How Effective Is EMG Biofeedback
in the Treatment of Incontinence?"

by John D. Perry, PhD.

Based on the Paper

EMG BIOFEEDBACK TREATMENT OF INCONTINENCE
(And other Disorders of the Pelvic Musculature)

by John D. Perry, Ph.D., Leslie T. Hullett, M.S., R.N., & James R. Bollinger, M.D.
Paoli Memorial Hospital Continence Program · Paoli, Pennsylvania

Presented at the Biofeedback Society of America
Colorado Springs, Colorado · March 26,1988

Published in California Biofeedback, Winter, 1989

Note: The original 1988 paper attempted to account for every patient who was ever referred to our clinic -- even inappropriately referred patients who were not candidates for biofeedback -- and patients with "other" problems like frequent Urinary Tract Infections, Sexual Dysfunctions, and Prostatitis. As a result the original tables and charts were extremely complex, and it was difficult to fathom out the conclusions pertaining to incontinence alone. This report is a revised version, using the same data, that limits its focus to the incontinent patients only. [Revised October, 1997]

Abstract

Although urinary and fecal incontinence have been successfully treated by behavioral and biofeedback methods for over a decade, most projects report a fixed number of therapy sessions and less than perfect success. In addition, the use of home training instruments has been sporadic or undocumented. The present project was based on a fee-for-service out-patient clinic population where all patients were provided home trainers and all were treated until cured.

Forty-six patients were treated at either of two outpatient fee-for-service Continence Clinics in suburban Philadelphia. Average age was 56 years; 73% were female. Subjects without a recent urological examination were required to have one prior to treatment.

Basic behavioral protocols established by the NIA were followed. At each visit the patient's pelvic muscles were evaluated using an EMG perineometer, and all subjects were afforded exercise practice opportunity using a computerized program. An EMG home trainer was issued for twice-daily at home practice. In addition, a telephone report line was installed to increase compliance with exercise instructions.

Of the 46 patients who were admitted to the program and completed training, all but two were cured of their incontinence in an average of 4.3 visits (for 36 Stress and Urge patients), or 8.7 visits (for 10 patients with other kinds). The two "failures" achieved 99.5% reduction in symptom, however. These results were better than previous projects using biofeedback methods. Contributing factors may have been: (1) this project was the first to use computerized software for diagnostic evauations, (2) the first to use EMG Home trainers with every patient, and (3) the use of the patient report telephone line to enhance compliance.

Problem: Urinary and fecal incontinence are the two leading non-life-threatening health problems in America. John Burton of the National Institute of Aging describes them as the second leading cause of admissions to nursing homes, yet fewer than 50 percent of victims even mention their affliction to any health care professional. One study showed that physicians were aware of only 10% of the incontinence found to exist in a large nursing home. Hu (1986) estimated the cost of elderly (only) incontinence to be about $8 Billion per year, but newer data (Diokno, 1986) raises Hu's calculations to at least double, or $16 Billion. When incontinent non-elderly are included in the calculations, the annual cost of incontinence may well approach $25 Billion. Since the incidence of incontinence increases with age, but the advisability of surgical or chemical treatment decreases with age, most sufferers are (1) resigned to mere "management" of their problem and (2) must bear the costs out-of-pocket. Neal Miller said (BSA Presidential Address, 1985) that the country could "save $13 billion annually" (across all age groups) by utilizing this application of biofeedback.

The NIA has shown in a series of published studies that biofeedback by means of anorectal manometry is both successful and cost-effective in reducing 75 to 94 percent of fecal or urinary incontinence incidents (although the NIA's actual "cure" rate has been only about 30% of subjects). Unfortunately, their polygraph equipment is expensive and non-portable, and the procedure is invasive, risky, and extremely uncomfortable. Most patients will only tolerate 3 or 4 biofeedback sessions.

More recently published studies have been based on an inexpensive EMG vaginal or rectal sensor that can be used with any EMG instrument. Henderson (1987) had 65 to 85% success treating urinary incontinence among elderly and middle aged woman. Smith et al (1987a) had 75% improvement in symptoms in a "free" out-patient clinic using a Clinical Perineometer™ for diagnosis and Personal Perineometer™ home tramers, and Smith et al (1987b) achieved similar success with an even more difficult population --- home-bound senior citizens --- using a portable version of the Clinical Perineometer™.

