Many readers are probably thinking that criticism of the famous "Guideline" on "Urinary Incontinence in Adults: Acute and Chronic Management" is an unfortunate example of "Biting the hand that feeds you". Since published in 1992, and revised and improved in 1996, the Guideline has been a rallying point and major weapon in the hands of biofeedback therapists in the perpetual war against third party payers who want to label everything newer than 20 years old as "experimental" and therefore "not a covered service". It is difficult for them to argue that what the U.S. Public Health Service labels as the first line of attack on incontinence is still "experimental". The inclusion of "levels of evidence" paragraphs in 1996 further strengthens this interpretation.
Indeed, legal experts (such as Elizabeth E. Hogue, Esq. of Silver Spring, Maryland) have opined that, given the existence of the guideline as defining current medical procedures, any person who offered riskier treatments (such as surgery or drugs) BEFORE offering behavioral interventions would likely be guilty of malpractice!
Nevertheless there are serious errors in the Clinical Practice Guideline which practitioners need to be aware of because they affect many of the treatment decisions that have to be made in clinical practice. This essay attempts to point out those errors, understand how they came about, and offer corrective information.
The context that produced the Guideline is important. Individual sections were first drafted by experts in each particular topic, but then the whole committee struggled to reconcile differences and produce a report that was acceptable to the majority. And, it is worth noting that a 63% majority (10 out of 16 members) were physicians, while three were nurses, only one psychologist, and one occupational therapist. Given the predominance of medically-trained personnel, it is a minor miracle that behavioral treatments came out on top. Their superiority in treating incontinence must have been uncontestable.
The biofeedback section of the Guideline was reportedly based on the contributions of Jeanette Tries, MS, OTR, the panel's biofeedback expert. Tries had been personally trained in ano-rectal manometry by Kathy Burgio, PhD, in her Baltimore laboratory, and later carried the Schuster balloons back to Milwaukee, were she used the Burgio method to treat patients at Sacred Heart Hospital. She soon developed an international reputation for her innovative and effective work, especially with spinal cord injured patients. She served as a consultant to many hospitals and clinics seeking to set up a similar service for severely disabled patients.
Tries became an advocate for Schuster balloons, and she worked closely with E. J. McGowan and Associates to develop and market a computer-based multi-channel manometric system. But large-balloon manometrics is a clumsy, highly invasive, quite painful and unpleasant method, and it was soon eclipsed by the EMG biofeedback systems. Tries reluctantly embraced the newer technology, but she never gave up her reliance on "multi-measurement" techniques that were required by the manometric (3-balloon) system.
Most people only know Tries as a dedicated and effective clinician, who teaches a popular annual workshop at the Association for Applied Psychophysiology and Biofeedback, and a talented writer of research reports in peer-reviewed journals. But according to papers which she has presented at AAP&B and at the International Continence Society meetings, she has also been hard at work for several years developing a "multi-measurement" commercial product. Tries claims -- but offers no real evidence -- that her two-channel anal sensor and electrified vaginal cone combination provides better diagnostic and therapeutic information than the traditional (single-channel) EMG sensor invented by this author. A few years ago Tries and her teacher-now-partner Eugene Eisman obtained a patent on their "Multi-Electrode Probe" ("MEP") and subsequently signed a licensing agreement with a well-known Boston-area manufacturer. The MEP is still in the testing stages, but Tries and Eisman are already receiving regular quarterly royalty checks for their "MEP" device.
Tries' commercial interest in a multi-measurement sensor product helps to explain the curious distinction which the Guideline makes between "multi-measurement" and "single-measurement" devices used in research studies. The fact that she received her original training from Kathy Burgio also contributes to her conclusion that Burgio's research sets the norm for biofeedback treatment of incontinence -- despite the fact that several single-measurement research projects have obtained far better results than Burgio's 3-channel ano-rectal manometry. Perhaps Tries is hoping that the professions will really believe that multi-measurement devices are superior, in which case she would reap financial benefit when her multi-measurement device, the MEP, is finally introduced in commercial distribution. (Except for a few gastroenterologists, no one is using or buying ano-rectal manometrics any more; the technical superiority of EMG devices has made them obsolete. Even the NIA lab started by Marvin Schuster himself is now using Perry brand sensors and PerryMeter biofeedback instruments.)
