John D. Perry, PhD

1192 Lakeville Circle

Petaluma, CA 94954

Voice: 707-789-9135

Fax: 707-789-9137

 

Monday, February 28, 2000

 

John Whyte, M.D.

Health Care Financing Administration

Mail Stop S3-02-01

7500 Security Boulevard

Baltimore, MD  21244

 

 

Dear Dr. Whyte:

 

I wish to submit this letter and its attachment for consideration by the Medicare Coverage Advisory Committee in its deliberations about the use of Biofeedback and Electrical Stimulation in the treatment of urinary incontinence.  As per our telephone conversation on 12/28/99, I am sending it directly to your attention. 

 

I am writing on behalf of myself, a retired Psychologist.  (I am still licensed to practice in Pennsylvania.)  I believe I can offer a unique and privileged perspective on the topic at hand, since I was the inventor, in 1975, of the vaginal EMG sensor device[1] most commonly used today in the treatment of incontinence [1992 version pictured, right].  I also conducted the first clinical trials with the device[2], and I developed the first published protocols[3] for its use.  My nurse-wife and I opened the first clinic devoted to behavioral treatment of incontinence in Bryn Mawr, PA, in 1985. 

 

Over the past twenty years my wife and I trained thousands of clinicians in the use of biofeedback for incontinence, including over 500 clinicians who attended 2, 3, or 4-day "Certification" workshops we offered during the period 1986 to 1994.  Since 1995 I have continued to provide educational materials on an Internet Website, "Incontinence on the Internet", which has more information on behavioral treatments, and receives far more visitors, than any other site in the world.

 

CONFLICT OF INTEREST DISCLOSURE

 

During the 15-year period from 1977 to 1992 I worked as a Psychologist in Private Practice to support not only my family but also to subsidize the development of pelvic muscle biofeedback.  Initially, when no "real" manufacturer was interested in this work, I became an FDA registered manufacturer and made several dozen of these devices in my kitchen.  In 1981 Farrall Instruments, Inc. of Nebraska took over manufacturing (and perfecting) my invention.  In the early 1980s I became the salesman, and personally supplied the devices that were used in the federally funded Wells-Brink-Diokno and Burns et al research projects, and in the state-funded Smith & Baigis-Smith projects in New Jersey.  In 1989 Synectics Medical (Sweden) briefly took over worldwide marketing of my device. 

 

My personal fortunes reversed favorably in 1992 when the Agency for Health Care Policy and Research recommended the use of conservative approaches, including biofeedback.  I suddenly began to get money from, rather than spend money on, EMG sensors.  In 1994 I retired, and have since been entirely supported by royalty payments deriving from the sale of devices licensed under my patent.  Thus any increase in the use of biofeedback for incontinence will likely result in direct financial benefit to me personally[4] -- as well as resulting in significant cost-savings to the federal government and the American people. 

 

A BIOFEEDBACK PERSPECTIVE: TRAINING

 

Most observers are aware that psychologists have played a major role in the development of incontinence biofeedback, including psychologists Bernard Engel, William Whitehead, and Kathryn Burgio at the Laboratory of Behavioral Sciences.  In fact, psychologists have been the largest profession within biofeedback for all of its 30-year history.  Three quarters of the contributors to Mark Schwartz' "bible", Biofeedback: A Practitioner's Guide [Guilford Press, 1995] are psychologists. 

 

In 1985 the National Institute on Aging produced an educational videotape on Behavioral Treatment of Urinary Incontinence: Biofeedback of the Bladder and Sphincter Muscles, in which NIA Director T. Franklin Williams put forth the then novel idea that many patients could be treated by "nurses who had received adequate instruction in the behavioral science principles and techniques", after proper diagnosis and screening by medical professionals. 

 

Unfortunately, "adequate instruction" was never defined by NIA, and we now find hundreds of nurses and physical therapists engaged in incontinence biofeedback with very minimal training -- if any -- in the underlying "behavioral science principles and techniques".  Most have been inspired by a lecture or short workshop at a professional meeting, and their only training has been reading the product's instruction manual. 

 

There are two unfortunate consequences.  First, many patients are now being discharged from biofeedback treatment with far less than optimal success, simply because the clinician has exhausted his or her limited repertoire of skills.  They are simply told, "That's all we can do for you", when in fact a more competent clinician would have been able to produce better results. 

 

Second, frustrated clinicians often resort to unproven or less successful techniques, including manual therapy and electrical stimulation, when they reach the limits of their biofeedback training. 

