Description:　
Biofeedback is a technique to teach patients self-regulation of physiological processes not generally considered to be under voluntary control; a variety of approaches and devices are available. Among possible indications, biofeedback is proposed as a treatment for fecal incontinence and constipation.

Background 
FECAL INCONTINENCE AND CONSTIPATION 
Adults
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 may affect the quality of life by 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 can bring about the 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 include dietary recommendations (e.g., fiber), bowel and toilet schedules, and medications (e.g., bulking or antidiarrheal agents).

Constipation refers to infrequent bowel movements and difficulty expelling stool during defecation. Primary constipation is categorized into 3 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, the 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 changes (i.e., adequate fiber and fluid intake), use of supplemental bulking substances, exercises, and medications.

Children
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 approximately 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 changes, bowel, and toilet scheduling, softening agents, and education. Behavioral interventions aim to restore 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
Biofeedback, a technique intended to teach patients self-regulation of certain physiologic processes not normally considered to be under voluntary control, is used for various conditions and is proposed as a treatment of fecal incontinence and constipation.

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 the delay in response to a sensation of distension. For constipation, biofeedback aims to teach patients how to tighten and relax their external anal sphincter to pass bowel movements.

Biofeedback attempts to improve rectal sensory perception, strength, coordination, or some combination of these 3 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 electromyography feedback of pelvic floor muscles. 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 peak strength. Coordination training uses pressure feedback of intrarectal balloon distention with a water-perfused catheter or Schuster-type balloon probe and pelvic floor muscle contractions in a simultaneous feedback display. The purpose of coordination training is to synchronize the contraction of the external anal sphincter with the relaxation of the internal anal sphincter.

Biofeedback techniques convert the physiologic measures from an intra-anal electromyography sensor, anal manometric probe (measuring intra-anal pressure), or perianal surface electromyography electrodes to either a visual or audio display for feedback. Ultrasound has also been 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, nonarousing environment.

Regulatory Status
A variety of biofeedback devices have been cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process. These devices are designated by the FDA as class II with special controls and are exempt from premarket notification requirements. The FDA defines a biofeedback device as “an instrument that provides a visual or auditory signal corresponding to the status of 1 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.”³ 

Related Policies
20127 Biofeedback as a Treatment of Urinary Incontinence in Adults
20158 Transanal Radiofrequency Treatment of Fecal Incontinence
70169 Sacral Nerve Neuromodulation/Stimulation

Policy
Biofeedback for constipation in adults may be considered MEDICALLY NECESSARY for patients with dyssynergia-type constipation as demonstrated by meeting all 3 of the following criteria:  

1. Symptoms of functional constipation that meet Rome IV criteria (see Policy Guidelines section).

2. Objective physiologic evidence of pelvic floor dyssynergia (see Policy Guidelines section) demonstrated by inappropriate contraction of the pelvic floor muscles or less than 20% relaxation of basal resting sphincter pressure by manometry, imaging, or electromyography;

3. Failed a 3-month trial of standard treatments for constipation including laxatives, dietary changes, and exercises (as many of the previous as are tolerated).

Biofeedback is considered investigational and/or unproven and therefore NOT MEDICALLY NECESSARY as a treatment of constipation in adults and children in all other situations.

Biofeedback is considered investigational and/or unproven and therefore NOT MEDICALLY NECESSARY as a treatment of fecal incontinence in adults and children.

Policy Guidelines
Rome IV diagnostic criteria for functional constipation include¹ :

Diagnostic Criteria^a for Functional Constipation  

1. Must include 2 or more of the following^b:

   1. Straining during more than one-fourth (25%) of defecations

   2. Lumpy or hard stools (Bristol Stool Form Scale 1 – 2) more than one-fourth (25%) of defecations

   3. Sensation of incomplete evacuation more than one-fourth (25%) of defecations

   4. Sensation of anorectal obstruction/blockage more than one-fourth (25%) of defecations

   5. Manual maneuvers to facilitate more than one-fourth (25%) of defecations (e.g., digital evacuation, support of the pelvic floor)

   6. Fewer than 3 spontaneous bowel movements per week

2. Loose stools are rarely present without the use of laxatives

3. Insufficient criteria for irritable bowel syndrome.

^a Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis.

^b For research studies, patients meeting criteria for OIC should not be given a diagnosis of FC because it is difficult to distinguish between opioid side effects and other causes of constipation. However, clinicians recognize that these 2 conditions might overlap.

Rome IV diagnostic criterion for dyssynergic defecation includes² 

Diagnostic Criteria for Dyssynergic Defecation

"Inappropriate contraction of the pelvic floor as measured with anal surface EMG [electromyography] or manometry with adequate propulsive forces during attempted defecation."

