Allied Health - Biofeedback as a Treatment of Fecal Incontinence

IMPORTANT REMINDER

This Medical Policy has been developed through consideration of medical necessity, generally accepted standards of medical practice, and review of medical literature and government approval status.

Benefit determinations should be based in all cases on the applicable contract language. To the extent there are any conflicts between these guidelines and the contract language, the contract language will control.

The purpose of medical policy is to provide a guide to coverage. Medical Policy is not intended to dictate to providers how to practice medicine. Providers are expected to exercise their medical judgment in providing the most appropriate care.

Description

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 affects quality of life through restricting work, recreation, and ability to leave home, impairing social role function, diminishing sexual activity, and increasing 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 incidence of fecal incontinence is about 7–9.5% in adults over age 65, and the majority of patients (approximately 75%) are female. The most common causes of fecal incontinence 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 include dietary recommendations (e.g., increasing fiber), bowel and toilet scheduling, and 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. No study has reported any adverse events associated with biofeedback. Because of this, pelvic floor exercise and biofeedback are often recommended as front-line treatments. Should either procedure fail, further treatments are not precluded.

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, poor self-esteem, and emotional, social and behavioral difficulties. The physical effects include abdominal pain and poor appetite. In addition, 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, hypercalcemia, 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 4 years of age. A contributing factor to functional encopresis and constipation is fear and/or pain associated with large, hard stools that 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).

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 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.

Biofeedback

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. The technique requires good clinician rapport, skill in biofeedback techniques, and knowledge of rectal and pelvic floor anatomy and physiology. 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. Nonspecific components of biofeedback treatment include education, attention, and use of medication.

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. Specifically, 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. The balloon is filled with air to produce a sensation of rectal filling. The patient is trained to perceive the stimulation of rectal distention and to respond without delay with an immediate and forceful external anal sphincter contraction to counteract reflex inhibition (relaxation) of the internal anal sphincter. The purpose of sensory training is to increase an awareness of the presence of fecal material in the rectum and to decrease delay in response to sensation of distention. By retraining the sensory threshold, the patient becomes able to discriminate and respond to smaller rectal volumes, thus lowering the threshold for sensing rectal distention.

Strength training uses either anal canal pressure (manometric) or intra-anal electromyographic (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.

Note: Biofeedback as a treatment of urinary incontinence, headache, chronic pain, or miscellaneous applications is considered separately in Allied Health Policy Nos. 26, 27, 28, and 29, respectively.

Policy/Criteria

Biofeedback is considered investigational as a treatment of fecal incontinence in adults and children.

Scientific Background

Adults

The relevant clinical outcome for biofeedback as a treatment of fecal 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); therefore, 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 of biofeedback in the treatment of fecal incontinence report improvement rates of 50% to 92%.  Five systematic reviews of biofeedback treatment for fecal incontinence in adults have been published, including two Cochrane Reviews. (2-5,28) Heymen and colleagues searched for studies published between 1970 and 1999. (2) They identified 35 articles, of which, 26 studied adults. Twenty-two of these articles were uncontrolled studies, leaving only four studies with concurrent comparisons. (6-9) The initial Norton and Kamm systematic review search was from 1966 to 2000 (3); they found 34 studies, but only 8 eight studies included control groups. Two of these eight studies involved patients with ileo-anal pouch with covering ileostomy, one did not involve biofeedback, and one compared augmented biofeedback with sensory biofeedback, leaving only 4 four relevant articles (7-10). In a subsequent Cochrane review, Norton and colleagues conducted a systematic review search through February 2006 and found eleven eligible studies with a total of 564 participants. (28) The methodological design was poor or uncertain in all but three and no evidence was found that biofeedback or exercises enhanced the outcome of treatment compared with other conservative management methods. The authors noted the need for larger well-designed trials.

