Biofeedback in Colorectal Practice A Multicenter, Statewide, Three-Year Experience Sanjiv K. Patankar, M.D., M.S. (Bom), F.R.C.S.(Ed.), Andrea Ferrara, M.D., Jacqueline R. Levy, M.D., Sergio W. Larach, M.D., Paul R. Williamson, M.D., Santiago E. Perozo, M.D. From The Colon and Rectal Clinic of Orlando, Orlando, Florida PURPOSE: Biofeedback treatment is often offered to patients in colorectal centers; however, standards of treatment are still lacking. A dedicated team approach is desirable but difficult to coordinate. We present our three-year experience of electromyographic-based biofeedback treatment offered within a multicenter, statewide organization. METHODS: Between October 1992 and October 1995, 188 patients completed a biofeedback treatment program in one of five coordinated centers within a 200-mile radius. A unified common database was established and continuously updated. A colorectal surgeon served as statewide director, and dedicated teams were established at each location. Each local team included the medical director and a certified biofeedback therapist and had access to a dietitian and a nurse data coordinator. Electromyographic-based biofeedback sessions were given weekly, and a home trainer program was established. RESULTS:A total of 116 patients with chronic constipation had a mean of eight (range, 2-14) weekly sessions. A total of 72 patients with fecal incontinence had a mean of seven (range, 2-11) weekly sessions. A total of 84 percent of the constipated and 85 percent of the incontinent patients had significant improvement with biofeedback treatment. Patient compliance and satisfaction were high. Constipated patients increased the mean number of weekly unassisted bowel movements from 0.8 to 6.5. Incontinent patients decreased the mean number of weekly gross incontinence episodes from 11.8 to 2. CONCLUSIONS: Biofeedback treatment can be extremely successful in both incontinent and constipated patients. A large geographic area can be covered with coordinated centers in which each dedicated team uses a unified treatment protocol, and a common database is established. [Key words: Fecal incontinence; Constipation; Biofeedback; Electromyographic biofeedback]

choice for certain subsets of severely c o n s t i p a t e d patients such as those with pelvic outlet o b s t r u c t i o n defecation. 3-6 H o w e v e r the delivery of b i o f e e d b a c k t h e r a p y in a s t a n d a r d i z e d f a s h i o n is a c o m p l e x u n d e r taking. Social a n d e c o n o m i c r e a s o n s m a k e it difficult to establish a b i o f e e d b a c k t h e r a p y t e a m in a small c o m m u n i t y . Furthermore, i n c r e a s e d u s a g e of b i o f e e d b a c k t r e a t m e n t in colorectal centers has n o t b e e n a c c o m p a n i e d b y the e m e r g e n c e or a d h e r e n c e to strict standards of treatment. A d e d i c a t e d t e a m a p p r o a c h is ideal b u t m a y p r o v e difficult to coordinate. The aim of this s t u d y was to create a system of u n i f o r m coordin a t e d delivery of a b i o f e e d b a c k t h e r a p y p r o g r a m o n a statewide scale u s i n g a multicenter, t e a m a p p r o a c h in w h i c h a colorectal s u r g e o n f u n c t i o n s as a m e d i c a l director a n d to assess the i m p a c t of this delivery system o n the patient's o u t c o m e . METHODS W e used a team approach to biofeedback therapy with a multicenter, statewide organization (Advantage Medical Services, Inc., Bradenton, FL). Patients presenting with fecal i n c o n t i n e n c e or severe chronic constipation were carefully evaluated with proctosigmoidoscopy, anorectal manometry, electromyography, p u d e n d a l nerve latency time, anorectal ultrasound, de-

Patankar SK, Ferrara A, Levy JR, Larach SW, Williamson PR, Perozo SE. Biofeedback in colorectal practice: a multicenter, statewide, three-year experience. Dis Colon Rectum 1997;40:827-831.

