Critical Reviews:
P. Paul, J. E. Cassisi, & P. Larson. Ethical and Practice Considerations for Biofeedback Therapists in the Treatment of Urinary Incontinence. Biofeedback and Self-Regulation, Vol. 21, No. 3, 1996 (p. 229-240)
Author's Information
Patrice Paul - Illnois
Institute of Technology
Jeffrey E. Cassisi - Jackson State University
Paul Larson - Illinois Institute of Technology
Authors' Abstract
The treatment of incontinence presents many unique issues for biofeedback therapists that are routine for professionals in fields such as nursing or medicine. Although all professional practice is guided by ethical standards, the unique circumstances encountered during biofeedback treatments for this disorder warrant the development of specific guidelines. This is true whether insertable or surface EMG devices are used. Therefore, the purpose of this article is to propose a set of ethical guidelines for biofeedback therapists. The intended audience includes professionals such as psychologists, clinical psychophysiologists, and other mental health-care providers who use biofeedback techniques. These are not formally endorsed by any professional organizations (e.g., APA, AAPB) at this time. Ethical considerations include proper medical evaluation, informed consent, paitent instruction, disrobing, nonerotic physical contact, patient safety, and patient satisfaction.
Descriptor Key Words: ethics; biofeedback; incontinence; exercise; pelvic floor.
Address all correspondence to Jeffrey E. Cassisi, Ph.D., Department of Psychology, Jackson State University, Jackson, Mississippi 39217-0350.This is a long-overdue and highly welcome essay broaching an important and previously undiscussed topic, the special ethical considerations required by the new and rapidly growing field of biofeedback treatment of incontinence. Fortunately, the authors fail to deliver on their promise to "propose a set of ethical guidelines"; there are no such guidelines actually included, but there is a good discussion of some of the important issues that should be incorporated into such guidelines in the future.
The paper covers several topics: (click on topics to jump there, or scroll down to read them all)
1. Some of the major
types of instruments involved in incontinence work
2. The Place of Medical Evaluations
3. Informed Consent
4. Patient Instruction
5. Disrobing
6. Nonerotic Physical Contact
7. Patient Safety
8. Patient Satisfaction
9. Continuing Education and
Certification
Each of these topics will be examined in greater detail.
The authors review the several types of equipment "currently used"; however, they fail to distinguish between equipment that is "commonly used" and several experimental devices which have been described in academic reserach literature but never actually committed to commercial distribution, which leads to some confusion, and misleading conclusions.
(1) Large-Balloon Manometry (mislabled as "the rectal tube") is described as "one of the most COMMON instruments used in biofeedback treatment of UI." (emphesis added). It is difficult to know how they could have come to this conclusion unless their exposure was limited to studying the published works of Kathy Burgio. Following Burgio's excellent work, E.J. McGowan tried for a time to interest biofeedback users in the Schuster balloons, but they never really caught on. The balloons are very uncomfortable and high "invasive" (they must be inserted into the rectum -- very carefully!)
Interestingly, the authors would have been correct if they had said that the balloons were commonly used in the treatment of fecal incontinence, which is true. Many colorectal manometrics labs, having the "Schuster balloons" on hand for standard manometric testing of the anal sphincter function, have attempted to utilize them for "biofeedback" training as well. However, few if any of their instruments have the specialized biofeedback "screens" and data collection programs built in, so it is not unlike using general purpose "relaxation" training EMG programs for pelvic muscle rehab; "crude" biofeedback at best.
(2) Specially-designed electromyography (EMG) sensor. The authors describe the EMG perineometer, which they credit to Perry & Hullett (1990) and Tries and Eisman (1995). Actually, only the Perry device is commercial available (and has been since 1978); the Tries device has been described in research reports but so far has never been sold. They correctly note that the perineometer is self-inserted by the patient (a fact that is later overlooked in the "disrobing" section.) Not mentioned is the fact that the Perry-type devices are the only ones which are commercially available in a single-user design to avoid transmission of diseases.