In her later publications, even Burgio stopped using the "internal anal sphincter" (IAS) channel, which was originally devised to detect the relaxation of the IAS in anticipation of a bowel movement. The IAS channel no longer had a role when Burgio translated the fecal incontinence and constipation technology into the urinary incontinence realm, since the IAS is irrelevant to urinary control.
So the "multi-measurement" biofeedback that the Guideline discusses for treating urinary incontinence is really only "two-channel" biofeedback, anyway. The first channel is for the external anal sphincter (EAS), important because it usually works in tandem with the entire pelvic floor, which in turn impinges on the urinary control area (usually!). The second channel (in manometrics) is the deeper rectal distention balloon. Originally this balloon was devised to be progressively inflated, in order to increase its size in the rectum, and thus determine the level of nerve sensitivity of the lower anal canal. This is valuable in treating fecal incontinence.
But because the rectal distention balloon sits behind the bladder, it was filled with air or water and used as an indirect measure of inter-abdominal pressure when treating urinary incontinence. But the EMG alternative is considerably less painful, less messy, and less dangerous. Standard surface EMG electrode pads are simply attached to the abdominal wall to readily detect contractions of these abdominal muscles, without the invasiveness of a rectal balloon.
Many clinicians, such as Linda West, RN, swear by these external abdominal electrodes, but the fact is that there has never been a single controlled study that showed any advantage to using the abdominal electrodes. Some people use them, some don't. Does that mean the others don't care about abdominal contractions? Of course not! The fact is we have found easier and cheaper ways to monitor abdominal contractions.
We have been training clinicians for years how to teach the patient to place her own hand on her belly, half-way between the umbilicus and the public bone. First depress the abdominal wall about an inch (poke a finger into the flesh) and THEN make a Kegel contraction. If the finger moves out, the patient is contracting the abdeminal muscles (either instead of, or in addition to, the pelvic muscles). But if done correctly, the finger remains in the same position. This "manual" technique also has the advantage that the patient can practice it at home while using a single-channel EMG home trainer. This is a good example of non-instrumented biofeedback, and it works very well. In other words, even if you do use an abdominal electrode, you should also teach the "finger" method.
So the distinction between "multi-measurement" and "single-measurement" biofeedback is not as clean as the Guideline would suggest. The difference is really between "two-measurement" and "one-measurement plus manual feedback" methods. In my own practice I always taught the finger-in-the-belly technique, and I only utilized an abdominal EMG electrode when the patient was having trouble -- which was rare (less than 1%?)
Some people (not biofeedback-trained) have suggested that patients could learn just as well by getting rid of the vaginal (or anal) EMG sensor, and use the same "finger" technique in the vagina or rectum. Although this appears plausible, there are distinct disadvantages. First, many people are not comfortable doing that for a variety of aesthetic and other reasons.
Second, one of the reasons EMG biofeedback is so very effective is that it allows precise quantifiable measurement of the muscle activity. We are able to say to a patient, with good scientific justification, "Last week your muscle was 5.2 microvolts, this week it is 10.4, or twice as strong. Now do you see the benefit of doing all that boring exercise?" This kind of reinforcement can be a major factor in motivating patients.
In contrast, the measurement of abdominal contractions does not need to be precise, because any contraction there is "bad". It's an all-or-nothing thing; you don't need to know precisely how much muscle was being used, because any is wrong. In addition, because of the effects of layers of fatty tissue on EMG signal pickup, there are not, and never will be, any "norms" for the magnitude of abdominal EMG signals.
Some people have contended that the superfluous advocating of EMG surface electrodes to the patients' bare flesh, just above the public hair, was an attempt on the part of (mostly female) nurses to keep (mostly male psychologists, who invented the technique) out of the practice -- not unlike the way obstetricians squeezed midwives out of the delivery room by making birth a "medical" problem. But I don't believe anyone consciously thought that out.
