Progress in Biofeedback Conditioning for
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1 GASTROENTEROLOGY 76: , 1979 Progress in Biofeedback Conditioning for Fecal Incontinence M. A. CERULLI, P. NIKOOMANESH, and M. M. SCHUSTER Department of Medicine, Division of Gastroenterology, Baltimore City Hospitals, The Johns Hopkins University School of Medicine, Baltimore, Maryland Fifty consecutive patients with severe daily fecal incontinence for 1-38 yr were treated with biofeedback training using a 3-balloon system connected to a physiograph. Ages ranged from 6 to 97 yr (average 46 yr) including 36 females and 14 males. Follow-up period was 4-11J mo (average 32 mo, median 26 mojo Twenty-four patients had incontinence associated with previous anorectal surgery. Eleven patients had spinal surgery. Medical problems associated with incontinence included irritable bowel syndrome, diabetes, rectal prolapse, multiple sclerosis, scleroderma, and stroke. Patients were taught to develop reflex transient contraction of the external sphincter in response to rectal distention. Increasing sensitivity was conditioned by gradually decreasing the distending volume. Thirty-six of 5 patients achieved a good symptomatic response to biofeedback training as evidenced by disappearance of incontinence or by decrease in frequency of incontinence by 9%. Before conditioning, threshold (minimal volume of distention required to produce external sphincter contraction) was similar (4 cc) in both good responders and poor responders. Eight good responders, before conditioning, had no contraction to volumes of 5 cc or greater. After conditioning, threshold diminished to 16 cc in the responders and 33 cc in the poor response group. Seventy-five percent (27) of those who achieved a good response did so after one conditioning session. Only 2 patients regressed temporarily, and they responded to repeat conditioning. The patients with impaired sphincter muscle but normal neural apparatus had better results. There are no medical contraindications to the procedure. It is simple, rapid, and without morbidity. The effectiveness of this biofeedback conditioning demonstrates for the first time that manometric techniques can Received February 14, Accepted November 3, Address requests for reprints to: Marvin M. Schuster, M.D., Baltimore City Hospitals, 494 Eastern Avenue, Baltimore, Maryland by the American Gastroenterological Association /79/4742-5$2. playa direct therapeutic role in the treatment of gastrointestinal disorders. In our rigidly toilet-trained society, fecal incontinence is a stigma of great magnitude. This symptom of disordered motility often imposes sharp limitations on geographic and social mobility. The application of biofeedback techniques in treating this problem was first described in 1974." The present report represents our experience in the followup of 5 patients with severe, chronic fecal incontinence by the previously described biofeedback conditioning method. Methods and Materials We studied 5 consecutive ambulatory patients referred with gross daily incontinence as their major complaint. All patients has solid incontinence, and some had liquid incontinence also. The duration of incontinence varied from 1 to 38 yr (average 6 yr). The follow-up period ranged from 4 to 18 mo (average 32 mo, median 26 mo). Patient ages ranged from 5 to 97 yr (average 46 yr). Thirtysix women and 14 men were studied. Eighteen patients had more than one factor associated with incontinence; 9 had chronic irritable bowel syndrome and superimposed anorectal surgery. Two had anorectal surgery associated with quiescent Crohn's, one with diabetes, and one with disk disease. One patient had irritable bowel syndrome and disk disease, and one had irritable bowel syndrome, disk disease, and scleroderma. The factor most closely associated in time to the beginning of incontinence was chosen as the etiology. A surgical etiology for incontinence was implicated in 35 patients (Table 1), a medical etiology in 15 (Table 2). A three balloon system 2 permitted simultaneous pressure measurements from the external sphincter, internal sphincter, and proximal rectum. Pressures were recorded on a Sanborn model 964 direct writing instrument. As part of the biofeedback technique, the patient was shown the manometric tracing of the external sphincter. The correct response was demonstrated to the patient by drawing it on the tracing.