All of the published EMG studies have deviated in one or another important respect from the "ideal" therapy protocols described in the Instruction Manual for the use of the vaginal and rectal sensors that were employed. (These recommendations were later codified in The Perry Protocol, 1990). Henderson, for example, used only home trainers even for office evaluations (making precise data collection impossible). The use of home trainers was sporadic and poorly documented in Smith et al (1987a) -- in general, patients were issued a PP-200 for the first week or two of therapy, after which they were on their own. Smith et al (1987b) used no home trainers.

One purpose of the present study was to determine the maximum effectiveness of the EMG biofeedback method if all elements of the manufacturer's therapy recommendations were followed in strict detail. In addition, maximal compliance was sought by (1) the institution of a patient report telephone line, combined with (2) careful tracking and rescheduling of missed appointments. Finally, although all patients (or their insurance) initially paid full price, fees were later waived in several instances when insurance companies balked. No one who followed the protocol was "allowed" to drop out. In contrast, in many previous reserach projects, patients received "free" treatment, and in some cases were even paid for their participation. It was hypothesized that patients who were paying for their therapy would work harder at it.

An important element of the recommended method is "training to criterion", a concept which became accepted in the biofeedback field in the 1980s. It was shown in well-executed studies that the "pharmacological model" -- a fixed dosage regardless of patient progress -- was not appropriate for biofeedback studies. In drug studies, the issue under investigation is the efficacy of the drug, which has nothing to do with the patient's characteristics. But in biofeedback, the issue is how long it takes the patient to develop good psychophysiological habits -- and some people simply learn faster than others.

In the newer conceptualization, biofeedback training is seen as similar to other forms of physical "training". One can, of course, take a six-lesson course in playing tennis. But the preferred method is to work directly with a "pro" who can individualize the training to the student's progress, and guide the student to whatever level of mastry they select.

In thermal biofeedback, for example, a person who takes say six sessions of biofeedback may be no better off than one who takes six sessions of yoga. (On the average, that is; some will be better, and some worse, but on the average, no better.) In contrast, a person who is training to the accepted criterion -- reaching a finger temperature of 96 degrees F in 20 minutes -- will have far greater resistance to migraines, etc. than someone who received a fixed number of sessions of anything.

In the historic NIA studies done by Whitehead and Burgio, training was limited to 3 to 5 biofeedback sessions, not because of the conceptual model, but because the training method was just too uncomfortable, if not actually painful, for patients to continue. Most opted out after having achieved dramatic improvements in their symptoms, even if they were not 100% cured. In the present study, which employed painless vaginal or rectal EMG sensors, no patient dropped out because of discomfort.

Experience has shown that in the initial stages of biofeedback-for-incontinence training, progress in terms of muscle improvment is generally linear -- when the assigned home training is done, virtually all patients show increasing strength scores from week to week, as one would expect. But symptom relief requires, in addition to physical strength, the psychological skill to remember to "contract" every time to sneeze or pick up objects. For many patients, with 10 to 20 years of "leaking", it takes more than 10 to 20 days of training to learn to do that with complete consistency. As a result, we adopted an extremely stringent criterion for success: thirty consecutive days without an accident were required before the patient was "graduated" from the program. Thus a patient who was treated for 5 sessions over eight weeks would have been dry after only four weeks, which was confirmed by an additional "30 days dry" criterion.

In addition to "training to criterion", another popular advance in general biofeedback has been the use of portable "home trainers", to supplement clinical training at home on a daily basis. The clinical efficacy of this approach is so obvious that no one has even bothered to do controlled studies. Common home trainers range from thousand dollar instruments to small thermographic plastic cards and inexpensive thermometers. Many experts would agree that doing "office" biofeedback without also using home trainers would be close to unethical for most conditions.

Unfortunately, there is no "home trainer" equivalent to the ano-rectal manometric system employed by NIA, so the Burgio patients were forced to learn on their own. The present program sought to improve on the Burgio "office-only" biofeedback model by requiring ALL patients to use and record home practice data on a daily or twice daily basis. At least two patients who refused to do so were expelled from the study and excluded from the data.

Subjects: The study population consisted of 46 patients who contacted, or were referred by their physician to, either of two outpatient fee-for-service Continence Clinics in suburban Philadelphia. In general, this geographic area is well above average in status, education and income. Average age was 56 years; the range was from 6 to 91; 22% were male. About one third were using Medicare to cover the cost of treatment.

