A Proposed Set of Ethical Practice Guidelines in the Assessment and Treatment of Pelvic Floor Disorders

2020-12-02 10:50:10

Sebastian Striefel Æ Howard I. Glazer

Abstract The treatment of pelvic floor disorders using biofeedback, behavioral therapies, and other applied psychophysiological treatments has been well documented as effective. Practitioners must take due care to ensure that they practice within the boundaries of what is common practice for their discipline and within the scope of practice allowed by their professional license as outlined by the appropriate state licensing law(s), the ethical principles and practice guidelines and standards for their discipline, and those of the Association of Applied Psychophysiology and Biofeedback if using a biofeedback assessment or treatment. Being competent to provide a particular treatment does not necessarily make it legal and/or ethical. This paper provides a set of recommended practice guidelines for use in the assessment and treatment of pelvic floor disorders. Please note that they have not at this time been endorsed as an official position of the Association of Applied Psychophysiology and Biofeedback or any other professional organization.

Keywords Pelvic floor disorders; Practice guidelines; Boundaries and scope of practice; Responsibility; Competence

Introduction

Pelvic floor disorders (PFDs) are fairly common, disrupt the lives of sufferers, may cause embarrassment, and are not always discussed with the sufferer’s physician (Sherman 2006). There are a wide range of PFDs including: (a) incontinence (fecal and urinary), (b) dysfunctional elimination patterns (muscle-related constipation, overactive bladder syndrome, and irritable bowel syndrome) (c) pain of the urogenital and anorectal systems, and (d) other related disorders, each with its own subcategories and often having overlapping symptoms (Dickinson 2006a; Moss 2006). The frequency of occurrence varies from disorder to disorder, is more common in females, increases in middle age, and is especially high among those over age 65 (Sherman 2006). Many of the PFDs can be cost-effectively assessed and treated using behavioral interventions such as electromyography (EMG) biofeedback (Glazer 2006; Sherman 2006), bladder inhibition biofeedback, and stable intra-abdominal and bladder pressure biofeedback (Tries and Eisman 2003a). Even then, the application of other adjunctive treatments may be called for, e.g., treatments like cognitive behavior therapy may be necessary for dealing with the anxiety and/or depression that often accompanies, and contributes to, conditions such as irritable bowel syndrome or vulvodynia (Tries and Eisman 2003a; Glazer and Rodke 2002). Because of the rapid expansion of knowledge, laws, court precedents, and public expectations, professionals need to commit additional time and resources to remaining current (Striefel 2004b). Attending AAPB’s annual conference, regional workshops, and/or participating in its teleseminars or becoming BCIA certified in pelvic muscle dysfunction biofeedback, will provide some of the needed updates in information.

Evidence-Based Practice

Evidence-based practice has become a very serious and often misapplied concept in recent years. Policy makers and insurance companies often use it in ways that unnecessarily restrict clinical practice (Barlow 2007). Practitioners need to be familiar with what the clinical and research data support as evidence-based practices so that they can properly inform the client about the treatment or treatments of choice for the client’s presenting problem(s), along with less empirically supported alternative treatments, and the pros and cons of each during the informed consent process.

Practitioners must also consider other variables during both the assessment and treatment phases, such as client symptoms, client history of successes or failures with various treatments, and client preferences (e.g., some clients may prefer to try alternatives other than pharmaceuticals or surgery before agreeing to such potentially drastic interventions). Such factors should be considered in deciding how all of this evidence and information can best be used to guide intervention with the individual client to alleviate his or her suffering or to enhance his or her performance (Barlow 2007).

In making the clinical decisions about treatment, the practitioner may decide to recommend and utilize an evidence-based treatment of choice or he or she may decide to recommend and utilize a less empirically supported treatment (Barlow 2007). The rationale for the treatment selections made should be clear from the careful documentation in the client’s file. The decision should be based on the medical diagnosis, a careful assessment, consideration of the empirically supported treatment options, and the support and consent of a well-informed client in ways that best meet the needs of the individual client. Rigidly applying the same evidence-based treatment to all clients with similar symptoms is not likely to be in the best interests of all clients and may well not motivate all clients to do their best in achieving desirable outcomes.
It is important to remember that the requirements for random selection, statistical significance, and other methodological requirements for conducting research studies, result in a one-fits-all set of results. To apply research findings in clinical settings, clinicians must often make modifications to apply group findings to individual clients/patients (Woolfolk et al. 2007). As such, a prime consideration must be to decide if and how a particular evidencebased practice might or might not apply to an individual patient. ‘‘No one treatment is effective or even appropriate for everyone who has a similar complaint’’ (Striefel 2008, p. 6).