2 April 1979 PROGRESS IN BIOFEEDBACK CONDITIONING FOR FECAL INCONTINENCE 743 Table 1. Types of Surgery Associated with Fecal Incontinence 56% Anal: 15 Hemorrhoidectomy 9 Sphincter repair 2 Fistulectomy 3 Imperforate anus 1 Rectal: 9 Prolapse repair 3 Polypectomy 2 Abscess drainage 2 Benign tumor removal 2 Spinal: 11 Laminectomy 4 Meningomyelocele 7 28% 16% 1 NO LESS THAN AT LEAST INCONTINENCE ONCE MONTHLY 9% DECREASE Figure 1. Results in good response group (35 patients) after successful conditioning. Noting what maneuver was necessary to produce an upward deflection (pressure rise) on the tracing, the patient was then trained to produce a momentary contraction of the external sphincter, synchronous with the sensed rectal distention. After conditioning with biofeedback of responses, visual feedback was withheld by blocking the patient's view of the tracing. The patient was first conditioned to appreciate graded amounts of rectal distention in order to affect sensory awareness of the stimulus. Distentions were performed out of sight of the patient. The initial distending volume was 5 cc of air. Subsequent distentions were reduced by decrements of 1 cc until the patient's threshold of sensitivity was reached. These methods were approved by Baltimore City Hospitals Human Research Committee. The procedure was thoroughly explained to the patients before obtaining consent. After the training session, the patient was instructed to apply the learned techniques consciously for the next 2 wk whenever he felt the sensation of rectal distention. He was told to expect the reflex to become automatic, not requiring attention, after the first 2 wk. In addition, for the first weeks, the patient practiced momentary contractions four times a day at times of his choice. Results We set rigid criteria for improvement by defining a good response as complete disappearance of incontinence or at least 9% decrease in frequency of incontinence; therefore, a patient with daily incontinence could have no more than one episode every 1 days. Anything less than a 9% reduction was considered a poor response. We defined in- Table 2. Medical Disorders Associated with Fecal Incontinence Localized: 9 Irritable bowel syndrome 4 Rectal prolapse 3 Radiation proctitis 1 Crohn's disease 1 Systemic: 6 Cerebrovascular 3 Diabetes 1 Scleroderma 1 Multiple sclerosis 1 continence as any soiling or staining, whether or not it was considered significant by the patient. Seventy-two percent (36 patients) obtained a good clinical response. Fifty-six percent of this group (2 patients) had no further incontinence whatsoever. Another 28% (1 patients) had no more than one episode of incontinence per month. The remaining 16% (6 patients) met the minimum criteria for a good response (Figure 1). Seventy-five percent (27 patients) of those who achieved a good response did so after one conditioning session. Two patients regressed and required repeat conditioning which was successful (22 mo follow-up for both). As previously noted, rectal distention in normals produces external sphincter contraction in synchrony with internal sphincter relaxation. Internal sphincter response was normal in all but one of our patients. Figure 2 shows the manometric tracings from a patient during a single session before and after successful biofeedback conditioning of the external sphincter. The patient initially had no response to 5 cc distentions, but with conditioning developed a response to volumes as low as 15 cc of air. Once developed, the external sphincter contraction occurred reflexly and in synchrony with internal sphincter relaxation, even after visual feedback was withheld. Twelve patients had no detectable response to rectal distentions of 5 cc of air before biofeedback conditioning. Eight of these responded well to conditioning. The threshold (volume of rectal distention required to produce external sphincter contraction) decreased by more than 5% in the good response group (P <.1), whereas threshold decreased by <2% after conditioning in the poor response group (Figure 3). The initial threshold values in the two groups were not significantly different. Thus, the objective manometric improvement correlated with the clinical improvement and could be used to predict clinical improvement. The duration of incontinence could not be used to predict the patient's response; the average duration
