 1 patient. Finally, at 5 years, 3 patients were improved, 1 had recurrence of FI symptoms (at 24 months) and 2 had no change. The authors concluded that this technique is a minimally invasive surgical treatment and constitutes a new therapeutic option for FI in case of failure of conventional treatment. The preliminary findings of this pilot study need to be validated by ell-designed studies.
Fenix Continence Restoration System
DeStephano and colleagues (2017) reported a new technique for the surgical management of FI using the Fenix Continence Restoration System in 2 patients. The Fenix System received FDA approval under a humanitarian device exemption and can be used with institutional review board approval in patients who have failed previous medical and surgical management of FI. The device is a small, flexible band of interlinked titanium, magnetic beads on a titanium string that is placed using a perineal approach around the anal canal. Increased intra-abdominal pressure opens the beads to allow for passage of stool. Placement of the device was performed in 2 patients. Case 1 was a 63-year old female with a long-standing history of FI who failed sphincteroplasy, sacral neuromodulation, and an artificial sphincter cuff and pump. Case 2 was a 60-year old female with a long-standing history of FI secondary to radiation therapy for rectal cancer who failed physical therapy and sacral neuromodulation. The authors concluded that both Fenix Continence Restoration Systems were placed successfully; long-term post-operative effectiveness is currently being evaluated.
The Renew Anal Insert
Leo and colleagues (2019) stated that the Renew anal insert is a recent treatment for patients who suffer from passive FI. These researchers examined the effectiveness of the insert and patients' satisfaction with it. A retrospective audit of patients who were treated with the Renew anal insert was undertaken. The St Mark's Incontinence Score was used to evaluate clinical outcome. Renew size, the number of inserts used per day and per week had also been recorded. Subjective assessment of symptoms, how beneficial Renew was and how satisfied patients were with the device were all recorded. Major events and side effects were also noted. A total of 30 patients received Renew as a treatment for passive FI in 2016. The median St Mark's Incontinence Score was 15 (range of 7 to 18) at baseline and 10 (range of 2 to 18) at first follow-up (p < 0.0001) at a median of 11 (range of 8 to 14) weeks; 11 (37 %) patients used the regular size and 19 (63 %) the large size. Patients used an average of 1.67 inserts per day (range of 1 to 3) on an average of 3.58 days per week (1 to 7); 3 patients reported a deterioration in symptoms, 7 (23 %) had no change and 20 (67 %) showed a significant improvement; 6 patients (20 %) did not like the device; while 24 (80 %) liked it; 17 patients (57 %) wanted to continue this treatment in the long-term. The authors concluded that the Renew device appeared to be an acceptable and effective therapeutic option for passive FI. Moreover, these researchers stated that further work is needed to compare it with other treatments and establish its position in the treatment pathway.
Topical Oxymetazoline
Barak and colleagues (2019) stated that topical alpha agonists (α-agonists ) contract the internal anal sphincter muscle; thus, they may serve as treatment for FI. In a randomized, double-blind, placebo-controlled, cross-over study, these investigators examined the effect of the α-agonist oxymetazoline 1.0 % on FI in patients with spinal cord injury (SCI). Before randomization, all patients underwent a 1-day, open-label anal manometry and pharmacokinetic study. A total of 19 patients were enrolled into this clinical trial with 2 arms: placebo for 4 weeks followed by oxymetazoline for 4 weeks, or vice versa, with an interval 2-week wash-out period, in a cross-over trial design. Treatment order was randomly assigned, and FI was captured with daily diaries. The primary outcome measured was the number of FI episodes in the 8 and 12 hours after drug administration. Resting anal pressure increased in response to oxymetzoline (25.2 %). The change in the mean FI episodes per month (12 hours post-drug application) favored oxymetazoline over placebo: 26.3 (SD ± 28.4) versus 36 (SD ± 39.8) (p = 0.021). When only non-gas episodes were included, the mean number of episodes decreased from 10.1 (+ 4.3) to 6.3 (± 2.1) FI episodes per month (p = 0.022). No difference was observed in AEs between treatment and placebo periods. All pharmacokinetic samples were below the detection limit. The authors concluded that oxymetazoline gel presented a clear clinical beneficial effect accompanied by a favorable safety and tolerability profile. Results of the pharmacokinetic analysis indicated that the clinical benefit was mainly due to a local effect of oxymetazoline. These researchers stated that future studies are planned to examine higher doses of oxymetazoline for this indication. The main limitation of this study was its small number of participants (n = 19).
Trans-Anal Irrigation
In a prospective study, Juul and Christensen (2017) examined the effect of trans-anal irrigation (TAI) on bowel function and QOL in a cohort of Danish patients with FI or constipation. Patients with FI or constipation of heterogeneous origin were treated by a specialist nurse at the Anal Physiology Clinic/Department of Surgery at Aarhus University Hospital, Aarhus, Denmark. If satisfactory results were not obtained after conservative bowel management, patients were instructed in the use the TAI procedure and were consecutively recruited for this observational cohort study in the period from March 2010 to September 2013. Patients completed questionnaires regarding bowel function, QOL and the TAI procedure at baseline and after 12 months. A total of 507 were introduced to TAI; 83 % were women; the median age was 56 (range of 19 to 86) years. At follow-up, 216 (43 %) patients still used TAI, 174 (34 %) reported that they had discontinued the treatment for various reasons, while no response was obtained from the remaining 117 (23 %) patients. The main reason for not adhering to the treatment was an unsatisfactory outcome, which was reported by 86 (49.4 %) of those who discontinued the treatment. Among patients still using the procedure at follow-up, a statistically significant improvement of bowel function scores (St. Marks/Wexner incontinence score, Wexner constipation score and obstructed defecation syndrome score) was detected: the Wexner incontinence score decreased from 12.4 at baseline to 10.2 at follow-up (p < 0.001); the St. Marks incontinence score decreased from 14.9 to 12.7 (p < 0.001); the Wexner constipation score decreased from 14.3 to 12.4 (p < 0.001); and the obstructed defecation syndrome score also dropped, from 15.1 to 11.8 (p < 0.001). Furthermore, the influence of bowel dysfunction on daily activities and QOL diminished significantly, while the general satisfaction with bowel function increased significantly (p < 0.001 in all 3 measures). The authors concluded that bowel function and QOL improved in the group of patients adhering to TAI after 12 months. However, more than 1/3 of the patients discontinued the treatment within the 1st year with TAI. Thus, further studies are needed to identify factors predicting success and failure with this treatment and to improve supervision during initiation and follow-up.
In a retrospective study, Gimenez Aleixandre and colleagues (2019) reported their findings with TAI for the treatment of FI and fecal constipation without response to other therapies. A Rintala questionnaire was performed comparing pre- and post-treatment findings. A total of 25 patients were included with a median age of 13 (range of 6 to 44) years; 19 patients had spinal pathology (76 %), 4 colorectal surgery (16 %) and 2 functional constipation (8 %). They presented FI in 20 % of cases, 12 % of fecal constipation and 68 % both conditions. Following a mean follow-up of 1.5 years (1 month to 4 years), 52 % of the patients abandoned the treatment. The mean Rintala score was 6.8 ± 4 before treatment, and 11.42 ± 2.75 after treatment (p = 0.001). The main complications throughout the treatment were pain (68 %) and balloon leaks (28 %). The patients declared as cause of treatment cessation: reduced mobility (15 %), fear or mis-information (32 %) and pain (76 %). All patients with reduced mobility (n = 3) left treatment, versus 45 % (n = 12) of the patients that had full mobility (p = 0.17, OR 8.3 [95 % CI: 0.3 to 38]). Complementary treatments such as laxatives, enemas or digital extraction were abandoned in 55 % of the patients. The authors concluded that TAI appeared to improve QOL in patients with fecal constipation and FI refractory to other treatments. The abandonment rate was higher than expected, so these researchers believed it is necessary to create a support group to improve follow-ups. This was a small (n = 25), retrospective study; its findings need to be validated by well-designed studies.The MiniACE Balloon Button (Antegrade Continence Enema (ACE) Button) for the Treatment of Fecal Incontinence
The MiniACE Balloon Button (Applied Medical Technology Inc., Brecksville, OH) is a low-profile, percutaneous antegrade continence enema (ACE) device. The MiniACE is inserted into the cecum via either a cecostomy or a Malone/appendicostomy procedure. It is held in place by an internal silicone balloon and an external silicone bolster. The low-profile external bolster contains an irrigation port and a balloon inflation port; these features allow the user to administer an enema and inflate/deflate the balloon, respectively. The MiniACE is used to facilitate antegrade enemas (via cecostomy or Malone / appendicostomy) in patients who have non-functioning colons and have not responded to conservative treatments (i.e., high-fiber diets, laxatives, rectal enemas, etc.). The MiniACE is not inserted into the rectum and it does not facilitate a rectal enema; it is not a bag or a pump. The MiniACE is a conduit for administering an antegrade enema into a non-functioning colon. This is analogous to how a low-profile gastrostomy/jejunostomy tube is a conduit for administering nutrition to a non-functioning gastro-intestinal (GI) tract.
