1. Authority.  The Association for Applied Psychophysiology and Biofeedback (AAPB) is the world's largest and oldest professional organization dealing with both clinical and research issues in the field of Biofeedback.  Virtually all of its members hold simultaneous membership in the various medical, psychological, nursing, physical therapy and social work organizations.  AAPB is recognized by the American Psychological Association as a qualified "dual membership" organization.  AAPB held its 30^th Annual Meeting in April 1999.  Historically, members of AAPB have contributed most of the early research leading to the contemporary use of biofeedback in the treatment of incontinence.[1]

 

2. Professional Collegiality.  Members of the AAPB have worked closely for many months with the members and officers of the SUNA/WOCN Continence Coalition in the research and preparation of their "Utilization Parameters for Pelvic Muscle Rehabilitation Using Biofeedback" which, we have been informed, was submitted to HCFA on October 7, 1999.

 

3. Limited Endorsement.  The AAPB is pleased to ENDORSE, in general, the Continence Coalition's Recommendations for Utilization Parameters.  We believe that they represent a reasonable, fair and accurate picture of the contemporary role of biofeedback in the treatment of incontinence, and that adoption of the parameters [with the qualifications below] would be in the best interests of the American people and would be cost-effective for the Medicare system.

 

4. Qualifications to Endorsement.  The Coalition's October 7^th document contains a small number of apparent errors and a few statements that, from a biofeedback expert's viewpoint, should be corrected before these Parameters become policy.  By implication now made explicit, we support those statements, which are not discussed in this paragraph (#4).  Our exceptions are listed in the order of their appearance in the original document, not in order of importance.

 

A.   "Kegel Exercises are the time-honored approach for treating UI…"  This statement, a popular misunderstanding, is historically inaccurate.  Verbally instructed exercises for UI have only been "honored" for about two decades, including the 1970s and 1980s.  Prior to that, the "time-honored approach" was the biofeedback method introduced by Arnold Kegel, MD, in the 1950s and 1960s.  Although the term "biofeedback" was not used until about 1969, the AAPB, at its 20^th Annual Meeting in 1979, gave special recognition to a paper that argued that the Kegel Perineometer (biofeedback) device antedated the formation of the Society by fully 20 years (Perry & Talcott, 1989)  "Verbal instruction" only became the fallback method when Kegel's biofeedback device became commercially unavailable.

 

B.    Inclusion Criteria.  The criteria for inclusion in biofeedback may be slightly overstated in the Coalition's position paper.  Many patients with some cognitive deficit have been successfully treated when actively supported by their primary caregiver. 

 

C.   Evaluation Prior to Biofeedback: Optional Tests.  This paragraph appears to contain a serious typographical error, which effectively reverses the original meaning.  In the early drafts of the document, the "Optional Tests" paragraph included only "urodynamics" and "cystoscopy".  Then followed a "paragraph mark", and the sentence beginning "In addition to these assessments [objective documentation, etc.]" was a freestanding next paragraph. 

The syntax "In addition" still makes it clear that "these assessments" refers to the entire list of six items, "history" through "optional tests".  The paragraph was intended to assert that "objective documentation of pelvic muscle function using EMG…or pressure manometry… for identification, recruitment, relaxation (release), isolation, strength, endurance and fine motor control" is prerequisite to undertaking a course of biofeedback therapy.

This Principle of Demonstrable Deficiency is a fundamental one in  all biofeedback therapies.  Essentially, it states that in order for biofeedback to be an effective treatment, there must be some externally measurable physiological parameter that can be monitored, displayed, and used by patients to enhance their own performance.  In the case of incontinence, that includes demonstrated abnormalities in the contractile strength, relaxation level, or neurological control of the pelvic muscles, or all three. 

Prior to this year this principle was well known and always taught in biofeedback training programs.  But in the September, 1999 issue of the Journal of Reproductive Medicine, Dr. Howard Glazer et al published the first formal study that empirically justified the practice.  In " Pelvic Floor Muscle Surface Electromyography; Reliability and Clinical Predictive Validity ", Glazer et al showed that "SEMG data demonstrated significant test-retest reliability (p<0.001) and significant predictive validity (p<0.05) to undifferentiated urinary incontinence, stress incontinence [and] urge incontinence…" (1999).

Therefore, we recommend that a competent EMG evaluation (CPT 51784) always be included as part of the assessment of potential biofeedback therapy patients.

