Biofeedback is superior to laxatives for normal transit constipation due to pelvic floor dyssynergia

BACKGROUND & AIMS: Uncontrolled trials suggest biofeedback is an effective treatment for pelvic floor dyssynergia (PFD), a type of constipation defined by paradoxical contraction, or inability to relax, pelvic floor muscles during defecation. The aim was to compare biofeedback to laxatives plus education. METHODS: Patients with chronic, severe PFD were first treated with 20 g/day fiber plus enemas or suppositories up to twice weekly. Nonresponders were randomized to either 5 weekly biofeedback sessions (n = 54) or polyethylene glycol 14.6-29.2 g/day plus 5 weekly counseling sessions in preventing constipation (n = 55). Satisfaction with treatment, symptoms of constipation, and pelvic floor physiology were assessed 6 and 12 months later. The biofeedback group was also assessed at 24 months. Laxative-treated patients were instructed to increase the dose of polyethylene glycol from 14.6 to 29.2 g/day after 6 months. RESULTS: At 6 months, major improvement was reported by 43 of 54 (80%) biofeedback patients vs 12 of 55 (22%) laxative-treated patients (P < .001). Biofeedback's benefits were sustained at 12 and 24 months. Biofeedback also produced greater reductions in straining, sensations of incomplete evacuation and anorectal blockage, use of enemas and suppositories, and abdominal pain (all P < .01). Stool frequency increased in both groups. All biofeedback-treated patients reporting major improvement were able to relax the pelvic floor and defecate a 50-mL balloon at 6 and 12 months. CONCLUSIONS: Five biofeedback sessions are more effective than continuous polyethylene glycol for treating PFD, and benefits last at least 2 years. Biofeedback should become the treatment of choice for this common and easily diagnosed type of constipation.     

The role of biofeedback in the treatment of gastrointestinal disorders

Biofeedback is a form of treatment that has no adverse effects and can be provided by physician extenders. The therapy relies on patients' ability to learn how to influence their bodily functions through dedicated machinery and teaching. This Review provides a comprehensive overview of all potential therapeutic applications of biofeedback for functional constipation, fecal incontinence, functional anorectal pain, IBS, functional dyspepsia, and aerophagia. Practical clinical applications of biofeedback therapy supported by randomized, controlled trials (RCTs) are limited to fecal incontinence and dyssynergic defecation. For fecal incontinence, RCTs suggest that biofeedback combining strength training and sensory discrimination training is effective in approximately 75% of patients and is more effective than placebo. However, verbal feedback provided by a therapist during extended digital examination may be equally effective, and children whose fecal incontinence is associated with constipation plus fecal impaction do no better with biofeedback than medical management. For dyssynergic defecation, RCTs show that biofeedback combining pelvic floor muscle relaxation training, practice in defecating a water-filled balloon, and instruction in effective straining is effective in approximately 70% of patients who have failed to respond to laxative treatment. For both incontinence and dyssynergic defecation, the benefits of biofeedback last at least 12 months.     

Controlled randomised trial of visual biofeedback versus muscle training without a visual display for intractable constipation.

Training to contract the abdominal muscles effectively and to relax the pelvic floor during defecation straining helps some patients with severe constipation. Hitherto all such training has used a visible or audible signal of sphincter muscle activity as a biofeedback method to assist in relaxation. A randomised controlled trial comparing the outcome of muscular training without any biofeedback device with the same training supplemented by an electromyographic (EMG) record visible to the patient is reported. Significant symptomatic improvement was noted and electromyographic measurements confirmed a decrease in pelvic floor muscle activity during defecation straining after treatment in both groups. The outcome was similar in the two treatment groups. Muscular coordination training using personal instruction and encouragement without a visual display is thus a potentially successful treatment suitable for outpatient use by paramedical personnel.     