Biofeedback was considered the treatment of choice for urinary incontinence by the US Agency for Health Care Policy and Research in 1992 (Moss 2006; Whitehead 1995). Still it is not clear if that finding applies equally to stress, urge, overflow, and reflex incontinence. Similar research-based conclusions were reached for fecal incontinence (Moss 2006; Whitehead and Drossman 1996). Yucha and Montgomery (2008) in their evidence-based practice book on biofeedback and neurofeedback used the five point rating scale adopted by AAPB and ISNR. The ratings range from level 1, insufficient support; to level 2, possibly efficacious; to level 3, probably efficacious; to level 4, efficacious; and to level 5, efficacious and specific (LaVaque et al. 2002). Yucha and Montgomery (2008) rated the efficacy of biofeedback for urinary incontinence at level 5, efficacious and specific, for females; at level 3, probably efficacious for males; and at level 2, possibly efficacious for children. It should be noted that the higher the number, the more the research support that exists for the conclusions reached. Yucha and Montgomery (2008) rated the treatment of vulvar vestibulitis and fecal elimination disorders at level 3, probably efficacious and rated irritable bowel syndrome at level 2, possibly efficacious. Yucha and Montgomery (2008) also rated constipation at level 4, efficacious. It should be noted that the Yucha and Montgomery (2008) publication is an update of an earlier published set of ratings by Yucha and Gilbert (2004). Palsson et al. (2004) rated biofeedback treatment for anorectal pain disorders at level 2, possibly efficacious. Biofeedback and other applied psychophysiological treatments were again concluded to be effective in the assessment and treatment of various PFDs as attested to by the US Department of Health and Human Services’ 1996 recommendation on using biofeedback for the rehabilitation of incontinence (stress, urge, and mixed). See the website of the Wound Ostomy and Continence Nurses Society at www.wocn.org for more information on effectiveness. Practitioners who treat PFDs are expected to remain current on both clinical and research findings.

Responsibility and Competence

Just because one has the technical skills to provide biofeedback training or treatment for PFDs does not mean that one should or can legally and ethically do so. For example, assume that you are a psychologist, a social worker, a licensed professional counselor, or other professional whose discipline treats primarily emotional, psychological, or mental health disorders, i.e., disorders often associated with cognitive or thought processes and the functioning of the brain. Are you competent and can you legally provide assessment and/or treatment services for PFDs within the state in which you practice? Some of the leading experts and teachers in the field of biofeedback treatment for PFDs, such as Howard Glazer and John Perry, are psychologists, yet this does not guarantee that other psychologists and mental health practitioners will not encounter challenges to their clinical work in this area within specific states and professional communities. Should a mental health worker treat elimination disorders and chronic pelvic pain syndromes? Is it appropriate for you to train patients to change the patient’s bowel and bladder habits? It could readily be argued that because the issues of touch for assessment and sensor placement and/or treatment, only licensed medical practitioners such as physicians, nurses, physical therapists, and occupational therapists should treat PFDs. Is it within your scope of practice to teach patients pelvic floor muscle exercises assisted by insertable vaginal or rectal sensors or surface EMG sensors? How do you decide if you can legally and ethically treat some or all types of PFDs?

Answering these questions is not an easy task and oversimplifying the answers by concluding something like, ‘‘Of course I can, I have been treating these pelvic floor disorders successfully for twenty years,’’ is not a professionally responsible answer. A number of factors need to be considered carefully in deciding what disorders you can and cannot legally, ethically, and responsibly treat.

