| Coverage Policy Manual | |
| Policy #: | 2009028 |
| Category: | Medicine |
| Initiated: | August 2009 |
| Last Review: | January 2024 |
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| Biofeedback as a Treatment of Fecal Incontinence or Constipation | |
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| Description: |
Biofeedback, a technique intended to teach patients self-regulation of certain physiologic processes not normally considered to be under voluntary control, is used to treat a variety of conditions and is proposed as a treatment of fecal incontinence and constipation.
Fecal incontinence in adults is the recurrent uncontrolled passage of fecal material. Pathophysiology of the disorder ranges from abnormalities in intestinal motility (diarrhea or constipation), to poor rectal compliance, impaired rectal sensation, or weak or damaged pelvic floor muscles. There is no increase in mortality attributable to fecal incontinence. Morbidity includes skin breakdown and urinary tract infections. Fecal incontinence affects quality of life through restricting work, recreation, and activities related to “getting out of the house,” impaired social role function, diminished sexual activity, and increase of social isolation due to embarrassment. Fecal incontinence brings about loss of independence and mobility. It is the second most common reason for elderly institutionalization. The most common causes of fecal incontinence in adults are obstetric trauma coupled with age-related degeneration, previous anorectal surgery, rectal prolapse, and perineal trauma. In many individuals, the condition is multifactorial, involving a combination of structural, physiological, and psychosocial factors. Conventional interventions to treat fecal incontinence includes dietary recommendations (e.g., fiber), bowel and toilet scheduling, and medications (e.g., bulking or antidiarrheal agents).
Constipation refers to infrequent bowel movements and difficulty during defecation. Primary constipation is generally categorized into three groups. The most common type is normal-transit constipation in which there is a normal rate of stool movement but patients feel constipated and may complain of abdominal pain and/or bloating. In the second type, slow-transit constipation, stool moves more slowly through the colon and individuals often experience a limited urge to defecate. The third type, dyssynergic defecation, refers to a loss of ability to coordinate contractions of the pelvic floor muscles and to relax the anal sphincter during defecation. Patients often report an inability to defecate despite the urge to do so. There are also secondary causes of constipation such as the use of certain medications including opioids and psychoactive drugs, neurologic, endocrine or metabolic disorders, structural abnormalities and lifestyle factors. Conventional treatment includes dietary recommendations (i.e., adequate fiber and fluid intake), use of supplemental bulking substances, exercises and medications.
In children, most cases of fecal incontinence and constipation are functional, in which structural, endocrine, or metabolic diseases have been ruled out. Factors contributing to functional incontinence and constipation are fear and/or pain associated with large, hard stools. This leads to retentive posturing in about half the children with chronic constipation (i.e., the avoidance of defecation by purposefully contracting the external anal sphincter, also termed anismus or paradoxical sphincter contraction). Customary or conventional medical intervention includes dietary recommendations, bowel and toilet scheduling, education and softening agents. Behavioral interventions aim at restoring normal bowel habits through toilet training, reward and incentive contingency management programs, desensitization of phobia and fear, or skill building and goal-setting techniques with home practice. Counseling and psychotherapy provide support to the child and address social and psychological problems.
Biofeedback training for fecal incontinence focuses on improving the ability to voluntarily contract the external anal sphincter and puborectalis muscles in response to rectal filling and to decrease delay in response to a sensation of distension. For constipation, the aim of biofeedback is to teach patients how to tighten and relax their external anal sphincter in order to pass bowel movements.
Biofeedback attempts to improve rectal sensory perception, strength, coordination, or some combination of these three components. Sensory training involves inducing intrarectal pressure using a balloon feedback device. A manometric balloon probe is inserted into the rectum and the balloon is filled with air to produce a sensation of rectal filling. Strength training uses either anal canal pressure (manometric) or intra-anal EMG feedback of pelvic floor muscles (PFM). The purpose is to strengthen the force of the pelvic floor muscle contraction without including rectal distention. Some training increases endurance (duration of external anal sphincter contraction) as well as its peak strength. Coordination training uses pressure feedback of intrarectal balloon distention using a water-perfused catheter or Schuster-type balloon probe and PFM contractions in a simultaneous feedback display. The purpose of coordination training is to synchronize the contraction of the external anal sphincter with relaxation of the internal anal sphincter.