There is currently insufficient evidence to support the use of the MiniACE Balloon Button for the treatment of FI.
Patel and co-workers (2015) noted that ACE is a proximal colonic stoma that allows antegrade lavage of the colon for the treatment of treatment of FI and functional constipation. Its role in the treatment of these conditions in adults has not been established. In a systematic review, these investigators examined the clinical response and complications of ACE in adults. They carried out a literature search of Medline, Embase, and Cochrane Central Register of Controlled Trials databases from January 1980 to October 2013. Studies reporting clinical outcomes of ACE in adult patients were considered; only studies with subjects aged 16 years and older were selected. The primary outcome was the number of patients irrigating their stoma; and secondary outcomes included the incidence of stoma stenosis, evaluation of functional outcome, and evaluation of QOL. A total of 15 studies were selected, describing outcomes in 374 patients. All of the reports were observational, cross-sectional studies, and 4 were prospective. The number of subjects still using their stoma ranged from 47 % to 100 % over a follow-up period of 6 to 55 months; 11 studies reported achievement of full continence in 33 % to 100 % of patients; 4 studies described functional outcomes, and 7 studies reported a wide range of patient satisfaction. The rate of stoma stenosis varied from 8 % to 50 %. The authors concluded that ACE has been reported as an acceptable treatment of both functional constipation and FI in adults across several analyses; however, there was wide variation regarding outcome measures. Most studies were of poor quality, as reflected in the methodological index for non-randomized studies score. These researchers stated that larger prospective studies are needed to examine the role of ACE in adults.
Bharucha et al (2017) noted that Malone described a surgically-created appendicostomy for delivering anterograde colonic enemas in children with constipation or FI. In adults, where the appendix is not always available or stenosed, Malone ACEs have been used in patients with medically-refractory severe defecatory disorders (DDs). These investigators provided follow-up data in 17 of 20 patients; 13 patients were satisfied with the outcome; the outcome of 2 patients was unchanged and 1 patient was worse. Enemas can be delivered via a button cecostomy device created by a colonoscopy and percutaneous technique. In these small series, follow-up was short, and success rates were lower in adults (approximately 50 %) than children (80 %). Long-term complications such as stoma stenosis or leakage, or failure to effectively treat symptoms commonly (greater than 50 % at 3 years) require revision, reversal or conversion to a formal stoma. Moreover, the authors stated that this procedure did not address the primary dysfunction, i.e., pelvic floor dysfunction. These researchers believed this procedure is not an effective long-term solution for adults with DDs.
Grabski and associates (2018) stated that the Malone appendicostomy is a continent channel used for antegrade enemas. It requires daily cannulation and is susceptible to stenosis. These investigators used an indwelling low-profile balloon button tube inserted through the appendix into the cecum for antegrade enemas. They hypothesized that this method is effective at managing constipation or FI and is associated with a low rate of stenosis. Children who underwent laparoscopic appendicostomy balloon button placement at the authors’ institution from January 2011 to April 2017 were identified. The primary outcome was success in managing constipation or FI as measured by the Malone continence scale; and post-operative complications were analyzed. A total of 36 children underwent the procedure, 35 of which met the inclusion criteria; 31 patients (88.5 %) underwent the operation for idiopathic constipation, 3 patients (8.6 %) for anorectal malformation, and 1 patient (2.9 %) for hypermobility; rate of open conversion was 3 %. A full response was obtained in 24 patients (68.6 %), partial response in 9 patients (25.7 %), 2 patients failed (5.7 %); and 1 patient developed an internal hernia requiring laparotomy and later developed mucosal prolapse; 1 patient developed a stricture noted at button change; 7 patients (20 %) underwent reversal of their appendicostomy tube: 5 due to return of normal bowel function and 2 due to discomfort with flushes. The authors concluded that a laparoscopic appendicostomy with a balloon button tube was an effective means of addressing chronic constipation or FI. The stenosis rate associated with tube appendicostomy may be lower than those reported for Malone ACE procedures.
These researchers stated that as a retrospective, descriptive, single-center review without a control arm comprised patients who underwent the Malone ACE procedure, this study had inherent drawbacks. The retrospective nature of this study eliminated the ability to collect and analyze information on patient and parent satisfaction of the low-profile button. Furthermore, there was the potential for reporting bias in the complication rates, specifically stomal leakage, which may be under-reported by families.
Mohamed and co-workers (2020) noted that few studies have directly compared between cecostomy and appendicostomy for the management of FI in children. In a systematic review, these investigators examined the literature regarding the outcomes and complications following both procedures. They also reviewed studies reporting impact on QOL and patient satisfaction. Medline, Embase, the Cochrane Central Register of Controlled Trials (CENTRAL), and Google Scholar were searched for chronic constipation pediatric patients who underwent cecostomy or appendicostomy. Two reviewers independently screened studies, extracted data, and assessed quality. An initial literature search retrieved 633 citations. After review of all abstracts, 40 studies were included in the final analysis with a total of 2,086 patients. The overall rate of complications was lower in the cecostomy group compared to the appendicostomy group (16.6 % versus 42.3 %). Achievement of fecal continence and improvement in patient QOL were found to be similar in both groups; however, the need for revision of surgery was approximately 15 % higher in the appendicostomy group. The authors concluded that cecostomy had less post procedural complications; however, rates of patient satisfaction and impact on QOL were similar following both procedures. Level of Evidence = III.
Short and colleagues (2022) noted that an appendicostomy is a surgical option for ACE in children with severe constipation and/or FI who have failed medical management. In 2019, these researchers initiated an expedited post-operative protocol and examined short-term outcomes compared with historical cohort. They carried out a retrospective review of all children undergoing appendicostomy between 2017 and 2020. Children were excluded if they underwent an associated procedure (e.g., colon resection). Patients were divided into 2 cohorts: historical cohort (2017 to 2018, Group A) and the expedited protocol (2019 to present, Group B). The primary outcome was length of stay (LOS). A total of 30 patients met inclusion (Group A = 16, Group B = 14). The most common indications for appendicostomy were constipation (50 %) and constipation or FI associated with anorectal malformation (43 %). Group B experienced a decreased LOS (1 versus 3 days, p = 0.001) without differences in 30-day surgical site infection (7.1 % versus 18.8 %, p = 0.61) or unplanned visit (15.4 % versus 18.8 %, p = 1.0). Group B had a higher prevalence of MiniACE button placed through the appendix versus Malone (42.8 % versus 12.5 %, p = 0.10). The authors concluded that the expedited post-operative protocol decreased LOS without other significant adverse clinical sequelae. Level of Evidence = III.
The Japanese practice guidelines for “Fecal incontinence: Part 3” (Maeda et al, 2021) noted that although ACE for FI has some morbidities, such as wound infection and post-operative stenosis, it is useful because it can be performed in a shorter time with lesser lavage fluid than with trans-anal irrigation (Grade of recommendation = C).
An UpToDate review on “Chronic functional constipation and fecal incontinence in infants, children, and adolescents: Treatment” (Sood, 2021) states that “The rare patient with intractable constipation and normal anorectal manometry (or one who fails to respond to botulinum toxin injection) may be considered for sacral nerve stimulation or for other surgical approaches, which include antegrade continence enema (ACE), intestinal diversion (ileostomy or colostomy), or colonic resection … ACE provides a conduit for daily colonic irrigation and is also used for patients with myelomeningocele and bowel dysfunction”.
On the other hand, an UpToDate review on “Fecal incontinence in adults: Management” (Robson and Lembo, 2021) does not mention MiniACE Balloon Button (antegrade continence enema device) as a management tool.
Ileal Neoappendicostomy for the Treatment of Fecal Incontinence
Abildgaard et al (2021a) noted that antegrade colonic enema (ACE) via an appendicostomy is a recognized method of treatment for medically intractable FI and/or constipation. In case of a missing appendix, ileal neoappendicostomy (INA) is considered a suitable alternative. In a systematic review, these investigators examined the post-operative complications, functional outcome, stoma-related complications and QOL of patients treated with this method. They carried out a systematic literature search in Embase, Medline, PubMed (NCBI) and Cochrane Library from inception to September 2020 using the search terms "antegrade enema" OR "continence enema". Studies on children and adults with FI, constipation or a combination of both, who underwent INA for ACE due to the failure of medical treatment and/or anal irrigation were included in the studies, which reported one or more of the following primary outcomes: post-operative complications, functional results, and stoma-related complications. A total of 780 studies were identified, 8 of which, comprising 6 studies in adults and 2 in children, were eligible for review; overall, 139 patients were included. All studies were retrospective and the methods for reporting outcomes were highly heterogeneous. Improvements in incontinence and constipation were reported in all studies, together with an improved QOL when reported (5 studies). Stomal stenosis and leakage rates were 0 % to 29 % and 14 % to 60 %, respectively. Post-operative complications were relatively common and included potentially life-threatening complications. The authors stated that taking into consideration that studies of INA were few and of poorly quality; ACE via an INA had a positive impact on bowel function and QOL; however, stoma-related complications and post-operative complications remain a concern. Moreover, these researchers stated that prospective studies and preferably randomized trials on alternatives to conventional Malone Antegrade Colonic Enema (MACE) with well-defined outcomes are needed. This will only be possible via international cooperation.
