Medical Policy: 02.01.51
Original Effective Date: September 2013
Reviewed: May 2021
Revised: May 2021
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This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.
Fecal incontinence (FI) is the involuntary loss of flatus, liquid, or stool. Fecal incontinence (FI) may be caused by damage to the anal sphincter (e.g., childbirth, surgery), diarrhea, fecal impaction, illnesses that cause the inability to expand and store fecal matter (e.g., inflammatory bowel disease [IBD], Crohn’s disease or injury). Although it is considered a benign disorder, severe fecal incontinence (FI) 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 (FI), 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 (FI) 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, defecation programs (bowel training), and dietary management (increase dietary fiber with psyllium products or synthetic analogues).
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 (FI) who have failed medical interventions and who are not candidates for sphincter repair, the choices are limited, and alternative treatment options have been proposed and investigated to include the following: transanal radiofrequency ablation; injectable bulking agents (Solesta or autologous fat); posterior tibial nerve stimulation (PTNS); vaginal bowel control, vaginal insert (Eclipse System); bowel control anal insert (Renew Anal Insert); peripheral floor stimulation (PFS) (electrical [InToneMV] or magnetic [translumbosacral neuromodulation therapy [TNT]) and surgical placement of anal rectal sling (TOPAS System).
In patients who have fecal incontinence (FI) is to provide a treatment option that is an alternative to or an improvement on existing therapies.
The relevant population of interest is patients with fecal incontinence (FI). Fecal incontinence (FI) can have a substantial impact on the quality of life (QOL). Estimates from the National Center for Health Statistics have suggested that among noninstitutionalized persons, 65 years of age or older, 17% have reported issues with fecal incontinence. Risk factors for fecal incontinence are similar in men and women: older age, diarrhea, fecal urgency, urinary incontinence, and diabetes.
The therapies being considered are transanal radiofrequency ablation; injectable bulking agents (Solesta or autologous fat); posterior tibial nerve stimulation (PTNS); vaginal bowel control, vaginal insert (Eclipse System); bowel control anal insert (Renew Anal Insert); peripheral floor stimulation (electrical [InToneMV] or magnetic [translumbosacral neuromodulation therapy [TNT]); and surgical placement of anal rectal sling (TOPAS system).
The following therapies are currently being used to make decisions about fecal incontinence: conservative therapy, sacral nerve stimulation and surgery.
The general outcomes of interest are symptom reduction, symptom recurrence, and treatment related adverse events.
Several agents (Durasphere, silicone biomaterial, etc) have been studied for the treatment of fecal incontinence. To date, only one bulking agent has been approved by the FDA for the treatment of fecal incontinence. This formulation is a non-animal stabilized hyaluronic acid/dextranomer in stabilized hyaluronic acid (NASHA Dx) and is marketed by Q-Med as Solesta. Solesta is a sterile gel that is injected into the anal canal. It is composed of naturally made materials, dextranomer and sodium hyaluronate. Solesta is classified as a medical device (injectable bulking agent) and not a drug.