fecography, a n d colonic transit time studies as appro-

a n y patients seek t r e a t m e n t for severe c h r o n i c

dian, 8) years, despite the use of laxatives a n d high-fiber

c o n s t i p a t i o n or fecal i n c o n t i n e n c e in colorectal clinics. B i o f e e d b a c k t h e r a p y has n o w e m e r g e d as a n

supplements. Inclusion criteria for the constipated patients were as follows: less than two unassisted b o w e l

effective t r e a t m e n t for fecal i n c o n t i n e n c e in c h i l d r e n a n d adults, with a n overall efficacy of a p p r o x i m a t e l y 80 p e r c e n t d e m o n s t r a t e d in various p u b l i s h e d studies.i, 2 B i o f e e d b a c k is n o w u s e d as the t r e a t m e n t of

m o v e m e n t s per week; straining for more than 25 percent of defecation time; a n d / o r frequent sensation of incomplete defecation. The standard criteria for paradoxical puborectalis contraction4 were used to identify

Poster presentation at the meeting of The American Society of Colon and Rectal Surgeons, Seattle, Washington, June 9 to 14, 1996. Address reprint requests to Dr. Ferrara: Colon and Rectal Clinic of Orlando, 110 West Underwood Street, Orlando, Florida 32806.

patients with pelvic function disorder constipation. Patients identified as having slow transit colonic time were not included in this study. O n e h u n d r e d eighty-eight patients enrolled in the biofeedback treatment program

M

priate. The constipated group of patients had severe, intractable constipation that did not r e s p o n d to a highfiber diet. Symptom duration ranged from 2 to 20 (me-

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during a three-year period from October 1992 to October 1995. Of these, 77 percent (145 patients) completed the treatment program. Patients were treated at one of the five centers in a 200-mile radius within the state of Florida. The medical director supervised each center in which biofeedback was provided by a certified therapist and that had access to a dietitian and a nurse data coordinator. The patients were instructed to maintain daily logs of the dietary record, water intake, and bowel m o v e ments. The dietitian assessed the pretreatment dietary fiber intake, discussed food likes and sensitivities, and helped to establish a gradual increase in the daily natural fiber intake by instructing the patient on appropriate dietary modifications. The biofeedback was electromyography (EMG)-based. Biofeedback was performed with a 12-mm diameter, 45-mm-long PerryMeter T M anal EMG sensor EPS-21 (PerryMeter Systems, Strafford, PA) connected to an Orion 8600 T M (Self Regulation Systems, Redmond, WA) biofeedback computer. After insertion of the sensor, the patients remained fully clothed during the entire session. A full color graphic display was used as the video unit to let both the patient and the therapist visualize the patient's sphincter muscle activity to facilitate teaching. A horizontal blue line on the video display marked the goal that was adjusted as the patient improved. Biofeedback-directed pelvic floor rehabilitation program consisted of instructions to the patient regarding the use and care of the sensor, Kegel exercises, and "constipation exercise" (bearing d o w n maneuver). Biofeedback sessions were conducted weekly until the patient's goal was met. The h o m e training program consisted of instructing the patient to use the sensor at h o m e and to practice the exercises with a h o m e trainer aided by a training tape. A simplified version of the teaching unit was used as a h o m e trainer. This allowed the patients to continue training in the privacy of their o w n h o m e using an attachment to a video cassette recorder. Quantitative evaluation was performed b y recording short-term and ten-second contractions (amplitude/microV) and sustained contractions (endurance, in seconds) at the beginning and the conclusion of therapy. At the conclusion of the biofeedback, patients were asked to subjectively grade their improvement. Changes in unassisted bowel m o v e m e n t s and episodes of incontinence were assessed. Significant i m p r o v e m e n t (objective improvement) was defined as a 75 percent decrease in the frequency of the incontinence episodes and increase in the frequency of unassisted bowel move-

Dis Colon Rectum, July 1997

ments to more than two per w e e k in the incontinent and constipated groups, respectively. Subjective satisfaction with the program was also assessed with a questionnaire. A unified database was established and continuously upgraded. Statistical analysis was done using the Wilcoxon's matched-pairs signed-rank test. The design of the study was to evaluate the efficacy o f biofeedback treatment in compliant patients w h o served as their o w n controls. Therefore, only patients w h o completed the full course of biofeedback, with pretreatment and posttreatment evaluation, were included in the statistical analysis. Data are presented as m e a n _+ standard error of the mean. The value of P < 0.05 was taken as the level of statistical significance.