The authors stated that this study has several drawbacks. The level of evidence was very low. A major concern was small patient series, with a total of only 12 children, and 127 adults included. Furthermore, the studies included a wide spectrum of background diseases, bowel problems, length of follow-up, differences in reporting patient outcomes and used non-validated or standardized questionnaires. Ideally, participants should have been separated into adults and children; however, due to the small number of patients these researchers did not find that informative. In the future, standardized and validated questionnaires should be developed to evaluate the patient outcome with the ACE-procedure irrespective of the surgical method used and the background disease. This would give a more precise answer on which method is the most appropriate for a given patient.
Abildgaard et al (2021b) stated that ACE via an appendicostomy has been shown to be effective in the management of functional bowel problems. In cases with a missing appendix, an INA may be considered. These investigators carried out a retrospective review of clinical outcomes in children who underwent INA for ACE. Medical records were reviewed for data on demography, intra- and post-operative complications. A follow-up questionnaire on stoma problems, ACE-related problems, bowel function, patient satisfaction, well-being, and effect on daily activities was performed. A total of 10 patients (average age of 10.6 years at surgery) were included in this trial. In 50 % of the subjects, minor post-operative complications (Clavien-Dindo grade-2 or less) were observed; 9 patients answered the questionnaire with a mean follow-up of 57 months. Despite complaints of stomal leakage, difficulties with catheterization, and pain during irrigation, they reported a high grade of satisfaction, improvements in well-being, and bowel function and the achievement of continence. The authors concluded that INA may be an alternative to ACE in children with severe and medically intractable constipation and or/and FI where the appendix is missing or has to be used for a Mitrofanoff procedure.
The authors stated that this study had several drawbacks. First, this trial was retrospective, and it was weakened by the fact that these researchers did not have detailed information regarding pre-operative QOL and FI. Second, the number of patients was also small (n = 10), which in part was a reflection of the relatively narrow population of patients for which this procedure is indicated. Third, the questionnaire was not validated and did not address problems related to cecoileal reflux.
Vaginal Bowel Control (e.g., Eclipse System)
Richter et al (2015) examined the safety and effectiveness of a vaginal bowel-control (VBC) device and pump system for the treatment of FI. Women with a minimum of 4 FI episodes over 2 weeks were fit with the intra-vaginal device. Treatment success, defined as a 50 % or greater reduction of incontinent episodes, was assessed at 1 month. Participants were invited into an optional extended-wear period of another 2 months. Secondary outcomes included symptom improvement measured by the Fecal Incontinence Quality of Life (FI-QOL), Modified Manchester Health Questionnaire, and Patient Global Impression of Improvement; AEs were collected. Intention-to-treat (ITT) analysis included participants who were successfully fit entering treatment. Per protocol, analysis included participants with a valid 1-month treatment diary. A total of 61 of 110 (55.5 %) participants from 6 clinical sites were successfully fit and entered treatment. At 1 month, ITT success was 78.7 % (48/61, p < 0.001); per protocol success, 85.7 % (48/56, p < 0.001) and 85.7 % (48/56) considered bowel symptoms "very much better" or "much better". There was significant improvement in all FI-QOL (p < 0.001) and Modified Manchester (p ≤ 0.007) subscales. Success rate at 3 months was 86.4 % (38/44; 95 % CI: 73 % to 95 %). There were no serious AEs; the most common device-related AE was pelvic cramping or discomfort (25/110 participants [22.7 %]), the majority of events (16/25 [64 %]) occurring during the fitting period. The authors concluded that in women successfully fit with a VBC device for non-surgical treatment for FI, there was significant improvement in FI by objective and subjective measures. Level of Evidence = II.
The authors stated that this study had several drawbacks. Optimally, a randomized trial would have minimized bias. The inclusion of a control arm, although desirable, is uncommon in trials of FI therapies because of the non-uniform presentation of the condition and the lack of a gold standard treatment. A common methodology in FI intervention trials, as selected in this study, was for participants to serve as their own controls. Although this method is subject to inherent treatment, selection, and recall bias, it does serve to minimize individual variation in disease presentation, a significant factor in studies regarding FI. In addition to study design, the length of follow-up was short. Because this is a completely new therapeutic option, it was important to examine the potential side effects and tolerability in addition to effectiveness. These investigators stated that a longer-term outcome study is being designed, soon to be initiated, and will provide this important information.
Matthews et al (2016) stated that they previously showed that management with a novel VBC system was effective in women with moderate-to-severe FI. The objective of this secondary analysis was to examine the clinical characteristics associated with device-fitting success. This was a secondary analysis of an institutional review board (IRB)-approved, prospective, open-label, multi-center study of women aged 19 to 75 years with 4 or more episodes of FI recorded on a 2-week baseline bowel diary. Those successfully fitted with the VBC device entered a 1-month treatment period, and effectiveness was assessed with a repeat bowel diary. Demographic data, medical and surgical history, and pelvic examination findings were compared across women with successful and unsuccessful completion of the fitting period. Multi-variate logistic regression analysis was performed. A total of 6 clinical sites in the U.S. were recruited from August 2012 through October 2013. A total of 110 women underwent attempted fitting, of which 61 (55.5 %) of 110 were successful and entered the treatment portion of the study. Multi-variate logistic regression analysis revealed that previous prolapse surgery (p = 0.007) and shorter vaginal length (p = 0.041) were independently associated with unsuccessful fitting. Women who have not undergone previous prolapse surgery had 4.7 times the odds (95 % CI: 1.53 to 14.53) of a successful fit. Furthermore, for every additional centimeter of vaginal length, women had 1.49 times the odds (95 % CI: 1.02 to 2.17) of a successful fit. The authors concluded that shorter vaginal length and previous prolapse surgery were associated with an increased risk of fitting failure. These findings may be used to inform patients regarding their expectation of successful fitting.
Varma et al (2016) noted that bowel dysfunction, including frequency, fecal urgency, stool consistency, and evacuation symptoms, contributes to FI. These investigators examined the impact of a VBC system on parameters of bowel function, including frequency, urgency, stool consistency, and evacuation. This was a secondary analysis of a prospective, multi-center study. It was carried out at 6 sites in the U.S., including university hospitals and private practices in urogynecology and colorectal surgery. A total of 56 evaluable female subjects aged 19 to 75 years with 4 or more FI episodes on a 2-week bowel diary were included. The study intervention was composed of the VBC system, consisting of a vaginal insert and pressure-regulated pump. Subjects completed a 2-week baseline diary of bowel function before and after treatment completed at 1 month. Fecal urgency, consistency of stool (Bristol score), and completeness of evacuation were recorded for all bowel movements. Use of the insert was associated with an improvement in bowel function across all 4 categories. Two thirds (8/12) of subjects with a high frequency of daily stools (more than 2 per day) shifted to a normal or low frequency of stools. Analysis of Bristol stool scale scores demonstrated a significant reduction in the proportion of all bowel movements reported as liquid (Bristol 6 or 7), from 36 % to 21 % (p = 0.0001). On average, 54 % of stools were associated with urgency at baseline compared with 26 % at 1 month (p < 0.0001). Incomplete evacuations with all bowel movements were reduced from 39 % to 26 % of subjects at 1 month (p = 0.0034). The authors concluded the VBC device showed short-term improvement in other associated bowel symptoms of stool frequency, bowel urgency, and stool consistency, with a reduction in reported incomplete evacuation. This information may help to inform women with respect to expectations of improvements in other bowel symptoms associated with the use of this new and novel device for the primary treatment of FI.
The authors stated that this study had several drawbacks. First, this was a descriptive analysis; however, it provided data that could be used to plan future studies with the VBC and other FI treatment modalities. These researchers stated that longer-term outcomes addressing these symptoms should also be studied to confirm the durability of these results. Given the immediately active mechanism of the device, it is appropriate to first examine the impact of short-term usage, especially in the context of an initial study on safety and effectiveness. Second, follow-up period was short -- only 1 month (with an optional additional 2 months). Third, the data were provided by patients; thus, may not capture or quantify these parameters perfectly; however, patient-reported outcomes using validated measures are increasingly recognized as the most important element of multi-component outcome assessment.