(3) Intravaginal balloon device (IVBD). Dougherty's vaginal balloon device is mentioned as a measurement tool, as well as her "posterior pressure balloon" that is intended to measure intra-abdominal pressure from a location not far from the "third balloon" of the Schuster device. Unfortunately, neither device has proven to be commercially viable and they have never been available for purchase. They have not been approved by the FDA, and there is a lack of research supporting their effectiveness.
(4) Surface ("patch") electrodes. The authors state that "this approach has been applied successfully in several clinical trials", and cite Drew's unpublished dissertation (1990) and O'Donnell & Doyle (1991) as evidence. There is no doubt that surface electrodes are widely used in treating incontinence, but it does not follow that they have been found to be valid or successful. The unpublished Drew dissertation did not actually compare surface electrodes to standard insertable sensors; he merely assumed they were valid, and he did not achieve a high rate of success. The other study did NOT use "standard pediatric disposable EKG electrodes...placed on the perianal region" as erroneously stated, but used Dantec (urodynamic) vaginal sponge electrodes carefully taped directly over the exterior anal sphincter. This placement was so precarious that they were forced to constantly monitor the input signal for 60 Hz noise because these tiny electodes would not stay in place reliably.
Many beginning therapists are confused by the unjustified claims made on behalf of perianal placements in a Thought Technology clinical brochure that pictures a "10 and 4 o'clock" perianal placement for such surface electrodes. No research has established that as a valid placement, and it runs counter to EMG surface electrode theory (that electrodes should be place parallel to the fibers of interest!). The fact that instruments will detect some EMG activity with this placement, but it probably isn't the pubococcygeus muscle, is a serious ethical problem that is overlooked here.
(5) EMPI's sensor-undergarment electodes. The authors, at least one of whom has done research sponsored in part by EMPI, describes this product as "a related approach" to standard surface electrodes, but this is very misleading at least. They "impartially" describe the underware as holding "great promise because it may be woven into undergarments and may be more convenient for both therapists and patients". In addition, they note that the underware sensor was shown to corrlate (r=.75) with Doroughty's IVBD device.
This is a very misleading description of these wonderful pants, which were first invented and developed for electrical stimulation by John Church of Physical Health Devices in Florida. The idea was that stimulation electrodes could be sewn into leg stockings, so that the electrodes would be automatically positioned for repeated applications of computerized electrical stimulation, to teach people to walk again. Since the electrodes were fastened to the garment, instead of the patient, it drastically reduced setup time; a brilliant innovation!
However, the application of Church's patent to incontinence work was not so brilliant. As a sensing (vs. stimulating) device, it required large amounts of electrode paste to be applied to little "brillo pads" that were positioned on either side of the vulva; a rather messy operation, according to those who have used them. In addition, the paste often had to be replenished in the middle of therapy. To prevent false data, Church's computer program had to do an impedance check in between EMG measurements to ensure the pads were still making contact inspite of patient movements.
Finally, the validation was curious. The underware was compared only to the intervaginal balloon, yielding an "r" of only 0.75 (and r-squared of 0.56). In contrast, longitudinal electrodes such as the Perry and Tries devices, have been shown to correlate 0.99 with fine-wire needle EMG electrodes, the "gold standard" of electomyography (and r-squared = 0.98!). But the underware has never been compared to either the longitudinal electrodes or to needle electrodes, which is the standard to meet. In fairness, these authors do admit that "Clearly more research is needed before fabric electrodes can be widely advocated", an understatement at least.
The authors correct point out that the special concerns of incontinence require close collaboration with appropriate medical colleagues. But they assert that "the (biofeedback) therapist has ultimate responsibility for evaluations, including verification of patient testing for medical causes of UI". Yes and No.
