Biofeedback is a technique intended to teach patients self-regulation of certain physiologic processes not normally considered to be under voluntary control.  The technique involves the feedback of a variety of types of information not normally available to the patient, followed by a concerted effort on the part of the patient to use this feedback to help alter the physiological process in some specific way.

In treating fecal incontinence, 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.  Recently, investigators have also used ultrasound to show patients contraction of the anal sphincter on a screen.  In children, the aim of biofeedback has been to teach them how to tighten and relax their external anal sphincter in order to pass bowel movements.

Biofeedback therapy for constipation may involve several phases.  In the initial phase, the patient is taught to relax pelvic floor muscles with the help of pressure or EMG recordings.  During the second phase, defecation is simulated by pulling a lubricated water-filled balloon from the rectum in order to teach the patient to recognize the sensations associated with defecation and to help the patient practice defecation.  During the third phase, the patient is taught how to strain more effectively by contracting the abdominal wall muscles while keeping the pelvic floor muscles relaxed.

Nonspecific components of biofeedback treatment include education, attention, and use of medication.  The technique requires good patient-physician rapport, skill in biofeedback techniques, and knowledge of rectal and pelvic floor anatomy and physiology.  Because biofeedback therapy involves visual, auditory or verbal feedback techniques, it is important that the patient is able to understand and comply with instructions.

This document addresses biofeedback for constipation and fecal incontinence.  For additional information regarding biofeedback, please refer to:

• MED.00062 Biofeedback for Muscle Re-Education and Chronic Pain; and
• MED.00023 Biofeedback Therapy and Neurofeedback.

Medically Necessary:

Biofeedback is considered medically necessary as a treatment of the following:

• Adults with severe constipation due to pelvic floor dysfunction which has not responded to more conservative treatment measures.
• Adults and children with clinically significant fecal incontinence due to pelvic floor dysfunction or neurogenic fecal incontinence which has not responded to more conservative treatment measures. 

Investigational and Not Medically Necessary: 

Biofeedback as a treatment of constipation or fecal incontinence is considered investigational and not medically necessary when the above criteria are not met.

Constipation

According to The American Gastroenterological Association (AGA) guidelines on the management of constipation, individuals seeking medical care frequently report symptoms of constipation.  Symptoms of constipation include but are not limited to straining, stools that are very hard, unproductive urges to defecate and infrequent defecation.  Although constipation can be associated with a more serious condition, it is frequently the result of a colorectal motility disorder such as pelvic floor dysfunction (also known as anismus, pelvic floor dyssynergia, or outlet obstruction) which consists of normal or slightly slower colonic transit time and a prolonged storage of stool in the rectum. (Locke, 2000a)

Adults
At least two professional medical societies support the use of biofeedback as a treatment of constipation in adults. The AGA guidelines on the management of constipation state that biofeedback can be used in combination with pelvic floor retraining in order to "train patients to relax their pelvic floor muscles during straining and to facilitate relaxation and pushing to achieve defecation."  However, the guidelines also state that while "formal evaluations of biofeedback training in constipation are sparse" and often lack important practical details of individual programs, the results from intensive programs for adults have resulted in a success rate of more than 75%. (Locke, 2000a) The AGA recommends that "patients with proven pelvic floor dysfunction, if the symptoms are severe enough, should be considered for biofeedback." (Locke, 2000b) 

The practice parameters published by the American Society of Colon and Rectal Surgeons assigned a level II-B rating for biofeedback therapy for the treatment of symptomatic pelvic floor dyssynergia indicating that there was at least one well-designed experimental study; randomized trials with high false-positive or high false-negative errors or both (low power) with generally consistent findings. (Ternent, 2007)

Children
Recommendations from professional medical organizations regarding the use of biofeedback for constipation in children are inconsistent.  The American Gastroenterological Association (AGA) guideline on constipation states that the results of biofeedback as a treatment for constipation in children "have been disappointing." (Locke, 2000a)  In contrast, the recommendations of the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHN) on the evaluation and treatment of constipation in infants and children indicate that biofeedback therapy is not a long-term solution, but can be an effective short-term treatment of intractable constipation in a select group of patients. (Constipation Guideline Committee of the NASPGHN, 2006)

Fecal Incontinence

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
Several professional medical organizations have endorsed the use of biofeedback for fecal incontinence;

• The American College of Gastroenterology states biofeedback is an appropriate therapy for the treatment of fecal incontinence in patients of all ages. (Rao, 2004) 
• In its state of the science statement, the National Institutes of Health (NIH) indicates that biofeedback is effective in preventing and reversing fecal incontinence in women for the first year after giving birth. (Landefeld, 2008)
• The guideline on fecal incontinence published by the National Institute for Health and Clinical Excellence (NICE) indicates that referral to a specialist for biofeedback therapy may be appropriate for individuals who continue to have episodes of fecal incontinence after initial medical management has failed. (NICE, 2007)
• The American Society of Colon and Rectal Surgeons states biofeedback may be an appropriate option for individuals suffering with fecal incontinence who have not responded to dietary modification or medication. (Tjandra, 2007).