Persistence of chronic constipation in children after biofeedback treatment

We investigated the efficacy of biofeedback treatment and evaluated anorectal factors that might be responsible for persistence of chronic constipation with or without encopresis in a group of 38 children with abnormal contraction of the pelvic floor during straining and persistence of chronic constipation with encopresis after conventional treatment. Nine children were unsuccessful in learning to relax the pelvic floor during straining with biofeedback treatment, and one patient had contraction of the pelvic floor on follow-up despite successful biofeedback treatment; none recovered. Twenty-eight children were able to relax the pelvic floor on follow-up; 14 recovered and 14 did not recover from chronic constipation. Nonrecovered patients who learned to relax the pelvic floor had significantly decreased rectal and anal responsiveness to rectal distension as compared to recovered patients during the initial and follow-up anorectal manometric study. Psychological factors such as social competence and behavior problems did not appear to be responsible for recovery or nonrecovery from chronic constipation and encopresis.This work was supported by grant M01-RR-00069 from the General Clinical Research Center Program, Division of Research Resources, National Institutes of Health.Results of this study were published in part as an abstract inJournal of Gastrointestinal Motility 1:69, 1989; and presented at the 12th International Symposium on Gastrointestinal Motility, Gmunden, Austria, September 13, 1989.     

Solitary rectal ulcer syndrome in children

SRUS is a rare condition in children, which usually presents with a symptom complex of rectal bleeding, passage of mucus and straining on defecation, tenesmus, perineal and abdominal pain, sensation of incomplete defecation, constipation and rectal prolapse. The underlying etiology of SRUS is not fully understood but it is likely to be secondary to ischemic changes in the rectum associated with paradoxical contraction of pelvic floor and external anal sphincter muscles and rectal prolapse. Conservative measures like high intake of fluids and fibers, laxatives, biofeedback and behavior modification therapy may be beneficial for treatment of constipation. Excision of rectal ulcer and surgery of overt rectal prolapse, however, may be required in refractory cases not responding to conservative treatments. A therapeutic role for botulinum toxin injection into the external anal sphincter for treatment of SRUS associated with constipation and paradoxical contraction of pelvic floor and external anal sphincter muscles in children, may exist.     

Biofeedback benefits only patients with outlet dysfunction, not patients with isolated slow transit constipation

BACKGROUND & AIMS: Biofeedback is reported to be as effective for slow transit constipation as for pelvic floor dyssynergia and no more effective than education. We aimed to test the hypothesis that biofeedback benefits only patients with pelvic floor dyssynergia, describe the physiologic mechanism of treatment, and identify predictors of success. METHODS: Fifty-two patients (49 women; average age, 35 years), all with delayed whole gut transit, included 34 with pelvic floor dyssynergia, 12 with slow transit only, and 6 who met only 1 of 2 criteria for pelvic floor dyssynergia. All received 5 weekly biofeedback sessions directed at increasing rectal pressure and relaxing pelvic floor muscles during straining plus practice defecating a balloon. Patients were retested by questionnaire; symptom diary; balloon defecation; transit study at 1, 6, 12, and 24 months; and anorectal manometry at 1 and 6 months. RESULTS: At 6 months, greater improvements were seen in pelvic floor dyssynergia compared with slow transit only; 71% versus 8% reported satisfaction ( P = .001), and 76% versus 8% reported >/=3 bowel movements per week ( P < .001). Improvements were maintained at 24 months of follow-up. Biofeedback eliminated dyssynergia in 91% and enabled 85% to defecate the balloon. Satisfaction was correlated with improved ability to defecate the balloon (rho = .73; P < .001), reductions in dyssynergia (rho = .69; P < .001), and increased rectal pressure during straining (rho = .36; P < .01). Success was predicted by pelvic floor dyssynergia, milder constipation, and less frequent abdominal pain at baseline. CONCLUSIONS: Biofeedback is an effective treatment for pelvic floor dyssynergia but not slow transit constipation.     