Currently, 45 percent of incontinence work is done by PTs, and 45 percent by RNs. The remaining 10 percent includes various other professionals. In every case it is necessary for the patient to be diagnosed by a physician in order to have a valid diagnostic "code" for insurance purposes. In addition, it is advisable for the BF therapist to "pass off" responsibility to the physician for detection and treatment of "medical conditions".
The therapist is responsible for explaining the behavioral aspects of therapy, as noted.
The "unusual circumstances" of incontinence work make a formal consent document advisable, according to the authors. This section is excellent, and includes discussing the nature and duration of treatment, the risks and prognosis, alternative treatments, and fees and other charges. A sample "informed consent form" is pictured.
Unfortunately, the "sample" form states that "a sensor device will be placed vaginally (or rectally) by my therapist". This is troublesome, since in fact only a very tiny percentage of such placements -- less than one percent -- is done "by the therapist", at least vaginally or rectally. As stated above, large-balloon manometrics is practically obsclete except in CR labs, and the balloon devices placed vaginally are still experimental (not FDA approved nor sold). So it is difficult to know what the author's experience and expectations are here. More than 99 percent of "vaginal" and "rectal" placements are done using Perry sensors, or the very similar Hollister/InCare, EMPI, and Verimed sensors -- all of which are self-inserted by patients! [According to Frost & Sullivan, 1993, Perry brand products comprised 69 percent of the biofeedback-for-incontinence market.] The FDA labeling for Perry sensors states that the sensor should be self-inserted whenever possible. When physical or mental dextarity prevents that, the primary care-giver is given the task, since the same care-giver will be doing it at home for daily practice sessions anyway. Insertion by the therapist is extremely rare indeed.
This portion of the sample form will not be relevant to persons using the self-inserted sensors.
There is a problem, however, with the use of perianal surface EMG sensors. Since accurate (repeatable) EMG readings require precise (1/4 inch) placement repeatability, it seems potentially unethical to allow patients to apply such electrodes to their own perineum. In this case, the therapist would have to apply the patches "perivaginally" or "perianally" to ensure exact placement. If patients are allowed to use patches at home, they should be given a detailed drawing of the placement. Also, in related branches of medicine a Magic Marker is always used to outline electrode placements to avoid error. Other than aesthetic reasons, is there any reason why this precaution should not be taken here, for those who insist on using surface electrodes?
The authors cite a lack of sources containing detailed instructions to give to patient for proper execution of exercises; this is baffling. Under FDA regulations, EMG home traing devices are necessarily accompanied by patient instructions. They do correctly note that face to face training and continuous monitoring of progess is advisable. They might have added that it is even REQUIRED by the FDA. Simply giving a patient a home trainer and turning her loose for a month is not only unethical, as noted, it is illegal under FDA regulations. A therapist who did so would be in danger if the patient has less than perfect outcome.
Once again, it is difficult to understand the experience and perspective of these authors when they state baldly that "biofeedback therapy with UI patients requires the patient to disrobe." In 99 percent of the biofeedback-for-incontinence therapy that is presently done in the real world, that is simply FALSE.
The Perry sensor was invented (in 1975) and developed by an ordinary psychologist (this author) who was challenged by the desire to conduct basic sex research (a la Masters and Johnson) without being able to afford a medical team of associates. The sensor was intentionally perfected to be self-inserting and self-locating, so that no unnecessary disrobing was required. When it was applied (in 1985) to biofeedback training for incontinence, it quickly became clear that this was a distinct advantage.
Although patients will submit to disrobing in order to save their own lives, nakedness does not create the ideal environment for self-reflection and learning of internal proprioceptive cues. We have always advocated the use of a biofeedback suite, rather than a physician's examing room, as the ideal locale for such training. It was our assumption that sitting in a comfortable reclining chair in a "living room" atmosphere was more conducive to psychophysiological learning than lying on one's side on a stainless steel table with one's butt exposed to passers-by.