Demonstrated Competence

One issue to consider before undertaking the assessment or treatment of PFDs, are your demonstrable areas of competence. The Association of Applied Psychophysiology and Biofeedback’s (AAPB) practice guidelines specify that ‘‘All providers strive to provide services only in those areas in which they are competent as based on education, training, and/or experience, unless appropriately supervised by a supervisor competent in the relevant skill areas’’ (Striefel 2004a, p. 27). Being licensed or certified in a health care discipline by the state in which you practice is one indicator of some level of competence to provide health care services. If you want to conduct assessments and treatment of those who have PFDs it would be useful and appropriate to become certified by the BCIA in the specialty certification of Pelvic Muscle Dysfunction Biofeedback as another indicator of competence to provide such services. After all, in order to be certified one needs to have not only content knowledge such as the anatomy and physiology involved, the placement of sensors, ethical considerations, treatment strategies, etc., but also one must have completed a certain number of hours of practicum, and have received a certain number of hours of mentoring (supervised practice). Practitioners should be sure that they can demonstrate the equivalent level of training and supervision even if not certified. If one is sued for negligence or has an ethics complaint filed against him or her, courts and boards often use existing guidelines and standards (e.g., the BCIA certification requirements or the AAPB practice guidelines and standards) to determine things such as a practitioner’s level of competence. To remain current is an ongoing education task and being certified and receiving continuing education hours is critical to competent practice. It could be argued that the BCIA certification requirements are only geared toward achieving minimal levels of competence in a highly complex array of disorders. There are clear differences in the levels of competence needed to treat a condition such as stress incontinence versus treating a condition such as vulvodynia. For more information on BCIA Certification go to www.bcia.org or send an email to bcia@resourcenter.com.

More Specific Competence

As with all biofeedback and other applied psychophysiological treatments, a practitioner needs to know:

1. When and if a patient needs a medical examination, physical evaluation, and diagnosis. All patients with PFDs need a medical examination and physical evaluation to rule out organic causes. Some diagnoses are legally allowed to be made only by a licensed medical practitioner such as a physician or nurse practitioner.

2. When and if medical consultation needs to be an ongoing part of the patient’s treatment plan. Ongoing medical consultation is recommended, if not required, in the treatment of all of the more complex forms of PFDs. In fact, a multidisciplinary assessment and treatment approach is more likely to achieve successful outcomes in comparison to single discipline approaches (Glazer and Rodke 2002; Tries and Eisman 2003a).

3. When and if biofeedback might be contraindicated,e.g.:

(a) When a tumor, inflammation, or other condition exists for which a medical treatment is indicated.

(b) When a patient is pregnant or has been told not to engage in sexual intercourse because it might cause problems. Manufacturers recommend that insertable sensors not be used if an active infection is present or if the patient is pregnant. In such cases the insertion and use of an anal or vaginal biofeedback sensor or even the use of pelvic floor muscle exercises might be inappropriate. However, to date the authors are unaware of any published data indicating negative effects when the sensors are used during pregnancy or an active infection. If a patient is pregnant, it might be useful to have her show the sensor to her gynecologist to ensure that he or she does not object to its use during the pregnancy. This might well entail a discussion between the biofeedback practitioner and the client’s physician, with client permission.

(c) When a patient has had pelvic surgery within the last 3 months, biofeedback for PFDs might be inappropriate without the approval of the treating surgeon (Glazer et al. 1995).

(d) When a patient is not likely to benefit from biofeedback and related treatments, e.g., those patients not motivated to achieve incontinence or other success and those not able to follow directions, including, but not limited to patients with advanced dementia, psychosis, severe mental retardation, and children under the age of four (Tries and Eisman 2003b).

4. How do you decide if or when the cause of a pelvic floor disorder is primarily a psychosocial problem, e.g., induced by emotional stress?

If treatment of PFDs is both legally and ethically acceptable within the boundaries of your discipline and scope of practice of your license, other factors must be addressed, including:

1. Are you knowledgeable and competent in the human anatomy and physiology involved in the different PFDs? For example, do you understand the relationship of the different muscle groups involved in controlling the sphincter and/or urine flow?

2. Are you knowledgeable and competent enough in the primary and alternative treatments for the PFDs you plan to treat, and not treat, to be able to obtain meaningful informed consent from the client and/or his or her guardian/parent? What, if any, are the risks and benefits of the major alternative treatment options?

3. What kind of touch and education process is acceptable that meets or exceeds the standard of care for your discipline? In most cases the use of diagrams and other educational materials is sufficient for a patient to be able to attach the sensors to the skin or insert the sensor into the sphincter or vagina. However, some patients may need assistance in that process and a family member may be an acceptable option to them. When the patient does not have a trusted family member or friend, do you have someone on your staff that can legally and ethically assist the patient in the process without overriding the patient’s sense of privacy? If not, you should probably not be treating that patient’s pelvic floor disorder. Are you aware of the privacy rights of your patients when attaching sensors (AAPB, 2003)?