^c These criteria are defined by age- and sex-appropriate normal values for the technique.

Guidance on biofeedback protocol:

The recommended treatment course for patients with constipation who meet criteria is up to 6 biofeedback sessions over 3 months. This is consistent with the protocol used in key randomized trials showing benefit of biofeedback for selected patients.

Coding
Please see the Codes table for details.

Benefit Application
BlueCard/National Account Issues
State or federal mandates (e.g., Federal Employee Program) may dictate that certain U.S. Food and Drug Administration-approved devices, drugs, or biologics may not be considered investigational, and thus these devices may be assessed only by their medical necessity.

Biofeedback and biofeedback devices are specifically excluded under many benefit plans. Also, biofeedback and biofeedback devices are considered behavioral training and education/training in nature, and such services are specifically excluded under many benefit plans.

Rationale
This evidence review was created in December 2003 and has been updated regularly with searches of the PubMed database. The most recent literature update was performed through Sept. 22, 2021.

Evidence reviews assess the clinical evidence to determine whether the use of technology improves the net health outcome. Broadly defined, health outcomes are the length of life, quality of life (QOL), and ability to function-including benefits and harms. Every clinical condition has specific outcomes that are important to patients and managing the course of that condition. Validated outcome measures are necessary to ascertain whether a condition improves or worsens; and whether the magnitude of that change is clinically significant. The net health outcome is a balance of benefits and harms.

To assess whether the evidence is sufficient to draw conclusions about the net health outcome of technology, two domains are examined: the relevance, and quality and credibility. To be relevant, studies must represent one or more intended clinical use of the technology in the intended population and compare an effective and appropriate alternative at a comparable intensity. For some conditions, the alternative will be supportive care or surveillance. The quality and credibility of the evidence depend on study design and conduct, minimizing bias and confounding that can generate incorrect findings. The randomized controlled trial (RCT) is preferred to assess efficacy; however, in some circumstances, nonrandomized studies may be adequate. RCTs are rarely large enough or long enough to capture less common adverse events and long-term effects. Other types of studies can be used for these purposes and to assess generalizability to broader clinical populations and settings of clinical practice.

Several specific methodologic difficulties exist in assessing biofeedback. For example, most interventions that include biofeedback are multimodal and include relaxation and behavioral instruction, which may have effects separate from those that may occur due to biofeedback. While some studies have reported a beneficial effect of multimodality treatment, without appropriate control conditions, it is impossible to isolate the specific contribution of biofeedback to the overall treatment effect. For example, relaxation, attention, or suggestion might account for successful results attributed to biofeedback. These are nonspecific therapeutic factors, some of which can be considered placebo effects. Moreover, it is important that studies demonstrate biofeedback improves disease-related health outcomes, as opposed to potentially affecting only physiologic, intermediate outcomes, and that they address the durability of effects beyond the initial, short-term biofeedback training period.

Fecal Incontinence
Clinical Context and Therapy Purpose
The purpose of biofeedback in patients who have fecal incontinence is to provide a treatment option that is an alternative to or an improvement on existing therapies.

The question addressed in this evidence review is: Does the use of biofeedback improve the net health outcome in patients with fecal incontinence?

The following PICO was used to select literature to inform this review.

Populations
The relevant population of interest are individuals with fecal incontinence.

Interventions
The therapy being considered is biofeedback. Biofeedback teaches patients self-regulation of certain physiologic processes not normally considered to be under voluntary control. Biofeedback attempts to improve rectal sensory perception, strength, coordination, or some combination of these 3 components.

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 the delay in response to a sensation of distension.

Comparators
The comparators of interest are medical management and sphincteroplasty. Medical management consists of bulking agents and anti-diarrheal agents. If anti-diarrheal agents are ineffective, bile acid binders may be recommended. Sphincteroplasty, which is recommended when conservative therapies have failed, involves the surgical reconstruction of a sphincter muscle.

Outcomes
The relevant clinical outcome for biofeedback as a treatment for fecal incontinence should be an overall change in patient symptoms. Reduction in episodes of fecal incontinence and increase in voluntary bowel movements are the primary clinical outcomes, and these are typically reported as the percentage of individuals cured or improved. Achieving normal defecation dynamics (e.g., anal pressure, squeeze pressure, sensory threshold, rectal inhibitory reflex, 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 a diary, questionnaire, or interview (completed by the patient and, in the case of children, parents).

Biofeedback training may take several weeks. Follow-up of patients occurs after training and should continue for several months.

Study Selection Criteria
Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs.
• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.
• To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.
• Studies with duplicative or overlapping populations were excluded.