Randomized,Controlled Trial Shows Biofeedback to be Superior to Alternative Treatments for Patients with Pelvic Floor Dyssynergia-Type Constipation

Purpose This study was designed to determine whether biofeedback is more effective than diazepam or placebo in a randomized, controlled trial for patients with pelvic floor dyssynergia-type constipation, and whether instrumented biofeedback is necessary for successful training. Methods A total of 117 patients participated in a four-week run-in (education and medical management). The 84 who remained constipated were randomized to biofeedback (n=30), diazepam (n=30), or placebo (n=24). All patients were trained to do pelvic floor muscle exercises to correct pelvic floor dyssynergia during six biweekly one-hour sessions, but only biofeedback patients received electromyography feedback. All other patients received pills one to two hours before attempting defecation. Diary data on cathartic use, straining, incomplete bowel movements, Bristol stool scores, and compliance with homework were reviewed biweekly. Results Before treatment, the groups did not differ on demographic (average age, 50 years; 85 percent females), physiologic or psychologic characteristics, severity of constipation, or expectation of benefit. Biofeedback was superior to diazepam by intention-to-treat analysis (70 vs. 23 percent reported adequate relief of constipation 3 months after treatment, chi-squared=13.1, P<0.001), and also superior to placebo (38 percent successful, chi-squared=5.7, P=0.017). Biofeedback patients had significantly more unassisted bowel movements at follow-up compared with placebo (P=0.005), with a trend favoring biofeedback over diazepam (P=0.067). Biofeedback patients reduced pelvic floor electromyography during straining significantly more than diazepam patients (P<0.001). Conclusions This investigation provides definitive support for the efficacy of biofeedback for pelvic floor dyssynergia and shows that instrumented biofeedback is essential to successful treatment. Support by NIDDK - Grant #R01DK57048, General Clinical Research Center, UNC at Chapel Hill, grant #RR00046, Sandhill? Scientific, Incorporated, Jansen Pharmaceuticals, Milan Pharmaceuticals. Presented at meeting of The American College of Gastroenterology, Honolulu, Hawaii, October 30 to November 2, 2005.     

Outpatient protocol for biofeedback therapy of pelvic floor outlet obstruction

Pelvic floor outlet obstruction is a rare cause of severe constipation. Anal myectomy, subtotal colectomy, and medical therapy have limited success. The purpose of this study was to develop a short outpatient treatment using biofeedback techniques. Nine patients with severe constipation and straining resulting from pelvic floor outlet obstruction underwent complete investigation of the pelvic floor musculature and anal sphincter mechanism. Patients were unable to expel a 60-cc rectal balloon and had nonrelaxing puborectalis on defecography. The treatment protocol utilized anal surface electromyography to document improper straining and retrain pelvic floor muscles to relax during defecation. Sensory retraining with a rectal balloon, behavioral relaxation techniques, and defecation of simulated stool using a 120-cc Metamucil^® (Procter & Gamble, Cincinnati, OH) slurry in the rectum allowed re-establishment of normal defecation in all nine patients. Repeat training was required in three patients during follow-up. Treatment of pelvic floor outlet obstruction with outpatient retraining techniques is possible.Read at the meeting of The American College of Gastroenterology, San Francisco, California, October 1990.     

When fiber is not enough: current thinking on constipation management

Constipation is a common disorder and many patients fail to respond to the simple constipation remedies of increased fiber and fluid intake. When secondary to other conditions, medications, or disease processes, the focus of constipation management is correction of causative factors. However, primary constipation - ie, constipation with no identifiable causative factor - is very common. Patients generally present with one of three patterns: constipation-predominant irritable bowel syndrome, slow transit constipation, or pelvic floor dysfunction resulting in dyssynergic defecation. Baseline evaluation for patients with chronic constipation includes a careful history, focused physical examination, and limited laboratory studies. Patients with dyssynergic defecation usually respond best to biofeedback therapy and pelvic muscle re-education. Constipation-predominant irritable bowel syndrome is best managed with dietary monitoring and modifications, fiber therapy, and education regarding self-monitoring and self-care. Patients with slow transit constipation may benefit from fiber therapy and increased activity, but most also will require laxative therapy. Current guidelines for prescribing laxatives suggest bulk agents as first line and osmotic agents as second line therapy. Stimulant laxatives should generally be reserved for PRN use. Current understanding about the etiology, pathology, and classification of different types of constipation are summarized and a stepwise approach to evaluation and management is presented.     