4. Are you knowledgeable in how to correctly use the Current Procedural Terminology (CPT) Codes 90900, 90901, 90911 and other appropriate codes, if any?

The AAPB practice guidelines and standards specify that a practitioner ‘‘has the knowledge to understand a particular client’s problem and to formulate an appropriate treatment plan, has the skills needed to apply that knowledge effectively, and the judgment to use such knowledge and skills appropriately’’ (Striefel 2004a, p. 27). Clients have an ethical right to be relieved of pain and suffering in the shortest time possible with exposure to the least intrusive treatment interventions (Cummings 1998, Striefel 2008). The bottom line is that a practitioner should ‘‘do no harm’’ and in fact, the client should benefit from the treatment (Striefel 2008). If a practitioner is not competent to do this for a particular client then he or she should seek supervision or consultation if that is appropriate, should refer the client elsewhere, and should probably get additional training so that he or she is competent the next time he or she receives such a referral (Striefel 2008).

Informed Consent and Patient Education

It is important for a practitioner to obtain appropriate informed consent from a client before undertaking any assessment or treatment. Before initiating the informed consent process, a practitioner might ask him or herself questions such as the following (Striefel 2003, 2007a, 2008):

1. What are the treatments of choice for this particular client with his or her symptoms, history, preferences, personal characteristics, medical referral, etc.? What level of support exists for each? What is the rationale for selecting one treatment rather than another, especially for selecting a treatment that is not yet considered validated (Striefel 2007a)?

2. What are the potential side effects, if any, for each potential treatment, and what are the potential risks and benefits of each?

3. Will the client’s insurance company pay for any of the treatment options that I am considering? If not, will they pay for some other appropriate treatment option? How do I inform the client about the limitations imposed by his or her insurance coverage?

4. How do I inform and educate the client about factors such as sensor placement, avoidance of infections, and respect for his or her sense of privacy, modesty, and decency?

5. In addition to the limits of confidentiality; information on fees, billings, insurance limitations, and collections; treatment options and the potential risks, benefits, and side effects of each, and the process and procedures for assessment and treatment, are there any other factors that should be included during the informed consent process?

6. If I plan to use any home training device, will the insurance company pay for any of the costs? How effective is home training? What support exists for the home training that I am proposing? What are the potential risks and how will I monitor progress and potential problems (e.g., negative side effects)? See the AAPB practice guidelines and standards (Striefel 2004a) and the Glazer (2005) DVD for more information and considerations.

Educational Materials

Practitioners are encouraged to develop educational materials to use with clients, e.g., materials to educate clients on how and where surface EMG sensors are attached or how to lubricate and insert probe sensors into the vaginal or anal canal. Materials should take into consideration factors such as: likely reading level of patients and difficulty level of the subject matter. For example, a patient may understand a discussion of muscle structure and other physiology more easily if it is accompanied by diagrams or pictures. Audiovisual DVDs are particularly helpful as are printed materials. The advantage of audiovisual materials is that it may overcome reading difficulties. Other topics could include, but are not limited to: the physiology and muscles responsible for controlling specific functions, information on how muscle recruitment can become dysfunctional, and information on safety and sterilization of equipment to prevent infections. Common issues related to informed consent such as fees, billing, limitations of insurance, collections; limits of confidentiality; appropriate vs. inappropriate touch; clinical and research support for various forms of treatment, etc., can also be made available. Standardized forms can be used for those areas of informed consent that are likely to be the same from client-to-client, e.g. limits of confidentiality and fees, billings, and collections.

It is important to remember that the availability of educational materials by themselves does not meet the informed consent requirements. Practitioners should ensure that the client understood the materials to which they were exposed. The best way to do that is to ask questions or have the client explain in his or her words specific items, e.g., where to place the sensors.

Standards of Dress and Touch

Licensed medical practitioners and other health care practitioners working with patients who suffer from PFDs have similar and yet very different standards of care when it comes to dress and touch. The similarities include: that each professional discipline is expected to adhere to all relevant ethical principles and practice guidelines and standards of practice for their discipline and the assessments and treatments that they use; to obtain informed consent for any proposed client/patient touch to avoid potential charges of assault, to ensure that any touch that occurs is within the acceptable standards of care for members of that specific discipline; and to ensure that all relevant standards of decency and client modesty are adhered to in terms of client dress or undress for assessments and/or treatment.