Biofeedback techniques convert the physiologic measures from an intra-anal EMG sensor, anal manometric probe (measuring intra-anal pressure) or perianal surface EMG electrodes to either visual or audio display for feedback. Ultrasound has also bee used to show patients contraction of the anal sphincter on a screen. Biofeedback training is done alone, or in combination with other behavioral therapies designed to teach relaxation. Training sessions are performed in a quiet, non-arousing environment
Regulatory Status
A variety of biofeedback devices are cleared for marketing though the U.S. Food and Drug Administration’s (FDA) 510(k) marketing clearance process. These devices are designated by the FDA as class II with special controls, and are exempt from the premarket notification requirements. The FDA defines a biofeedback device as “an instrument that provides a visual or auditory signal corresponding to the status of one or more of a patient's physiological parameters (e.g., brain alpha wave activity, muscle activity, skin temperature, etc.) so that the patient can control voluntarily these physiological parameters.”
RELATED POLICIES:
2009025 - Biofeedback as a Treatment of Urinary Incontinence in Adults
2005004 - Sacral Nerve Stimulation for the Treatment of Fecal Incontinence
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Policy/ Coverage: |
Effective November 2010
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Biofeedback for any condition is an exclusion in most member benefit certificates of coverage.
For member benefit certificates without this specific contract exclusion, biofeedback for the treatment of fecal incontinence or constipation does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
For members with contracts without primary coverage criteria, biofeedback is considered investigational as a treatment of fecal incontinence or constipation in adults and children. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Effective August 2009 through October 2010
Biofeedback for any condition is an exclusion in the member certificate of coverage in most member benefit certificates.
For member benefit certificates without this specific contract exclusion, biofeedback is considered investigational as a treatment of fecal incontinence in adults and children. Investigational services are not covered.
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| Rationale: |
The relevant clinical outcome for biofeedback as a treatment in incontinence should be an overall change in the patient’s symptoms, i.e., relief from bowel incontinence. Reduction in episodes of fecal incontinence is the primary clinical outcome. Changes in physiological assessment (e.g., anal pressure or sensory threshold) often do not correlate with symptom relief (i.e., clinical outcomes). Anorectal physiology measurements are a poor proxy for changes in clinical symptoms. Patient symptoms are usually assessed through diary, questionnaire, or interview. Case series and observational studies report improvement rates of 50% to 92%.
Adults
Four systematic reviews of biofeedback treatment for fecal incontinence in adults have been recently published, including one Cochrane Review. Heymen et al. searched for studies published between 1970 and 1999 (Heyman, 2001). They found 35 articles, of which, 26 focused on adults. Twenty-two of these articles were uncontrolled studies, leaving only 4 studies with concurrent comparisons. The Norton and Kamm systematic review search covered the years from 1966 to 2000; they found 34 studies, but only 8 studies with control groups (Norton, 2001). Two of these 8 studies were patients with ileo-anal pouch with covering ileostomy, 1 did not involve biofeedback, and 1 compared augmented biofeedback with sensory biofeedback; leaving only 4 relevant articles. The Coulter et al. review searched from 1974 to 1999 and found 7 randomized controlled trials; 3 of these randomized, controlled trials were on fecal incontinence in adults (Coulter, 2002). Norton et al. searched the literature through January 2003 for their Cochrane review of biofeedback for fecal incontinence in adults (Norton, 2006). Only 5 randomized, controlled trials were identified as eligible. One of these 5 studies compared modalities of biofeedback , leaving 4 relevant studies. Our search of the literature found 1 additional comparative randomized, controlled trial that involved only groups with different components of biofeedback and no control group.
In the Guillemot et al. study, patients chose whether to participate in 4 weekly sessions of manometric pressure biofeedback or medical treatment consisting of an antidiarrheal or enema (Guillemot, 1995). Eight patients choose medical treatment; after 30 months, none was cured or showed improvement. Sixteen patients chose sensory biofeedback and had cure rates of 38% at 6 months and 0% at 30 months. The critical methodological flaw of this study is selection bias produced by patient selection of their treatment option. Latimer et al. provided single case experiments for 8 patients that involved multiple crossovers (Latimer, 1984). The study suffered from small sample size and order effects. The Miner et al. study randomized 13 patients to three 20-minute sessions of sensory biofeedback and 12 patients to a sham procedure of no feedback (Miner, 1990). The no-feedback control group showed an improvement rate of 42% and cure rate of 0%. The sensory biofeedback group obtained an 85% improvement rate and 31% cure rate. There was no correlation between improvement in incontinence and training in sphincter function. The diminishing returns following phase one and small sample size prevented any further meaningful statistical analysis for the crossover conditions. McHugh et al. reported results for a randomized controlled trial involving 18 patients (McHugh, 1986). The study design was a crossover between medical care (i.e., dietary fiber and exercise) and sphincter biofeedback. There was no statistical difference between medical care and biofeedback interventions. The Whitehead et al. study reports on 13 patients who underwent biofeedback after failure of a sphincter exercise program and had no comparison group (Whitehead, 1985).