3 744 CERULLI ET AL. GASTROENTEROLOGY Vol. 76, No.4 A INCONTINENT II I) RECTAL ~ ~ ~ INTERNAL 5cc SPHINCTER ~ ~ l\/vv'--',"- V ~ ) lommhgi EXTERNAL SPHINCTER ' " ' - - ~ - - ~ B H losec A A l5cc that the external sphincter contracts only when needed and is relatively relaxed during the long in INTERNAL..I\fV'--,I1 -- -_.1 ~.\ tervals of internal sphincter contraction. With practice,, the. external I V sphincter ~ contraction becomes S P H I N C T E R ~ \ once again part of the continence preserving reflex lommhgi involving coordinated reflex responses of the internal and external sphincters. The patients with impaired sphincter muscle but EXTERNAL S P H I N C T E R - - ~ A r - - A H losec Figure 2. Manometric recording from a patient with fecal incontinence. Tracing is from a single session A. before and B. after biofeedback conditioning. External sphincter reflex (lower tracing) is absent before conditioning and is present after conditioning. was 5 yr for the good response group and 8 yr in the poor response group (median 5 yr in both groups). Results were better in patients who developed incontinence after anorectal surgery than in patients who had had spinal surgery or those who had incontinence not related to surgery (Figure 4). Among the patients who had incontinence associated with medical disorders (Figure 5), two-thirds obtained a good response to conditioning. Discussion Since Miller 3 reported the results of operant conditioning of visceral responses in the curarized rat, others have used biofeedback to control heart rate,4 blood pressure,5,6 muscle spasm,7 and vascular toneb in humans. For successful conditioning, the subject must be able to sense the stimulus, which in our study is rectal distention. When afferent nerve damage impaired sensation, conditioning was often successful in improving sensory awareness as demonstrated by the decreased threshold for sensation noted in the good response group, especially in the 8 patients who initially had no response to large distentions, but after conditioning developed a good manometric and clinical response. The patient must learn how to contract the sphincter and when. The internal sphincter is composed of smooth muscle fibers and is thus suited to remain chronically in a state of near maximal contraction, while the striated fibers of the external sphincter normally can remain strongly contracted AFTER OPERANT CONDITIONING for <1 min before fatiguing. 9 Normal reflex contraction of the external sphincter occurs in synchrony with internal sphincter relaxation. This synchronized response is automatic and is crucial for maintaining continence. Our conditioning technique R E C T A L ~ r - - is -designed l ~ to reinstate - this synchronous response so normal neural apparatus had good results, probably because of the absence of sensory or motor nerve impairment. Patients with sphincter muscle damage as a result of anorectal surgery were better able to sense the rectal distentions and to contract the sphincter than those with primarily neurologic dysfunction, in which afferent as well as efferent impairment may occur. This may explain the greater percentage of patients with anorectal surgery in the good response group as compared to the poorer results in patients with diabetes, meningomyelocele, or laminectomy. This concept is supported by our findings. Of the 14 patients in the poor response group, two-thirds had severe organic lesions involving the afferent nerve pathways with loss of sensation, as a result of meningomyelocele, diabetic neuropathy, multiple sclerosis, or vertebral disk disease. One patient with radiation proctitis could not tolerate the procedure because of rectal tenderness; no other patients found the procedure uncomfortable or painful. The patients in this study were all referred for evaluation and treatment of daily chronic and intractable gross fecal incontinence. Although our pa-