Differing Standards of Dress

It is common practice for licensed medical practitioners and other closely allied health care professions such as physical therapy and occupational therapy to have patients, in privacy, undress and put on a gown for medical evaluations and/or treatments of PFDs or to work with patients who are so dressed. Such dress or undress makes it easier to access various body areas for conducting a physical evaluation and/or placement of various sensors or other measurement devices (e.g., pressure balloons). Such dress also prevents friction from clothing that could exacerbate pain or result in the unintended shift in sensor placement. If that is the case, the practice guidelines and standards for that discipline clearly point out that this is part of standardized practice or at least do not prohibit use of such dress. It is also common for touch of the female breasts or the genitalia or anal areas of the body of either gender (female and male) to occur if it is a part of the standardized medical evaluation or treatment. Medical practitioners are expected to explain what they are going to do, and why before doing so, and to obtain client consent before doing so. Failure to obtain informed consent and/or failure to be sensitive to the characteristics of the specific patient can result in legal or ethical problems for the physician. If the patient is of the opposite gender from the medical practitioner, a second health care practitioner (usually a nurse) will generally be present before certain types of touch necessary for the medical procedure occur. The presence of this second person decreases the likelihood that the medical practitioner will engage in any uncalled for voyeurism or inappropriate touch. It also decreases the likelihood of the medical practitioner being accused of engaging in any inappropriate behavior regarding dress and/or touch.

Health care practitioners, both licensed and unlicensed, who are not licensed medical practitioners are expected to adhere to a different standard when it comes to patient dress/undress and touch. These practitioners would generally not have patients undress and put on a gown when conducting an assessment or treatment of PFDs because doing so would be outside the realm of common practice for such a practitioner. Non medical personnel rarely deal with patients who are wearing only a gown. The rare exception might be when a person is a patient in a hospital and is so dressed because of the hospitalization, or when a physician has just completed an assessment or diagnosis of a pelvic floor disorder and then invites another practitioner (not medically licensed) into the examination room to discuss treatment options with the patient. If treatment is then provided in the hospital setting by a non-medical practitioner the patient would in all probability be dressed in a gown. The use of a gown might also occur if the clothing that a client is wearing would not allow comfort or accurate placement of sensors. Non-medical personnel are at higher risk when having clients dress in a gown if great care is not taken during the informed consent process and if great care is not taken to protect client privacy. Just because the use of gowns is common in a medical setting by medical personnel, does not mean that gowns should be routinely used by non-medical personnel. Thinking through the implications and obtaining appropriate consultation and review by professional colleagues and/or members of the licensing board might be highly desirable.

Relevant Principles

Three principles should be considered in deciding whether to use gowns for treatment of pelvic floor disorders. First is to ensure that the rights of the client are not violated. This includes, but is not limited to the client’s right to privacy in ways that protect the client’s sense of modesty, his or her right to informed consent, and his or her comfort during the placement or attachment of sensors for assessment and treatment. If gowns are used a client might well keep the clothing for the top half of the body on under the gown, could be offered a blanket or sheet to cover with in addition to the gown, might be offered a set of clothing to wear that less revealing than the typical hospital gown, e.g., an oversized pair of sweat pants. The second principle is to ensure that the ethical principles, standards of practice, and laws that govern the practitioner’s discipline or that apply to him or her in another discipline are not violated. The third principle is related to remembering that different situations and different settings might well have different standards of what is and what is not acceptable practice for members of a specific discipline. The location, membership of the health care team, rules and regulations, client comfort, conservativeness of the licensing board, and other factors all need to be considered. The treatment of PFDs by health care practitioners who are not medically licensed is still relatively new. As such, the standards of practice may not yet reflect what are both practical and good practice for members of all disciplines.

Touch

In like manner, the practice guidelines and standards of non-medical personnel prohibit them from touching or viewing certain areas of the bodies of their clients/patients, including the breasts of females if the practitioner is male, and in most cases also if the practitioner is female. Nor is touch or viewing of the genitalia or anal areas of the body allowed. The rare exception might be when a patient is of the same gender as the practitioner and requests and consents specifically for that practitioner to assist him or her in attaching or inserting an EMG sensor. Across gender assistance is not allowable unless it is a part of common practice for members of a specific discipline and such assistance, even then, places that practitioner at risk. As such, it is best if that type of assistance not be offered or provided.