RESULTS Between October 1992 and October 1995, a total of 188 patients enrolled in the study. One hundred sixteen patients had severe chronic constipation, and 72 suffered from fecal incontinence. Mean age for the constipated group was 73 + 2 (range, 33-85) years. Mean age for the incontinent group was 70 --- 1.9 (range, 34-87) years. There were 75.86 percent (88) females and 24.14 percent (28) males in the constipated group, whereas in the incontinence group there were 59.72 percent (43) females and 40.28 percent (29) males. Of these patients, 74.13 percent (86) constipated and 81.94 percent (59) incontinent patients completed the biofeedback treatment program (compliance rate) and were eligible for statistical analysis. Analysis of the noncompliant group of patients shows that 50 percent of the patients underwent either sphincteroplasty for incontinence or continued on medical management. The remaining 50 percent of patients were discouraged by the complexity of the biofeedback delivery system. In the incontinent group, the distribution of various diagnostic categories was as follows: idiopathic neurogenic dysfunction (idiopathic sphincter hypotonia), 42 percent; postobstetric trauma, 10 percent; descending perin e u m syndrome, 10 percent; posthemorrhoidectomy, 12 percent; postradiotherapy, 6 percent; miscellaneous, 20 percent. In the constipated group, the pathologies were as follows: pelvic function disorder, 42 percent; irritable bowel syndrome, 36 percent; rectocele, 12 percent; rectal prolapse, 8 percent; solitary rectal ulcer syndrome, 2 percent. The chronically constipated group received a m e a n of 8 +- 0.3 (range, 2-14) weekly biofeedback sessions. The incontinence

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group received a m e a n of 7 -+ 0.3 (range, 2-11) weekly sessions. The objective i m p r o v e m e n t rates are s h o w n in Table 1. Before biofeedback treatment, the constipated patients had 0.8 + 0.2 (range, 0-2) unassisted bowel m o v e m e n t s per week. After the treatment, this m e a n n u m b e r increased to 6.5 -+ 0.3 (range, 4-7) per w e e k ( P < 0.001, statistically significant). Before biofeedback therapy, the incontinent group had the m e a n n u m b e r of grossly incontinent episodes per w e e k of 11.8 +_ 0.4 (range, 7-14). This decreased to 2 _+ 0.2 (range, 0-6) episodes per w e e k after biofeedback (P = 0.001, statistically significant). A total of 73.25 percent (63) of constipated and 76.27 percent (45) of incontinent patients were satisfied with the program (subjective satisfaction rate). DISCUSSION Biofeedback is a behavioral technique of operant conditioning to train the mind to control the activity of somatic functions] It has b e e n successfully used for the treatment of chronic pain syndromes s-l~ and to some extent in hypertension. During the past two decades, biofeedback has emerged as an accepted therapeutic modality for relief of m a n y gastrointestinal disorders in which altered functioning of the striated muscle exists. Biofeedback is successfully used to reduce gastroesophageal reflux by achieving strengthening of the {ower esophageal sphincter. Biofeedback treatment was initially used in anorectal disorders to treat fecal incontinence. Colorectal surgeons frequently have an opportunity to treat m a n y patients with severe, chronic constipation and fecal incontinence. Fecal incontinence m a y result from varTable 1. Results of Biofeedback Treatment Constipated Patients

No. enrolled No. completed Compliance rate (%) No. of sessions Improved* Objective improvement rate %lObjective improvement rate %:I:

116 86 74.13 8 _+ 0.3 72 83.72 62.07

Incontinent Patients 72 59 81.94 7 -+ 0.3 50 84.75 69.44

* More than 75% objective improvement. 1" Denominator is the number of patients completing the protocol. :1: Denominator is the number of patients enrolling in the study.