 

D.   Therapies Suggested Prior to Biofeedback-Directed PMR.  This paragraph appears to be a "committee compromise" which in fact contains contradictory recommendations.

It begins by authorizing the use of common nursing interventions (verbal feedback from manual palpation [of the vagina]) because it "is sometimes effective."  If that fails, then biofeedback is recommended.  This appears to be a concession to the (so-called) "time-honored tradition" of nursing.  However, these is no precedent in medicine for continued use of ineffective treatments based on the fact that "we have always done it this way", and it "might" be effective. 

Moreever, the same paragraph then sets forth three conditions, any one of which would override the first recommendation.  In fact, the first two conditions would be readily detected in the "EMG evaluation" (C, above) and the third (use of pharmacological therapy) would be evident in the "history". 

There is no Medicare advantage in subjecting patients to older, less effective (and more time-consuming) treatments.  If the role of the EMG evaluation (C, above) is restored to its original emphasis as the ultimate test of suitability, and if the patient meets any of the three conditions described in this section, there is no reason why such patients should not proceed directly to biofeedback treatment programs. 

E.    The Use of Home Trainers.  The original Kegel training program was based entirely on the thrice-daily use of his at-home biofeedback trainer, as described in all of his published articles.  And, we agree, published research strongly suggests that better results are obtained when patients are able to use biofeedback to practice on a regular daily basis, with periodic professional supervision.  [This is consistent with the use of home training devices, when ever possible, in all other applications of biofeedback.]  

Currently many patients nationwide rely on rental home trainers available from a wide variety of medical device suppliers, specialized rental companies, and many equipment manufacturers.  The use of home trainers is widely believed to shorten the overall therapy time, and thus ultimately reduce costs of treatment.  We support Medicare reimbursement for these rental devices.

Moreover, Medicare regulations should be written in such a way as to be flexible to technological advances that are expected to lower the cost of outright purchase of these devices in the very near future. 

F.    Inadvertent omission of male patients.  The Coalitition's UP document fails to include consideration of a common difference between female patients, who make up some 80% of clientele at Continence Clinics, and males.  Most male patients suffer from incontinence secondary to prostate surgery, and many clinics confirm that, in general, their therapy takes about twice as long as female stress and urge incontinence.  This sex difference needs to be acknowledged in the sections dealing with the allowable number of sessions and the need for additional sessions. 

G.   Number of Sessions and Documentation.  We find the current list of documentation items could be improved by changing the sequence as follows, and making clear what "progress" is expected in item #1:

1. Progress in Symptom Reduction and Muscle Condition since the last session.  (Review patient diary and assess function, which is now listed as item #4).
2. Goal of each session (no change)
3. Documentation of compliance with treatment plan. (no change)
4. Plan for continued rehabilitation (no change)

 

 

With the inclusion of the seven (7) items listed above, the AAPB emphatically endorses the remaining observations, recommendations, and suggestions contained in the Continence Coalition's Biofeedback Utilization Parameters document of October 7, 1999. 

 

 

 

References

 

Perry JD, Talcott LB.  The Kegel Perineometer: Biofeedback Twenty Years Before Its Time.  A "Special Historical Paper". Proceedings of the 20th Annual Meeting of the Association for Applied Psychophysiology and Biofeedback, San Diego, CA, March 17-22,1989, pp. 169-172.

 

CONCLUSION: Thus the Kegel Perineometer fulfills all of the criterion laid down by the most respected of contemporary authorities, and we are forced to the uneasy conclusion that Biofeedback, by any other name, first began in the late 1940s, and not some twenty years later. Based on our historical analysis, it is clear that Arnold Kegel and his Perineometer deserve far greater recognition than this society has hitherto accorded them.

 

Glazer HI, Romanzi L, Polaneczky M.  Pelvic Floor Muscle Surface Electromyography; Reliability and Clinical Predictive Validity.  J. Reprod. Med. 1999; 44:779-782.

ABSTRACT CONCLUSION: Pelvic floor muscle sEMG is reliable and consistently predictive of several important clinical status variables, suggesting that it can be a useful tool in early at-risk detection and prophylactic intervention for disorders of pelvic floor muscle laxity.  Recent advances in sEMG technology make it cost effective, convenient, noninvasive and easy to learn and administer by assisting staff.  This technology is a powerful complementary tool for digital assessment of pelvic floor muscles and should be considered for use in gynecologic practice.