The conclusion from the 4 systematic reviews of these studies is similar: there is not sufficient evidence from controlled trials to evaluate whether biofeedback treatments are helpful, nor which aspects of biofeedback are the most helpful and which patients are the most likely to be helped by biofeedback. The evidence for biofeedback based on observational studies and methodologically weak controlled trials can be viewed only as tentative.
Because of these methodological problems, the evidence is insufficient to support the efficacy and effectiveness of biofeedback for treatment of fecal incontinence in adults. Stronger research with more rigorous quality is needed to allow a reliable assessment of biofeedback therapy in the management of adults with fecal incontinence. There is a necessity for sham-placebo, randomized, controlled trials that have replicable standardized interventions, that control for confounding factors and bias, and that provide valid short- and long-term outcome measures and adequate power.
Children
The outcome criterion should be an overall change in the patient’s symptoms, i.e., relief from constipation and bowel incontinence. Reduction in episodes of fecal incontinence and increase in voluntary bowel movements are the primary clinical outcome, typically reported as the percentage of children cured or improved. Achieving normal defecation dynamics (e.g., anal pressure, squeeze pressure, sensory threshold, rectal inhibitory reflex, or defecation dynamics) does not correspond with symptom relief (i.e., clinical outcomes). Anorectal physiology measurements are a poor proxy for changes in clinical symptoms. Patient symptoms are usually assessed through parent and child diary, questionnaire, or interview.
Three systematic reviews of biofeedback treatment for fecal incontinence in children have been recently published, including one Cochrane review. Heymen et al. (1) searched for studies published between 1970 and 1999 (Heyman, 2001). They found 35 articles, 9 of which were in a pediatric population. All 9 of these articles were uncontrolled studies. The Coulter et al. systematic review searched from 1974 to 1999 and found 7 randomized, controlled trials; 5 of these trials were on fecal incontinence in children (Coulter, 2002). None of these trials was statistically significant, and 4 of the 5 studies actually showed that the control group had greater benefit from intervention than the biofeedback training group.
Brazzelli and Griffiths searched the literature through March 2001 for their Cochrane review of defecation disorders in children (Brazzelli, 2003). This review found 14 original randomized trials. Nine of these trials contained biofeedback as an intervention arm. One of these trials compared biofeedback versus biofeedback with oral laxatives , leaving 8 trials comparing biofeedback with conventional treatment. A meta-analysis among these 8 trials resulted in higher rather than lower rates of persistent encopresis when biofeedback was added to conventional treatment. Only one study has reported significant results in favor of biofeedback. However, a long-term follow-up study showed that biofeedback training did not improve recovery rate over conventional treatment in children with abnormal defecation dynamics. Our updated search of the literature found one additional comparative randomized, controlled trial. This study reported on 6-month follow-up of a previous publication by the same investigators showing once more that biofeedback did not differ from customary care.
The conclusion from the 3 systematic reviews of these randomized, comparative studies is similar: there is no evidence that biofeedback training adds benefit to conventional treatment in the management of constipation and encopresis in children. The evidence for biofeedback based on observational studies and methodologically weak controlled trials can be viewed only as tentative.
Norton and colleagues reported on the results of a trial that randomized 171 patients with fecal incontinence to 1 of 4 groups: standard care (advice), advice plus instruction on sphincter exercises, hospital-based computer-assisted sphincter presssure biofeedback, and hospital biofeedback plus the use of a home EMG biofeedback device (Norton, 2003). Outcomes included diary reports of incontinence, quality of life, and anal manometry measurements. The authors reported that biofeedback yielded no greater benefit than standard care. Solomon and colleagues reported on the results of a trial that randomized 120 with mild to moderate fecal incontinence of 1 of 3 groups: biofeedback with anal manometry, biofeedback with transanal ultrasound, or pelvic floor exercises with feedback from digital examination alone. There were no significant differences in outcomes among the treatment groups; all reported modest improvements. Finally, Mahony and colleagues conducted a randomized trial in patients with postpartum fecal incontinence that compared the effects of intra-anal EMG biofeedback with or without additional treatment with intra-anal electrical stimulation (Mahony, 2004). This trial is not relevant to this policy since there was no placebo-controlled group.
In a randomized controlled trial of only 23 female patients, Ilnyckyj and colleagues found no evidence biofeedback with education improved fecal continence over pelvic exercises with education (Ilnyckyj, 2005). In addition, a Cochrane review found no evidence that biofeedback training improved fecal continence in children over conventional treatment. Therefore, the policy statement is unchanged.
An updated Cochrane review of randomized or quasi-randomized controlled trials did not find evidence that biofeedback enhanced the outcome of treatment compared to other conservative management methods. The authors noted a suggestion that some particular elements of biofeedback and sphincter exercises may have a therapeutic effect, but that larger well-designed trials are needed to enable safe conclusions.