Patients had been incontinent for 1 to 27 years, with most patients in the range of 5 to 10 years. They used at least one, and up to 7 incontinence products per day, with an estimated average of 3 pads per day. [Author's note: The raw "leakage" data, upon which the percentage reduction in daily accidents was calculated, was lost in a computer crash in March, 1988. The loss of this data is the primary reason that this project was never submitted for publication in a peer-reviewed journal. The majority of the patients were referred consecutively from Dr. Bolinger's urology practice, and therefore represent a typical cross-section of stress and urge incontinence patients at a suburban medical office outside Philadelphia.]

Minimum criterion of acceptance into the program was (1) documented urinary or fecal incontinence (as defined by a physician), (2) ability to get to or be transported to the out-patient facilities (one of which was located inside a hospital), and (3) either (a) sufficient presence of mind to understand and follow directions for keeping bladder records and using the home trainer, or (b) the presence of a caregiver who could perform these functions.

Method: All subjects were interviewed on the telephone by a nurse prior to making their first appointment. In the absence of a recent (within six months) urological workup, one was scheduled, usually prior to the first visit. The behavioral and biofeedback components of the program were explained by the nurse. Forms for two weeks of bladder (or bowel) and fluid intake records were mailed to the patient for completion prior to the first visit.

At the first visit the records were reviewed and the procedures explained. All patients were seen at each visit by a Psychologist-Nurse team. At each visit, the pafient's pelvic muscles were first evaluated using the Electronic Perineometer™ brand vaginal (or, for males, rectal) sensor and Computerized Perineometer™ software program (Biotechnologies, Inc.) with a modular EMG Interface (J&J Enterprises Model 1-300) for a personal computer (Commodore C-64). After evaluation, at each visit, all subjects were afforded exercise practice opportunity using the program's "Kegel Counter" option.

The "Kegel Counter" has a dual-threshold design that "counts" valid exercises which exceed a therapist-established criterion on contraction and then drop below a similar criterion on relaxation. The rationale for this copyrighted algorithm is that patients should only be rewarded for exercise that is of sufficient quality to be likely to contribute to their improvement. As the patient improves, the goal is progressively increased. As in other behavioral research, criteria are set so that the patient is successful about 80 percent of the time.

During the office practice sessions, the therapists watch closely to ensure that the exercises are being done correctly. Particular attention is devoted to (1) breathing patterns (many patients hold their breath during exercise), (2) the use of accessory muscles, and (3) development of "control" over the muscles.

Accessory muscles were monitored primarily by palpation and visual inspection. The use of gluteal muscles can be detected by the fact that the patient appears to "levitate" in the chair on each contraction. The use of aductor muscles can be detected by having the patient keep the knees at least six inches apart and noticing any movement. The use of abdominal muscles can be detected by having the patient press a finger an inch or two into the abdominal wall, half-way between the pubic bone and the umbilicus. If the abdominal muscles are contracted, the movement is readily visible to both therapist and patient. This method is considered less invasive and embarrassing than using abdominal EMG electrodes in the same area. In addition, the patient can do it at home without resorting to an expensive two-channel EMG trainer.

All subjects were issued Personal Perineometer™ (Farrall Instruments, Model PP-200) EMG home trainer for twice-daily at home practice, and a supply of bladder and fluid record forms. Patients were generally seen weekly for three or four weeks and bi-weekly thereafter. All patients were required to keep daily fluid, bowel and bladder records throughout the entire course of therapy. (Besides the traditional "in" and "out" records, a space was provided for the patient to indicate and calculate the number and cost of any incontinence products used each day. In addition, all patients were required to telephone their practice results and symptom experience to a dedicated "patient report line" answering machine every 48 hours. In this way, a patient would be "caught" if they missed two days of home practice, and would receive a follow-up call immedately.

All patients were continued in treatment (including the daily use of an EMG home trainer) until they met the program's goal of being symptom-free for 30 consecutive days. (For stress or fecal incontinence, for example, 30 days without a single leak of urine or feces was required. For Urge incontinence, inter-toileting intervals greater than two hours were also required.)