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ious etiologies, and an interplay of m a n y complex pathophysiologic factors plays a role. Medical treatment of fecal incontinence is unsatisfactory as are various surgical options. Biofeedback treatment results in significant i m p r o v e m e n t in 70 to 80 percent of these patients 2 by positively altering such physiologic parameters as the sensation of rectal filling, TM 12 external anal sphincter strength during voluntary contraction, 13 and the coordination of the sphincteric activity following rectal distention. 14 Biofeedback training is the treatment of choice in most instances of adult-type fecal incontinence. 15' 16 In particular, Guillemot e t al. 1~ undertook a controlled study in which the outcome after biofeedback was c o m p a r e d with a well-matched group treated medically only. Excellent outcome after biofeedback therapy was demonstrated in these studies 15' 16 in which the patient populations had a diverse range of underlying pathologies such as diabetic periphera~ neuropathy, postradiotherapy, and descending perineum syndrome. In hight of these several articles, the dissenting, recent article of van Tets e t al. iv merits special mention. In this study, a small group of incontinent patients classified as having neurogenic incontinence were not helped by a biofeedback program. Although we cannot explain on the basis of the data in that article the reason for the failure of biofeedback, perhaps a larger study with more effective control of h o m e exercise compliance could better elucidate the results. Constipation is a c o m m o n complaint of m a n y patients. It is often amenable to medical treatment. H o w ever, severe chronic constipation, defined as an infrequent defecation occurring for at least a three-month period with two or fewer bowel m o v e m e n t s per week, often constitutes a major problem for the individual patient and poses an e n o r m o u s challenge to the physician. Anal m a n o m e t r y studies, is defecograms,~9, 20 and EMG studies 2~' 2z led to an improved understanding of the underlying pathophysiology of these patients, including identification of the syndrome of pelvic outlet obstruction. 23 An insight that the same functional basis as exists in incontinence, i.e., learning/relearning the control of striated anal sphincter, and the lack of availability of suitable medical or surgical therapy for this condition led to the application of the principles of biofeedback training to the treatment of these patients. Several published reports document the effectiveness of biofeedback therapy for selected patients of severe chronic constipation in w h o m medical or surgical causes have b e e n ruled OUt. 2~5' 21, 24--30

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Bleijenberg and Kuijpers 5 reported an effective biofeedback training protocol that involved an inpatient procedure. However, the n e e d to reduce the cost of therapy led to its use in the outpatient setting that p r o v e d equally successful. 24 W e b e r e t al. 25 used the protocol of biweekly biofeedback sessions that did not include a general relaxation training c o m p o n e n t and reported that this resulted in an i m p r o v e m e n t in only 5 of 22 constipated adult w o m e n . Turnbull and Ritvo 26 reported excellent results with "massed practice" a p p r o a c h as daily hour-long sessions of both anal manometric biofeedback and general relaxation training extending for a total of 10 to 20 sessions for one to two w e e k s for the treatment of intractable constipation s y m p t o m s in women. Loening-Baucke 27 reported a 77 percent success rate from EMG-based biofeedback therapy for the treatment of constipated children with encopresis. Wexner e t al. 4 reported excellent results using anal plug EMG-based biofeedback sessions lasting one hour each and conducted by a certified biofeedback therapist. Their patients underwent a m e a n of 8.9 sessions, but they do not report the frequency of the sessions. To date, no study has focused on the aspect of the delivery of biofeedback therapy. Delivery of biofeedback treatment in a uniform, standardized fashion over a large geographic area has m a n y logistic problems. We created a system of coordinated delivery of biofeedback treatment that is easily reproducible. We have used EMG-based biofeedback training and introduced the concept of standardization in its delivery to the patient. Our a p p r o a c h to delivering biofeedback training resulted in a statistically significant imp r o v e m e n t in patients' symptoms. In incontinent patients, biofeedback obtained a 77 percent subjective patient satisfaction rate, 85 percent objective success, and a high compliance rate of 80 percent. In chronically constipated patients, biofeedback resulted in a 73 percent subjective satisfaction rate, 84 percent objective success, and 74.8 percent compliance rate. Proximi W of the training centers to the patient's residence and reinforcement with a h o m e trainer, 31 we believe, are important factors leading to high patient compliance. T e a m approach and supervision by the colorectal surgeon led to the high level of overall patient satisfaction. It is important to realize that w e do not claim that multicenter availability of treatment is of superior benefit to patients. In particular, the design of this study has relied on the numerous published reports of