The Guidelines discussion of biofeedback takes place in the context of pelvic muscle exercises in general (p. 36-38), and biofeedback is seen as one way -- albeit the best way -- to "augment" naked pelvic muscle exercise ("PME"). PMEs are introduced as "also called Kegel exercises", despite the fact that Dr. Kegel NEVER advocated PME without biofeedback (see the several papers on this website dealing with this misattribution).
Additional critical comments are provided within the text, using a different typeface. Underscores are used to call attention to especially significant statements in the original, which are then discussed below.
Pelvic muscle rehabilitation and bladder inhibition using biofeedback therapy are recommended for patients with stress UI, urge UI, and mixed UI. (Strength of Evidence = A.)
Some type of biofeedback device is often used to assist patients to gain function and pelvic muscle awareness (Burns, Pranikoff, Nochajski, et al., 1990). The aim of biofeedback therapy, which uses electronic or mechanical instruments to relay information to patients about their physiologic activity, is to improve bladder dysfunction by teaching people to change physiologic responses that mediate bladder control (Burgio and Engel, 1990). Auditory or visual display of this information forms the core of biofeedback procedures (Schwartz, 1995). Biofeedback for UI typically uses single measurement (surface, needle, vaginal, or anal probe) EMG or manometric methods. Biofeedback using multimeasurement feedback methods involves simultaneous measurement of pelvic and abdominal/detrusor muscle activity. Biofeedback should be used in conjunction with other behavioral techniques such as PME and bladder training. As with all of the behavioral techniques, successful application of biofeedback depends greatly on the knowledge and skill of the health care provider, whose knowledge must include familiarity with evaluation techniques, anatomic and physiologic correlates of the different forms and symptoms of bladder dysfunction, instrumentation, and behavioral principles that guide the procedure.
Studies on the various applications of biofeedback combined with behavioral treatment report a range of 54-87 percent improvement in incontinence across various patient groups using different biofeedback and behavioral procedures. Some biofeedback protocols use only one measure for reinforcement of pelvic muscle contraction, whereas others use up to three, and include measures of abdominal and detrusor activity. The biofeedback protocol that has been associated with the largest and most consistent symptom reduction is one that reinforces pelvic muscle contraction concurrently with inhibition of abdominal and detrusor contraction. Reports using this multimeasurement method show a 75.9-82 percent reduction in UI across six studies involving 166 subjects (Burgio, Robinson, and Engel, 1986; Burgio, Stutzman, and Engel, 1989; Burgio, Whitehead, and Engel, 1985 Burton, Pearce, Burgio, et al., 1988; McDowell, Burgio, Dombrowski, et al., 1992).
Comment: In order to define a range of 54 to only 87 percent improvement rate, the Guidelines committee had to leave out a number of published reports that contradict their "modest" results. Arnold Kegel, for instance, reported several times a "93%" or better success rate. The very best published results were given by Perry et al (1988) who reported a 98% cure rate for EMG biofeedback. This study, unlike almost all others except Kegel's, used paying patients (rather than PAID research subject), so their motivation level was quite high. In addition, all patients were required to use EMG home trainers on a daily basis. Williams et al (1996) reported an 88% improvement (with intermittent use of home trainers), and Sussett (1990) reported a 87% improvement rate using only manometric home trainers.
The Guidelines claim that "The biofeedback protocol that has been associated with the largest and most consistent symptom reduction is one that reinforces pelvic muscle contractions concurrently with inhibition of abdominal and detrusor contractions. Reports using this multimeasurement method show a 75.9-82 percent reduction in UI across six studies involving 166 subjects [with references to five studies involving Kathy Burgio's use of anorectal manometry.]"
In other words, the Guideline is saying that, even though other methods get better results, the "multimeasurement" method of Burgio has been the protocol with the "largest and most consistent symptom reduction". In this choice example of government doublespeak the superior results of other methods are overlooked in favor of the more "consistent" results of Burgio's method. In this context we can only assume that "consistent" refers to the fact that Burgio participated in several studies, all of which got the same rather mediocre results. Even still, the statement is just plain WRONG; Burgio's published results ranged from 75.9 to 95 percent reduction.