Review of Evidence
Adults
Systematic Reviews
Several systematic reviews of RCTs on biofeedback treatment for fecal incontinence in adults have been published. A systematic review by Vonthein et al. (2013) identified 13 RCTs on biofeedback, electrical stimulation, or their combination for the treatment of fecal incontinence.² Ten trials compared biofeedback with an alternative treatment; some of the biofeedback interventions involved other components such as sensory training and pelvic floor exercises. A meta-analysis of studies comparing biofeedback with a control intervention significantly favored biofeedback (relative risk, 2.12; 95% confidence interval [CI], 1.42 to 3.16). Reviewers did not isolate the effect of biofeedback in multicomponent interventions that included pelvic floor exercise or other treatments.

A Cochrane review by Norton et al. (2012) identified 21 RCTs evaluating biofeedback and/or sphincter exercises for treating fecal incontinence in adults.³ Most studies used multifaceted interventions (e.g., biofeedback, education, sphincter exercise). Additionally, a wide variety of control interventions were used. Three trials compared biofeedback plus sphincter exercises with sphincter exercises alone, and a single trial compared biofeedback plus 1 type of exercise with biofeedback plus another type of exercise. Reviewers did not pool study findings due to heterogeneity among trials.

Enck et al. (2009) identified 11 RCTs evaluating the efficacy of biofeedback therapy for fecal incontinence in adults.⁴ Two RCTs were excluded, 1 because of the small sample size and the other because it did not include an appropriate control group. The remaining 9 studies comprised 5 comparisons of different biofeedback modalities and 6 comparisons of electromyographic (EMG) biofeedback versus other types of therapy, mainly pelvic floor exercises. (Two studies had multiple treatment groups and were included in both categories.) The total number of patients included in the 9 studies was 540 (sample size ranges, 18 to 171 patients). A meta-analysis of 5 studies did not find a significant difference in the efficacy of different types of biofeedback (odds ratio [OR], 1.23; 95% CI, 0.74 to 2.20; p = .38). Similarly, a meta-analysis of studies comparing biofeedback with other therapies did not find a significant difference in efficacy (OR, 1.19; 95% CI, 0.69 to 2.05). Outcome measures used were not always specified and appeared to vary from study to study.

Randomized Controlled Trials
An RCT published subsequent to the systematic reviews randomized 300 women with fecal incontinence to biofeedback or patient education, plus loperamide or placebo.⁵ 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% CI, -2.6 to 1.2; p = .47) or between the biofeedback plus loperamide versus biofeedback plus placebo groups (mean difference, -1.9; 95% CI, -4.1 to 0.3; p = .09). In patient-reported bowel diaries, the combination of biofeedback plus loperamide was associated with less stool leakage (p = .04) and more continent days per week (p = .03) relative to biofeedback plus placebo.

Heymen et al. (2009), included in the Vonthein systematic review, randomized 168 individuals with fecal incontinence to 3 months of biweekly pelvic floor exercise training alone (n = 85) or exercise training with manometric biofeedback (n = 83).⁶ 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 a decrease in scores on the Fecal Incontinence Severity Instrument, a validated 4-item scale, from the end of the run-in to 3 months. The analysis included all patients who completed at least 1 treatment (15 patients dropped out). The study reported a greater reduction in Fecal Incontinence Severity Instrument scores in the biofeedback group than in the exercise-only group (p = .01; exact scores were not reported). Complete continence (no staining) was reported by 13 (21%) of 63 patients in the exercise-only group and 20 (44%) of 45 in the biofeedback group (p = .008). A trial limitation was that only 108 (64%) of 168 randomized patients received the intervention and, therefore, baseline imbalances in the treatment groups might have affected outcomes. A stronger design would have been to randomize patients after, not before, a run-in period.

Children
Systematic Reviews
An updated Cochrane review by Brazzelli et al. (2011) assessed behavioral and cognitive interventions for children with fecal incontinence.⁷ Of 21 included studies, 9 compared conventional treatment alone (i.e., laxatives, toilet training, dietary advice) with conventional treatment plus biofeedback. Eight trials included children with functional fecal incontinence and the ninth included children with fecal incontinence due to myelomeningocele (n = 12). Four trials included children who had fecal incontinence due to constipation, and 3 others included children who had fecal incontinence due to constipation and pelvic floor dyssynergia. When data from the 9 studies were combined, 133 (51%) of 260 children in the conventional treatment plus biofeedback group were not cured or improved at follow-up compared with 121 (48%) of 250 children in the conventional treatment-only group. In a meta-analysis, this difference was not statistically significant (OR, 1.08; 95% CI, 0.63 to 1.84). The analysis combined 6- and 12-month follow-up data; 12-month data were used when available. Reviewers concluded that findings from RCTs did not support the claim that biofeedback training provides additional benefit to conventional treatment in the management of fecal incontinence associated with constipation. They also stated that, due to a lack of sufficient trials, they could not evaluate the effects of biofeedback in children with organic fecal incontinence.