The review by Coulter and colleagues (4) searched from 1974 to 1999 and identified 7 randomized controlled trials; 3 of these trials studied fecal incontinence in adults. (6, 8, 9) Norton and colleagues (5) searched the literature through January 2003 for their Cochrane review of biofeedback for fecal incontinence in adults. Only 5 randomized controlled trials were identified as eligible. One of these 5 studies compared modalities of biofeedback, leaving 4 relevant studies (7-10). An updated search of the MEDLINE database through April 4, 2007 identified two additional comparative randomized, controlled trials, one that involved only groups with different components of biofeedback and no control group. (11) The second trial randomized patients to four treatment groups. (12)

In the study by Guillemot and colleagues, patients chose whether to participate in four weekly sessions of manometric pressure biofeedback or medical treatment consisting of an antidiarrheal or enema. (6) Eight patients chose medical treatment; after 30 months, none showed improvement or were cured. 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 was selection bias produced by patient selection of their treatment option. Latimer and colleagues provided single case experiments for 8 patients that involved multiple crossover. (7) This study suffered from small sample size and order effects. Miner and colleagues randomized 13 patients to three 20-minute sessions of sensory biofeedback and 12 patients to a sham procedure or no feedback. (8) 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 and colleagues reported results for a randomized controlled trial involving 18 patients. (9) 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 study by Whitehead and colleagues reported on 13 patients who underwent biofeedback after failure of a sphincter exercise program; however, this study had no comparison group. (10) Norton and colleagues reported results from a study in which 171 patients were randomized to four treatment groups: 1) standard care consisting of advice; 2) advice plus instruction on sphincter exercises; 3) hospital-based computer-assisted sphincter pressure biofeedback; and 4) hospital biofeedback plus the use of a home electromyelogram biofeedback device. (12) In this study, biofeedback yielded no greater benefit than standard care with advice. Solomon and colleagues reported results from a study in which 120 patients were randomized to three treatment groups: 1) biofeedback with anal manometry; 2) biofeedback with transanal ultrasound; and 3) pelvic floor exercises with feedback from digital examination alone. (25) There were no significant differences in outcomes among the treatment groups; all reported modest improvements. Mahony and colleagues conducted a randomized trial in patients with postpartum fecal incontinence, comparing the effects of intra-anal EMG biofeedback with or without additional treatment with intra-anal electric stimulation. (26) Scientific conclusions cannot be reached from this trial because there was no placebo-controlled group. Ilnyckyj and colleagues reported results from a randomized study of 23 women, comparing education and exercise instruction vs. education and biofeedback exercise instruction. (27) The authors conclude that the specific effect of biofeedback cannot be determined in this study as there was no difference in treatment success between the two treatments arms.

The conclusions from the five systematic reviews (2-5,28) of these studies (6-10) are similar, as follows:

• There is insufficient evidence from controlled trials to evaluate whether biofeedback treatments are helpful
• There is insufficient evidence to determine 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

In summary, because of 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: 1) have replicable standardized interventions; 2) control for confounding factors and bias; and 3) provide valid short and long-term outcome measures and adequate power.

Children

As in adults, the outcome criterion in children should be an overall improvement 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); therefore, 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.

Four systematic reviews of biofeedback treatment for fecal incontinence in children have been recently published, including two Cochrane reviews. (2,13,14,29) Heymen and colleagues searched for studies published between 1970 and 1999. (2) They identified 35 articles, of which 9 involved children. All 9 of these articles were uncontrolled studies. The systematic review by Coulter and colleagues (13) searched from 1974 to 1999 and found 7 randomized controlled trials; 5 of these trials investigated fecal incontinence in children. (15–19) None of these trials demonstrated statistically significant improvements with biofeedback, 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 (14) searched the literature through March 2001 for their Cochrane review of defecation disorders in children. This review identified 14 randomized trials. Ten of these trials contained biofeedback as an intervention arm. One of these trials compared biofeedback versus biofeedback with oral laxatives; one compared exercise training versus sensory discrimination training versus biofeedback.  Only 8 trials (15, 17–23) compared 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. (21) 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. (16) A 2006 update in which Brazelli and Griffiths conducted a Cochrane review through February 1, 2006 confirmed those results. (29) Eighteen randomized trials with a total of 1168 children met the inclusion criteria. Sample sizes were generally small. Interventions varied amongst trials and few outcomes were shared by trials addressing the same comparisons. Combined results of nine trials showed higher rather than lower rates of persisting symptoms of fecal incontinence up to 12 months when biofeedback was added to conventional treatment. The authors concluded that there is no evidence that biofeedback training adds any benefit to conventional treatment in the management of functional fecal incontinence in children. There was not enough evidence on which to assess the effects of biofeedback for the management of organic fecal incontinence.