Technology Assessments and Systematic Reviews
In December 2007, an Evidence Report/Technology Assessment, Prevention of Urinary and Fecal Incontinence in Adults, based on research conducted by the Minnesota Evidence-based Practice Center under contract to the Agency for Healthcare Research and Quality (AHRQ) was issued (Shamliyan, 2007). The research objectives were to assess the prevalence of and risk factors for urinary (UI) and fecal (FI) incontinence in adults in long-term care settings and in the community, the effectiveness of diagnostic methods to identify adults at risk and patients with incontinence, and to review the effectiveness of clinical interventions to reduce the risk of incontinence. Observational studies were reviewed to examine the prevalence and incidence of UI and FI and the association with risk factors. The effects of treatments on patient outcomes were analyzed from randomized controlled trials and multicenter clinical trials. Of the 6,097 articles identified, 1,077 articles were eligible for analysis. The report’s Executive Summary section titled “Clinical Interventions to Reduce the Risk of FI” includes the authors’ overview of the evidence on the clinical effectiveness of interventions including biofeedback for various fecal incontinence conditions. Limited evidence, consisting of one randomized, controlled, single-blind trial (n=40; 9), suggested a reduction in FI after complex behavioral interventions, including lifestyle changes and exercises augmented with biofeedback. The authors of the AHRQ report suggest that future research should include well-designed randomized, controlled trials focused on the high-risk populations, e.g., pregnant and premenopausal women.
In discussing evidence limitations, the authors of the AHRQ review concluded that the report confirmed the significant diversity of interventions used, sampling strategies, definitions of incontinence, and measurement of outcomes. Therefore, the applicability of clinical interventions that demonstrated significant improvement in incontinence was restricted to the sampled population groups. Whether these effective interventions would result in the same clinical benefit in other populations requires future research.
In June 2007, National Institute for Health and Clinical Excellence (NICE) issued a guideline; Fecal Incontinence: the Management of Fecal Incontinence in Adults, which states the following regarding biofeedback as a treatment for fecal incontinence: “The evidence we found did not show biofeedback to be more effective than standard care, exercises alone, or other conservative therapies. The limited number of studies and the small number of participants in each group of the studies make it difficult to come to any definitive conclusion about its effectiveness.”
Physician Specialty Society Guidelines and Position Statements
In December 2007, the National Institutes of Health convened a Consensus Development Conference; Prevention of Fecal and Urinary Incontinence and subsequent to the conference released a conference statement. Included in this statement was the following regarding pelvic floor muscle training and biofeedback: “…Pelvic floor muscle training and biofeedback are effective in preventing and reversing some pregnancy-related fecal and urinary incontinence for the first year after delivery. There is insufficient research on the sustained long-term benefits of pelvic floor muscle training or biofeedback on preventing fecal or urinary incontinence.”
In October 2007, American Society of Colon and Rectal surgeons released Practice Parameters for theTreatment of Fecal Incontinence; the following is an excerpt from the “Nonoperative Treatment” section of the guidelines: “…Biofeedback is recommended as an initial treatment for motivated patients with incontinence with some voluntary sphincter contraction. Level of Evidence: III; Grade of Recommendation: B. Biofeedback may be considered a first-line option for many patients with fecal incontinence who have not responded to simple dietary modification or medication. Supportive counseling and practical advice regarding diet and skin care can improve the success of biofeedback. Biofeedback may be considered before attempting sphincter repair or for those who have persistent or recurrent symptoms after sphincter repair. It may have a role in the early postpartum period in females with symptomatic sphincter weakness. Biofeedback and a pelvic floor exercise program can produce improvement that lasts more than two years. Biofeedback home training is an alternative to ambulatory training programs, especially in the elderly.”
Summary
The reviews of biofeedback for adults and children point out several methodological problems in the literature:
2010 Update
A literature search was conducted through June 2010. The following is a summary of the relevant literature identified with this update.
Fecal Incontinence
The Enck review searched the literature through 2008 and identified 11 randomized controlled trials with adult populations (Enck, 2009). Two were excluded, one because of the small sample size and the other because it did not include an appropriate control group. The remaining 9 studies consisted of 5 comparisons of different modalities of biofeedback and 6 comparisons of electromyographic (EMG) biofeedback versus other types of therapy, mainly pelvic floor exercises (2 studies had multiple treatment groups and were included in both categories). The total number of patients included in the 9 studies was 540; sample sizes of individual studies ranged from 18 to171. A meta-analysis of 5 studies did not find a significant difference in the efficacy of different types of biofeedback (pooled odds ratio [OR]=1.23, 95% confidence interval [CI] =0.74-2.20, p=0.38). Similarly, a meta-analysis of studies comparing biofeedback to other therapies did not find a significant difference in efficacy (pooled OR=1.19, 95% CI=0.69-2.05). The outcome measure used in the analysis was not specified and appears to vary from study to study.