Sokol (2016) stated that FI, also referred to as accidental bowel leakage, is a debilitating condition that impacts QOL in a significant number of women. Current treatments for FI include behavioral modification, biofeedback (BFB), drug therapy, and invasive surgical procedures. However, these treatments have suboptimal effectiveness due to patient adherence, variability of presentation across patients, cost, and additional health risks. A VBC system (Eclipse System) was developed to offer a low-risk, effective, and patient-managed approach to treating accidental bowel leakage. The VBC system consists of a vaginal insert and user-controlled, pressure-regulated pump. Once inflated, the balloon of the vaginal insert is directed posteriorly to occlude the rectum, allowing the woman to immediately regain control of bowel function. The author introduced the design evolution and feasibility studies of the Eclipse System. Furthermore, this review discussed the results from a recent clinical trial that showed the safety and effectiveness of the VBC system in the management of patients with FI and other symptoms of bowel dysfunction. The author noted that future directions (for the Eclipse System) include continued clinical investigations of a larger cohort of responders to the Eclipse therapy, with a longer duration of wear to examine the durability of its long-term safety and effectiveness. A prospective, open-label, multi-center, 1-year outcome clinical study is currently underway to extend the support for the VBC system as a low-risk, patient-regulated treatment for ABL, restoring a woman’s ability to control her bowel function and return to her daily activities.
Sokol (2017) stated that successful development of a novel medical device requires an early understanding of anatomical feasibility and acceptance by both patient and clinician. In the absence of acceptable artificial anatomical test models, short-term evaluation with controlled observation in a small number of patients can be pursued to demonstrate initial feasibility. The VBC system, a non-surgical device for the treatment of FI, is difficult to evaluate in artificial models. In-person usage was required to understand the potential for a vaginal insert to provide comfortable, dynamic rectal occlusion. A total of 13 female subjects aged 18 years or older with self-reported FI were enrolled in a prospective, open-label, single-center, pilot study. The VBC therapy consists of a vaginal insert and pressure-regulated pump. The vaginal insert includes a balloon that, when inflated, creates an occlusion of the rectum. Subjects’ FI symptoms were collected in a baseline questionnaire. The investigator fitted subjects with multiple sizes of VBC inserts and evaluated the fit, position and degree of rectal occlusion. Subject comfort levels were evaluated throughout the fitting process with a verbal response and on a subject questionnaire using a 10-point scale (1 =no discomfort, 10 = extremely uncomfortable). The insert was returned at the end of the study visit. The majority of the rectum was occluded in 77 % of patients. In addition, comfort scores during insertion (2.1 ± 2.0), inflation (3.3 ± 2.6) and ambulation (2.6 ± 2.0) states indicated minor discomfort with 42 % of women indicating no discomfort in any states. No AEs were reported. The authors concluded that pilot evaluation of an early VBC system design and its delivery during a single study visit provided evidence for effectiveness, patient comfort and ease of use of a novel VBC for FI in women. This first-in-woman study confirmed feasibility of VBC and informed continued product development and subsequent clinical research.
The author stated that this study was not intended as a rigorous outcome study of the intervention; but was instead designed to provide initial inputs needed to design physician training and patient education, and to further the development of the device. Furthermore, this experience provided valuable understanding of how to study the device and fitting procedure, a necessary preliminary step in anticipation of subsequent studies. This feasibility study was limited by number of subjects (n = 13), duration of time that patients experienced the VBC insert and evaluation of rectal occlusion from a single assessor.
Takase-Sanchez (2017) noted that FI (accidental bowel leakage) impacts the QOL in women of all ages. A minimally invasive VBC system was designed to reduce accidents and provide a new healthcare option for women. A feasibility study was carried out to examine fit, patient comfort, and ease-of-use of this novel VBC therapy at home to better inform device design, treatment delivery, and the design of a subsequent pivotal clinical trial protocol. Staged examinations were carried out in women without and with self-reported FI of any severity. Wear duration progressed from an initial 1-time, in-office fitting to extended-wear periods at home. Device-related AEs were collected in all subjects exposed to the device. Treatment responses were collected at baseline and after 1-month wear in women with FI. In addition, device comfort and satisfaction were assessed. A total of 86 women were fitted with 45 women continuing to wear the VBC system for 1 week or longer. A total of 15 women with FI were extended to 1-month or longer wear. A total of 9 minor device-related AEs were reported; 8 of 9 women who completed diaries experienced 50 % or greater reduction in episodes at 1-month wear. Device comfort and satisfaction were high. The author concluded that this progressively staged, clinical evaluation study showed the feasibility of extended wear of a novel VBC system for the treatment of FI. Positive response endpoints at 1-month were observed along with a good safety profile and high device satisfaction. The authors concluded that these findings informed subsequent clinical delivery and trial design.
In a prospective, open-label study, Richter et al (2019) characterized clinical success, impact on QOL, and durability up to 1 year in women with FI responsive to an initial test period with a trial VBC system. Participants were patients with FI and successfully fit who underwent an initial 2-week trial period. Those achieving 50 % or greater reduction in FI episodes were provided the long-term system. Primary outcome was success at 3 months defined as 50 % or greater reduction in baseline FI episodes, also evaluated at 6 and 12 months. Secondary outcomes included symptom impact measured with FI-QOL, symptom severity by the St Mark's (Vaizey) questionnaire, Patient Global Impression of Improvement, and satisfaction; AEs were collected. Primary analysis was ITT. A total of 73 subjects with baseline mean of 14.1 ± 12.15 FI episodes over 2 weeks entered the treatment period. Success rate at 3 months was 72.6 % (53/73, p < 0.0001); per-protocol, 84.1 % (53/63, p < 0.0001). Significant improvement in all FI-QOL subscales and St Mark's questionnaire meeting minimally important differences was noted. Satisfaction was 91.7 %, 89.7 %, and 94.4 % at 3, 6, and 12 months, respectively; 77.4 %, 77.6 %, and 79.6 % were very much/much better on the Patient Global Impression of Improvement at 3, 6, and 12 months, respectively. Most common AE was vaginal wall injury, with most AEs (90/134, 67% ) occurring during fitting period. The authors concluded that in women with successful fitting and initial treatment response, durable efficacy was observed at 3, 6, and 12 months by objective and subjective measures, with favorable safety. Moreover, these researchers stated that future efforts should focus on long-term, comparative studies of this VBC system.
The authors stated this study had several drawbacks. First, not all women were able to be successfully fit, similar to a vaginal pessary. Yet, 62 % (85/137) of the women underwent a successful fitting, an improvement from the 54.5 % in the initial study, which may be related to the provider learning curve. Furthermore, shorter vaginal length and prior prolapse surgery may decrease the likelihood of successful fitting. Second, the current study population had relatively severe FI, with a minimum of 4 major incontinence episodes over 2 weeks; thus, the results may not be generalizable to those with less severe FI or staining only. However, it was reassuring that an improvement was noted in both major and minor incontinence episodes. Third, because this was a safety and effectiveness trial with strict inclusion/exclusion criteria, external validity, or generalizability, may be limited to populations different from the current participants. However, one could note that in subjects with more or fewer FI episodes the described trial period was straight-forward; and the device risk was low; thus, offering this therapeutic approach would not be unreasonable in the algorithm of clinical practice for women with FI. Fourth, there was no control group to control for placebo effect, but with sustained benefit noted over 12 months with both objective and subjective assessments using a low-risk device, these researchers felt that these results were valid.
The American College of Obstetricians and Gynecologists’ practice bulletin on FI (ACOG, 2019) noted that FI, or the involuntary leakage of solid or loose stool, is estimated to affect 7 % to 15 % of community-dwelling women. It is associated with reduced QOL, negative psychologic effects, and social stigma, yet many women do not report their symptoms or seek treatment. Less than 3 % of women who do self-report FI will have this diagnosis recorded in their medical record. Obstetrician-gynecologists are in a unique position to identify women with FI because pregnancy, childbirth, obstetric anal sphincter injuries (OASIS), and pelvic floor dysfunction are important risk factors that contribute to FI in women. This practice bulletin stated that although limited data support the effectiveness of anal plugs and VBC devices, patient tolerability and product availability limit their use. Newer devices appear to be better tolerated; however, more long-term data are needed to make a recommendation about their use as a therapeutic option for the treatment of FI.