Section Summary: Fecal Incontinence
The available evidence on biofeedback for fecal incontinence in adults and children includes RCTs and systematic reviews of those RCTs. The pooling results of the studies were limited by the heterogeneity of the interventions, comparators, and follow-up durations used. The studies generally failed to report significant differences between biofeedback and comparison groups in outcome improvements.

Constipation, Other Than Dyssynergic Type Constipation
Clinical Context and Therapy Purpose
The purpose of biofeedback in patients who have constipation other than dyssynergia-type constipation to provide a treatment option that is an alternative to or an improvement on existing therapies.

The question addressed in this evidence review is: Does the use of biofeedback improve the net health outcome in patients with constipation other than dyssynergia-type constipation?

The following PICO was used to select literature to inform this review.

Populations
The relevant population of interest are individuals with constipation other than dyssynergia-type constipation.

Interventions
The therapy being considered is biofeedback. Biofeedback teaches patients self-regulation of certain physiologic processes not normally considered to be under voluntary control. Biofeedback attempts to improve rectal sensory perception, strength, coordination, or some combination of these 3 components.

Biofeedback aims to teach patients how to tighten and relax their external anal sphincter to facilitate bowel movements.

Comparators
The comparator of interest is medical management, which may consist of fiber supplementation, laxatives, or osmotic agents.

Outcomes
The relevant clinical outcome for biofeedback as a treatment for constipation other than dyssynergia-type constipation is an overall change in patient symptoms. The main clinical outcome is an increase in voluntary bowel movements. Achieving normal defecation dynamics (e.g., anal pressure, squeeze pressure, sensory threshold, rectal inhibitory reflex, 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 a diary, questionnaire, or interview (completed by the patient and, in the case of children, parents).

Study Selection Criteria
Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs.
• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.
• To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.
• Studies with duplicative or overlapping populations were excluded.

Review of Evidence
Adults
Systematic Reviews
Several systematic reviews of RCTs have been published on constipation other than dyssynergia-type constipation. A Cochrane review by Woodward et al. (2014) identified 17 trials (N = 931 ) addressing the efficacy of biofeedback for treating adults with idiopathic constipation.⁸ Seven trials compared biofeedback with conventional nonsurgical treatment, 6 compared alternative approaches with biofeedback, 2 compared biofeedback with surgical intervention, 1 compared biofeedback with electrical stimulation, and 1 used a sham control. Sample sizes ranged from 21 to 109 patients (mean, 48 patients per trial). Sixteen RCTs were judged to be at high-risk of bias due to lack of blinding of patients and outcome assessment. Blinding in the remaining study was unclear. Trials all used different biofeedback protocols and 11 used EMG biofeedback. Length of follow-up varied; 4 trials followed patients to the end of the intervention and 7 trials followed patients for 1 year. In most trials, a symptom scoring system was used as an outcome, with scores varying by symptoms included. Due to heterogeneity among trials, meta-analyses were not conducted. Reviewers concluded that there was insufficient evidence to determine the efficacy of any particular biofeedback protocol used to treat chronic constipation in adults.

The Enck et al. (2009) review, discussed in the Fecal Incontinence section, also reviewed the literature on biofeedback for constipation and conducted several meta-analyses.⁴ Eight RCTs conducted in adults were identified. Four compared 2 types of biofeedback; a meta-analysis of these 4 studies did not find a significant benefit for 1 technique over another (OR, 1.44; 95% CI, 0.69 to 3.09; p = .32). The other 4 studies compared biofeedback with another treatment (1 study each): botulinum toxin, laxatives, diazepam, and best supportive care (diet, exercise, 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. Meta-analysis of the 4 studies comparing 1 treatment with another (using the active intervention arm as the comparator in the 3-arm trials) found a significantly greater benefit of biofeedback in improving constipation symptoms (OR, 3.23; 95% CI, 1.88 to 5.58; p < .001). Results of this systematic review were limited by heterogeneity in patient populations, comparator treatments, and outcome measures.

Children
Systematic Reviews
A systematic review conducted by Wegh et al. (2021) assessed the effectiveness of nonpharmacological interventions for functional constipation in children.⁹ 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.