The American Gastroenterological Association (AGA) Technical Review on Constipation highlights the relationship between constipation and fecal incontinence.  Descending perineum syndrome is a condition in which the pelvic floor descends to a greater than normal extent when the individual strains during defecation. This results in weakened pelvic floor muscles and difficulty expulsing stool from the rectum. Individuals may strain endlessly at stool but the rectum fails to evacuate completely.  'Incomplete evacuation leads to more straining, more traction on the nerves, and progressive denervation of the external anal sphincter and puborectalis.  In time, this scenario leads to fecal incontinence and thereby compounds the patient's misery".  According to the AGA, biofeedback .is the best treatment option for this condition although the expected success rate is approximately 50%.   (Locke, 2000b)

In its medical position statement on anorectal testing techniques, the AGA states that "neurogenic fecal incontinence associated with weakness of the external anal sphincter and/or decreased ability to perceive rectal distention because of nerve injury can be treated with biofeedback training." (Barnett, 1999)

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, and rectal inhibitory reflex) 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.

There is some support for the use of biofeedback for the treatment of fecal incontinence in children. Of the professional medical organizations/societies listed above, only the recommendations of the American College of Gastroenterology are broad enough to include children as candidates for biofeedback therapy as a treatment of fecal incontinence. (Rao, 2004)

Constipation

As mentioned above, symptoms of constipation include but are not limited to straining, stools that are very hard, unproductive urges to defecate and infrequent defecation.  Although constipation can be associated with a more serious condition, it is frequently the result of a colorectal motility disorder such as pelvic floor dysfunction (also known as anismus, pelvic floor dyssynergia, or outlet obstruction) which consists of normal or slightly slower colonic transit time and a prolonged storage of stool in the rectum.

It has been estimated that approximately 4 1/2 million people in the United States report being constipated most or all of the time.  Women, children, and adults age 65 and over are those most frequently reported to experience constipation.  Constipation is also a common complaint in pregnant women and following childbirth.  Conventional treatment for constipation includes a gradual increase in fiber intake as well as drinking enough water and other liquids.  If more treatment is needed, the health care practitioner may consider the use of medications, therapy or surgery for extreme cases. (NDDIC, 2007)

Fecal Incontinence

Fecal incontinence in adults describes 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. Fecal incontinence affects quality of life through restricting work, recreation, and activities related to "getting out of the house," and is the second most common reason for elderly institutionalization. The incidence of fecal incontinence is about 7–9.5% in adults over age 65. The majority of patients (about 75%) are female; the most common causes 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.

Supportive measures used in the management of individuals with fecal incontinence include ritualizing bowel habit, improving skin hygiene, and dietary recommendations (e.g., fiber and the avoidance of offending foods).  Pharmacologic therapy may include various medications (e.g., bulking or antidiarrheal agents). Surgical interventions for correctable abnormalities have shown good to excellent results in 70–90% of patients. Uncontrolled trials have suggested that biofeedback is associated with outcomes that equal medical management or surgery and no study has reported any adverse event with biofeedback. Because biofeedback has no significant adverse effects, pelvic floor exercise and biofeedback are often recommended as front-line treatments since neither procedure precludes further treatment should it fail.

According to the American College of Gastroenterology, the goals of biofeedback therapy in patients with "fecal incontinence are to:  " (1) improve the strength of the anal sphincter muscles; (2)  improve the coordination between the abdominal, gluteal and anal sphincter muscles during voluntary squeeze and following rectal perception; and (3) enhance the anorectal sensory perception.  Because each goal may require a specific method of training, the treatment protocol is generally customized for each patient based upon the underlying pathophysiolgic mechanisms." (Rao, 2004)  Candidates for biofeedback therapy as a treatment for fecal incontinence should be cooperative, motivated, have some ability to sense rectal distention and have the ability to voluntarily contract the external anal sphincter. (Feldman, 2006)

Children
Encopresis, generally defined as incontinence of feces not due to an organic defect or illness, affects about 1.5% of children ages 4 to 12; boys are affected 4 to 5 times more than girls. More than 80% of children with encopresis have chronic constipation or fecal retention. Hence, medical therapy generally focuses on evacuating the colon followed by laxative use to assure that stools are soft, frequent, and painless. However, childhood encopresis and constipation are conditions that are difficult to treat; the cure rate is approximately 50% at 1-year follow-up. The condition of chronic constipation and encopresis is associated with psychological distress for the child and family, child's self-esteem, and emotional, social and behavioral difficulties. The physical effects include abdominal pain, poor appetite, and physical discomfort, and chronic constipation can lead to megacolon, rectal bleeding, rectal fissures or prolapse.