Results: Among patients with a primary diagnosis of Stress, Urge, or both, 34 out of 36 achieved complete continence in an average of 4.3 office visits, spead over 7 or 8 weeks. Since 30 days "dry" was requried, on the average patients were "dry" after only four weeks of therapy, with four more weeks being required to meet the "30 days dry" criterion. (See Table 1). Among patients with other forms of incontinence, including fecal incontinence, all 10 patients were "dry" (for thirty days) after an average of 8.7 visits, spread over a period of about 12 weeks.

Table l: Treatment Outcomes

Length of treatment ranged from a mean of 3.5 visits for patients with Urge Incontinence with Pain to 15 visits for a young girl with "Giggle lncontinence" (usually considered untreatable).

44 of the 46 treated patients (98%) were symptom-free for 30 days or more before being "graduated" from the Continence Program. Only two patients failed to meet the program's stringent criterion of thirty consecutive days without an incident. One, a mental patient under heavy sedation, continued to wear perineal pads whenever she left the house, even though she reported only a single leaking episode in the second month of therapy. [The use of protection products was strongly discouraged, even in the first weeks of therapy, since they provide an "out" and reduce the patient's motivation to remember to "squeeze before you sneeze".]

The other woman was encouraged to consider herself a "success" when her symptoms were reduced from 35 accidents a week at the start of the program to one per week at the end of 12 visits. The exception was decided after the patient's best friend (who was also a patient) revealed that the women had confided to her that she was, in fact, lying to the therapists about keeping up with exercises. She had been incontinent for some 20 years, and was actually very content with her 97% reduction in leakage accidents.

The reduction in urinary accidents (or other symptom relief) was accompanied by a corresponding increase in pelvic muscle strength as measured by the Computerized Perineometer program (see Table 2).

Table 2- EMG Measures: Before and After; and Net Changes

Significant data in Table 2 has been highlighted to reveal patterns. For seven of the eight diagnoses (marked in yellow), a significant increases in net contraction strength, of 79 to 193 percent, are evident. For two conditions in which high muscle resting tension is a component (marked in aqua) -- Urge with pain and Nocturanal Enuresis -- significant reductions in resting tension of 48 to 79 percent are demonstrated.

The only group that did not show a significant increase in strenght post-therapy (Urge with Pain) already had muscles as strong at the start of their training as the Stress Incontinence group had the end of their therapy (6.8 microvolts, shown in fuscia).

The data from Table 2 is shown below in graphic form to facilitate visual inspection. In Graph 1, the raw scores are presented. In Graph 2, changes are shown as percentages.

Graph 1 - Changes in EMG scores by Diagnosis

Note: "Net" refers to the "Net Strength" score, which is the average EMG during a ten-second interval, minus the preceding resting level. All values are narrow band RMS integrated EMG using J&J M-501 EMG modules. See technical note at end of article.

Graph 2 - Changes in EMG scores as percentages

Note that post-prostate surgery patients showed the smallest gain among weakness-related conditions. This reflects the fact that for such patients, the therapeutic goal is not raw strength but increasing the bulk of the muscle (to compensate for removed tissue), so sub-maximal contractions are perscribed. The modest improvement among stress incontinent patients may be a reflection a somewhat older population in this group, and hence, less improvement was possible.

Discussion: The present research model is based on a "client-centered" algorithm which involves treating the patient for as long as necessary to cure the problem.

The results obtained by these clinics were somewhat better than other similar projects using other biofeedback protocols. Some of the success may be attributable to the use of the new Computerized Perineometer software, which provides standardized data collection and vivid, criteria-referenced exercise patterns. The algorithm employed in the "Kegel Counter" program only rewards patients for exercise that is strong enough and long enough to be of therapeutic value. Also, this was the first project to use the specially-designed Personal Perineometer EMG home trainers with each and every patient for as long as necessary to achieve results. Other programs (such as Smith et al, 1987a) have provided home trainers only to selected patients, or only for an initial two week period, or both.

It is difficult to measure the contribution of the Patient Report Line, but clinical observation suggests it may be a major factor in insuring compliance, often cited as the most difficult aspect of pelvic muscle rehabilitation. One patient, only 95% improved and still in treatment after 12 visits, admitted to her best friend (also a patient) that she had lied to us about the amount of exercise done. The complicance problem will be resolved when the new home trainer instruments become available, which store the results of at home practice in a memory chip for downloading at the therapist's office. Preliminary testing has already begun, with funding from a SBIR grant.