Graciloplasty for the Treatment of Fecal Incontinence
Garoufalia et al (2023) stated that patients with refractory FI symptoms can be treated with several surgical procedures including graciloplasty. Reported outcomes and morbidity rates of this procedure are highly variable. In a systematic review and meta-analysis, these investigators examined continence rate and safety of dynamic and adynamic graciloplasty. PubMed and Google Scholar databases were systematically searched from inception until January 2022 according to preferred reporting items for systematic reviews and meta-analyses (PRISMA) guidelines. Reviews, animal studies, studies with patients less than 18 years of age or less than 10 patients, with no success rate reported or non-English text, were excluded. Main outcome measures were overall continence and morbidity rates of each technique. A total of 14 studies were identified, entailing 450 patients (337 females), published between 1980 and 2021. Most common etiology of incontinence (35.5 %; n = 160) was obstetric trauma followed by anorectal trauma (20 %; n = 90). The weighted mean rate of continence after dynamic graciloplasty was 69.1 % (95 % CI: 0.53 % to 0.84 %, I2 = 90 %) compared to 71 % (95 % CI: 0.54 to 0.87, I2 = 82.5 %) after adynamic. Although the weighted mean short-term complication rate was lower in the dynamic group (26 % versus 40 %), when focusing on complications requiring intervention under general anesthesia, there was a much higher incidence (43.4 % versus 10.5 %) in the dynamic group. The weighted mean rate of long-term complications was 59.4 % (95 % CI: 0.13 % to 1.04 %, I2 = 97.7 %) in the dynamic group, almost 2x higher than in the adynamic group [30 % (95 % CI: 0.03 to 0.63), I2 = 95.8 %]. Median follow-up ranged from 1 to 13 years. The authors concluded that these findings suggested that graciloplasty may be considered for incontinent patients. Dynamic graciloplasty may harbor higher risk for re-operation and complications compared to adynamic.
An UpToDate review on “Fecal incontinence in adults: Management” (Robson and Lembo, 2023) states that “Dynamic graciloplasty may improve fecal incontinence, but the procedure is complicated by considerable morbidity. Dynamic graciloplasty involves continuous electrical stimulation of the gracilis muscle that is surgically transposed around the anal canal to increase resting tone. The implantable pulse generator that provides the electrical stimulation is not available in the United States but is available in some other countries”.
Guidelines on fecal incontinence from the United European Gastroenterology (UEG), European Society of Coloproctology (ESCP), European Society of Neurogastroenterology and Motility (ESNM) and the European Society for Primary Care Gastroenterology (ESPCG) (Assmann, et al., 2022) state: "In patients where first line treatment and/or second line non-surgical procedures have not resulted in acceptable outcomes, or where second line non-surgical procedures are not preferred, surgical procedures could be considered. Augmentation of a defective anal sphincter such as through a Dynamic Graciloplasty (DGP) or the Artificial Bowel Sphincter (ABS) were common treatment options for faecal incontinence in the past. However, with the introduction of sacral neuromodulation (SNM), these treatment options have mostly discontinued. Any treatments which have been discontinued were not included in these guidelines."
Similarly, guidelines from the American Society of Colon and Rectal Surgeons (Paquette, et al., 2015) states that "[s]everal other treatments have been described, including ... dynamic graciloplasty (which is not available in the United States) .... These techniques are not in mainstream use, and a discussion is beyond the scope of this practice parameter."
References
The above policy is based on the following references:
General references
- American College of Gastroenterology (ACG) Website. Practice Guideline. Diagnosis and management of fecal incontinence. Bethesda, MD: ACG; 2004.
- American Society of Colon and Rectal Surgeons (ASCRS) Website. The American Society of Colon and Rectal Surgeon’ clinical practice guideline for the treatment of fecal incontinence. Bannockburn, IL: ASCRS; 2015.
- Assmann SL, Keszthelyi D, Kleijnen J, et al. Guideline for the diagnosis and treatment of faecal incontinence-A UEG/ESCP/ESNM/ESPCG collaboration. United European Gastroenterol J. 2022;10(3):251-286.
- Gu P, Kuenzig ME, Kaplan GG, et al. Fecal incontinence in inflammatory bowel disease: A systematic review and meta-analysis. Inflamm Bowel Dis. 2018;24(6):1280-1290.
- Mohamed H, Wayne C, Weir A, et al. Tube cecostomy versus appendicostomy for antegrade enemas in the management of fecal incontinence in children: A systematic review. J Pediatr Surg. 2020;55(7):1196-1200.
- National Institute for Health and Care Excellence (NICE). Faecal incontinence in adults. Clinical Guideline 49. London, UK: NICE; June 27. 2007.
- National Institute for Health and Care Excellence (NICE). Faecal incontinence in adults. Quality Standard 54. London, UK: NICE; February 6, 2014.
- National Institute for Health and Care Excellence (NICE). Insertion of a magnetic bead band for faecal incontinence. Interventional Procedure Guidance 483. London, UK: NICE; March 27, 2014.
- National Institute for Health and Care Excellence (NICE). Stimulated graciloplasty for faecal incontinence. Interventional Procedure Guidance 159. London, UK: NICE; March 22, 2006.
- Paquette IM, Varma MG, Kaiser AM, et al. The American Society of Colon and Rectal Surgeons' Clinical Practice Guideline for the Treatment of Fecal Incontinence. Dis Colon Rectum. 2015;58(7):623-636.
Acticon Neosphincter
- Agencia de Evaluacion de Tecnologias Sanitarias (AETS). Supervised use of artificial anal sphincter - database and technology assessment. Madrid, Spain: Agencia de Evaluacion de Tecnologias Sanitarias (AETS); 2003.
- American Medical Systems, Inc. (AMS). AMS Acticon Neosphincter. Product Labeling. Minnetonka, MN: AMS; December 2001.
- Bisset AF. Artificial anal sphincter for faecal incontinence. STEER: Succint and Timely Evaluated Evidence Reviews. London, UK: Bazian Ltd. (Eds), Wessex Institute for Health Research and Development, University of Southampton; 2004;4(3):1-19.
- Bokey EL, Chapuis PH, Fung C, et al. Postoperative morbidity and mortality following resection of the colon and rectum for cancer. Dis Colon Rectum. 1995;38(5):480-486; discussion 486-487.
- Brown SR, Nelson RL. Surgery for faecal incontinence in adults. Cochrane Database Syst Rev. 2007;(2):CD001757.
- Buckley E, Merlin T, Hiller JE. Placement of Acticon artificial bowel sphincters in the management of faecal incontinence. Assessment Report. MSAC Application 1107. Adelaide, SA: Adelaide Health Technology Assessment (AHTA); December 2007.
- Devesa JM, Rey A, Hervas PL, et al. Artificial anal sphincter: Complications and functional results of a large personal series. Dis Colon Rectum. 2002;45(9):1154-1163.
- Medical Services Advisory Committee (MSAC). Placement of artificial bowel sphincters in the management of faecal incontinence: Assessment Report. MSAC Application 1053. Canberra, ACT: MSAC; 2003.
- Medicare Services Advisory Committee (MSAC). Placement of artificial bowl sphincters in the management of faecal incontinence. Final Assessment Report. MSAC Application 1023. Canberra, ACT: MSAC; December 1999.
- Michot F, Tuech JJ, Lefebure B, et al. A new implantation procedure of artificial sphincter for anal incontinence: The transvaginal approach. Dis Colon Rectum. 2007;50(9):1401-1404.
- Mundy L, Merlin TL, Maddern GJ, Hiller JE. Systematic review of safety and effectiveness of an artificial bowel sphincter for faecal incontinence. Br J Surg. 2004;91(6):665-672.
- National Institute for Clinical Excellence (NICE). Artificial anal sphincter implantation. Interventional Procedure Guidance 66. London, UK: NICE; 2004.
- National Institute for Health and Care Excellence (NICE) Website. Transabdominal artificial bowel sphincter implantation for faecal incontinence. Interventional Procedure Guidance 276. London, UK: NICE; November 26, 2008.
- Nwiloh J, Dardik H, Dardik M, et al. Changing patterns in the morbidity and mortality of colorectal surgery. Am J Surg. 1991;162(1):83-85.
- O'Brien PE. Restoring control: The Acticon Neosphincter artificial bowel sphincter in the treatment of anal incontinence. Dis Colon Rectum. 2000; 43(9):1213-1216.
- Ortiz H, Armendariz P, DeMiguel M, et al. Complications and functional outcome following artificial anal sphincter implantation. Br J Surg. 2002;89(7):877-881.
- Rudolph W, Galandiuk S. A practical guide to the diagnosis and management of fecal incontinence. Mayo Clin Proc. 2002;77(3):271-275.
- Tan EK, Vaizey C, Cornish J, et al. Surgical strategies for faecal incontinence: A decision analysis between dynamic graciloplasty, artificial bowel sphincter and end stoma. Colorectal Dis. 2008;10(6):577-586.
- U.S. Food and Drug Administration (FDA), Center for Devices and Radiologic Health (CDRH). Acticon Neosphincter. Summary of Safety and Effectiveness Data. PMA No. P010020. Rockville, MD: FDA; December 18, 2001.
- Wong WD, Congliosi SM, Spencer MP, et al. The safety and efficacy of the artificial bowel sphincter for fecal incontinence: Results from a multicenter cohort study. Dis Colon Rectum. 2002;45(9):1139-1153.