A study by Heymen and colleagues was published in 2009, after the systematic review literature search dates (Heymen, 2009). A total of 168 individuals with fecal incontinence were randomized to 3 months of bi-weekly pelvic floor exercise training alone (n=85) or exercise training with manometric biofeedback (n=83). Twenty-two patients in the exercise-only group and 38 in the biofeedback group improved during a 4-week run-in period and did not participate further, leaving 63 in the exercise group and 45 in the biofeedback group. The primary efficacy outcome was decrease in scores on the Fecal Incontinence Severity Instrument (FISI), a validated 4-item scale, from the end of the run-in to 3 months. The analysis included all patients who completed at least one treatment (a total of 15 patients dropped out). The authors reported that there was a greater reduction in FISI scores in the biofeedback group compared to the exercise-only group (p=0.01, exact scores were not reported). Complete continence (no staining) was reported by 13 of 63 (21%) in the exercise-only group and 20 of 45 (44%) in the biofeedback group; this difference was statistically significant (p=0.008). A study limitation was that only 108 of 168 randomized patients (64%) received the intervention and therefore there may have been baseline differences in the treated groups that affected study outcomes. A stronger design is to randomize patients after, not before, a run-in period.
Constipation
Biofeedback for constipation was added to the policy with this update.
Adults
The Enck systematic review, searched the literature on biofeedback for constipation (Enck, 2009). Eight randomized controlled trials conducted in adults were identified. Four of these compared 2 types of biofeedback; a meta-analysis of these 4 studies did not find a significant benefit of one technique over another (pooled OR= 1.44, 95% CI=0.69-3.09, p=0.32). The other 4 studies compared biofeedback to another treatment. Comparison treatments (1 study each) were botulinum toxin, laxatives, diazepam and best supportive care (diet, exercise and laxatives). Two studies also included a third arm, in which treatment was a sham or placebo intervention. Three of the 4 studies included patients with dyssynergia-type constipation and the fourth included patients with anismus. A meta-analysis of the 4 studies comparing one treatment to another (using the active intervention arm as the comparison in the 3-arm trials) found a significantly greater benefit of biofeedback in improving constipation symptoms (pooled OR=3.23, 95% CI=1.88-5.58, p<0.001). As evidenced by the wide confidence interval, the combined sample size was still relatively small leading to an imprecise estimate.
The two 3-arm studies, as well as a publication with long-term follow-up of patients in one of the studies, are described in more detail below:
Heyman and colleagues included adults who met Rome II diagnostic criteria for pelvic floor dyssynergia, had 2 or more symptoms of functional constipation for at least 12 weeks in the past year and had manometry or electromyography findings consistent with chronic constipation (e.g., evidence of inadequate propulsive forces and incomplete evacuation) (Heymen, 2007). Patients participated in a 4 week run-in period consisting of education on diet and exercise, and provision of fiber and stool softeners. Those who still met eligibility criteria at the end of the run-in period (84 of 117, 72%) were randomized to EMG biofeedback (n=30), diazepam 5 mg (n=30) or placebo medication (n=24). All participants were trained to perform pelvic floor exercises and all received 6 biweekly visits over 3 months, each lasting about 50 minutes. Patients and investigators were blinded to which patients received active versus placebo medication but not to whether or not they received biofeedback. In an intention to treat (ITT) analysis after the 3-month intervention, the proportion of patients reporting adequate relief of constipation symptoms was 70% in the biofeedback group, 23% in the diazepam group and 38% in the placebo group; biofeedback had a significantly greater benefit when compared either to diazepam (p<0.001) or placebo (p<0.017). A strength of this study was that it attempted to control for nonspecific effects of biofeedback e.g., increased contact with a health care provider and lifestyle modification advice by including a run-in period and similar follow-up visits for all groups. Moreover, randomization did not occur until after the run-in period so treatment groups were more likely to be similar at the start of the treatment phase.