Most cases of encopresis develop as a result of constipation or fecal retention. Organic causes of fecal incontinence or constipation include Hirschsprung's disease, malabsorption syndromes, hypothyroidism, hypercalcaemia, diabetes insipidus, or neurological conditions. Children whose fecal incontinence is due to physical abnormalities require surgery; residual incontinence is then treated by medical and behavioral interventions. Most encopresis and constipation are functional, in which structural, endocrine or metabolic diseases have been ruled out in children at least four years of age. Biofeedback training in children has been directed at training the relaxation of the external anal sphincter to reverse the abnormal defecation dynamics of paradoxical contraction. Similar to adults, some children with fecal incontinence have decreased sensation of rectal fullness and weak external anal sphincter function that indicate sensory and strength-training biofeedback.

Customary or conventional medical intervention for children is similar to that for adults and typically includes dietary recommendations (e.g., fiber and fluid intake), bowel and toilet scheduling, education about underlying constipation, and softening agents (e.g., emollients or enemas and laxatives). 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.

Constipation: a condition in which bowel movements occur less often than usual or consist of excessively hard stools which are which are difficult to pass

Descending perineum syndrome: a condition in which the pelvic floor descends to a greater than normal extent when the individual strains during defecation. This results in weakened pelvic floor muscles and difficulty expulsing stool from the rectum. Individuals may strain endlessly at stool but the rectum fails to evacuate completely 

Fecal Incontinence: the involuntary passage for stool thru the anus

Neurogenic fecal incontinence: involuntary passage of stool due to weakness of the external anal sphincter and/or a decreased ability to perceive distension of the rectum due to nerve injury

Pelvic floor dyssynergia:  a condition in which the pelvic floor muscles fail to relax with defecation

The following codes for treatments and procedures applicable to this document are included below for informational purposes.  Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy.  Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member. 

When services may be Medically Necessary when criteria are met:

When services are Investigational and Not Medically Necessary:
For the procedure and diagnosis codes listed above when criteria are not met, or when the code describes a procedure indicated in the Position Statement as investigational and not medically necessary.

Peer Reviewed Publications:

1. Borowitz SM, Cox DJ, Sutphen JL, et al. Treatment of childhood encopresis: a randomized trial comparing three treatment protocols. J Pediatr Gastroenterol Nutr. 2002; 34(4):378-384.
2. Brazzelli M, Griffiths P. Behavioral and cognitive interventions with or without other treatments for defaecation disorders in children. Cochrane Database Syst Rev. 2003:CD002240. Oxford: Update Software.
3. Brazzelli M, Griffiths PV. Behavioural and cognitive interventions with or without other treatments for the management of faecal incontinence in children. Cochrane Database of Systematic Reviews 2006, Issue 1. Art. No.: CD002240. DOI: 10.1002/14651858.CD002240.pub3.
4. Byrne CM, Solomon MJ, Young JM, et al. Biofeedback for fecal incontinence: short-term outcomes of 513 consecutive patients and predictors of successful treatment. Dis Colon Rectum. 2007; 50(4):417-427.
5. Chiarioni G, Whitehead W. The role of biofeedback in the treatment of gastrointestinal disorders. Nat Clin Pract Gastroenterol Hepatol. 2008; 5(7):371-382.
6. Chiarioni G, Whitehead WE, Pezza V, et al. Biofeedback is superior to laxatives for normal transit constipation due to pelvic floor dyssynergia. Gastroenterology. 2006; 130(3):657-664.
7. Coulter ID, Favreau JT, Hardy ML, et al. Biofeedback interventions for gastrointestinal conditions: a systematic review. Altern Ther Health Med. 2002; 8(3):76-83.
8. Croffie JM, Ammar MS, Pfefferkorn MD, et al. Assessment of the effectiveness of biofeedback in children with dyssynergic defecation and recalcitrant constipation/encopresis: does home biofeedback improve long-term outcomes. Clin Pediatr (Phila). 2005; 44(1):63-71.
9. 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. 2007; 50(4):428-441.
10. Ilnyckyj A, Fachnie E, Tougas G. A randomized-controlled trial comparing an educational intervention alone vs. education and biofeedback in the management of faecal incontinence in women. Neurogastroenterol Motil 2005; 17:58-63.
11. Naimy N, Lindam AT, Bakka A, et al. Biofeedback vs. electrostimulation in the treatment of postdelivery anal incontinence: a randomized, clinical trial. Dis Colon Rectum. 2007; 50(12):2040-2046.
12. Norton CC, Cody JD, Hosker G. Biofeedback and/or sphincter exercises for the treatment of faecal incontinence in adults. Cochrane Database of Systematic Reviews 2006, Issue 2. Art. No.: CD002111. DOI: 10.1002/14651858.CD002111.pub2. 
13. Norton C, Hosker G, Brazzelli M. Biofeedback and/or sphincter exercises for the treatment of faecal incontinence in adults. Cochrane Database Syst Rev. 2003:CD002111.
14. Norton C, Kamm MA. Anal sphincter biofeedback and pelvic floor exercises for faecal incontinence in adults – a systematic review. Aliment Pharmacol Ther. 2001; 15(8):1147-1154.
15. Ozturk R, Niazi S, Stessman M, Rao SS. Long-term outcome and objective changes of anorectal function after biofeedback therapy for faecal incontinence. Aliment Pharmacol Ther. 2004 Sep 15;20(6):667-674.  Available at:  http://www3.interscience.wiley.com/cgi-bin/fulltext/118774409/PDFSTART  Accessed on July 19, 2009.
16. Rao SS, Seaton K, Miller M, et al. Randomized controlled trial of biofeedback, sham feedback, and standard therapy for dyssynergic defecation. Clin Gastroenterol Hepatol. 2007; 5(3):331-338.