Effectiveness of Biofeedback Therapy on Quality of Life in Patients with Dyssynergic Defecation Disorder

Background: The first option to be considered in the treatment of functional defecation disorder is to correct the dyssynergia. However, limited studies exist to show the effectiveness of biofeedback.Objective: We evaluated the effect of biofeedback on the severity of constipation, quality of life, and anorectal manometry in patients with dyssynergic defecation in which the biofeedback method was applied.Methods: Effectiveness of biofeedback method on the quality of life of 24 dyssynergic defecation patients according to Rome III criteria after clinical and balloon expulsion tests (BETs) and colonic transit time was measured. Data were collected with patient identification form, Bristol Stool Chart, Constipation Quality of Life Scale forms, Visual Analogue Scale, diaphragmatic breathing exercises form, constipation diary, and constipation biofeedback monitoring form. Dyssnergic defecation cases received 6-week biofeedback training. For the same timeframe, the control group had a catheter into the rectum without any intervention.Results: Constipation severity was reduced in both groups before biofeedback to post-biofeedback (P < .05). Anal canal pressure, BET, colonic transit time, and quality of life significantly improved in biofeedback patients compared with controls.Conclusions: Biofeedback has a favorable effect on therapy and quality of life in dyssynergic defecation cases.     

Comparing the efficacy of biofeedback and balloon-assisted training in the treatment of dyssynergic defecation

BACKGROUND:

Dyssynergic defecation does not respond appropriately to routine treatments for constipation. Recently, research has shown that biofeedback therapy is useful in anorectal dyssynergia.

OBJECTIVE:

To compare two treatment modalities for patients experiencing dyssynergic defecation.

METHODS:

Sixty-five subjects with dyssynergic defecation were recruited and randomly allocated to one of two treatment groups: balloon defecation training and biofeedback therapy. In the first group, a balloon was inserted into the rectum and inflated by water injection so that the patient experienced the sensation of a full rectum and, thus, the need to defecate. The patient was subsequently asked to reject the balloon. In the biofeedback group, the pen electrode of an electromyographic biofeedback device was inserted into the rectum, with the patient subsequently being asked to increase abdominal pressure and relax the rectal muscles accordingly.

RESULTS:

The findings showed a reduction in constipation in both groups. The ability to reject the balloon (volume and time) was significantly better in postintervention measurements; however, better results were found in the biofeedback arm of the study. Patient satisfaction after treatment reached 52% with balloon training and 79% in the biofeedback group. Reports of incomplete evacuation and the need for digit use during defecation remained constant after treatment in balloon-trained patients.

CONCLUSION:

Biofeedback training appeared to be superior to balloon defecation training and resulted in measurable changes in subjective and objective variables of dyssynergia.     

Constipation: evaluation and treatment

Constipation is a common clinical problem that comprises a constellation of symptoms that include excessive straining, hard stools, feeling of incomplete evacuation, use of digital maneuvers, or infrequent defecation. Although many conditions, such as metabolic problems, fiber deficiency, anorectal problems, and drugs, can cause constipation, when excluded functional constipation consists of two subtypes: slow-transit constipation and dyssynergic defecation. Some patients with irritable bowel syndrome may exhibit features of both types of constipation. The Rome criteria for functional constipation together with modifications proposed here for dyssynergic defecation may serve as useful guidelines for making a diagnosis. Recent advances in technology, together with a better understanding of the underlying mechanisms, have led to real progress in the diagnosis of this condition. Management options are limited, however, and evidence to support these treatments is only modest. The treatment is primarily medical; surgical options should be reserved for refractory disease and after careful diagnostic work-up. Although laxatives remain the mainstay of therapy, prokinetics that are colon-selective are optimal for treating patients with slow-transit constipation, but they are not yet available for clinical use. Recent controlled trials, however, are promising. Biofeedback therapy is the preferred treatment for patients with dyssynergia, but is not widely available. In the near future, user-friendly biofeedback programs including home therapy may facilitate wider use of these methods for patients with dyssynergic defecation.     