An updated search of the literature identified one additional comparative randomized controlled trial. This study (24) reported 6-month follow-up results of a previous publication (13) by the same investigators, demonstrating again that biofeedback did not differ from customary care.

The conclusion from the above four systematic reviews of the randomized, comparative studies is similar to that reached for adults:

• There is insufficient evidence from controlled trials to evaluate whether biofeedback treatments are helpful
• The evidence for biofeedback based on observational studies and methodologically weak controlled trials can be viewed only as tentative

Summary

The reviews of biofeedback for the treatment of fecal incontinence in adults and children point out a number of methodological problems with the published literature:

1. Lack of uniform criteria for patient inclusion. Some studies include only chronic constipation patients, some only encopresis, and some constipation with encopresis. Studies will often fail to specify the characteristics of the population and the subgroups with different symptoms and diseases. Additionally, patients with weak pelvic floor muscles and normal rectal sensation may only need strength training, and patients with normal pelvic floor muscle strength and poor rectal sensation may only need sensory or coordination training. Most studies do not identify and report the cause of incontinence and do not conduct analysis on patient subgroups.
2. Lack of standardized criteria for assessing outcome. Studies report cure rates and improvement rates, but the outcomes and methods underlying their measurement varies across studies. The criterion for success has ranged arbitrarily from 25% to 90% reduction in episodes across studies.
3. Diversity among treatment protocols. In their review of 34 studies, Norton and Kamm noted that many different treatment modalities have been described by the term 'biofeedback.' They state, "No two studies have described exactly the same treatment as 'biofeedback'.' (3)
4. Lack of randomized controlled trials. Most studies are uncontrolled observational studies of patients who underwent biofeedback treatment. Non-randomized controlled trials are subject to selection bias when patients or investigators chose which intervention group they will join.
5. Small sample size and lack of statistical power. Small samples limit detection of small-to-moderate effects and eliminate the opportunity for separate subgroup analysis.
6. Short follow-up period. Outcomes for most studies were evaluated at end of treatment or six months; studies rarely conducted follow-up analysis at two or more years.
7. Lack of validated outcome measures. Diary, questionnaire, and interview methods were used to assess patient symptoms; researchers have not conducted reliability and validity psychometric studies to standardize operational definitions and methodological procedures.
8. Nonspecific treatment effects. Biofeedback treatment is often performed concurrent with adjunctive therapy, including use of medication, diet modification, home instruction, and a home exercise program. Critical factors to success may include the following: therapist attention, psychological support, social and psychological counseling for anxiety and confidence, patient education, dietary assessment and advice, medication and lifestyle changes, instruction in pelvic floor muscle or sphincter exercises, and patient motivation. It is not clear from the evidence that biofeedback plays a more significant role in achieving successful outcomes than these other interventions.