In 2016, the Agency for Healthcare Research and Quality (AHRQ) assessed the efficacy and comparative effectiveness of surgical and nonsurgical treatments for fecal incontinence (FI) in adults. Sixty-three unique studies met inclusion criteria; an additional 53 surgical case series were examined for adverse effects. Enrolled adults were mostly female with mixed FI etiologies. Most randomized controlled trials (RCTs) were nonsurgical (n = 38); 13 examined pelvic floor muscle training (PFMT) and PFMT with biofeedback (PFMT-BF). Meta-analysis was not possible because numerous outcomes were used. Low-strength evidence suggests that dietary fiber (psyllium) decreases FI episodes (-2.5 per week) at 1 month; clonidine has no effect; and PFMT-BF with electrostimulation is no more effective than PFMT-BF for FI severity and the FI Quality of Life scale (FIQL) over 2 to 3 months. Low-strength evidence at 6 months suggests that dextranomer anal bulking injections are more effective than sham injections on the FIQL, the number of FI-free days, and the percent of adults with at least 50-percent reduction from baseline in FI episodes, but no more effective than PFMT-BF with or without electrostimulation on FI severity (PFMT-BF -5.4 vs. dextranomer -4.6 point Vaizey score improvements) and the FIQL, and no more effective than sham injection on FI severity (-2.5 vs. -1.7 point sham improvement in Cleveland Clinic FI score [CCFIS]) or FI episode frequency. Moderate-strength evidence suggests that Durasphere® (off label) bulking injections reduce FI severity up to 6 months (-4 to -5 points CCFIS), but gains diminish thereafter. Evidence was insufficient for all other surgical and nonsurgical comparisons. Surgical improvements varied. Noninvasive nonsurgical treatments had few minor adverse effects (AEs). Surgical treatments were associated with more frequent and more severe complications than nonsurgical interventions. AEs were most frequent for the artificial bowel sphincter (22–100% of adults). Surgical AEs ranged from minor to major (infection, bowel obstruction, perforation, fistula). Major surgical complications often required reoperation; fewer required permanent colostomy. Only 12 percent of RCTs were high quality. The authors found limited evidence to support any FI treatments beyond 3 to 6 months. Comparing the effectiveness of FI surgical and nonsurgical treatments is difficult because nonsurgical approaches generally precede surgery. Most current interventions show modest improvements in FI outcomes that meet minimal important differences (MIDs) in the short term, where MID is known. More invasive surgical procedures have substantial complications. Numerous outcome measures and lack of compliance with study reporting standards are modifiable impediments in the field. Future studies should focus on longer term effects and attempt to identify subgroups of adults by FI etiology that might benefit from specific interventions.
Based on review of the available literature on Solesta (NASHA/Dx) for fecal incontinence (FI), which included RCTs (n=2 studies) and prospective uncontrolled trials (n=6 studies). Patient populations in studies ranged from 21–206 and consisted of non-responders to conservative treatment. Outcomes included the change in the number of incontinence episodes and the number of days without incontinence. Follow-up ranged from three months to three years. The available evidence showed that NASHA/Dx treatment for fecal incontinence is associated with modest but statistically significant improvements at follow-up compared with pretreatment status in 64%–74% of patients at one year, 59%–63% at two years, and 45% at three years. However, the overall quality of the evidence was found to be low due to the paucity of controlled studies and small sample sizes. Loss to follow-up was also found to be a limitation of the evidence. Given the large placebo effect observed in studies of treatments for fecal incontinence, larger, independent, randomized, sham-controlled studies are needed to further evaluate the efficacy, durability, and safety of this treatment. The evidence is insufficient to determine the effects of the technology on net health outcomes.
Other materials such as autologous fat have been used as bulking agents for the treatment of fecal incontinence (FI) but have not demonstrated sustained effectiveness and did not show they were more efficacious than placebo. While autologous substances may have a nonimmunogenic advantage, their use may be limited by resorption and fibrous replacement along with local discomfort associated with harvesting procedures. Larger, independent, randomized, sham-controlled studies are needed to further evaluate the efficacy, durability, and safety of this treatment. The evidence is insufficient to determine the effects of the technology on net health outcomes.
Transanal radiofrequency (RF) therapy, the Secca System has been investigated as a minimally invasive treatment of fecal incontinence (FI). In this outpatient procedure using conscious sedation, radiofrequency entery is delivered to the sphincteric complex of the anal canal to create discrete thermal lesions. Over several months, these lesions heal and the tissue contracts, changing the tone of the tissue and improving continence.