Constipation of anorectal outlet obstruction: pathophysiology, evaluation and management

Constipation is a subjective symptom of various pathological conditions. Incidence of constipation fluctuates from 2 to 30% in the general population. Approximately 50% of constipated patients referred to tertiary care centers have obstructed defecation constipation. Constipation of obstructed defecation may be due to mechanical causes or functional disorders of the anorectal region. Mechanical causes are related to morphological abnormalities of the anorectum (megarectum, rectal prolapse, rectocele, enterocele, neoplasms, stenosis). Functional disorders are associated with neurological disorders and dysfunction of the pelvic floor muscles or anorectal muscles (anismus, descending perineum syndrome, Hirschsprung's disease). However, this type of constipation should be differentiated by colonic slow transit constipation which, if coexists, should be managed to a second time. Assessment of patients with severe constipation includes a good history, physical examination and specialized investigations (colonic transit time, anorectal manometry, rectal balloon expulsion test, defecography, electromyography), which contribute to the diagnosis and the differential diagnosis of the cause of the obstructed defecation. Thereby, constipated patients can be given appropriate treatment for their problem, which may be conservative (bulk agents, high-fiber diet or laxatives), biofeedback training or surgery.     

Functional disorders of defecation: Evaluation and treatment

Opinion statement Functional disorders of defecation are common and often overlap with slow-transit constipation. They are comprised of functional obstructive conditions such as dyssynergic defecation, as well as structural obstructive conditions such as rectal prolapse, excessive perineal descent, and rectocele. Evaluation includes detailed history and rectal and pelvic exam together with physiologic tests such as anorectal manometry, balloon expulsion test, defecography, and MRI. Treatment involves several medical, behavioral, and surgical approaches. Recently, randomized controlled trials have shown that biofeedback therapy is an effective treatment for dyssynergic defecation. Stapled transanal rectal resection appears to be a promising technique for treating defecation disorders associated with rectocele, excessive perineal descent, and mucosal intussusception, but controlled trials are lacking.     

Treating pelvic floor disorders of defecation: Management or cure?

Pelvic floor disorders that affect defecation consist of structural disorders (eg, rectocele) and functional disorders (eg, dyssynergic defecation). Evaluation includes a thorough history and physical examination, a careful digital rectal examination, and physiologic tests such as anorectal manometry, colonic transit study, and balloon expulsion test. Defecography and dynamic MRI may facilitate detection of structural defects. Management consists of education and counseling regarding bowel function, diet, laxatives, and behavioral therapies. Recently, several randomized, clinical trials have shown that biofeedback therapy is effective in dyssynergic defecation. Dyssynergia may also coexist in structural disorders such as solitary rectal ulcer syndrome or rectocele. Hence, before proceeding with surgery, neuromuscular training or biofeedback should be considered. Several surgical approaches, including stapled transanal rectal resection, have been advocated, but well-controlled randomized studies are lacking and their efficacy is unproven.     

Studies of Manometric Abnormalities of the Rectoanal Region during Defecation in Constipated and Soiling Children: Modification through Biofeedback Therapy

Anorectal manometry was performed on 12 normal children and 18 patients suffering from constipation and soiling. In both groups, the results of the rectoanal inhibitory reflex and the squeezing anal pressure were similar. The pressure recording in all the normal children showed that the anal canal relaxed during defecation. Fourteen (78%) constipated children closed the anal canal while straining by contracting the anal sphincter. This paradoxical contraction appears to be the cause of chronic constipation. Twelve children with paradoxical anal closure were treated by biofeedback therapy. The results show that all these children were successfully conditioned to relax their anal sphincter during defecation. This therapy improved their bowel habits and relieved them from constipation and soiling. It is proposed that the paradoxical anal closure itself is the result of a self-conditioning process. In this process, the patient learns to paradoxically contract the external anal sphincter in response to the urge and the act of defecation. Biofeedback therapy seems to be the appropriate treatment in such cases.     

Outlet obstruction constipation (anismus) managed by biofeedback.

Fifteen subjects presenting with intractable constipation due to obstructive defecation, mean (SEM) duration 8.8 (1.8) years, had the inappropriate contraction and electromyographic changes in the pelvic floor muscles and external and sphincter typical of this condition. An electromyographically derived index was used to grade its severity. A self applied biofeedback device was used to allow electromyographic recording of the abnormal external anal sphincter. The subjects were encouraged to reduce the abnormal electromyographic activity on straining after instruction and training. The procedure was intended as a relearning process in which the non-relaxing activity of the pelvic floor was gradually suppressed. Biofeedback training was maintained on a domiciliary basis for a mean time of 3.1 weeks and resulted in a significant reduction in the anismus index (mean (SEM) 69.9 (7.8)% before biofeedback, mean 14 (3.9)% after biofeedback, p less than 0.01). There was an associated reduction in the time spent straining at stool and in the difficulty of defecation and an increased frequency of defecation. Defecatory video proctograms in six subjects showed improvements in the anorectal angle during straining and evacuation. The clinical benefit to the patients persisted after a mean follow up of 6.2 months.     