Rao and colleagues included patients who met Rome II diagnostic criteria for functional constipation, had dyssnergic-type constipation and, when expelling a simulated stool, had either prolonged difficulty (at least one minute) or prolonged delay (at least 20% marker retention in colonic transfer) (Rao, 2007). All participants had failed routine management of constipation. A total of 77 patients were randomized to receive 3 months of standard therapy i.e., education, dietary advice (n=24), standard therapy and biofeedback therapy (n=28) or standard therapy and sham feedback (n=24). In the sham treatment group, patients used a rectal manometry probe but did not receive visual and verbal feedback. Patients were not blinded to treatment group but the manometry reader was unaware of treatment assignment. In an intention-to-treat analysis after the 3-month intervention, patients in the biofeedback group reported a significantly greater increase in complete spontaneous bowel movements than the sham feedback group (p<0.05) and the standard treatment group (p<0.062). In addition, a greater proportion of the patients in the biofeedback group reported improved global bowel satisfaction compared to the sham feedback group (p-0.04) but the comparison with the standard treatment group was not significantly different. (The authors did not report exact numbers for either of these preceding primary analyses). Of the primary physiologic parameters, the intention-to-treat analysis found that the dyssnergia pattern was corrected in 79% of those in the biofeedback group, 4% in the sham group, and 8% in the standard treatment group. This difference was statistically significant in favor of the biofeedback group compared to each of the other groups (p<0.001 for both analyses). Moreover, the balloon expulsion time during simulated defecation decreased significantly more in the biofeedback group compared to sham (p=0.003) or standard treatment (p=0.03) (exact times not reported for the ITT analysis).
An additional publication reported on one-year findings in 13 of 21 (62%) patients in the biofeedback group and 13 of 23 (57%) in the standard treatment group (Rao, 2010). Patients in the sham group were not included in the follow-up study. The extension study included visits at 3-month intervals, with additional advice provided as needed. Seven of the 13 (54%) biofeedback patients and all 13 patients in the standard treatment group completed the one-year follow-up. The numbers of patients in the follow-up study and the drop-out in the biofeedback group were too small for meaningful data analysis. However, the primary outcome, mean change in complete spontaneous bowel movements, favored the biofeedback group (increase of 2.9) compared to the standard treatment group (decrease of 0.2), p<0.005.
Children
No systematic reviews or meta-analyses on biofeedback for constipation in children, not associated with fecal incontinence, were identified. The literature search did identify one randomized controlled trial published since 2000. Van Ginkel and colleagues in the Netherlands included 212 children at least 5 years old with constipation who met at least 2 of the following 4 criteria: 1) stool frequency fewer than 3 times per week; 2) 2 or more soiling and/or encopresis episodes per week; 3) periodic passage of very large amounts of stool every 7 to 30 days; or 4) a palpable abdominal or rectal fecal mass (van Ginkel, 2001). Participants were randomized to 6 weeks of standard treatment i.e., education, laxatives (n=111) or standard treatment plus 2 sessions of anorectal manometry (n=91). During the manometry sessions, the child was asked to squeeze the sphincter as tight as possible 5 times. Squeeze pressure data were converted to digital values and transmitted to a computer; the data could be viewed by the child and parent. The data were discussed after the sessions and instructions were given on how to perform defection exercises at home. Ten of 212 (5%) randomized patients did not receive treatment and the remainder completed the intervention. Treatment success was defined as achievement of 3 or more bowel movements per week and fewer than 1 soiling and/or encopresis episodes per 2 weeks while not receiving laxatives. At 6 weeks, 4 of 111 (4%) in the standard treatment group and 6 of 91 (7%) in the biofeedback group were considered to have successful treatment; this difference was not significantly different. There was also no statistically significant difference between groups at any other follow-up point. At the final 104-week follow-up, 36/83 (43%) patients in the standard treatment group and 23 of 65 (35%) in the biofeedback group were considered treatment successes. Data on 30% of the randomized patients were missing at the final follow-up. This intervention did not control for the non-specific effects of biofeedback.
In May 2010, the National Institute for Clinical Excellence (NICE) issued a guideline on constipation in children and young people which states that biofeedback should not be used for ongoing treatment. In June 2007, they issued a guideline on fecal incontinence in adults which states the following regarding biofeedback: “The evidence we found did not show biofeedback to be more effective than standard care, exercises alone, or other conservative therapies. The limited number of studies and the small number of participants in each group of the studies make it difficult to come to any definitive conclusion about its effectiveness.”
In 2008, the National Institutes of Health issued a state-of-the science statement on fecal and urinary incontinence based on a consensus conference held in December 2007 (Landefeld, 2008). Included in the conclusions was the following statement, “pelvic floor muscle training and biofeedback are effective in preventing and reversing fecal and urinary incontinence in women for the first year after giving birth…”
Summary
Systematic reviews of biofeedback for treating fecal incontinence in adults and children have not found that biofeedback provides additional benefit when offered in conjunction with conventional therapy compared to conventional therapy alone. One recent RCT found that, when biofeedback was added to exercise training, there was a significantly greater decrease in fecal incontinence symptoms than with exercise training alone. However, this RCT had limitations and findings need to be examined in conjunction with those of the systematic reviews. Overall, the evidence is insufficient to conclude that biofeedback improves the net health outcome for adults and children with fecal incontinence.