Randomized Controlled Trials
An RCT conducted by Van Ginkel et al. (2001) selected 212 Dutch children who were at least 5 years old and had 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.¹⁰ 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, children were asked to squeeze the sphincter as tightly as possible 5 times. Squeeze pressure data were digitally converted; data could be viewed on a computer by the child and parent. Data were discussed after the sessions, and instructions were given on how to perform defecation exercises at home. Ten (5%) of 212 randomized patients did not receive treatment; the remainder completed the intervention. Treatment success was defined as achieving 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 (4%) of 111 patients in the standard treatment group and 6 (7%) of 91 patients in the biofeedback group were considered to have successful treatment; this difference was not statistically significant. There was also no statistically significant difference between groups at any other follow-up point. At the final follow-up, 36 (43%) of 83 patients in the standard treatment group and 23 (35%) of 65 patients in the biofeedback group were considered treatment successes. Data on 30% of randomized patients were missing at the final follow-up. This trial did not control for nonspecific effects of biofeedback.

Section Summary: Constipation, Other Than Dyssynergic-Type Constipation
For adults with onstipation other than dyssynergic type constipation, the evidence for biofeedback consists of multiple randomized trials, which have been summarized in several systematic reviews. Overall, the evidence is limited by the heterogeneity of patient populations, comparator groups, biofeedback interventions, and outcome measures, and does not show a significant benefit with biofeedback. For children, the evidence includes a systematic review of 3 RCTs and a separate single RCT not included in the systematic review. Neither the review nor the RCT found statistically significant differences for biofeedback regarding most treatment outcomes.

Dyssynergic-Type Constipation
Clinical Context and Therapy Purpose
The purpose of biofeedback in patients who have dyssynergic-type constipation to provide a treatment option that is an alternative to or an improvement on existing therapies.

The question addressed in this evidence review is: Does the use of biofeedback improve the net health outcome in patients with dyssynergic-type constipation?

The following PICO was used to select literature to inform this review.

Populations
The relevant population of interest are individuals with dyssynergia-type constipation.

Interventions
The therapy being considered is biofeedback. Biofeedback teaches patients self-regulation of certain physiologic processes not normally considered to be under voluntary control. Biofeedback attempts to improve rectal sensory perception, strength, coordination, or some combination of these 3 components.

Biofeedback aims to teach patients how to tighten and relax their external anal sphincter to facilitate bowel movements.

Comparators
The comparator of interest is medical management, which may consist of fiber supplementation, laxatives, or osmotic agents.

Outcomes
The relevant clinical outcome for biofeedback as a treatment for dyssynergia-type constipation is an overall change in patient symptoms. Increase in voluntary bowel movements is the primary clinical outcome. Achieving normal defecation dynamics (e.g., anal pressure, squeeze pressure, sensory threshold, rectal inhibitory reflex, 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 a diary, questionnaire, or interview (completed by the patient and, in the case of children, parents).

Study Selection Criteria
Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs.
• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.
• To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.
• Studies with duplicative or overlapping populations were excluded.

Review of Evidence
Systematic Reviews
A systematic review of 11 RCTs (N = 725) compared biofeedback with various interventions for dyssynergic constipation in adults.¹¹ Both the Heyman and Rao trials, discussed below, were included in the review. Biofeedback was compared with a variety of interventions, including oral medications, botulinum toxin 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 (OR, 3.63; 95% CI, 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 ( OR, 9.43; 95% CI, 0.80 to 111.20; I2 = 93%). Due to variance in reporting, the review did not report pooled estimates for other outcomes.

Randomized Controlled Trials
Heymen et al. (2007) assessed adults who met Rome II diagnostic criteria for pelvic floor dyssynergia, had at least 2 symptoms of functional constipation for at least 12 weeks in the past year, and had manometry or EMG findings consistent with chronic constipation (e.g., evidence of inadequate propulsive forces and incomplete evacuation).¹² Patients participated in a 4 week run-in period comprising 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 (84/117 [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 received 6 biweekly visits over 3 months, each lasting approximately 50 minutes. Patients and investigators were blinded to which patients received active versus placebo medication but not to whether 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 with diazepam (p < .001) or placebo (p < .017). A strength of this study design was its attempt to control for nonspecific effects of biofeedback (e.g., increased contact with a health care provider, 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 et al. (2007) included patients who met Rome diagnostic criteria for functional constipation, had dyssynergia-type constipation, and, when expelling a simulated stool, had either prolonged difficulty (at least 1 minute) or prolonged delay (at least 20% marker retention in colonic transfer).¹³ All participants had failed routine management of constipation. Seventy-seven patients were randomized for 3 months to 1 of 3 therapies: education and dietary advice (n = 24), standard therapy and biofeedback therapy (n = 28), or standard therapy and sham feedback (n = 24). Patients receiving active biofeedback received up to 6 biweekly 1 hour sessions. Training was performed using a rectal manometry probe and software for displaying biofeedback data. In the sham treatment group, patients also used a rectal manometry probe but did not receive visual and verbal feedback. Patients were not blinded to the treatment group, but the manometry reader was unaware of treatment assignment. In ITT 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 < .05) and the standard treatment group (p < .062). Additionally, a greater proportion of patients in the biofeedback group reported improved global bowel satisfaction compared with the sham feedback group (p = .04), but the difference from the standard treatment group was not statistically significant. For primary physiologic parameters, ITT analysis found that the dyssynergia 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 with the other groups (p<.001 for both analyses). Moreover, balloon expulsion time during simulated defecation decreased significantly more in the biofeedback group than in the sham (p = .003) or standard treatment (p = .03) groups (exact times not reported for ITT analysis).