Transanal Radiofrequency Therapy (Secca Procedure)
- Abbas MA, Tam MS, Chun LJ. Radiofrequency treatment for fecal incontinence: Is it effective long-term? Dis Colon Rectum. 2012;55(5):605-610.
- Curon Medical, Inc. The Secca Procedure for Fecal Incontinence [website]. Fremont, CA: Curon Medical; 2003. Available at: http://www.curonmedical.com/Physicians/secca_fi.html. Accessed September 15, 2004.
- Efron JE, Corman ML, Fleshman J, et al. Safety and effectiveness of temperature-controlled radio-frequency energy delivery to the anal canal (Secca procedure) for the treatment of fecal incontinence. Dis Colon Rectum. 2003;46(12):1606-1616; discussion 1616-1618.
- Felt-Bersma RJ, Szojda MM, Mulder CJ. Temperature-controlled radiofrequency energy (SECCA) to the anal canal for the treatment of faecal incontinence offers moderate improvement. Eur J Gastroenterol Hepatol. 2007;19(7):575-580.
- Felt-Bersma RJ. Temperature-controlled radiofrequency energy in patients with anal incontinence: An interim analysis of worldwide data. Gastroenterol Rep (Oxf). 2014;2(2):121-125.
- Kim DW, Yoon HM, Park JS, et al. Radiofrequency energy delivery to the anal canal: Is it a promising new approach to the treatment of fecal incontinence? Am J Surg. 2009;197(1):14-18.
- Lam TJ, Visscher AP, Meurs-Szojda MM, Felt-Bersma RJ. Clinical response and sustainability of treatment with temperature-controlled radiofrequency energy (Secca) in patients with faecal incontinence: 3 years follow-up. Int J Colorectal Dis. 2014;29(6):755-761.
- National Institute for Health and Clinical Excellence (NICE). Endoscopic radiofrequency therapy of the anal sphincter for faecal incontinence. Interventional Procedure Guidance 393. London, UK: NICE; May 2011.
- Takahashi T, Garcia-Osogobio S, Valdovinos MA, et al. Extended two-year results of radio-frequency energy delivery for the treatment of fecal incontinence (the Secca procedure). Dis Colon Rectum. 2003;46(6):711-715.
- Takahashi T, Garcia-Osogobio S, Valdovinos MA, et al. Radio-frequency energy delivery to the anal canal for the treatment of fecal incontinence. Dis Colon Rectum. 2002;45(7):915-922.
- Takahashi-Monroy T, Morales M, et al. SECCA procedure for the treatment of fecal incontinence: Results of five-year follow-up. Dis Colon Rectum. 2008;51(3):355-359.
- Visscher AP, Lam TJ, Meurs-Szojda MM, Felt-Bersma RJF. Temperature-controlled delivery of radiofrequency energy in fecal incontinence: A randomized sham-controlled clinical trial. Dis Colon Rectum. 2017;60(8):860-865.
Sacral Nerve Stimulation (Sacral Neuromodulation)
- Baeten CG, Uludag O. Second-line treatment for faecal incontinence. Scand J Gastroenterol Suppl. 2002;(236):72-75.
- Fischer S, Zechmeister I. [Sacral nerve stimulation for fecal incontinence]. Rapid Assessment No. 0042011 [summary]. Vienna, Austria: Ludwig Boltzmann Institut for Health Technology Assessment (LBI-HTA); 2011.
- Fraser C, Glazener C, Grant A, et al. Systematic review of the efficacy and safety of sacral nerve stimulation for faecal incontinence. Report Commissioned by the National Institute for Clinical Excellence. Aberdeen, Scotland: Review Body for Interventional Procedures; 2004.
- Holzer B, Rosen HR, Novi G, et al. Sacral nerve stimulation for neurogenic faecal incontinence. Br J Surg. 2007;94(6):749-753.
- Jarrett ME, Varma JS, Duthie GS, et al. Sacral nerve stimulation for faecal incontinence in the UK. Br J Surg. 2004;91(6):755-761.
- Kenefick NJ, Christiansen J. A review of sacral nerve stimulation for the treatment of faecal incontinence. Colorectal Dis. 2004 r;6(2):75-80.
- Kenefick NJ, Vaizey CJ, Nicholls RJ, Sacral nerve stimulation for faecal incontinence due to systemic sclerosis. Gut. 2002;51(6):881-883.
- Kenefick NJ. Sacral nerve neuromodulation for the treatment of lower bowel motility disorders. Ann R Coll Surg Engl. 2006;88(7):617-623.
- Lapointe A, Brophy J. Sacral nerve stimulation in fecal incontinence. Technology Evaluation. Montreal, QC: Centre Hospitalier de l'Universite de Montreal (CHUM); May 2007.
- Leroi AM, Lenne X, Dervaux B, et al. Outcome and cost analysis of sacral nerve modulation for treating urinary and/or fecal incontinence. Ann Surg. 2011;253(4):720-732.
- Maeda Y, O'Connell PR, Lehur PA, et al. Sacral nerve stimulation for faecal incontinence and constipation: A European consensus statement. Colorectal Dis. 2015;17(4):74-87.
- Matzel KE, Kamm MA, Stosser M, et al. Sacral spinal nerve stimulation for faecal incontinence: Multicentre study. Lancet. 2004;363(9417):1270-1276.
- Medical Services Advisory Committee (MSAC). Sacral nerve stimulation for faecal incontinence. MSAC application 1077. Canberra, ACT: MSAC; 2005.
- Mowatt G, Glazener C, Jarrett M. Sacral nerve stimulation for faecal incontinence and constipation in adults. Cochrane Database Syst Rev. 2007;(3):CD004464.
- Mowatt G, Glazener C, Jarrett M. Sacral nerve stimulation for fecal incontinence and constipation in adults: A short version Cochrane review. Neurourol Urodynamics. 2008;27(3):155-161.
- National Institute for Clinical Excellence (NICE). Sacral nerve stimulation for faecal incontinence. Interventional Procedures Guidance 99. London, UK: NICE; November 2004.
- National Institute for Clinical Excellence (NICE). Sacral nerve stimulation for faecal incontinence (second consultation). Interventional Procedure Consultation Document. London, UK: NICE; July 2004.
- Ontario Ministry of Health and Long-Term Care, Medical Advisory Secretariat (MAS). Sacral nerve stimulation for urinary urge incontinence, urgency-frequency, urinary retention, and fecal incontinence. Health Technology Literature Review. Toronto, ON: MAS; 2005.
- Pettit PD, Thompson JR, Chen AH. Sacral neuromodulation: New applications in the treatment of female pelvic floor dysfunction. Curr Opin Obstet Gynecol. 2002;14(5):521-525.
- Pillinger SH, Gardiner A, Duthie GS. Sacral nerve stimulation for faecal incontinence. Dig Surg. 2005;22(1-2):1-5.
- Ripetti V, Caputo D, Ausania F, et al. Sacral nerve neuromodulation improves physical, psychological and social quality of life in patients with fecal incontinence. Tech Coloproctol. 2002;6(3):147-152.
- Robert-Yap J, Zufferey G, Rosen H, et al. Sacral nerve modulation in the treatment of fecal incontinence following repair of rectal prolapse. Dis Colon Rectum. 2010;53(4):428-431.
- Tan E, Ngo NT, Darzi A, et al. Meta-analysis: sacral nerve stimulation versus conservative therapy in the treatment of faecal incontinence. Int J Colorect Dis. 2011;26(3):275-294.
- Thaha MA, Abukar AA, Thin NN, et al. Sacral nerve stimulation for faecal incontinence and constipation in adults. Cochrane Database Syst Rev. 2015;(8):CD004464.
- Tjandra JJ, Chan MK, Yeh CH, Murray-Green C. Sacral nerve stimulation is more effective than optimal medical therapy for severe fecal incontinence: A randomized, controlled study. Dis Colon Rectum. 2008;51(5):494-502.
- Zhao X, Pasricha PJ. Novel surgical approaches to fecal incontinence: Neurostimulation and artificial anal sphincter. Curr Gastroenterol Rep. 2003;5(5):419-424.
- Zhu Y, Wu G, Zhang J, et al. Meta-analysis of sacral nerve stimulation for fecal incontinence. Zhonghua Wei Chang Wai Ke Za Zhi. 2017;20(12):1417-1421.
Perianal Electrical Stimulation
- Cruz E, Miller C, Zhang W, et al. Does non-implanted electrical stimulation reduce post-stroke urinary or fecal incontinence? A systematic review with meta-analysis. Int J Stroke. 2022;17(4):378-388.
- Hosker G, Norton C, Brazzelli M. Electrical stimulation for faecal incontinence in adults. Cochrane Database Syst Rev. 2000;(2):CD001310.
- Leroi AM, Siproudhis L, Etienney I, et al. Transcutaneous electrical tibial nerve stimulation in the treatment of fecal incontinence: A randomized trial (CONSORT 1a). Am J Gastroenterol. 2012;107(12):1888-1896.