In order to determine the long-term efficacy of transanal radiofrequency therapy as a treatment of fecal incontinence (FI), it should be compared to conservative therapies that are considered standard of care for this condition. The peer-reviewed literature on this topic consists primarily of non-randomized uncontrolled trials, none of which compared transanal radiofrequency treatment to conservative treatments or alternative treatments. Additionally, most of the peer-reviewed literature consists of small studies with short-term follow-up. Studies to date have not distinguished between the five types of fecal incontinence (stress, urge, overflow, functional and mixed incontinence). Larger, prospective randomized trials comparing transanal radiofrequency treatment to other conservative or alternative treatments of fecal incontinence and demonstrating long-term improved patient outcomes are needed to accurately determine the efficacy of this treatment and identify which population of individuals with fecal incontinence might benefit from this treatment. The evidence is insufficient to determine the effects of the technology on net health outcomes.
In 2014, the American College of Gastroenterology (ACG), in a clinical guideline on the management of benign anorectal disorders, concluded that “there is insufficient evidence to recommend radiofrequency ablation treatment to the anal sphincter (SECCA) at this time (no recommendation, insufficient evidence).”
In 2015, a clinical practice guideline for the treatment of fecal incontinence by the American Society of Colon and Rectal Surgeons (ASCRS) concluded that the reported evidence for radiofrequency treatment is relatively sparse and has relevant limitations. Most studies reviewed have been small, single-center series with short-term follow-up. In addition, the authors observed that while long-term follow-up is very limited, any clinical benefit achieved in the short term appears to be sustained in the long term. The authors also noted that individuals with inflammatory bowel disease (IBD), chronic constipation, diarrhea, and history of pelvic radiation were not included in the studies reviewed. They stated that “because of the limitations in the available data, alternative treatments should be pursued before considering radiofrequency energy delivery.”
In 2016, the Agency for Healthcare Research and Quality (AHRQ) published a systematic review on treatments for fecal incontinence. The authors found a lack of comparative studies on Secca procedure and concluded that the evidence for the procedure was insufficient.
Pelvic floor stimulation (PFS) involves electrical stimulation of pelvic floor muscles using either a probe wired to a device for controlling the electrical stimulation or, more recently, extracorporeal electromagnetic (also called magnetic) pulses. Methods of electrical PFS have varied in location (e.g., vaginal, rectal), stimulus frequency, stimulus intensity or amplitude, pulse duration, pulse to rest ratio, treatments per day, number of treatment days per week, length of time for each treatment session, and overall time period for device use between clinical and home settings. Variations in the amplitude and frequency of the electrical pulse are used to mimic and stimulate the different physiologic mechanisms of the voiding response, depending on the etiology of the incontinence (i.e., either detrusor instability, stress incontinence, or a mixed pattern). Magnetic PFS does not require an internal electrode.
Patients receiving electrical PFS may undergo treatment in a physician's office or physical therapy facility, or patients may undergo initial training in a physician's office followed by home treatment with a rented or purchased pelvic floor stimulator. Magnetic PFS may be administered in the physician's office.
In 2014, the InTone® MV (InControl Medical), a non-implantable device that provides electrical stimulation and/or biofeedback via manometry, was cleared by the FDA. The device is intended to treat male and female urinary and fecal incontinence.
Several RCTs have evaluated electrical stimulation for treating fecal incontinence. Only 1 was sham-controlled, and it did not find that active stimulation produced better results than sham stimulation. Systematic reviews of RCTs have not found that electrical stimulation is superior to control interventions for treating fecal incontinence.
Magnetic pelvic floor stimulation device the FENIX Continence Restoration System is comprised of an annular series of connected titanium beads and each bead contains a magnetic core which is magnetically attracted to adjacent beads. Collectively, this attraction augments the native anal sphincter providing needed resistance to involuntary opening of the anal canal. The Fenix implant is supplied sterile and placed through a perineal incision. However, in 2017 Torax Medical announced the discontinuation of sales and clinical studies of the FENIX Continence Restoration System.