It is worth nothing that Burgio pioneered the "percent symptom reduction" statistic in her NIA research studies. When one takes a closer look at her data, one discovers the the number of patients actually CURED is only 29% (across her first four studies). A closer look at these Burgio studies may be enlightening.
(1) Burgio, Robinson & Engel (1986) compared manometric biofeedback with verbal instruction (with digital palpation) and found 75.9% improvement, vs. 51% (n=13 & 11) (Running Total, 24 patients)
(2) Burgio, Stutzman, & Engel, (1989) studied 20 post-prostatectomy patients with UI; those with urge incontinence reduced their accidents 80.7%, stress was down 78.3%. (Running Total, 44 patients)
(3) Burgio, Whitehead & Engel (1985) studied 39 elderly patients with urinary incontinence. The Stress Incontinent group dropped 82 percent, the Motor-Urge group dropped 85%, and the straight "urge" group dropped 95%. For unknown reasons, this study, which contradicts the "75.9 to 82%" dictum, is not discussed in the text, although all the others are discussed there. (Running Total, 83 patients)
(4) Burton, Pearce, Burgio, Engel, and Whitehead (1988) compared verbal instruction to sphincter biofeedback in 27 patients; the former improved 82%, the later only 79%. However, most patients (3/4) suffered urge incontinence, and the therapy was carried on for six sessions (50% longer than most manometric studies.) (Running Total, 110 patients) [Compared to the 95% success rate in the preceding study, this was a rather mediocre result, especially since they actually got more practice sessions.]
(5) McDowell, Burgio, Dombrowski, Locher & Rodriquez (1992) provided behavioral treatments including biofeedback to 29 non-demented outpatients, resulting in an average improvement of 81.6% (symptom reduction). One third (10) of them achieved continence, which is on a par with Burgio's other studies (averaging 29% continent). Curiously, they used both ano-rectal manometry and Perry-brand EMG sensors, but comparative data was not reported. As in the other Burgio studies, no patients were able to use home trainers. (Running Total, 139 patients)
(6) Although "six" studies were mentioned, only five references were provided. And instead of the promised "166 patients" we find only 139 patients -- a discrepancy of 27 patients!
So there are two major problems with this pivotal paragraph. Even a cursory glance shows that the "75.9-82%" figure is incorrect; these studies in fact reported a 75.9 to 95% reduction in symptoms. Experience with "committee editing" suggests that the panel hastily changed the summary statement from 95% to 82%, without realizing that the 82% was contradicted a few sentences away.
Second, by their own calculation, even the Susset study demonstrated an 87% improvement, so how can they conclude that the Burgio technique is consistently "superior"? Susset got the same results with a few $500 home trainers that Burgio got with a $25,000 polygraph system.
The presumed benefit of the multimeasurement procedure is that it reinforces pelvic floor contraction directly with moment-to-moment feedback, which characterizes for the patient the quality and intensity of the kinesthetic feedback to the desired contraction, and as a result the patient uses an attenuated internal reference to upgrade muscle contractions. Combining bladder and sphincter biofeedback also allows teaching pelvic muscle contraction in response to increasing bladder volume and observed detrusor activity.
Here's another choice example of doublespeak; no benefit has been shown for multi-measurement technique, despite its prejudicial "presumption". The first sentence applies equally to ANY number of channels. The second sentence may be confusing to some readers, because the Guideline text does not mention the fact that Burgio often used Cystometric Biofeedback -- filling the bladder with water and showing the results either with electronics or visually (standing water column). (Quite possibly a description of that was removed from an earlier draft to shorten the text.) However effective it may have first seemed, the practice has been largely discontinued since (1) Burgio admitted at the 1988 Consensus Development Conference that she got a "three to five percent" infection rate from the method and (2) as good or better results are obtained with simple EMG biofeedback of sphincter contractions (Plummer, 1996, p. 25).