- Mahony RT, Malone PA, Nalty J, et al. Randomized clinical trial of intra-anal electromyographic biofeedback physiotherapy with intra-anal electromyographic biofeedback augmented with electrical stimulation of the anal sphincter in the early treatment of postpartum fecal incontinence. Am J Obstet Gynecol. 2004;191(3):885-890.
- Riedy LW, Chintam R, Walter JS. Use of a neuromuscular stimulator to increase anS9470al sphincter pressure. Spinal Cord. 2000;38(12):724-727.
- Vitton V, Damon H, Roman S, et al. Transcutaneous posterior tibial nerve stimulation for fecal incontinence in inflammatory bowel disease patients: A therapeutic option? Inflamm Bowel Dis. 2009;15(3):402-405.
Injectable Bulking Agents
- Agency for Healthcare Research and Quality. AHRQ Healthcare Horizon Scanning System – Potential High-Impact Interventions Report. Priority area 08: Functional limitations and disability. Rockville, MD: AHRQ; December 2012.
- Aigner F, Conrad F, Margreiter R, Oberwalder M; Coloproctology Working Group. Anal submucosal carbon bead injection for treatment of idiopathic fecal incontinence: A preliminary report. Dis Colon Rectum. 2009;52(2):293-298.
- Altomare DF, La Torre F, Rinaldi M, et al. Carbon-coated microbeads anal injection in outpatient treatment of minor fecal incontinence. Dis Colon Rectum. 2008;51(4):432-435.
- Brunner M, Bittorf B, Matzel K. Modern strategies for the treatment of fecal incontinence. Zentralbl Chir. 2019;144(2):190-201.
- Dehli T, Lindsetmo RO, Mevik K, Vonen B. Anal incontinence--assessment of a new treatment. Tidsskr Nor Laegeforen. 2007;127(22):2934-2936.
- Ferry GD. Treatment of chronic functional constipation and fecal incontinence in infants and children. UpToDate [online serial]. Waltham, MA: UpToDate; reviewed April 2012.
- Ganio E, Marino F, Giani I, et al. Injectable synthetic calcium hydroxylapatite ceramic microspheres (Coaptite) for passive fecal incontinence. Tech Coloproctol. 2008;12(2):99-102.
- Graf W, Mellgren A, Matzel KE, et al; NASHA Dx Study Group. Efficacy of dextranomer in stabilised hyaluronic acid for treatment of faecal incontinence: A randomised, sham-controlled trial. Lancet. 2011;377(9770):997-1003.
- Hong KD, Kim JS, Ji WB, Um JW. Midterm outcomes of injectable bulking agents for fecal incontinence: A systematic review and meta-analysis. Tech Coloproctol. 2017;21(3):203-210.
- Hoy SM. Dextranomer in stabilized sodium hyaluronate (Solesta®): In adults with faecal incontinence. Drugs. 2012;72(12):1671-1678.
- La Torre F, de la Portilla F. Long-term efficacy of dextranomer in stabilized hyaluronic acid (NASHA/Dx) for treatment of faecal incontinence. Colorectal Dis. 2013;15(5):569-574.
- Leung FW. Treatment of fecal incontinence - review of observational studies (OS) and randomized controlled trials (RCT) related to injection of bulking agent into peri-anal tissue. J Interv Gastroenterol. 2011;1(4):202-206.
- Luo C, Samaranayake CB, Plank LD, Bissett IP. Systematic review on the efficacy and safety of injectable bulking agents for passive faecal incontinence. Colorectal Dis. 2010;12(4):296-303.
- Maeda Y, Laurberg S, Norton C. Perianal injectable bulking agents as treatment for faecal incontinence in adults. Cochrane Database Syst Rev. 2010;5:CD007959.
- Maeda Y, Laurberg S, Norton C. Perianal injectable bulking agents as treatment for faecal incontinence in adults. Cochrane Database Syst Rev. 2013;2:CD007959.
- Maeda Y, Vaizey CJ, Kamm MA. Long-term results of perianal silicone injection for faecal incontinence. Colorectal Dis. 2007;9(4):357-361.
- Malouf AJ, Vaizey CJ, Norton CS, Kamm MA. Internal anal sphincter augmentation for fecal incontinence using injectable silicone biomaterial. Dis Colon Rectum. 2001;44(4):595-600.
- Medical Services Advisory Committee (MSAC). Intersphinteric injection of silicone biomaterial for severe passive faecal incontinence. MSAC Application 1100. Canberra, ACT: Medical Services Advisory Committee (MSAC); 2006.
- Nandivada P, Nagle D. Surgical therapies for fecal incontinence. Curr Opin Gastroenterol. 2014;30(1):69-74.
- National Association For Continence. Fecal incontinence [website]. Charleston, SC: NAFC; March 7, 2012. Available at: http://www.nafc.org/index.php?page=fecal-incontinence. Accessed June 18, 2012.
- National Institute for Health and Clinical Excellence (NICE). Injectable bulking agents for faecal incontinence. Interventional Procedure Guidance 210. London, UK: NICE; 2007.
- Norton C. Treating faecal incontinence with bulking-agent injections. Lancet. 2011;377(9770):971-972.
- Robson K, Lembo AJ. Fecal incontinence in adults. UpToDate [online serial]. Waltham, MA: UpToDate; reviewed April 2012.
- Schwandner O, Brunner M, Dietl O. Quality of life and functional results of submucosal injection therapy using dextranomer hyaluronic acid for fecal incontinence. Surg Innov. 2011;18(2):130-135.
- Soerensen MM, Lundby L, Buntzen S, Laurberg S. Intersphincteric injected silicone biomaterial implants: A treatment for faecal incontinence. Colorectal Dis. 2009;11(1):73-76.
- U.S. Food and Drug Administration (FDA). FDA approves injectable gel to treat fecal incontinence. FDA News. Silver Spring, MD: FDA; May 27, 2011.
- Ullah S, Tayyab M, Arsalani-Zadeh R, Duthie GS. Injectable anal bulking agent for the management of faecal incontinence. J Coll Physicians Surg Pak. 2011;21(4):227-229.
- Vaizey CJ, Kamm MA. Injectable bulking agents for treating faecal incontinence. Br J Surg. 2005;92(5):521-527.
Regenerative Medicine (e.g., Biocompatible Materials, Injection of Autologous Myoblast Cells/Mesenchymal Stem Cell/Stem Cells)
- De Ligny WR, Kerkhof MH, Ruiz-Zapata AM. Regenerative medicine as a therapeutic option for fecal incontinence: A systematic review of preclinical and clinical studies. Am J Obstet Gynecol. 2019;220(2):142-154.e2.
- El-Said M, Emile SH. Regenerative medicine in treatment of fecal incontinence: Do we understand how it works? Am J Obstet Gynecol. 2019;220(3):291.
- Frudinger A, Kölle D, Schwaiger W, et al. Muscle-derived cell injection to treat anal incontinence due to obstetric trauma: Pilot study with 1 year follow-up. Gut. 2010;59(1):55-61.
- Park EJ, Kang 1, Baik SH. Treatment of faecal incontinence using allogeneic-adipose-derived mesenchymal stem cells: A study protocol for a pilot randomised controlled trial. BMJ Open. 2016;6(2):e010450.
Topical Estrogen
- Pinedo G, García E, Zárate AJ, et al. Are topical oestrogens useful in faecal incontinence? Double-blind randomized trial. Colorectal Dis. 2009;11(4):390-393.
Posterior Tibial Nerve Stimulation
- Edenfield AL, Amundsen CL, Wu JM, et al. Posterior tibial nerve stimulation for the treatment of fecal incontinence: A systematic evidence review. Obstet Gynecol Surv. 2015;70(5):329-341.
- Findlay JM, Maxwell-Armstrong C. Posterior tibial nerve stimulation and faecal incontinence: A review. Int J Colorectal Dis. 2011;26(3):265-273.
- Horrocks EJ, Bremner SA, Stevens N, et al. Double-blind randomised controlled trial of percutaneous tibial nerve stimulation versus sham electrical stimulation in the treatment of faecal incontinence: CONtrol of Faecal Incontinence using Distal NeuromodulaTion (the CONFIDeNT trial). Health Technol Assess. 2015;19(77):1-164.
- Horrocks EJ, Chadi SA, Stevens NJ, et al. Factors associated with efficacy of percutaneous tibial nerve stimulation for fecal incontinence, based on post-hoc analysis of data from a randomized trial. Clin Gastroenterol Hepatol. 2017;15(12):1915-1921.
- Horrocks EJ, Thin N, Thaha MA, et al. Systematic review of tibial nerve stimulation to treat faecal incontinence. Br J Surg. 2014;101(5):457-468.
- Iacona R, Ramage L, Malakounides G. Current state of neuromodulation for constipation and fecal incontinence in children: A systematic review. Eur J Pediatr Surg. 2019;29(6):495-503.