In a follow-up publication, Rao et al. (2010) reported on 1-year findings for 13 (62%) of 21 patients in the biofeedback group and 13 (57%) of 23 patients in the standard treatment group.¹⁴ Patients in the sham group were not included in this follow-up. The extension study included visits at 3 month intervals, with additional advice provided as needed. Seven (54%) of the 13 biofeedback patients and all 13 patients in the standard treatment group completed a 1-year follow-up. Mean change in complete spontaneous bowel movements (the primary outcome) favored the biofeedback group (increase, 2.9) compared to the standard treatment group (decrease, 0.2). The small numbers of patients who completed 1 year of follow-up limited conclusions that can be drawn; however, the follow-up study suggested longer-term effectiveness of biofeedback for this patient population.

Section Summary: Dyssynergic-Type Constipation
For patients with dyssynergic constipation treated with biofeedback, several RCTs and a systematic review have reported improvements in constipation symptoms.

Summary of Evidence
For individuals who have fecal incontinence who receive biofeedback, the evidence includes RCTs and systematic reviews. Relevant outcomes are symptoms, functional outcomes, and QOL. One RCT reported a significantly greater decrease in fecal incontinence symptoms with biofeedback plus exercise training compared with exercise training alone; however, most trials have not shown a significant benefit. Systematic reviews have not found that biofeedback plus conventional therapy provides an additional benefit compared with conventional therapy alone. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have constipation other than dyssynergia-type constipation who receive biofeedback, the evidence includes RCTs and systematic reviews. Relevant outcomes are symptoms, functional outcomes, and QOL. A systematic review of RCTs found a benefit of biofeedback as a treatment for constipation in adults. Conclusions of the systematic review were limited by variability in patient populations (which combined both dyssynergia-type and non-dyssynergia-type), comparator groups, and outcome measures, and biofeedback was not clearly beneficial for nondyssynergia types of constipation. A systematic review conducted in children also found no clear benefit of biofeedback when added to medical management. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have dyssynergia-type constipation who receive biofeedback, the evidence includes RCTs and a systematic review. Relevant outcomes are symptoms, functional outcomes, and QOL. Several well-conducted RCTs focusing on patients with dyssynergia-type constipation have reported benefits in a subgroup of patients meeting well-defined criteria. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

The purpose of the following information is to provide reference material. Inclusion does not imply endorsement or alignment with the evidence review conclusions.

Practice Guidelines and Position Statements
Guidelines or position statements will be considered for inclusion in Supplemental Information if they were issued by, or jointly by, a U.S. professional society, an international society with U.S. representation, or National Institute for Health and Care Excellence (NICE). Priority will be given to guidelines that are informed by a systematic review, include strength of evidence ratings, and include a description of management of conflict of interest.

American Neurogastroenterology and Motility Society and European Society of Neurogastroenterology and Mobility
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.¹⁵ The guidelines included the following recommendations:

• "Biofeedback is recommended for the short-term and long-term treatment of constipation with dyssynergic defecation."
• "Biofeedback therapy is recommended for the short-term and long-term treatment of fecal incontinence."
• "Biofeedback therapy is not recommended for the routine treatment of children with functional constipation, with or without overflow fecal incontinence."

American Society of Colon and Rectal Surgeons
In 2015, the American Society of Colon and Rectal Surgeons (ASCRS) updated its guidelines on the treatment of fecal incontinence.¹⁶ The guidelines recommended that biofeedback be considered as an initial treatment for patients with fecal incontinence who have some preserved voluntary sphincter contraction ability.

In 2016, the ASCRS published guidelines on the evaluation and management of constipation.¹⁷ The guidelines stated that biofeedback therapy is a first-line treatment for symptomatic pelvic floor dyssynergia (strong recommendation, moderate quality of evidence).