4 April 1979 PROGRESS IN BIOFEEDBACK CONDITIONING FOR FECAL INCONTINENCE 745 u.j ::2' :::> -' CJ > c.!j z: is z: u.j f- e/.) is THRESHOLD 5 >_. T ---l 4D I! I 1 '-_ BEFORE AFTER BEFORE AFTER OP OP OP OP COND COND COND COND GOOD RESPONSE POOR RESPONSE Figure 3. Threshold for external sphincter contraction before and after conditioning. The brackets represent the standard deviation. tients did experience emotional distress because of their incontinence, no attempt was made to focus on the patients' psychological problems. Although the patients with irritable bowel syndrome have increased life stresses, to they received only the biofeedback conditioning directed at their specific organic problem. Psychotherapy, psychoactive medications, or antidiarrheal agents were not employed. All patients had measurable deficits of external sphincter function before conditioning, and these were corrected in the good response group. Although there was no formal control group, patients SURGICAL PROCEDURES Figure 4. Response to conditioning in patients with incontinence after surgical procedures. CI) z VJ >-... CI) Z ~ a: u.. <!:l a:, CD CI) ~ z ~... 2 Z VJ a: a: All MEDICAL DISORDERS... Figure 5. Response to conditioning in medical patients with incontinence. who did not receive conditioning on the day of the first baseline study demonstrated no improvement manometrically or clinically on a subsequent baseline study. Fecal incontinence is not uncommon. In the nursing-home setting and in chronig care facilities, fecal incontinence is a major nursing problem. In a recent review, Brocklehurst ll cited prevalence rates of fecal incontinence among institutionalized old people as being from 16 to 6%. Fifteen of our patients were over 6-yr old (the oldest was 97); 11 of these were in the good response group. The median age was similar in the good and poor response groups over age 6 (67 and 65 yr, respectively). One of our good responders had developed incontinence after a stroke. In a retrospective analysis of the late results of hemorrhoidectomy, Bennett et ap' reported that 6% of 138 patients had fecal incontinence, and an additional 17% were described as having frequent soiling of underclothes, which, by our definition, constitutes incontinence. A 4% rate of "incontinence" (not defined) at 1 yr was noted after the Lord procedure '3 (brusk stretching of the sphincter under anesthesia). We cannot estimate the incidence or prevalence of fecal incontinence in any specific groups from our data. This procedure has advantages over surgical approaches, in that it is simple, rapid, and without morbidity. There are no medical contraindications. The probability of success can be assessed after the first conditioning session. The equipment required is an easily obtainable balloon system* and recording apparatus present in most gastrointestinal or physiology laboratories. The dramatic clinical effectiveness of biofeedback conditioning under these circumstances demonstrates for the first time that manometric techniques can playa direct therapeutic as well as diagnostic role in the treatment of gastrointestinal disorders. Mr. Richard Hiner, Machinist, Gerontology Research Center, Baltimore City Hospitals, 494 Eastern Avenue, Baltimore, Md.,
5 746 CERULLI ET AL. GASTROENTEROLOGY Vol. 76, No.4 References 1. Engel BT, Nikoomanesh p, Schuster MM: Operant conditioning of recto sphincteric responses in the treatment of fecal incontinence. N Engl J Med 29: , Schuster MM, Hookman P, Hendrix T, et al: Simultaneous manometric recording of internal and external anal sphincteric reflexes. Bull John Hopkins Hospital 116:79-88, Miller NE: Learning of visceral and glandular responses. Science 163: , Engel BT, Bleecker ER: Application of operant conditioning techniques to the control of the cardiac arrythmias, cardiovascular psychophysiology. Edited by PA Obrist, AH Black, J Brener, et al. Chicago, Aldine Publishing Co., 1974, p Kristt DA, Engel BT: Learned control of blood pressure in patients with high blood pressure. Circulation 5i (2):37-78, Plumlee LA: Operant conditioning of increases in blood pressure. Psychophysiology 6:283-39, Budzynski T, Stoyva J, Adler C: Feedback-induced muscle relaxation: application to tension headaches. J Behave Ther Exp Psychiatr 1:25-211, Miller NE, Dworkin BR: Effects of learning on visceral functions-biofeedback. N Engl J Med 296: , Schuster MM: Motor action of rectum and anal sphincters in continence and defecation. In Handbook of Physiology, Section 6. Edited by CF Code. Washington, D.C., American Physiological Society, 1968, p Mendeloff AI, Monk M, Siegel Cr. et al: Illness experience and life stresses in patients with irritable colon and with ulcerative colitis. N Engl J Med 282:14-17, Brocklehurst JC: Management of fecal incontinence. Clinics in Gastroenterol 4: , Bennett RC, Freidman MHW, Golighter JC: Late results of hemorrhoidectomy by ligature and excision. Br Med J 11: , MacIntyre IMC, Balfour TW: Results of the Lord nonoperative treatment for hemorrhoids. Lancet 1: , 1972
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