- National Institute for Health and Care Excellence (NICE). Percutaneous tibial nerve stimulation for faecal incontinence. Interventional Procedure Guidance 394. London, UK: NICE: May 25, 2011.
- Sanagapalli S, Neilan L, Lo JYT, et al. Efficacy of percutaneous posterior tibial nerve stimulation for the management of fecal incontinence in multiple sclerosis: A pilot study. Neuromodulation. 2018;21(7):682-687.
- Simillis C, Lal N, Pellino G, et al. A systematic review and network meta-analysis comparing treatments for faecal incontinence. Int J Surg. 2019;66:37-47.
- Simillis C, Lal N, Qiu S, et al. Sacral nerve stimulation versus percutaneous tibial nerve stimulation for faecal incontinence: A systematic review and meta-analysis. Int J Colorectal Dis. 2018;33(5):645-648.
- Tan K, Wells CI, Dinning P, et al. Placebo response rates in electrical nerve stimulation trials for fecal incontinence and constipation: A systematic review and meta-analysis. Neuromodulation. 2020;23(8):1108-1116.
- Thomas GP, Dudding TC, Rahbour G, et al. A review of posterior tibial nerve stimulation for faecal incontinence. Colorectal Dis. 2013;15(5):519-526.
Pudendal Nerve Terminal Motor Latency
- Barnett JL, Hasler WL, Camilleri M. American Gastroenterological Association medical position statement on anorectal testing techniques. Gastroenterology. 1999;116(3):732-760.
- Robson K, Lembo AJ. Fecal incontinence in adults: Etiology and evaluation. UpToDate [online serial]. Waltham, MA: UpToDate; reviewed April 2015b.
- Saraidaridis JT, Molina G, Savit LR, et al. Pudendal nerve terminal motor latency testing does not provide useful information in guiding therapy for fecal incontinence. Int J Colorectal Dis. 2018;33(3):305-310.
- Sood MR. Functional fecal incontinence in infants and children: Definition, clinical manifestations and evaluation. UpToDate [online serial]. Waltham, MA: UpToDate; reviewed April 2015.
- Weledji EP. Electrophysiological basis of fecal incontinence and its implications for treatment. Ann Coloproctol. 2017;33(5):161-168.
Rectal Banding
- Robson K, Lembo AJ. Fecal incontinence in adults: Management. UpToDate [online serial]. Waltham, MA: UpToDate; reviewed April 2015a.
Surgical Treatments
- Abildgaard HA, Borgager M, Ellebæk MB, Qvist N. Ileal neoappendicostomy for antegrade colonic enema (ACE) in the treatment of fecal incontinence and chronic constipation: A systematic review. Tech Coloproctol. 2021a;25(8):915-921.
- Abildgaard HA, Ellebæk MB, Rawashdeh YF, Qvist N. Ileal neoappendicostomy in the treatment of fecal incontinence in children. Eur J Pediatr Surg. 2021b;31(5):427-431.
- Bharucha AE, Rao SSC, Shin AS. Surgical interventions and the use of device-aided therapy for the treatment of fecal incontinence and defecatory disorders. Clin Gastroenterol Hepatol. 2017;15(12):1844-1854.
- Brochard C, Queralto M, Cabarrot P, et al. Technique of the transobturator puborectal sling in fecal incontinence. Tech Coloproctol. 2017;21(4):315-318.
- Danielson J, Karlbom U, Wester T, Graf W. Long-term outcome after dynamic graciloplasty for treatment of persistent fecal incontinence in patients with anorectal malformations. Eur J Pediatr Surg. 2019;29(3):276-281.
- DeStephano CC, Chen AH, Pettit PD. The Fenix® System for fecal incontinence: An overview and surgical demonstration. J Minim Invasive Gynecol. 2017;24(7):1078.
- Forte ML, Andrade KE, Lowry AC, et al. Systematic review of surgical treatments for fecal incontinence. Dis Colon Rectum. 2016;59(5):443-469.
- Garoufalia Z, Gefen R, Emile SH, et al. Outcomes of graciloplasty in the treatment of fecal incontinence: A systematic review and meta-analysis of the literature. Tech Coloproctol. 2023;27(6):429-441.
- Meyer I, Richter HE. Evidence-based update on treatments of fecal incontinence in women. Obstet Gynecol Clin North Am. 2016;43(1):93-119.
- Robson KM, Lembo AJ. Fecal incontinence in adults: Management. UpToDate [online serial]. Waltham, MA: UpToDate; reviewed April 2017; April 2023.
The Renew Anal Insert
- Leo CA, Thomas GP, Hodgkinson JD, et al. The Renew® anal insert for passive faecal incontinence: A retrospective audit of our use of a novel device. Colorectal Dis. 2019;21(6):684-688.
Topical Oxymetazoline
- Barak N, Gecse KB, Takács I. Topical oxymetazoline for fecal incontinence in patients with spinal cord injury: A double-bind randomized controlled crossover study. Dis Colon Rectum. 2019;62(2):234-240.
Trans-Anal Irrigation
- Gimenez Aleixandre C, Ruiz Pruneda R, Aranda García MJ, et al. Transanal irrigations in patients with constipation and fecal incontinence: Results, indications and follow up in our center. Cir Pediatr. 2019;32(2):81-85.
- Juul T, Christensen P. Prospective evaluation of transanal irrigation for fecal incontinence and constipation. Tech Coloproctol. 2017;21(5):363-371.
The MiniACE Balloon Button (Antegrade Continence Enema (ACE) Button)
- Bharucha AE, Rao SSC, Shin AS, et al. Surgical interventions and the use of device-aided therapy for the treatment of fecal incontinence and defecatory disorders. Clin Gastroenterol Hepatol. 2017;15(12):1844-1854.
- Grabski DF, Hu Y, Rasmussen SK, et al. Laparoscopic appendicostomy low-profile balloon button for antegrade enemas in children. J Laparoendosc Adv Surg Tech A. 2018;28(3):354-358.
- Maeda K, Katsuno H, Tsunoda A, et al. Japanese practice guidelines for fecal incontinence Part 3 -- Surgical treatment for fecal incontinence, fecal incontinence in a special conditions -- English version. J Anus Rectum Colon. 2021;5(1):84-99.
- Mohamed H, Wayne C, Weir A, et al. Tube cecostomy versus appendicostomy for antegrade enemas in the management of fecal incontinence in children: A systematic review. J Pediatr Surg. 2020;55(7):1196-1200.
- Patel AS, Saratzis A, Arasaradnam R, Harmston C. Use of antegrade continence enema for the treatment of fecal incontinence and functional constipation in adults: A systematic review. Dis Colon Rectum. 2015;58(10):999-1013.
- Robson KM, Lembo AJ. Fecal incontinence in adults: Management. UpToDate [online serial]. Waltham, MA: UpToDate; reviewed April 2021.
- Short SS, Zobell S, Gaddis K, et al. Use of expedited post-operative protocol for children undergoing appendicostomy reduces length of hospitalization. J Pediatr Surg. 2022;57(3):406-409.
- Sood MR. Chronic functional constipation and fecal incontinence in infants, children, and adolescents: Treatment. UpToDate [online serial]. Waltham, MA: UpToDate; reviewed April 2021.
Vaginal Bowel Control (e.g., Eclipse System)
- American College of Obstetricians and Gynecologists. ACOG Practice Bulletin No. 210 Summary: Fecal incontinence. Obstet Gynecol. 2019;133(4):837-839.
- Matthews CA, Varma MG, Takase-Sanchez MM, et al. Characteristics associated with successful fitting of a vaginal bowel control system for fecal incontinence. Female Pelvic Med Reconstr Surg. 2016;22(5):359-363.
- Richter HE, Dunivan G, Brown HW, et al. A 12-month clinical durability of effectiveness and safety evaluation of a vaginal bowel control system for the nonsurgical treatment of fecal incontinence. Female Pelvic Med Reconstr Surg. 2019;25(2):113-119.
- Richter HE, Matthews CA, Muir T, et al. A vaginal bowel-control system for the treatment of fecal incontinence. Obstet Gynecol. 2015;125(3):540-547.
- Sokol ER. Initial assessment of device mechanism of action and patient acceptance of a novel medical device: Feasibility study of vaginal bowel control therapy for the treatment of fecal incontinence BMJ Innovations. 2017;3:221-226.
- Sokol ER. Management of fecal incontinence -- focus on a vaginal insert for bowel control. Med Devices (Auckl). 2016;9:85-91.
- Takase-Sanchez MM. A staged feasibility study of a novel vaginal bowel control system for the treatment of accidental bowel leakage in sdult women. SOJ Gynecol Obstet Women Health. 2017;3(1):1-5.
- Varma MG, Matthews CA, Muir T, et al. Impact of a novel vaginal bowel control system on bowel function. Dis Colon Rectum. 2016;59(2):127-131.