Translumbosacral neuromodulation therapy (TNT) is a non-invasive treatment that uses the power of the magnet to stimulate and heal nerves key to bowel control. This is currently an ongoing study for the disabling and common problem of stool leakage, or fecal incontinence (FI). Translumbosacral neuromodulation therapy (TNT) has shown some early promise in strengthening connections between nerves and muscles that enable an individual to control stool release. Participants in the trial should have had problems with fecal incontinence for about six months and at least one episode per week. Some exclusionary criteria for this study include those with known neurological problems like a spinal cord or head injury and other anal problems like inflamed hemorrhoids. This larger study will help to determine the optimal dose and give investigators more insight on how it works. Investigators at the Medical College of Georgia and Augusta University Health System as well as Harvard University’s Massachusetts General Hospital in Boston are exploring the potential of magnetic stimulation in 132 patients, including 44 participants receiving sham treatment to help assess its efficacy and safety. They are giving TNT sessions once a week for over six weeks to 88 patients at a dose of either 2,400 or 3,600 magnetic stimulations at 1 hertz the frequency per second and performing the lookalike sham on 44 patients. The study outcomes will include whether participants experience a 50% or greater reduction in episodes of stool leakage, like those in an earlier, smaller study. They also will look at related factors like the consistency of the stool, the severity of fecal incontinence episodes, rectal sensation, quality of life and examine nerve function and gut and brain interactions. To further assess its long-term efficacy, the investigators are evaluating whether reinforcement treatment helps and how long the effects last. They will examine 88 patients again at 12, 24 and 48 weeks and assess whether the actual treatment, rather than the placebo or sham, improves leakage. The only side effects patients have reported to date is some temporary tingling in the treatment area, likely prompted by rejuvenated nerves.
Currently no completed randomized or non-randomized RCTs were identified that evaluated magnetic pelvic floor stimulation as a treatment of fecal incontinence. There is currently an ongoing study regarding the use of translumbosacral neuromodulation therapy (TNT) which is a non-invasive treatment that uses the power of the magnet to stimulate and heal nerves key to bowel control.
For individuals who have fecal incontinence who receive electrical pelvic floor stimulation (PFS), the evidence includes randomized controlled trials (RCTs) and systematic reviews. Among the RCTs that have evaluated electrical PFS as a treatment for fecal incontinence only 1 trial was sham-controlled, and it did not find that electrical stimulation improved the net health outcome. Systematic reviews of RCTs have not found that electrical stimulation is superior to control interventions for treating fecal incontinence. The evidence is insufficient to determine the effects of the technology on net health outcomes.
For individuals who have fecal incontinence who receive magnetic pelvic floor stimulation (PFS), the evidence includes no randomized or non-randomized controlled trials (RCTs). The evidence is insufficient to determine the effects of the technology on net health outcomes.
Posterior tibial nerve stimulation (PTNS) involves a battery powered external electrical pulse generator and a needle electrode lead set. The needle probe is implanted in the tibial nerve and is attached to the electrical pulse generator. This minimally invasive neuromodulation system was developed as a less-invasive alternative to sacral nerve stimulation (SNS). It is designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. PTNS has also been proposed for treatment of fecal incontinence. Published literature consists of small observational studies quantified by measurements of fecal incontinence (FI) episodes, ability to defer defecation, quality of life improvement and treatment success.
PTNS treatment includes a 12-week initial treatment phase followed by an indefinite maintenance treatment phase, with each of these phases having different treatment protocols. The initial treatment phase consists of 1 to 3 weekly 30-minute treatment sessions for 12 weeks.