Defecation disorders: An important subgroup of functional constipation, its pathophysiology, evaluation and treatment with biofeedback.

Functional defecation disorders are common and affect approximately 50% of patients with chronic constipation. The etiology of functional defecation disorders is not well known, but several pathophysiologic mechanisms have been described, including failure of rectoanal coordination, paradoxical anal contraction or insufficient relaxation of anal sphincter during defecation and impairment of rectal sensation as well as secondary slowing of colonic transit. Symptoms alone are inadequate to distinguish patients with defecation disorders from those with other types of constipation. Detailed clinical evaluation and anorectal physiologic tests are required for definitive diagnosis. There is also a pathophysiological association between functional defecation disorders and other anorectal conditions such as solitary rectal ulcer syndrome. Among the various treatment modalities, biofeedback therapy has emerged as an effective and specific treatment method for functional defecation disorders. The main goals of biofeedback therapy are to relax the pelvic floor and anal sphincter muscles during defecation and to improve rectoanal coordination and sensory perception. Today, it is possible to diagnose most functional disorders of defecation and either effectively treat or ameliorate symptoms in a majority of these patients.     

Long-Term Study on the Effects of Visual Biofeedback and Muscle Training as a Therapeutic Modality in Pelvic Floor Dyssynergia and Slow-Transit Constipation

PURPOSE: Biofeedback training has been shown as an effective therapeutic measure in patients with pelvic floor dyssynergia, at least in the short term. Long-term effects have received less attention. Moreover, its effects in patients with slow-transit constipation have been scarcely investigated. This study was designed to assess in an objective way the medium- and long-term effects of biofeedback and muscle training in patients with pelvic floor dyssynergia and slow-transit constipation. METHODS: Twenty-four patients (14 with pelvic floor dyssynergia and 10 with slow transit) meeting the Rome II criteria for constipation, and unresponsive to conventional treatments, entered the study. Clinical evaluation and anorectal manometry were performed basally and three months after a cycle of electromyographic biofeedback and muscle training; moreover, a clinical interview was obtained one year after biofeedback. Patients with slow-transit constipation also had colonic transit time reassessed at one year. RESULTS: Clinical variables (abdominal pain, straining, number of evacuations/week, use of laxatives) all significantly improved in both groups at three-month assessment; anorectal manometric variables remained unchanged, apart from a significant decrease of sensation threshold in the pelvic floor dyssynergia group and of the maximum rectal tolerable volume in the slow-transit constipation group. At one-year control, 50 percent of patients with pelvic floor dyssynergia still maintained a beneficial effect from biofeedback, whereas only 20 percent of those complaining of slow-transit constipation did so. Moreover, the latter displayed no improvement in colonic transit time. CONCLUSIONS: In our experience, patients with pelvic floor dyssynergia are likely to have continued benefit from biofeedback training in the time course, whereas its effects on slow-transit constipation seems to be maximal in the short-term course.     

Treatment of the spastic pelvic floor syndrome with biofeedback

The spastic pelvic floor syndrome is a functional disorder based on contraction instead of relaxation of the pelvic floor muscle during straining, which inhibits defecation and gives rise to constipation. Until now no adequate treatment has been found for this condition. The treatment described here is aimed at teaching patients to relax their pelvic floor muscle during straining. Treatment consists of a training program with EMG feedback, followed by simulation of the defecation process, using oatmeal porridge. Patients are then given instructions to generalize the relaxation response in their daily lives. Treatment was completely successful in seven of ten patients. The three remaining patients learned to strain in the correct manner, but could not achieve generalization. Two of them underwent subtotal colectomy because of delayed colonic transit times, which subsequently resulted in normal evacuation. In the third patient, the generalization was most likely hampered by psychologic problems, for which she now receives psychotherapy.