A systematic review of randomized controlled trials found a significant benefit of biofeedback as a treatment of constipation in adults; most of the studies included individuals with dyssynergia-type constipation and participants had failed conservative treatment. However, the combined sample size was still relatively small. Data on additional patients are required before concluding whether biofeedback has an incremental impact on the net health outcome for adults with constipation beyond that of standard therapy. There is a lack of evidence from controlled studies that biofeedback is an effective treatment for constipation in children.
2012 Update
A review of literature was conducted on PubMed through September 2012.
Norton and Cody (2012) identified randomized or quasi-randomized trials evaluating biofeedback and/or anal sphincter exercises in adults with faecal incontinence. Twenty one eligible studies were identified with a total of 1525 participants. About half of the trials had low risk of bias for randomisation and allocation concealment. One small trial showed that biofeedback plus exercises was better than exercises alone (RR for failing to achieve full continence 0.70, 95% CI 0.52 to 0.94).One small trial showed that adding biofeedback to electrical stimulation was better than electrical stimulation alone (RR for failing to achieve full continence 0.47, 95% CI 0.33 to 0.65). The combined data of two trials showed that the number of people failing to achieve full continence was significantly lower when electrical stimulation was added to biofeedback compared against biofeedback alone (RR 0.60, 95% CI 0.46 to 0.78). Sacral nerve stimulation was better than conservative management which included biofeedback and PFMT (at 12 months the incontinence episodes were significantly fewer with sacral nerve stimulation (MD 6.30, 95% CI 2.26 to 10.34). There was not enough evidence as to whether there was a difference in outcome between any method of biofeedback or exercises. There are suggestions that rectal volume discrimination training improves continence more than sham training.
Norton and Cody concluded that the limited number of identified trials together with methodological weaknesses of many do not allow a definitive assessment of the role of anal sphincter exercises and biofeedback therapy in the management of people with fecal incontinence. Some evidence was found that biofeedback and electrical stimulation may enhance the outcome of treatment compared to electrical stimulation alone or exercises alone. Exercises appear to be less effective than an implanted sacral nerve stimulator. While there is a suggestion that some elements of biofeedback therapy and sphincter exercises may have a therapeutic effect, this is not certain. Larger well-designed trials are needed to enable safe conclusions.
There are eleven (11) clinical trials listed on the www.clinicaltrials.gov site for biofeedback for fecal incontinence or constipation. The status for the studies includes four that have been completed, but no results have been published, two are still recruiting and two that have not yet started recruiting. The others are listed as suspended or unknown.
The completed studies are:
2014 Update
A literature search conducted through September 2014 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
A 2013 systematic review by Vonthein et al identified 13 RCTS on biofeedback, electrical stimulation or their combination for treatment of fecal incontinence (Vonthein, 2013). Ten trials included comparisons of biofeedback and an alternative treatment; some of the biofeedback interventions also involved other components such as sensory training and pelvic floor exercises. A meta-analysis of studies comparing biofeedback to a control intervention significantly favored biofeedback (relative risk, 2.12; 95% CI, 1.42 to 3.16). This study did not attempt to isolate the effect of biofeedback in multicomponent interventions that included pelvic floor exercise or other treatments.
Ongoing Clinical Trials
Comparison of PTNS and Biofeedback for Fecal Incontinence (NCT01882101): This open-label study is randomizing 50 adults with fecal incontinence to treatment with posterior tibial nerve stimulation (PTNS) or EMG biofeedback. The primary outcome is change in weekly episodes of fecal incontinence. The expected date of completion is December 2014.
2015 Update
A literature search conducted through December 2014 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
Several systematic reviews of RCTs have been published. Most recently, in 2014, a Cochrane review identified 17 trials (total of 931 patients) addressing the efficacy of biofeedback for treating adults with idiopathic constipation (Woodward, 2014). Seven trials compared biofeedback with conventional nonsurgical treatment, 6 compared alternative approaches to biofeedback, 2 compared biofeedback with a surgical intervention, 1 compared biofeedback with electrical stimulation, and 1 used a sham control. Sample sizes ranged from 21 to 109, with a mean of 48 patients per trial. Sixteen RCTs were judged to be at high risk of bias related to blinding of patients and outcome assessment, and blinding in the remaining study was unclear. Trials all used different biofeedback protocols, although EMG biofeedback was used in 11 trials. Length of follow-up varied; 4 trials did not follow patients beyond the end of the intervention, and 7 trials had a year of follow-up after the intervention. In most trials, a symptom scoring system was used as an outcome, but scores varied in the symptoms they included. Due to heterogeneity among trials, meta-analyses were not conducted. The authors concluded that there is insufficient evidence to draw conclusions about the efficacy of any particular biofeedback protocol used to treat chronic constipation in adults.