All health care practitioners conducting an assessment, diagnosis, or treatment within the scope of practice for their discipline using biofeedback instrumentation should think the process through carefully from both a practical and risk management perspective. The process might well include how to:

1. Give clients instructions on how to dress comfortably for assessment and treatment session, e.g., for females, a halter top, a loose, but long skirt, loose shorts or slacks as preferred by the client.

2. Give clients/patients instructions (with or without the use of educational materials) on where and how to insert or attach biofeedback sensors.

3. Answer any questions clients/patients have appropriately. All other areas of informed consent are also to be addressed appropriately.

4. Ask specific questions to ensure that the clients do in fact consent, e.g., to the use of insertable sensors. Some simple discussion and questions might include, but are not limited to:

a. After the patient has received an explanation of the type of sensors to be used for the assessment and/ or treatment, the practitioner might say, ‘‘You have seen the type of insertable sensors that we typically use for conducting assessments and treatment of your type of pelvic floor disorder. Such sensors give us the most accurate measurement of what is going on with the specific muscles that need to be retrained.’’

b. ‘‘Do you understand that if these sensors are used that you yourself will insert them in the privacy of the bathroom?’’ ‘‘Would you describe how you will do that and how you will be dressed when you come out of the bathroom?’’

c. ‘‘Is it acceptable to you to use these sensors during your assessment and treatment?’’

d. ‘‘Do you understand that you can have a friend or relative of your choosing assist you and/or be present during all of your assessment and treatment sessions?’’ ‘‘If you do not have someone available who can assist you but feel that you need assistance, is it acceptable if __________ (an assistant of the same gender as the client) helps you?’’ ‘‘Do you need assistance?’’ ‘‘If so, who do you want to assist you?’’ ‘‘It does need to be someone who can be available.’’

e. ‘‘If you do not need assistance, are you willing to go to the private area that we discussed and insert/attach the sensors under your clothing?’’

f. If the practitioner plans to palpate any muscles he or she should be sure he or she has obtained client consent and that such touch is within the guidelines of common practice for his or her profession. He or she should ask him or herself what a licensing board, the patients’ family, other professionals, ones worst professional enemy, or the general public would think if the procedure were disclosed in a newspaper article or television program. Can the same information be obtained by having the client attach additional surface EMG sensors to specific muscles? Practitioners should not put themselves at risk by crossing the boundaries of acceptable practice. Not only can they and their reputation be harmed, but the reputation of other members of their discipline and/or other practitioners treating PFDs can also be harmed.

5. Inform the client that he or she has the right to refuse to give consent for the proposed treatment or the use of insertable sensors and what the treatment options are if that occurs. For example, it might mean that the client does not receive treatment from this specific practitioner for his or her pelvic floor disorder or it might mean that a less efficient biofeedback or behavioral treatment might be used wherein only surface EMG sensors are used, if in fact that is the case.

6. Proceed if, and only if, a client consents to treatment, e.g., he or she is given the needed equipment (e.g., sensors, diagram, a lubricant, and materials for washing the hands before and after attaching/inserting sensors), is directed to an area that ensures privacy for inserting and/or attaching the sensors, e.g., a lockable, appropriately equipped restroom. It is not clear that all biofeedback measurement and recording devices can be attached or inserted correctly without professional assistance. For example, Tries and Eisman (2003a) discuss the use of a multiple electrode probe with a specialized recording T on the end that needs to be in a very specific location within the anal canal in order for accurate data to be recorded. They also discussed the use of theEisman-Tries intravaginal probe and the need for precise placement. Selecting the correct probe and being sure it is placed correctly may be an issue in the treatment of some PFDs.

7. When the client/patient returns with the sensors attached, any remaining questions he or she has should be answered and the assessment and/or treatment should be conducted within the practice guidelines and standards appropriate for that discipline.