The original pelvic muscle incontinence protocol described by Arnold Kegel, MD, in 1948, involved the thrice-daily use of an at-home biofeedback training device to obtain the "91% success rate[5]" he boasted.  In sharp contrast, the NIA Lab relied on office-only treatments using bulky, expensive and complex manometric instruments, in part because there was no compatible home training device.  But it appears that the NIA may have been justified in using their model, since they obtained results as good as the Kegel protocol.  The critical question today is, what happens when someone with less experience and training uses the NIA model but does not obtain NIA-level results?[6] 

 

Many clinicians whose patients are not getting NIA-level results with biofeedback turn to electrical stimulation devices for at-home "practice".  Their rationale is that (1) these devices might help, (2) they are effortless to dispense, (3) they require hardly any patient education and (4) neither device is reimbursable anyway.  Those are not good reasons.

 

 

THE INTRUSION OF ELECTRICAL STIMULATION

 

I have been told by very reliable sources that, in some sections of the country, Medicare carrier policies are now "bundling" electrical stimulation with biofeedback, and at least one clinician in New York has reported that she was told she would only receive reimbursement for biofeedback if she also provided electrical stimulation! 

 

I would like to point out that the practice of combining "office biofeedback" with "at-home electrical stimulation", while it may be becoming popular, has never been the subject of any published research, peer reviewed or otherwise.  There is absolutely no scientific basis for mixing these apples and those oranges. 

 

The original treatment model developed in 1948 by Dr. Arnold Kegel involved the use of his simple "perineometer" for both office evaluations and home practice.  When I first became involved in helping Farrall Instruments of Nebraska develop suitable modern devices for biofeedback in 1981-82, I designed (1) a Clinical Perineometer™ for office evaluations and (2) a Personal Perineometer™ for at-home practice.  A decade later this Self Regulation Systems adopted this model and manufactured the "Orion-Perry Teacher" (office unit) and the "Orion-Perry Trainer" (home unit) for many years.

 

Subsequently several manufacturers -- over which I have no control -- have copied my dual device model (office and home biofeedback instruments), and developed specialized products optimized for treating incontinence.  These include Hollister/InCare, The Prometheus Group, Verimed International, Thought Technology Ltd, and others.  All of these systems are technologically sophisticated and they are probably equally effective, differing only in price, style and operating convenience.  In addition, virtually all conventional EMG biofeedback instruments may be used in rehabilitation of the pelvic muscles for continence control[7].

 

Several years ago I was chatting at a professional convention with a representative of one of the largest and best-known manufacturers of stimulators for incontinence.  "We are going to come out with a biofeedback device soon," he boasted.  "When are you going to come out with electrical stimulation?"   I replied that I would do that just as soon as I encountered a single patient who could not get 100% relief with biofeedback alone.  That is still my position.

 

In my reviews of the literature, it is clear that electrical stimulation studies invariably produce results that are typically close to only half as effective as biofeedback studies.[8]  This fact is sometimes obscured, as stimulation studies usually boast about the "patients improved" rather than the actual symptom (leak) reductions.  Even the AHCPR Guidelines were sometimes confused by the two reporting methods.[9]  In the tables in the attachment to this letter I have described both rates for biofeedback studies.  I urge the panel to pay close attention to this problem in evaluating research. 

 

There are, therefore, two paths to consider in making these technologies available to the American people in an effort to reduce suffering while reducing unnecessary and ineffective treatments for incontinence. 

 

You could expand the available options by approving both biofeedback and electrical stimulation devices for reimbursement.  This would result in many patients getting less effective therapy, but it would still cut down on surgery and pharmaceutical expenses that would otherwise be paid for by Medicare.

 

Second, you can require that clinicians who submit claims for biofeedback actually be trained in the use of that modality, as first stipulated in 1985 by Dr. Williams of the NIA.  This would result in the vastly improved patient outcomes, and ultimately greater cost savings to Medicare.

 

 

AUA OVERLOOKS AMERICAN RESEARCH

 

The American Urological Association has never been enthusiastic about the intrusion of behavioral treatment methods into what was formerly the exclusive realm of surgery and drug therapies.  When the AHCPR released their Guideline in March of 1992, several medical organizations quickly endorsed their "least invasive method first" approach.  But it took the AUA some nine months before even a limited endorsement was announced. 