2016 Update
A literature search conducted using the MEDLINE database did not reveal any new information that would prompt a change in the coverage statement. Two new society guidelines were identified and are summarized below.
American Neurogastroenterology and Motility Society et al
In 2015, the American Neurogastroenterology and Motility Society and the European Society of Neurogastroenterology and Mobility jointly published consensus guidelines on biofeedback therapy for anorectal disorders (Rao, 2015). The guideline included the following recommendations:
American Society of Colon and Rectal Surgeons
In 2015, the American Society of Colon and Rectal Surgeons (ASCRS) published an updated guideline
on treatment of fecal incontinence (Paquette, 2015). The guideline recommends that biofeedback should be considered as an initial treatment for patients with fecal incontinence who have some preserved voluntary sphincter contraction ability. A 2007 guideline from ASCRS on evaluation and management of constipation recommended biofeedback therapy for patients with symptomatic pelvic floor dyssynergia (Ternent, 2007).
2017 Update
A literature search conducted through January 2017 did not reveal any new information that would prompt a change in the coverage statement.
2018 Update
Annual policy review completed with a literature search using the MEDLINE database through January 2018. No new literature was identified that would prompt a change in the coverage statement.
2019 Update
A literature search was conducted through December 2018. There was no new information identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
National Institute for Health and Care Excellence
The National Institute for Health and Care Excellence updated its guidance on constipation in children and young people (NIHCE, 2017). The guidance indicated that biofeedback should not be used for ongoing treatment.
2020 Update
A literature search was conducted through December 2019. There was no new information identified that would prompt a change in the coverage statement.
2021 Update
Annual policy review completed with a literature search using the MEDLINE database through December 2020. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
A RCT published subsequent to the systematic reviews randomized 300 women with fecal incontinence to biofeedback or patient education, plus loperamide or placebo (Jelovsek, 2019). The primary outcome of the study was change from baseline in St. Mark's Fecal Incontinence severity scale score. A 5-point change in score was determined a priori as clinically meaningful. After 24 weeks follow-up, there was no statistical or clinical difference in fecal incontinence score between the biofeedback and education groups (mean difference -0.7, 95% confidence interval -2.6 to 1.2; p=0.47) or between the biofeedback plus loperamide versus biofeedback plus placebo groups (mean difference -1.9, 95% confidence interval -4.1 to 0.3; p=0.09). In patient-reported bowel diaries, the combination of biofeedback plus loperamide was associated with less stool leakage (p=0.04) and more continent days per week (p=0.03) relative to biofeedback plus placebo.
A systematic review of 11 RCTs (N=725) compared biofeedback with various interventions for dyssynergic constipation in adults (Moore, 2020). Both the Heyman and Rao trials, discussed below, were included in the review. Biofeedback was compared with a variety of interventions, including oral medications, botox injection and sham biofeedback. Pooled evidence from 6 of the trials (including Heyman and Rao) found a significant benefit of biofeedback versus no biofeedback in global clinical improvement (odds ratio 3.63, 95% confidence interval 1.10 to 11.93) but heterogeneity was high (I2=87%). Resolution of dyssynergia favored biofeedback based on pooled evidence from 4 trials, but the risk estimate was very imprecise (odds ratio 9.43, 95% confidence interval 0.80 to 111.20; I2=93%). Due to variance in reporting, the review did not report pooled estimates for other outcomes.
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through December 2021. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
A systematic review conducted by Wegh et al. assessed the effectiveness of nonpharmacological interventions for functional constipation in children (Wegh, 2021). Studies included in the review were RCTs that enrolled children aged 0 to 18 years with functional constipation as defined by Rome III or IV criteria and reported defecation outcomes and/or QOL outcomes. The review included 3 RCTs comparing biofeedback alone with biofeedback in conjunction with laxative use. The trials were all assessed as having a high risk of bias. Meta-analysis found no difference between groups in study-defined treatment success (risk difference, 0.23; 95% CI, -0.08 to 0.54) and heterogeneity was high (I2=86%). Other clinical outcomes and harms of treatment were not reported.
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through December 2022. No new literature was identified that would prompt a change in the coverage statement.
2024 Update
Annual policy review completed with a literature search using the MEDLINE database through December 2023. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
In 2015, the American Society of Colon and Rectal Surgeons (ASCRS) updated its guideline on the treatment of fecal incontinence (Parquette, 2015). Those guidelines were updated in 2023 (Bordeianou, 2023). Biofeedback is no longer considered first line but may still be considered for patients with fecal incontinence (conditional recommendation, low quality of evidence).
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Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
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