Finally, this is the first incontinence project to be based entirely on data from fee-for-service patients. While not all patients were required to pay full price (according to their circumstances), all were required to pay a significant portion of the fee. According to Fritz Perls' theory that "they don't get better unless they pay", this policy may have also been a contributing factor in the success of the project.

The use of unpaid, or even paid, research subjects is so widespread in medicine that we seldom reflect on the influence this may have on clinical outcomes. The practice, borrowed from pharmaceutical research, may be confounding results in behavioral therapies like biofeedback. The basic issue is that drugs are supposed to work their magic regardless of the patients' attitude towards the drug. But this is NOT a valid assumption in biofeedback research. Unless the patient becomes committed to regular instrumented and non-instrumented practice of pelvic muscle exercises, there will be no lasting improvement. The fact that fee-paying incontinent subjects showed greater improvement than non-paying reserach subjects may be a reflection of a motivational difference.

It is difficult to determine whether any of these factors, or some other unknown factors, account for the greater success rate that this program had compared with other programs. Obviously further research is indicated.

References:

Diokno, Anajas C., Brock, Bruce M., Brown, Morton B., and Herzog, A. Regula. Prevalence of Urinary Incontinence and other Urological Symptoms in the Noninstitutionalized Elderly. The Journal of Urology, November, 1986, 136:1022-1025.

Henderson, B. & Taylor, J. Age as a Variable in an Exercise Program for the Treatment of Simple Urinary Stress Incontinence. Journal of Obstetric & Gynecological Nursing. 1987.

Hu, Teh-wei. The Economic Impact of Urinary Incontinence. Clinics in Geriatric Medicine, November, 1986, 2,4:673-687. [The title is misleading, since he deals only with the "over 65" population.]

Miller, Neal. Presidential Address. Biofeedback Socieiy of America. New Orleans, 1985.

Perry, John D. Handbook of EMG Perineometry. Biotechnologies, Inc. 1984. (Sixth Edition)

Smith, D., Smith, J., Rose, M. & Kaschak, D. Kegel's Exercise, Biofeedback, and Relaxation Training for the Treatment of Urinary Incontinence in a Community Setting. Proceedings of the International Continence Society, 1987(a)

Smith, D., Smith, J. & Rose, M. Control of Urniary Incontinence in the acutely ill home patient. Proceedings of the International Continence Society, 1987(b)

Technical Notes on EMG "scores"

The measurement standards employed in this research are described in greater detail in the document The Perry Protocol, available on this website. Three points are important in this study.

1. The Ten Second "Window of Opportunity". Early research indicated that two factors -- strength and control -- play a role in controling urinary and fecal incontinence. The "scores" reported here are ten-second averages which reflect both factors. If muscle recruitment takes a couple of seconds or more to reach a peak, and all ten seconds are averaged together, the poor recruitment will lower the "score". [For instance, scores of 1,2,3,4,5,5,5,5,5,5 = 40/10 = 4.0 microvolts, but 5,5,5,5,5,5,5,5,5,5 = 50/10 = 5.0 microvolts, a 25% difference!] Burns et al, which reported rather mediocre results for biofeedback assisted therapy, used "the best five seconds out of ten" to calculate scores. In other words, "control" was not measured in Burns' research.

2. The "Net Strength" Concept. From the earliest days of pelvic muscle EMG research, it was noted that different patients begin therapy with different levels of resting tension. In order to reflect the true impact of a contraction, we elected to report the difference between resting and contracting, rather than the raw strength score. Usually, as seen in the graphics that accompany this article, it is necessary to both lower the resting level and increase the contraction level to achieve continence. It should be noted that the inexpensive air-pressure operated perineometers which have recently come on the market only report the "net" strength, as they are incapable of measuring resting tension.

3. The Importance of Dual Criteria. In early research on rehabilitation of pelvic muscles with EMG biofeedback, it quickly became apparent that the pelvic muscles of most patients became more tense as a result of attempting to learn Kegel's exercises. That is, at the second and third weekly sessions, we observed increases in resting level as well as strength. We quickly learned that we had to instruct patients to (1) make their contractions "higher" and (2) make their relaxations "lower". The "Kegel Counter" concept -- only counting contractions that meet BOTH criteria -- was the result of this research discovery. [The use of the copyrighted "dual criteria" and "Kegel Counter" protocols require prior written permission, and credit must be given.]

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