Side Effects

Practitioners should be familiar with likely side effects for the treatments they use and competent to deal with them if they occur (Striefel 2007b, c). Side effects in treatment are always a possibility and not all of them are negative (Striefel 2006, 2007b, c). For example, anxiety seems to be fairly common in all forms of treatment as patients are faced with an unknown set of thoughts, feelings, and/or behaviors replacing the symptoms that they have been experiencing. As such, practitioners can discuss the possibility of anxiety occurring and can comfort the patient in advance by helping him or her understand that it is common and to discuss it with the practitioner if it occurs. Predicting likely side effects in advance can help build rapport and credibility with the client. Anxiety later in treatment can be a positive sign that something is changing.

In doing Kegel exercise training without the use of physiological monitoring equipment it is possible and even likely that patients will learn to contract and/or relax the wrong muscles in trying to learn to control the sphincter muscles (Sherman 2006; Tries and Eisman 2003a). Sherman (2006) pointed out that many of the PFDs are caused by inappropriate muscle recruitment problems and/or hypertonus in the pelvic floor muscles. In fact, attributing most PFDs to muscle recruitment issues may be an oversimplification of a very complex set of issues.

In the treatment of vulvar vestibulitis syndrome, swelling, erythema, and tenderness to touch of the vestibule of the vagina results in pain are common (Glazer 2006). As such, pain may well be exacerbated if a self-inserted vaginal probe is used for recording EMG from the vaginal canal instead of using other surface EMG sensors placed elsewhere. Some insertable probes are large and more likely to be more painful than some of the smaller probes that seem to work just as well if not better and without looking so much like a man’s penis. Care should be used in selecting the most appropriate type of sensors for use in order to prevent unnecessary pain or concern on the part of the patient. Side effects of sensor use may also include temporary exacerbation of symptoms under treatment, temporary cramping, soreness or unpleasant sensations in the pelvic floor muscle. Practitioners should expect a period in which patients feel frustrated and uncertain during the pelvic floor muscle contraction skill acquisition phase of training since the skill acquisition phase varies considerably from patient to patient and may, on occasion, take several weeks during which there is a high risk of noncompliance and dropout. Other side effects may include sexual sensations resulting from instructions related to focal awareness of genital sensations. Glazer has had patients who suddenly experience panic as a result of such sensations and literally ‘‘run out of the consulting room.’’ Just as mental health practitioners working with PFDs must be trained in areas less traditionally associated with their educational background, e.g., the specific anatomy and physiology of the pelvic floor area; so too must those trained in physical and occupational therapy be trained to deal with the psychological and psychosexual aspects of pelvic floor muscle sEMG biofeedback use. It is important for there to be a balance of knowledge and skills for all those working with PFDs so that physicians, biofeedback practitioners, physical and occupational therapists, and others to understand the physiology and anatomy, psychological and psychosexual aspects, use of EMG, etc., so that all can work together for the benefit of the patient. Are you familiar with any other side effects that are likely to occur and do you know how to deal with them appropriately if they occur?

Other Contraindication to Treatment

Other contraindications to treatment by a specific practitioner are also possible, including factors such as, the client’s time and financial resources for completing treatment, an Axis II disorder (APA 2001) or other diagnosis which might interfere with treatment if that condition is not treated first, a lack of appropriate competence and/or experience on the part of the practitioner, the motivational level of the client, and/or some other variable such as psychosis, age, mental retardation, or learning disability that makes it unlikely that the client will profit from the treatment being proposed (Striefel 2007b). Practitioners should consider factors such as these and others in deciding if biofeedback, behavioral, or other applied psychophysiological treatments are likely to be successful.

Boundaries of Common Practice for Discipline

All healthcare professionals are held to a higher standard of expectation than the general public because they hold themselves out to the public as experts (Striefel 2006). As such, state and federal laws, rules, and regulations provide some guidelines concerning how professionals should and should not behave. In addition, professional associations have established their own guidelines in the form of ethical principles (AAPB 2003) and practice guidelines and standards (Striefel 2004a, 2006). BCIA certification and other publications (e.g., the recent efficacy book by Yucha and Montgomery 2008), provide further guidance. Professionals are ethically and/or legally expected to be familiar with these various guidelines and to adhere to them. The applicable legal and ethical expectations may vary somewhat across disciplines and states, e.g., state licensing laws for the same discipline on what is considered acceptable practice vary somewhat from state-to-state, as do the interpretations made about the law by different licensing boards (Corey et al. 2000; Striefel 2004b). These various sources of guidance are often not specific enough by themselves to make clear what a professional should or should not do in a specific situation. For example, most guidelines do not mention the diagnosis or treatment of PFDs, so professionals must make inferences from the guidelines and seek consultation or even supervision from other professionals before undertaking such professional activities. This article is being written to provide some more specific clinical practice guidelines for those wishing to provide treatment for PFDs.