In 2018, Simillis et. al. completed a systematic review and meta-analysis comparing the clinical outcomes and effectiveness of sacral nerve stimulation (SNS) versus percutaneous tibial nerve stimulation (PTNS) for treating fecal incontinence (FI) in adults. A literature search of MEDLINE, Embase, Science Citation Index Expanded and Cochrane was performed in order 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. Four studies (one randomized controlled trial and three nonrandomized 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 2.27; 95% confidence interval 3.42, 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 Quality of Life coping and depression domains, compared to PTNS on short-term follow-up. Only two studies reported on adverse events, reporting no serious adverse events with neither SNS nor PTNS. The authors concluded current evidence suggests that SNS results in significantly improved functional outcomes and quality of life compared to PTNS. No serious adverse events were identified with either treatment. Further, high-quality, multi-center randomized controlled trials with standardized outcome measures and long-term follow-up are required in this field.
In 2019, Sarveazad et. al. completed a systematic review and meta-analysis to investigate the role of posterior tibial nerve stimulation (PTNS) in the control of fecal incontinence (FI). Two independent reviewers extensively searched in the electronic databases of Medline, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), Web of Science, CINAHL, and Scopus for the studies published until the end of 2016. Only randomized clinical trials were included. The studied outcomes included FI episodes, FI score, resting pressure, squeezing pressure, and maximum tolerable pressure. The data were reported as Standardized Mean Differences (SMD) with 95% confidence interval. Five articles were included in the present study (249 patients under treatment with PTNS and 239 in the sham group). Analyses showed that PTNS led to a significant decrease in the number of FI episodes (SMD=-0.38; 95% CI: -0.67-0.10; P=0.009). Yet, it did not have an effect on FI score (SMD=0.13; 95% CI: -0.49-0.75; P=0.68), resting pressure (SMD=0.12; 95% CI: -0.14-0.37; P=0.67), squeezing pressure (SMD=-0.27; 95% CI: -1.03-0.50; P=0.50), and maximum tolerable pressure (SMD=-0.10; 95% CI: -0.40-0.24; P=0.52). The authors concluded based on the results, it seems that the prescription of PTNS alone cannot significantly improve FI.
In 2020, Tan et.al. performed a systematic review and meta-analysis to quantify placebo effects and responses following sham electrical nerve stimulation in fecal incontinence (FI) and constipation. Successful treatments following electrical nerve stimulation have been commonly reported in patients with fecal incontinence and constipation. However, many of these nerve stimulation trials have not implemented sham controls, and are, therefore, unable to differentiate overall treatment responses from placebo. A literature search of Ovid MEDLINE, PubMed, EMBASE, and Cochrane databases was conducted from inception to April 2017. Randomized sham-controlled trials investigating the effect of lower gastrointestinal electrical nerve stimulation in fecal incontinence and constipation were included. Pediatric and non-sham- controlled trials were excluded. Ten randomized sham-controlled trials were included. Sham stimulation resulted in improvements in fecal incontinence 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 Gastrointestinal Quality of Life scores (7.9 points, CI -0.46 to 16.18, p = 0.06). The authors concluded Sham stimulation is associated with clinical and statistically meaningful improvements in symptoms of fecal incontinence and constipation, as well as quality of life scores, highlighting the importance of sham controls in nerve stimulation trials. Noncontrolled studies should be interpreted with caution.
In 2017, Horrocks et. al. conducted a post hoc analysis of data from the CONFIDeNT trial, to evaluate factors associated with the efficacy of percutaneous tibial nerve stimulation (PTNS) for fecal incontinence. 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 (≥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. Univariable and multivariable analyses were performed to explore these factors as predictors of response to PTNS and sham. In both univariable and multivariable analysis, the presence of OD symptoms negatively predicted outcome in patients who received PTNS (OR, 0.38; 95% CI, 0.16-0.91; P = .029), and positively predicted sham response (OR, 3.45; 95% CI, 1.31-9.21; P = .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% vs 18.2% response, P = .002; multivariable OR, 4.71; 95% CI, 1.71-12.93; P = .003). The authors concluded concomitant OD symptoms negatively affected the clinical outcome of PTNS versus sham in a major randomized controlled trial. Future appropriately designed studies could further explore this observation with potential for future stratified patient selection.