In a controlled study, Burgio, Robinson, and Engel (1986) found that 13 subjects (mean age 47.9) receiving multimeasurement biofeedback reduced incontinence by 75.9 percent compared with a 51-percent reduction obtained in 11 subjects (mean age 40.7) who received only verbal feedback and instruction for PME with digital palpation. The multimeasurement biofeedback method has also been used successfully in the treatment of UI in postprostatectomy patients with urge and intermittent stress incontinence (Burgio, Stutzman, and Engel, 1989). However, another study demonstrated that when subjects complained primarily of urge incontinence, no benefit was obtained with the addition of biofeedback to behavioral training and PME, which was provided by a well-trained clinician over an average of five clinic sessions (Burton, Pearce, Burgio, et al., 1988). The results of this study should be interpreted with caution, however, because the groups differed in severity before treatment.
That's an understatement.
Several studies have also demonstrated significant reductions in UI associated with neurologic disease and in the frail elderly using a combination of multimeasurement biofeedback and other behavioral techniques such as bladder training (McDowell, Engberg, Weber, et al., 1994; Middaugh, Whitehead, Burgio, et al., 1989; O'Donnell and Doyle, 1991). Because multimeasurement biofeedback can provide specific reinforcement for pelvic muscle contraction that is isolated from counterproductive abdominal contraction, it is assumed that awareness of pelvic muscle contraction can be achieved more efficiently than from vaginal palpation alone.
Note more doublespeek. The first part of this is about multimeasurement biofeedback, but the whole applies equally to single-channel biofeedback as well. Only the one primary channel carries information about pelvic muscle contractions. The reason (any) biofeedback is "more efficient" than vaginal palpation alone is that the later technique (subjective rating on a 0 to 4 scale) is notoriously inaccurate and imprecise. EMG biofeedback is more efficient because it is (1) more precise -- data in tenths of a microvolt -- and (2) it is an order of magnitude (10X) more sensitive, since it can detect muscle polarization well below the level that results in actual contraction of the muscle.
Contrary to the implications of this paragraph, Kegel NEVER advocated "vaginal palpation" as a means of "reinforcing" contractions. Palpation was used to identify the muscle. Reinforcement came from observing the needle on Kegel's biofeedback instrument.
The Guideline then selects from the available single-channel studies an example of a poor outcome and an excellent outcome -- with better results than Burgio's average.
In contrast to multimeasurement methods, the reduction in number of pad changes per 24 hours ranged from 43 to 54 percent when single-measurement biofeedback is used, when excluding a subgroup who had received only one biofeedback session (Wilson, Faragher, Butler, et al., 1987). This improvement was attained in an approximate average of 11 sessions (0.5-1.5 hours each). Another study (Susset, Galea, and Read, 1990) used single-channel biofeedback over six weekly clinic visits and a home trainer with which the subjects practiced daily. These subjects demonstrated an 87-percent reduction of leakage on pad test, suggesting that a home training device may provide an added benefit to clinic biofeedback visits, especially when only single-channel biofeedback is used.
This is a curious statement. If a home training device (used alone) provides better results than Burgio's cumbersome polygraph, why add the final phrase (above)? Obviously the home training device "may provide an added benefit" to any clinical system, be it one or two or ten channels!
In a randomized controlled study, Burns, Pranifoff, Nochajski, et al. (1993) studied 135 women (age range 55-75 years) with primary stress incontinence in three groups. One group received PME, and another group received single-measurement EMG biofeedback to perivaginal contraction for 20 minutes per week. The two treatment groups demonstrated a 54- to 61-percent reduction in incontinent episodes, compared with a 6-percent reduction of incontinence in the control group, but no difference between the two treatment groups was found. The improvements were maintained over a 6-month followup, and patients with moderate-to-severe symptoms showed even more improvement in the posttreatment phase. This study demonstrated that PME reduces incontinence and provided evidence that symptom severity has a role in response.
The Burns el al study has so many flaws that it will itself be the subject of a critical review on this website. The study is presently being used by Aetna to "prove" that biofeedback is superfluous (and therefore, not covered), since the "non-biofeedback group" got "almost" as good a result as the biofeedback group (54 to 61%).