Government Agency, Medical Society, and Other Authoritative Publications: 

1. Barnett JL, Hasler WL, Camilleri M. American Gastroenterological Association medical position statement on anorectal testing techniques. American Gastroenterological Association. Gastroenterology. 1999;116(3):732-760.
2. Constipation Guideline Committee of the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition. Evaluation and treatment of constipation in infants and children: recommendations of the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition. J Pediatr Gastroenterol Nutr. 2006;43(3):e1-13.  Available at:  http://www.guideline.gov/summary/pdf.aspx?doc_id=9792&stat=1&string=   Accessed on July 19, 2009.
3. Feldman: Sleisenger & Fordtran's Gastrointestinal and Liver Disease, 8th ed. Philadelphia. Saunders Elsevier. 2006. Chapter 11 – Fecal Incontinence.
4. Landefeld CS, Bowers BJ, Feld AD, et al. National Institute of Health (NIH) state-of-the-science conference statement on prevention of fecal and urinary incontinence in adults. Ann Intern Med. 2008;148(6):449-458.  Available at:  http://www.annals.org/cgi/reprint/148/6/449.pdf  Accessed on July 19, 2009.
5. Locke GR, Pemberton JH, Phillips SF. American Gastroenterological Association medical position statement: Guidelines on constipation. Gastroenterology. 2000a;119(6):1761-1766.  Available at:  http://www.gastrojournal.org/article/S0016-5085(00)70023-0/fulltext  Accessed on July 19, 2009.
6. Locke GR 3rd, Pemberton JH, Phillips SF. AGA technical review on constipation. American Gastroenterological Association. Gastroenterology. 2000b;119(6):1766-1778.  Available at: http://www.gastro.org/user-assets/Documents/02_Clinical_Practice/medical_position_statments/constipation_tr.pdf  Accessed on July 19, 2009.
7. National Institute for Health and Clinical Excellence (NICE). Clinical guideline 49. Faecal incontinence. Jun 2007. Available at: http://www.nice.org.uk/nicemedia/pdf/CG49NICEGuidance.pdf.  Accessed on July 19, 2009.
8. Rao SS; American College of Gastroenterology Practice Parameters Committee. Diagnosis and management of fecal incontinence. American College of Gastroenterology Practice Parameters Committee. Am J Gastroenterol. 2004;99(8):1585-1604. 
9. Shamliyan T, Wyman J, Bliss DZ, et al. Prevention of urinary and fecal incontinence in adults. Evid Rep Technol Assess (Full Rep). 2007 Dec;(161):1-379. Available at:  http://www.ahrq.gov/downloads/pub/evidence/pdf/fuiad/fuiad.pdf  Accessed on July 19, 2009.
10. Ternent CA, Bastawrous AL, Morin NA et al. Practice parameters for the evaluation and management of constipation. Dis Colon Rectum. 2007;50(12):2013-2022.  Available at: http://www.guideline.gov/summary/pdf.aspx?doc_id=12544&stat=1&string=  Accessed on July 19, 2009.
11. Tjandra JJ, Dykes SL, Kumar RR, et al. Standards Practice Task Force of the American Society of Colon and Rectal Surgeons. Practice parameters for the treatment of fecal incontinence. Dis Colon Rectum 2007;50(10):1497-1507.  Available at: http://www.guideline.gov/summary/pdf.aspx?doc_id=12542&stat=1&string=  Accessed on July 19, 2009.

1. National Digestive Diseases Information Clearinghouse (NDDIC). Constipation (2007).  Available at: http://digestive.niddk.nih.gov/ddiseases/pubs/constipation/  Accessed on July 19, 2009.

Biofeedback for Constipation
Biofeedback for Fecal Incontinence
Encopresis, Biofeedback for