The Neuromodulation for Accidental Bowel Leakage (NOTABLe) sham-controlled trial of PTNS in women with fecal incontinence (N=166) was completed in March 2020 (NCT03278613) and results have not yet been published.
Based on review of the literature for individuals who have fecal incontinence who receive posterior tibial nerve stimulation (PTNS), the evidence includes several randomized controlled trials (RCTs) and systematic reviews. The available RCTs have not found a clear benefit of PTNS. Neither of the sham-controlled trials found that active stimulation was superior to sham for achieving the primary outcome, at least a 50% reduction in mean weekly fecal incontinence episodes. The larger sham-controlled randomized trial did find a significantly greater decrease in the absolute number of weekly incontinence episodes in the active treatment group, but the overall trial findings did not suggest the superiority of PTNS over sham treatment. A meta-analysis of a single RCT and several observational studies reported that patients receiving sacral nerve simulation experienced significant benefits compared with patients receiving PTNS. A post hoc analysis of the larger trial suggested a subset of patients with fecal incontinence (those without concomitant obstructive defecation) may benefit from PTNS. Also, The Urgent® PC Neuromodulation System and NURO™ Neuromodulation System are not FDA cleared for the treatment of fecal incontinence. The evidence is insufficient to determine the effects of the technology on net health outcomes.
The Eclipse™ Vaginal Insert system (Pelvalon, Inc.) is a non-surgical therapy for women experiencing loss of bowel control. The inflatable vaginal insert is designed to exert pressure on the rectal vault to treat fecal incontinence. According to the manufacturer, the Eclipse™ system consists of a vaginal insert and a pressure-regulated pump. The insert, consisting of a silicone-covered stainless steel base and a posteriorly directed balloon, is placed in the vaginal vault and inflated. The balloon is deflated via the pump when the user needs to have a bowel movement and the balloon is inflated again when the bowel movement is finished. The initial fitting and inflation is performed by a clinician, and a trial period is provided for one week or so for the patient to decide if the insert fits well and whether it is right for the individual. If the trial period is successful, the patient may begin using the Eclipse insert which is intended for long-term use, in which the patient can inflate and deflate the device as needed at home.
In 2015 Holly et. al. evaluated the effectiveness and safety of a vaginal bowel-control device and pump system (Eclipse System) for fecal incontinence treatment. Women with a minimum of four fecal incontinence episodes over 2 weeks were fit with the intravaginal 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, Modified Manchester Health Questionnaire, and Patient Global Impression of Improvement. Adverse events were collected. Intention-to-treat analysis included participants who were successfully fit entering treatment. Per protocol, analysis included participants with a valid 1-month treatment diary. Sixty-one of 110 (55.5%) participants from six clinical sites were successfully fit and entered treatment. At 1 month, intention-to-treat success was 78.7% (48/61, P<.001); per protocol success, 85.7% (48/56, P<.001) and 85.7% (48/56) considered bowel symptoms “very much better” or “much better.” There was significant improvement in all Fecal Incontinence Quality of Life (P<.001) and Modified Manchester (P≤.007) subscales. Success rate at 3 months was 86.4% (38/44; 95% confidence interval 73–95%). There were no serious adverse events; the most common study-wide device-related adverse event was pelvic cramping or discomfort (25/110 participants [22.7%]), the majority of events (16/25 [64%]) occurring during the fitting period. This study has several limitations. Optimally, a randomized trial would have minimized bias. The inclusion of a control arm, although desirable, is uncommon in trials of fecal incontinence therapies because of the nonuniform presentation of the condition and the lack of a gold standard treatment. A common methodology in fecal incontinence 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 fecal incontinence. In addition to study design, the length of follow-up was short. Because this is a completely new treatment option, it was important to investigate the potential side effects and tolerability in addition to efficacy. A longer-term outcome study is needed to provide this important information.