These authors apparently use instrumentation that requires patient disrobing, and they offer suggestions drawn from medical practice to protect patient dignity. Most of their concerns will not apply to clinicians using the popular incontinence systems that are now available.
The issues raised by this section are complex, because these authors apparently are assuming that patients are disrobed and their genitalia probed by the therapist, which simply does not apply to most incontinence treatment situations. Thus their overly-cautious and overly expensive solution, to "require the presence of a third party during treatment", seems unnecesary for most therapists.
An alternative, drawn from our own clinical experience, is to carefully screen patients and refuse to treat the obviously psychotic ones. There is nothing to fear from the rest. For instance, we once had a patient who asked "What does that certificate mean!!!?" and similar inappropriate and excessive questions. We advised her to return when she was more convinced of the value of biofeedback to her condition. Then I called the referring physician, and demanded an explanation. "Well, yes", he admitted, "she is nuttier than a fruitcake, but I thought you guys could help her." No thanks.
There is a confusing section about the demonstration of home training instruments. The authors correctly point out that home practice with a portable biofeedback unit has been shown to improve the liklihood of success, but this is incorrectly credited to Burns et al, 1993. Burns et al did not use home training instruments at all. The correct citation should have been my own article (Perry & Hullett, The Role of Home Trainers in Kegel's Exercise Program for the Treatment of Incontinence), which is listed in their bibliography but not elsewhere cited.
The authors state: "...home trainers require that the patient properly attach the probe to herself. This requires in-office demonstrations, which can be problematic for the biofeedback therapist who is not also an M.D., R.N., or L.P.N. [Apparently they are unaware that there are as many PTs doing this work as RNs!]. Biofeedback therapists should be trained in this particular aspect of patient care before they conduct in-office demonstrations. Until a biofeedback therapist receives proper training in the implementation of insertable devices, a collaborative or multidisciplinary team approach should be used."
Clearly, these authors are talking about some kind of sensor that is different from that used by 99 percent of patients in the real world.
It is doubtful that any amount of training would enable a psychologist or biofeedback technician to "attach" probes to patients without serious ethical violations. Fortunately, it is also seldom necessary in the real world. Perry, Hollister, EMPI, and Verimed sensors are not "attached" to patients, they are simply self-inserted by the patients. The process is usually described as similar to inserting a tampon.
Readers may be interested to know that in the 18 years that Perry brand self-inserted sensors have been on the market, there has only been one case of "ethical" misconduct reported that has involved a malpractice insurance claim. Several years ago a therapist in Alaska was charged with sexual misconduct because he inserted a Perry sensor in a female patient and "inspected it" to ensure the correct placement. The patient later sued. It turns out that this same psychologist was practicing in Alaska because he had been run out of Iowa a few years earlier for a different charge of sexual misconduct. Interestingly, when the patient found out that the APA insurance had a cap of $25,000 on SEXUAL misconduct, she changed her claim to general malpractice ($ 1,000,000 cap). I understand that tactic failed; she should have stuck with the sexual misconduct claim! In virtually ALL cases, there is simply no need for the patient to disrobe.
There is a general warning about the necessity of observing appropriate labortory and hospital codes. Apparently the authors are unaware (since they do not mention) that the FDA regulates all such devices; in addition to their general precautions, the theapist should ensure that devices used to treat incontinence are "registered" with the FDA. This is not an idle warning, as many European manufacturers have sold several such unregistered devices in the United States before getting caught. Using non-approved devices could make one vulnerable to addition charges in the event of trouble.
The authors also stress the importance of "proper infection control procedures", and recommend that insertable devices be sterilized between patients. Apparently they are not aware that many hospitals and jurisdictions have flatly refused to permit re-useable devices in the incontinence field. They describe devices issued "to each patient individually" as "not cost-effective", apparently unaware that such devices (from Perry, Hollister, EMPI, and Verimed) in fact constitute 95 percent of the devices actually used in the real world.)