American Gastroenterological Association
In 2013, the American Gastroenterological Association (AGA) updated its position statement on constipation. The statement included the following on biofeedback: “Pelvic floor retraining by biofeedback therapy rather than laxatives is recommended for defecatory disorders (Strong Recommendation, High-Quality Evidence).”¹⁸

In 2017, the AGA published an expert review on surgical interventions and device-aided therapy for the treatment of fecal incontinence and defecation disorders.¹⁹ 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.

National Institute for Health and Care Excellence
In 2017, NICE updated its guidance on constipation in children and young people.²⁰ The guidance indicated that biofeedback should not be used for ongoing treatment.

In 2007, the NICE issued guidance on fecal incontinence in adults which was reaffirmed in 2018. The guidance stated the following on 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.”²¹

American College of Gastroenterology
In 2014, the American College of Gastroenterology published guidelines on the management of fecal incontinence.²² The guidelines indicated that pelvic floor rehabilitation techniques (e.g., biofeedback, therapeutic exercises) are effective in patients with fecal incontinence who have not responded to conservative measures (strong recommendation, moderate quality of evidence).

U.S. Preventive Services Task Force Recommendations
The U.S. Preventive Services Task Force has not addressed biofeedback for fecal incontinence or constipation.

Ongoing and Unpublished Clinical Trials
Some currently unpublished trials that might influence this review are listed in Table 1.

Table 1. Summary of Key Trials

NCT No.	Trial Name	Planned Enrollment	Completion Date
Ongoing
NCT03811821	Comparative Effectiveness of Biofeedback, Sacral Nerve Stimulation, and Injectable Bulking Agents for Treatment of Fecal Incontinence: The Fecal Incontinence Treatment (FIT) Study	569	Dec 2023
Unpublished
NCT02888899	Percutaneous Tibial Nerve Stimulation in Combination with Biofeedback in Patients with Fecal Incontinence: a Randomized Controlled Trial	NR	Mar 2019

NCT: national clinical trial; NR: not reported 

References: 

1. Food and Drug Administration. Biofeedback device. 21 CFR - 882.5050 (1998).
2. Vonthein R, Heimerl T, Schwandner T, et al. Electrical stimulation and biofeedback for the treatment of fecal incontinence: a systematic review. Int J Colorectal Dis. Nov 2013; 28(11): 1567-77. PMID 23900652
3. Norton C, Cody JD. Biofeedback and/or sphincter exercises for the treatment of faecal incontinence in adults. Cochrane Database Syst Rev. Jul 11 2012; (7): CD002111. PMID 22786479
4. Enck P, Van der Voort IR, Klosterhalfen S. Biofeedback therapy in fecal incontinence and constipation. Neurogastroenterol Motil. Nov 2009; 21(11): 1133-41. PMID 19566591
5. Jelovsek JE, Markland AD, Whitehead WE, et al. Controlling faecal incontinence in women by performing anal exercises with biofeedback or loperamide: a randomised clinical trial. Lancet Gastroenterol Hepatol. Sep 2019; 4(9): 698-710. PMID 31320277
6. Heymen S, Scarlett Y, Jones K, et al. Randomized controlled trial shows biofeedback to be superior to pelvic floor exercises for fecal incontinence. Dis Colon Rectum. Oct 2009; 52(10): 1730-7. PMID 19966605
7. Brazzelli M, Griffiths PV, Cody JD, et al. Behavioural and cognitive interventions with or without other treatments for the management of faecal incontinence in children. Cochrane Database Syst Rev. Dec 07 2011; (12): CD002240. PMID 22161370
8. Woodward S, Norton C, Chiarelli P. Biofeedback for treatment of chronic idiopathic constipation in adults. Cochrane Database Syst Rev. Mar 26 2014; (3): CD008486. PMID 24668156
9. Wegh CAM, Baaleman DF, Tabbers MM, et al. Nonpharmacologic Treatment for Children with Functional Constipation: A Systematic Review and Meta-analysis. J Pediatr. Sep 16 2021. PMID 34536492
10. van Ginkel R, Buller HA, Boeckxstaens GE, et al. The effect of anorectal manometry on the outcome of treatment in severe childhood constipation: a randomized, controlled trial. Pediatrics. Jul 2001; 108(1): E9. PMID 11433088
11. Moore D, Young CJ. A systematic review and meta-analysis of biofeedback therapy for dyssynergic defaecation in adults. Tech Coloproctol. Sep 2020; 24(9): 909-918. PMID 32372153
12. Heymen S, Scarlett Y, Jones K, et al. Randomized, controlled trial shows biofeedback to be superior to alternative treatments for patients with pelvic floor dyssynergia-type constipation. Dis Colon Rectum. Apr 2007; 50(4): 428-41. PMID 17294322
13. Rao SS, Seaton K, Miller M, et al. Randomized controlled trial of biofeedback, sham feedback, and standard therapy for dyssynergic defecation. Clin Gastroenterol Hepatol. Mar 2007; 5(3): 331-8. PMID 17368232
14. Rao SS, Valestin J, Brown CK, et al. Long-term efficacy of biofeedback therapy for dyssynergic defecation: randomized controlled trial. Am J Gastroenterol. Apr 2010; 105(4): 890-6. PMID 20179692
15. Rao SS, Benninga MA, Bharucha AE, et al. ANMS-ESNM position paper and consensus guidelines on biofeedback therapy for anorectal disorders. Neurogastroenterol Motil. May 2015; 27(5): 594-609. PMID 25828100
16. 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. Jul 2015; 58(7): 623-36. PMID 26200676
17. Paquette IM, Varma M, Ternent C, et al. The American Society of Colon and Rectal Surgeons' Clinical Practice Guideline for the Evaluation and Management of Constipation. Dis Colon Rectum. Jun 2016; 59(6): 479-92. PMID 27145304
18. Bharucha AE, Dorn SD, Lembo A, et al. American Gastroenterological Association medical position statement on constipation. Gastroenterology. Jan 2013; 144(1): 211-7. PMID 23261064
19. 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. Dec 2017; 15(12): 1844-1854. PMID 28838787
20. National Institute for Health and Care Excellence (NICE). Constipation in children and young people: diagnosis and management [CG99]. 2017; http://www.nice.org.uk/guidance/CG99. Accessed September 23, 2021.
21. National Institute for Health and Care Excellence (NICE). Faecal incontinence in adults: management [CG49]. 2007; https://www.nice.org.uk/guidance/cg49. Accessed September 24, 2021.
22. Wald A, Bharucha AE, Cosman BC, et al. ACG clinical guideline: management of benign anorectal disorders. Am J Gastroenterol. Aug 2014; 109(8): 1141-57; (Quiz) 1058. PMID 25022811
23. Centers for Medicare & Medicaid Services. National Coverage Determination (NCD) for Biofeedback Therapy (30.1). n.d.; https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId = 41&ncdver = 1&bc = AAAAQAAAAAAA&. Accessed September 23, 2021.