Based on review of the available literature while this device may show promise in reducing fecal incontinence (FI) episodes in women, the study was non-randomized and was only evaluated for one month. Randomized controlled trials (RCTs) with longer-term follow-up are needed to evaluate the long-term efficacy of this device. The evidence is insufficient to determine the effects of the technology on net health outcomes.
The Renew Anal Insert (Renew Medical, Inc.) is a silicone rectal insert device available by prescription for patients with accidental bowel leakage (ABL) or fecal bowel incontinence. This device is designed for self-insertion to comfortably seal the rectum from the inside to help prevent accidental bowel leakage (ABL)/fecal incontinence (FI) and is suitable for use in men and women. Renew inserts are designed for single-use and are naturally expelled with a bowel movement.
In 2019, Leo et. al. stated that the Renew Anal Insert is a recent treatment for patients who suffer from passive fecal incontinence (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. However, these researchers stated that further work is needed to compare it with other treatments and establish its position in the treatment pathway.
Based on review of the literature the Renew Anal Insert is a treatment for patients who suffer from fecal incontinence (FI)/accidental bowel leakage (ABL). While this device may be promising as a therapeutic option for the treatment of FI/ABL, further randomized controlled trials (RCTs) are needed to compare the Renew Anal Insert with other treatments for FI/ABL to establish the efficacy of this device. The evidence is insufficient to determine the effects of the technology on net health outcomes.
The Trans-Obturator Posterior Anal Sling (TOPAS) System is a posterior anal sling that is minimally invasive, permanent mesh implant designed to restore and maintain anatomic support of the pelvic floor muscles in women with fecal incontinence who have failed conservative therapy.
The TOPAS system is comprised of a knitted, Type 1 polypropylene monofilament mesh, which is covered by removable insertion sheaths, and two insertion needles. Implantation is through a transobturator approach via two small incisions in both the thighs and buttocks, requiring about 30 minutes for implantation and a short period for recovery. The implanted mesh is self-fixating and permanent with tissue in-growth providing additional anatomical support to the anorectum.
The FDA approval for the TOPAS system was based on the following pre-market approval study that reported 1- year outcomes in a prospective multicenter study evaluating this treatment modality. A total of 152 women were implanted with the TOPAS system at 14 centers in the United States. Fecal incontinence (FI) was assessed preoperatively and at the 12-month follow up with a 14-day bowel diary, Cleveland Clinic Incontinence Scores, and FI Quality of Life questionnaires. Treatment success was defined as reduction in number of FI episodes of ≥50% compared to baseline. Missing bowel diary data were considered treatment failures. The Wilcoxon signed rank test was used to compare changes observed at 12 months versus baseline. Mean age was 59.6 years old (SD 9.7). The mean duration of FI was 110 months (range 8-712 months). Mean length of the implant procedure was 33.4 (SD 11.6) minutes. Mean EBL was 12.9 (SD 10.5) mL. Average follow-up was 24.9 months. At 12 months, 69.1% of patients met the criteria for treatment success, and 19% of subjects reported complete continence. FI episodes/week decreased from a median of 9.0 (range 2-40) at baseline to 2.5 (range 0-40) (P < .001). FI days decreased from a median of 5.0 (range 1.5-7) at baseline to 2.0 (range 0-7) (P < .001) over a 7-day period. FI associated with urgency decreased from a median at baseline of 2.0 (range 0-26) to 0 (range 0-14.5) (P < .001). The mean Cleveland Clinic Incontinence Scores decreased from 13.9 at baseline to 9.6 at 12 months (P < .001). FI Quality of Life scores for all 4 domains improved significantly from baseline to 12 months (P < .001). A total of 66 subjects experienced 104 procedure and/or device-related adverse events (AEs). Most AEs were short in duration and 97% were managed without therapy or with nonsurgical interventions. No treatment-related deaths, erosions, extrusions, or device revisions were reported. The most common AE categories were pelvic pain (n = 47) and infection (n = 26). Those subjects experiencing pelvic pain had a mean pain score (0-10 scale, 0 = no pain) during the 12-month follow-up of 1.2 (SD 2.4).