 

In the past eight years, very little has changed.  Many urological websites, for example, continue to list "Surgery and Drugs" ahead of Behavioral Methods, which are sometimes not even mentioned at all[10].  Thus it is not unexpected, however unjustified, that biofeedback is only weakly mentioned in the report AUA submitted to HCFA (The "Report of the Ad Hoc Committee to Suggest Broad Guidelines for the Management of Urinary Incontinence", chaired by Alan J. Wein, M.D.) 

 

And it is understandable that the AUA Guidelines are based almost entirely on the 1998 Monaco Report, of which Dr. Wein was also a co-author.  What is less than understandable is that the AUA report, written in the summer of 1999, fails to even mention one of the most significant biofeedback publications of the decade: Burgio et al, "Behavioral vs. Drug Treatment for Urge Urinary Incontinence in Older Women", a RCT published in the respected Journal of the American Medical Association, December 16, 1998. 

 

JAMA is hardly an obscure publication, and this article even attracted a lengthy Guest Editorial, "Improving Treatment of Urinary Incontinence", by Neil Resnick, M.D.  "The efficacy of biofeedback was impressive", Resnick wrote, but somehow the research did not attract the attention of the AUA. 

 

The AUA Broad Guideline gives a faint acknowledgement of biofeedback (and the other AHCPR Guidelines Behavioral Therapy recommendations) in Appendix 8.  This appendix lists treatments for "Bladder Related Incontinence" and "Sphincter Related Incontinence" as including "Pelvic floor exercises +/- Biofeedback" (presumably, "with and without biofeedback"). 

 

But even this luke-warm endorsement disappears when AUA turns to the detailed treatment algorithms devised by the Monaco conference.  Those European algorithms allow very little room for biofeedback.  Biofeedback is only mentioned as a first-line treatment in one place, the "Frail Elderly" (p. 969), a population not generally considered good candidates for surgical intervention anyway.  For "Women", it is only recommended as an advanced treatment for overflow incontinence (p. 963).  (This is rather odd, since "Women" with stress and/or urge incontinence comprise the vast majority of both the published research studies and the patient populations at US Continence Clinics.)  In the treatment of "Men", biofeedback is not mentioned at all. (Yet men with post-prostate incontinence make up as much as 20% of the clientele of Continence Clinics.)  Biofeedback is not mentioned at all in the treatment of "Neurogenic Urinary Incontinence" (p. 953, 955). 

 

Finally, Biofeedback is not mentioned as a treatment in the flow charts for "Children", except for this one passing reference: Formal urodynamic studies are not recommended for children who will be "treated by non-invasive means, for example, bio-feedback [sic]…(p. 954)".  But there is no direct statement of which children should be treated with biofeedback.

 

The poor opinion of biofeedback on the part of the predominantly European experts may be a result of the fact that biofeedback is still largely an American art, with comparatively few practitioners in Europe, Australia, Africa, or Asia.  This is reflected by the fact that the "Association for Applied Psychophysiology and Biofeedback"[11] will hold its 31^st annual convention in March 2000; in contrast, the new Biofeedback Foundation of Europe will hold only its fourth annual meeting this year.  Although AAPB encourages international participation, 97% of its members live in North America.

 

The Monaco conclusions are largely derived from the experience of countries where biofeedback has barely begun to be practiced, for incontinence or for any other condition.  Since AUA's position is based so heavily on the Monaco conclusions about research, a detailed consideration of the accuracy of Monaco is in order, and that is the subject of an extensive attachment to this letter. 

 

I believe this attachment shows that the Monaco conclusions about biofeedback, like the Berghmans et al (1998) paper on which they are based, draws very erroneous conclusions about the efficacy of biofeedback.  Since the AUA used the Monaco conclusions verbatim (with actual photocopies) it seems clear that AUA did not conduct its own evaluation of the primary literature on biofeedback for incontinence.  Thus any misleading conclusions of the Monaco report would simply be echoed in the AUA Broad Guidelines. 

 

This is not meant to be a comprehensive review of the AUA's Broad Guidelines.  Suffice it to say that the AUA's position appears to be a restatement of traditional and European practices that have never acknowledged or recognized the Incontinence Guidelines published by the U.S. Public Health Service in 1992 and restated in 1996. 

 

I thank you for your attention to my testimony.  It is my plan to attend the public hearing in Baltimore on April 12-13, and I will be happy to clarify any statements or opinions expressed here at that time.  I would also respond to questions received directly in the intervening time. 

 

 

Very Truly Yours,

 

 

 

 

John D. Perry, PhD, MDiv, Senior Fellow - BCIA, FAACS

Psychologist (Licensed in Pennsylvania)

 

Enclosure: "Monaco Report Reviewed"