Coding Section  

Codes	Number	Description
CPT	90875-90876	Individual psychophysiological therapy incorporating biofeedback training by any modality (face-to-face with the patient), with psychotherapy (e.g., insight oriented, behavior modifying, or supportive psychotherapy); code range
	90901	Biofeedback training by any modality
	90912	Biofeedback training, perineal muscles, anorectal or urethral sphincter, including EMG and/or manometry, when performed; initial 15 minutes of one-on-one physician or other qualified health care professional contact with the patient
	90913	Biofeedback training, perineal muscles, anorectal or urethral sphincter, including EMG and/or manometry, when performed; each additional 15 minutes of one-on-one physician or other qualified health care professional contact with the patient (List separately in addition to code for primary procedure)
HCPCS	E0746	Electromyography (EMG), biofeedback device
ICD-10-CM	K59.00-K59.09	Constipation code range (there is no specific code for dyssynergia-type constipation)
ICD-10-PCS		ICD-10-PCS codes are only used for inpatient services.
	GZC9ZZZ	Biofeedback
Type of service	Medicine
Place of service	Outpatient

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, Blue Cross Blue Shield Association technology assessment program (TEC) and other nonaffiliated technology evaluation centers, reference to federal regulations, other plan medical policies, and accredited national guidelines.

"Current Procedural Terminology © American Medical Association. All Rights Reserved" 

History From 2014 Forward     

10/06/2022	Annual review, no change to policy intent. Updating rationale and references.
10/08/2021	Annual review, no change to policy intent.
04/01/2021	Interim review to add coverage criteria for dyssynergia-type constipation. Updating Description, background, guidelines, regulatory status, rationale and references.
10/01/2020	Annual review, no change to policy intent. Updating references.
10/01/2019	Annual review, no change to policy intent. Updating description, rationale and references.
10/11/2018	Annual review, no change to policy intent. Updating background, description, rationale and references.
10/03/2017	Annual review, no change to policy intent. Updating background, description, rationale and references.
10/04/2016	Annual review, no change to policy intent. Updating background, description, rationale and references.
10/13/2015	Annual review,no change to policy intent.Updated background, description, rationale, references and coding.
10/06/2014	Annual review. No change in policy intent. Updating rationale and references. Added coding section.