Dis Colon Rectum, July 1997

efficacy of biofeedback. We have, rather, concentrated on the delivery aspects of this treatment, which is logistically difficult. Our study shows that biofeedback can be effectively delivered to a large geographic area, leading to patient satisfaction, and that it remains as effective as demonstrated in various published articles. CONCLUSIONS We have s h o w n that biofeedback is effective w h e n used in a multicenter system. It can be supervised by a single colorectal surgeon and offered in multiple centers. These individual centers m a y cover a large geographic region. This allows m a n y patients to be treated by trained biofeedback therapists in facilities based in their o w n communities. It also facilitates the formation of a large, centralized database, using a unified treatment protocol. ACKNOWLEDGMENTS The authors thank the Advantage Medical Services, Inc., Bradenton, Florida, for support in the delivery of biofeedback therapy on a statewide level and for maintaining the unified database. REFERENCES 1. Kohlenberg JR. Operant conditioning of human anal sphincter pressure. J Appl Behav Anal 1973;6:201-8. 2. Enck P. Biofeedback training in disordered defecation: a critical review. Dig Dis Sci 1993;38:1953-60. 3. Dahl J, Lindquist BL, Tysk C, Leissner P, Philipson L, Jarnerot G. Behavioral medicine treatment in chronic constipation with paradoxical anal sphincter contraction. Dis Colon Rectum 1991;34:769-76. 4. Wexner SD, Cheape JD, Jorge JM, Heymen S, Jagelman DG. Prospective assessment of biofeedback for the treatment of paradoxical puborectalis contraction. Dis Colon Rectum 1992;35:145-50. 5. Bleijenberg G, Kuijpers HC. Treatment of the spastic pelvic floor syndrome with biofeedback. Dis Colon Rectum 1987;30:108-11. 6. Camilleri M, Thompson WG, Fleshman JW, Pemberton JH. Clinical management of intractable constipation. Ann Intern Med 1994;121:520-8. 7. MacLeod JH. Biofeedback in the management of partial anal incontinence. Dis Colon Rectum 1983;26:244-6. 8. Bennink CD, Hulst LL, BenthemJA. The effects of EMG biofeedback relaxation training on primary dysmenorrhea. J Behav Med 1982;5:329-41. 9. Budzynski T, Stoyva J, Adler C. Feedback-induced muscle relaxation: application to tension headache. J Behav Ther Exp Psychiatry 1970;1:205-11.

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10. GrimaudJ-C, Bouvier M, Naudy B, Guien C, SalducciJ. Manometric and radiologic investigations and biofeedback treatment of chronic idiopathic anal pain. Dis Colon Rectum 1991;34:690-5. 11. Latimer PR, Campbell D, Kasperski J. A component analysis of biofeedback in the management of fecal incontinence. Biofeedback Self Regul 1984;9:311-24. 12. Miner PB, Donelly TC, Read NW. Investigation of the mode of action of biofeedback in treatment of fecal incontinence. Dig Dis Sci 1990;35:1291-8. 13. MacLeod JH. Management of anal incontinence by biofeedback. Gastroenterology 1987;93:291-4. 14. Whitehead WE, Burgio KL, Engel BT. Biofeedback treatment of fecal incontinence in geriatric patients. J Am Geriatr Soc 1985;33:320-4. 15. Enck P, Daublin G, Lubke HJ, Strohmeyer G. Long-term efficiency of biofeedback training for fecal incontinence. Dis Colon Rectum 1994;37:997-1001. 16. 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: 393-7. 17. van Tets WF, Kuijpers JH, Bleijenberg G. Biofeedback treatment is ineffective in neurogenic fecal incontinence. Dis Colon Rectum 1996;39:992-4. 18. Keighley MR, Shouler P. Clinical and manometric features of the solitary rectal ulcer syndrome. Dis Colon Rectum 1984;27:507-12. 19. Bartolo DC, Roe AM, Virjee J, Mortensen N, LuckeEdmunds JC. An analysis of rectal morphology in obstructed defecation. Int J Colorectal Dis 1988;3:17-22. 20. Kuijpers HC, Bleijenberg G, de Morree H. The spastic floor syndrome. Large bowel obstruction caused by pelvic floor dysfunction: a radiological study. IntJ Colorectal Dis 1986;1:44-8. 21. Kuijpers HC. Application of the colorectal laboratory in

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