It is curious that these authors acknowledge the superiority of protocols which use home trainers, and then mistakenly assert that single-user sensors are "not cost effective". Assuming that the patient is getting the same high level of therapy (a dubious assumption), the average patient uses an insertable single-user sensor about 100 times (3 x 30 days, plus a few office visits); the sensor costs the therapist less than $60. In contrast, 100 high-quality surface electrode sets at 75 cents each cost $75! And, if the patient needs a brief refresher course next year, the single-user sensor is still available; patches will cost extra. Finally, many patients are encouraged to use the single-user sensor as a "resistive device" on a weekly to monthly basis for the rest of their lives, something not possible with patch electrodes. Obviously, the "cost effective" choice is associated with fewer biofeedback sessions, and therefore inferior therapy. (See also the essay on the Rationale of the Single User Sensor on this site.)
Except for large-balloon manometry, there are NO sterilizable incontinence devices on the market today (in the USA). Some manufacturers are explicit in labeling their products as "single-user" devices, while others seek to avoid liability by not even addressing the issue in their labeling (and NOT providing any instructions on how to re-use them!) The failure to recognize this distinction is a serious fault in the essay, since some therapists might be misled into thinking that they CAN sterilize and re-use the EMG sensors. That is simply not true, highly dangerous, and legally, very risky.
(A couple of years ago, when single-user EMG sensors were more expensive and sometimes difficult to obtain, we encountered a few therapists who were sterilizing them. However, when we point out the legal consequences of this practice, they came to their senses! Briefly, if a patient claimed to get AIDS from a re-used single-user sensor, the therapist would have zero grounds for defense. Good-bye house, Good-bye license, Good-bye Career!)
This is an exceptionally good section, advocating time at the beginning and end of each session for face-to-face verbal interaction, careful listening, and assessment of home practice. Since incontinence is perhaps the most psychologically sensitive problem area that nurses and physical theapists will encounter, the warnings are well taken.
One nationally-known physical therapy center (John F. Barnes' Myofascial Release Treatment Center) recognized the limited verbal therapy skills of their PTs, and hired a "nurse counselor" interview each patient regularly.
Here the authors call for continuing education and state that "advanced certification in biofeedback for urinary incontinence may eventually be necessary. The BCIA currently does not have any established advanced biofeedback certification programs."
Apparently the authors are unaware of the rich history here. The Perry Institute has been certifying therapists in perineometry since 1986; more than 500 therapists have taken the course. Two years ago the Institute (which had lost $40,000 in the process) formally asked BCIA to take over the certification process.
The current bottleneck in Certification stems from the BCIA's "advanced" concept of Certification, in contrast to the "specific" Certification recommended by the Perry Institute. The BCIA currently certifies "general" practitioners in biofeedback, and adds higher requirements for specialty Certification in EEG, for instance. In contrast, the Perry Institute noted that 95 percent of the theapists they Certifed in Perineometry did NOT wish to engage in a general biofeedback practice, and had declined to apply for the BCIA general certificate. Perry Institute therefore recommend a "specific" Certification in Incontinence (etc.) work only, but BCIA has not yet agreed.
This essay presents long-needed and generally appropriate suggestions for moving towards an ethical statement for the biofeedback of incontinence. But in its present form, the current suggestions represent the concerns of ivory-tower academics, who have little awareness of the kind of biofeedback therapy which is currently being practiced in the real world. We surely need discussion of ethics in this new field, but we need to include people who really know that is going on.
A major problem in this endevor is that 95 percent of the therapists currently treating incontinence by biofeedback methods are nurses and physical therapists who do not identify themselves as part of the biofeedback profession. They are already involved in and responsive to the ethical requirements of their license and profession, and would not be affected by any BCIA or AAPB pontifications on the subject. It may be more fruitful to discuss these ethical considerations within these two primary professions.
© 1996 by InContiNet.com. All Rights Reserved.
Version 1.0; this page was last revised on May 04, 2005
Click here to return to our Home Page.