Based on the FDA approval (2016) for the TOPAS system the patients currently enrolled in the TOPAS PMA study will be followed through 5 years (60 months) of follow-up to monitor the long-term performance and safety of the TOPAS system.
Based on the available literature regarding the Trans-Obturator Posterior Anal Sling (TOPAS) System which is a posterior anal sling designed to restore and maintain anatomic support of the pelvic floor muscles in women with fecal incontinence (FI) who have failed conservative therapy, while the premarket study was promising further randomized controlled trials (RCTs) are needed to determine long term efficacy of this device. The evidence is insufficient to determine the effects of the technology on net health outcomes.
National Institute for Health and Clinical Excellence concluded "Current evidence on the safety and efficacy of injectable bulking agents for fecal 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 2014, the American College of Gastroenterology (ACG) published guidelines on the management of benign anorectal disorders. The guideline indicated that there is insufficient evidence to recommend radiofrequency ablation to the anal sphincter as treatment for fecal incontinence. ACG also asserted that the biological rationale for this type of treatment is unproven.
In 2015, the American Society of Colon and Rectal Surgeons updated its practice parameters for the treatment of fecal incontinence:
In 2017, the American Gastroenterological Association (AGA) published an expert review on surgical interventions and device-aided therapy for the treatment of fecal incontinence and defecation disorders. The Association stated that surgical options may be considered in patients with fecal incontinence and defecation disorders, but only after conservative therapy has failed. Examples of conservative therapies include dietary modification, fiber supplements, bowel training programs, pelvic floor exercises, medications, or biofeedback.
In 2014, the InTone® MV (InControl Medical), a non-implantable device that provides electrical stimulation and/or biofeedback via manometry, was cleared by the FDA. The device is intended to treat male and female urinary and fecal incontinence.
In 2005, the Urgent® PC Neuromodulation System was the initial PTNS device cleared for marketing by FDA through the 510(k) process to treat patients suffering from urinary urgency, urinary frequency, and urge incontinence. Additional percutaneous tibial nerve stimulators have been cleared for marketing through the 510(k) process. The Urgent® PC Neuromodulation System and NURO™ Neuromodulation System are not FDA cleared for other indications, such as the treatment of fecal incontinence.
In 2011, NASHA Dx, marketed as Solesta® (Q-Med), was approved by FDA through the premarket approval process as a bulking agent to treat fecal incontinence in patients 18 years and older who have failed conservative therapy.
The Secca System (Curon Medical, Inc.), which received U.S. Food and Drug Administration (FDA) clearance under the investigational device exemption in March of 2002, consists of a hand-held anoscopic device with electrodes and a radiofrequency generator. Per FDA label indications, the Secca System is intended for use specifically in the treatment of fecal incontinence in patients who experience incontinence of stool (solid or liquid) at least once per week and who have failed conservative therapy.
In 2015, the U.S. Food and Drug Administration (FDA) approved the Eclipse System which is vaginal insert designed to provide bowl control in women with fecal incontinence.
In 2016, the U.S. Food and Drug Administration (FDA) approved the TOPAS Treatment (hereafter TOPAS System), which is a mesh implant with minimally invasive delivery, to provide support to the anorectum and reduce the incidence of fecal incontinence (FI) episodes in women who have failed conservative therapies.
Not applicable.
See Related Medical Policies
The following are considered investigational for the treatment of fecal incontinence (FI), because the effectiveness has not been established by the available published peer reviewed literature and therefore, the evidence is insufficient to determine the effects of the technology on net health outcomes:
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Wellmark medical policies address the complex issue of technology assessment of new and emerging treatments, devices, drugs, etc. They are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Wellmark medical policies contain only a partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice.
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