References

1. BlueCross BlueShield Association Medical Policy Reference Manual, Policy No. 2.01.64
2. Heymen S, Jones KR, Ringel Y et al. Biofeedback treatment of fecal incontinence: a critical review. Dis Colon Rectum 2001;44(5):728-36
3. 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):1147-54
4. 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
5. Norton C, Hosker G, Brazzelli M. Biofeedback and/or sphincter exercises for the treatment of faecal incontinence in adults (Cochrane Review). In: The Cochrane Library, Issue 2, 2003. Oxford: Update Software
6. Guillemot F, Bouche B, Gower-Rousseau C et al. Biofeedback for the treatment of fecal incontinence. Long-term clinical results. Dis Colon Rectum 1995;38(4):393-7
7. Latimer PR, Campbell D, Kasperski J. A components analysis of biofeedback in the treatment of fecal incontinence. Biofeedback Self Regul 1984;9(3):311-24
8. Miner PB, Donnelly TC, Read NW. Investigation of mode of action of biofeedback in treatment of fecal incontinence. Dig Dis Sci 1990;35(10):1291-8
9. McHugh S, Walma K, Diamant NE. Faecal incontinence: a controlled trial of biofeedback. [Abstract] Gastroenterology 1986;90(N5):1545
10. Whitehead WE, Burgio KL, Engel BT. Biofeedback treatment of fecal incontinence in geriatric patients. J Am Geriatr Soc 1985;33(5):320-4
11. Heymen S, Pikarsky AJ, Wexner SD et al. A prospective randomized trial comparing four biofeedback techniques for patients with faecal incontinence. Colorectal Disease 2000;2(2):88-92
12. Norton C, Chelvanayagam S, Wilson-Barnett J et al. Randomized controlled trial of biofeedback for fecal incontinence. Gastroenterology 2003;125(5):1320-9
13. 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
14. Brazzelli M, Griffiths P. Behavioral and cognitive interventions with or without other treatments for defaecation disorders in children (Cochrane Review). In: The Cochrane Library, Issue 2, 2003. Oxford: Update Software
15. Wald A, Chandra R, Gabel S et al. Evaluation of biofeedback in childhood encopresis. J Pediatr Gastroenterol Nutr 1987;6(4):554-8
16. Loening-Baucke V. Biofeedback treatment for chronic constipation and encopresis in childhood: long-term outcome. Pediatrics 1995;96(1):105-10
17. van der Plas RN, Benninga MA, Redekop WK et al. Randomized trial of biofeedback training for encopresis. Arch Dis Child 1996;75(5):367-74
18. van der Plas RN, Benninga MA, Buller HA et al. Biofeedback training in treatment of childhood constipation: a randomised controlled study. Lancet 1996;348(9030):776-80
19. Nolan T, Catto-Smith T, Coffey C et al. Randomised controlled trial of biofeedback training in persistent encopresis with anismus. Arch Dis Child 1998;79(2):131-5
20. Loening-Baucke V, Desch L, Wolraich M. Biofeedback training for patients with myelomeningocele and fecal incontinence. Dev Med Child Neurol 1988;30(6):781-90
21. Loening-Baucke V. Modulation of abnormal defecation dynamics by biofeedback treatment in chronically constipated children with encopresis. J Pediatr 1990;116(2):214-22
22. Davila E, de Rodriguez GG, Adrianza A et al. [The usefulness of biofeedback in children with encopresis. A preliminary report.] GEN [Revista de la Sociedad Venezolana de Gastroenterologia] 1992; 46(4):297-301. Spanish
23. Cox DJ, Sutphen J, Borowitz S et al. Contribution of behavior therapy and biofeedback to laxative therapy in the treatment of pediatric encopresis. Ann Behav Med 1998;20(2):70-6
24. 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):378-84
25. Solomon MJ, Pager CK, Rex J, et.al. Randomized controlled trial of biofeedback with anal manometry, transanal ultrasound, or pelvic floor retraining with digital guidance alone in the treatment of mild to moderate fecal incontinence. Dis Colon Rectum 2003;46:703-10
26. Mahoney RT, Malone PA, Nalty J, et.al. Randomized clinical trial of intra-anal electromyographic biofeedback physiotherapy with intra-anal electromyographic biofeedback augmented with electrical stimulation of the anal sphincter in the early treatment of postpartum fecal incontinence. Am J Obstet Gynecol 2004;191:885-90
27. 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
28. Norton C, Cody JD, Hosker G. Biofeedback and/or sphincter exercises for the treatment of faecal incontinence in adults (Cochrane Review). In: Cochrane Database of Systematic Reviews 2006, Issue 3. Art No.; CD002111
29. Brazelli M, Griffiths P. Behavioural and cognitive interventions with or without other treatments for the management of faecal incontinence in children. Cochrane Database of Systematic Reviews 2006, 19(2): Art No.; CD002240

Cross References

Biofeedback as a Treatment of Urinary Incontinence in Adults, Regence Medical Policy Manual, Allied Health, Policy No. 26

Biofeedback as a Treatment of Headache, Regence Medical Policy Manual, Allied Health, Policy No. 27

Biofeedback as a Treatment of Chronic Pain, Regence Medical Policy Manual, Allied Health, Policy No. 28

Biofeedback for Miscellaneous Indications, Regence Medical Policy Manual, Allied Health, Policy No. 29

Allied Health Table of Contents