(1) One problem with this study is that the "no-biofeedback" group wasn't really virgin; they actually received two testing (evaluation) sessions with the Perry brand sensors and EMG instruments, one before and one after their so-called verbal-instruction-alone exercises. I have seen several patients who "got it" with only a single EMG biofeedback session, so there is a high probability that this "control group" actually obtained some benefit from their two "testing" sessions. (See the discussion of the Heisenberg Principle at work in The Kegel Bibliography.)
(2) Of greater concern is the fact that neither group did very well, in spite of the author's claims to the contrary. Burns' 61% improvement for "biofeedback" is the poorest published result ever obtained with the use of Perry brand sensors. In Burns' grant application she had specified that the biofeedback technician would obtain BCIA certification, but that never happened, so we are unable to confirm that the tech was competant.
(3) One reason for the poor results is that the instruments Burns used did not collect data in the industry-standard way. It has been known for some years, and the instruction manuals (that Burns received when she bought the sensors from me) pointed out that only the "10-second hold" data is significantly related to incontinence control. Despite having a big government grant, Burns refused to purchase standard equipment, and instead used an small computer (this in the early 1980's!) to collect data "her own way". She recorded not the ten-second average, but the "best five seconds" that a patient could produce, thus obtaining an irrelevant "phasic" muscle score. In other words, we don't really know if Burn's patients learned anything from their biofeedback training because we don't have their "tonic" muscle scores. Judging from their poor improvement, they probably didn't learn much. 20 minutes of EMG biofeedback once a week for 10 weeks is not an effective protocol.
(4) Another concern is the discrepancy between various reports given by Burns. At the 1989 AUA meeting in Dallas, I was present when she reported that the six month follow-up showed that the biofeedback group actually improved on their continence control, where as the PME (verbal) group had regressed towards the control group, so that only the biofeedback group was statistically significant now. But when this study was published four years later, the verbal group's "regression" had mysteriously disappeared. Unfortunately there was no written report of the AUA paper to document this discrepancy.
Further research is needed to determine which biofeedback protocols ensure that optimal outcomes are achieved in individual conditions and what methods provide the most valid measures of pelvic muscle function. The multimeasurement biofeedback appears to produce greater reduction in incontinence compared with PME alone or single measurement biofeedback. It is not known, however, to what degree detrusor or intra-abdominal pressure biofeedback individually contributes to the outcomes reported.
As detailed above, this "summary statement" is flat-out FALSE. The best results have clearly been obtained with the use of home trainers (Kegel, Perry, Susset) and single-channel EMG biofeedback (Williams). And the concluding statement is a gross understatement; not only is it "not known" but there is not one shred of evidence that it does contribute to improved outcome. This essential fact may get lost because of the constant advocacy for the multi-measurement system.
Summary of findings. Overall, the literature indicates that PME and other behavioral strategies, with or without biofeedback, can "cure" or reduce incontinence. Maximum benefit is derived from any pelvic muscle rehabilitation and education program when ongoing reinforcement and guidance are provided. Also, the intensity of the exercise program seems to influence both functional and physiological outcomes, and multimeasurement biofeedback protocols seem to yield the greatest and most consistent reductions in UI (Bo, Hagen, Kvarstein, et al., 1990; Burgio, Robinson, and Engel, 1986; Elia and Bergman, 1993; McDowell, Burgio, Dombrowski, et al., 1992).
One way that "intensity" is related to good outcomes is that patients who use home trainers get many more biofeedback practice sessions than patients who do not. It is easy to slack off on practice when (as in verbal exercise alone) there is no external evidence that you are doing the exercises. One study found an 85 percent NON-compliance rate with plain PMEs. In this vein, the use of audio exercise tapes is probably better than nothing, since the patient can't fool herself; either she worked through the whole tape, or she didn't. For an extensive discussion of this topic, see "The Role of Home Trainers in Kegel's Exercise Program", on this website.
In another critique we will examine the PME section itself, which has many problems. In the opening section, for example, it describes PMEs as "drawing in" or "lifting up" of the internal muscles -- and attributes this description to Rose, Baigis-Smith, Smith et al, 1990. But that study actually taught their patients how to contract with EMG biofeedback using Perry brand sensors!
Such are the liberties that the AHCPR Guideline took with the scientific literature.
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Draft of: 05/04/05 12:46 AM