Some guidance on the boundaries of common practice can be found in the practice guidelines and standard of practice and the ethical principles of the Association of Applied Psychophysiology and Biofeedback (Striefel 2004a; AAPB 2003) and especially those of your professional discipline. Other sources of information can be found in the publications of these groups and can be obtained by attending their annual conferences.

What are the boundaries of common practice for your professional discipline and/or that of your supervisor? How many professionals from your discipline do you know who provide biofeedback training for PFDs within their practice? Do they provide the treatment themselves or do they work with a colleague from another discipline who provides the treatment, e.g., a nurse or occupational therapist (OT)?

What would the members of your profession in your community think about you providing treatment for PFDs? You can always ask some of them if they think it is a common or an acceptable area of treatment for members of your professional discipline. Just because they think it is not an acceptable area of practice for your discipline does not by itself mean that providing such treatment is unethical or illegal. However, many complaints received by state licensing boards and ethics committees are submitted by members of one’s own discipline. The complaints are submitted either because a professional is required by their code of ethics to report or deal directly with what they consider to be unethical or illegal behavior on the part of their colleagues (AAPB 2003) or because of jealousy or territorial issues. Do you know the boundaries of acceptable common practice for your discipline? If not, you should contact your state licensing board or other members of your discipline to find out. The answers to questions on the boundaries of common practice for one’s discipline overlap with what is legally allowed within the scope of practice for one’s professional license. If you have any doubts about what is or is not allowed by your professional

license (scope of practice), it would be prudent to hire an attorney who specializes in issues such as interpretation of licensing laws to provide you with appropriate guidance.

Legal Scope of Practice

Are you familiar with, and do you have copies of the licensing and any other laws relevant to your professional practice? It is important to remember that sometimes restrictions on what you can do are contained within the body and/or rules and regulations of another licensing law such as that for physicians. You should be familiar with them and have copies of such laws. Most are now available at the website of the state’s professional licensing office. What disorders does your professional license allow you to treat legally? Are there any restrictions, and if so, what are they? What behaviors on your part might be considered to be practicing medicine without a license or to be operating outside the legal scope of practice allowed by your license? For example, in 1999, a psychologist in Arizona was sanctioned by the state licensing board for practicing beyond the scope of practice as defined in that state’s licensing law for psychologists (APA 1999). The psychologist was using Thought Field Therapy, a process of touching specific muscle or acupuncture points to release emotional trauma. The psychologist was mandated to cease and desist in providing thought field therapy within his psychology practice. If he wished to provide such treatment, and if it was not prohibited by any other state or federal law, it had to be provided at a different physical location than that in which he practiced psychology. In 2006 the licensing board for medicine in Maryland accused a social worker of practicing medicine without a license because she was using the neurofeedback equipment which introduced a minuscule electrical current as a part of the process. The licensing board considered that to be an invasive procedure and thus they considered it to be the practice of medicine. The social work licensing board, the BCIA board, and ultimately the medical licensing board found in favor of the social worker. Could the use of insertable sensors be considered by the licensing board in your state to be an invasive procedure allowable only by licensed medical personnel? Does the medical licensing act restrict the use of invasive procedures to licensed medical practitioners in your state?

Would the licensing board in your state or country of practice consider the treatment of PFDs to be outside of the scope of practice for members of your discipline? What does or would your state licensing board say if they learned that you were treating PFDs? Would it matter to them if the cause of the problem being treated was emotional stress, a surgical side effect, or an after effect of a pregnancy and delivery? In your state of practice are PFDs treated primarily by medically and closely associated licensed professionals such as physicians, nurses, physical therapists and occupational therapists?

It is important to remember that licensing boards often do not become aware of or interested in what a practitioner is doing until a patient files a complaint or there is some public outcry that cannot be ignored.

Diagnosis

In your state, who is legally allowed to make a diagnosis of PFDs? You clearly should not make a diagnosis that is outside the scope of practice for your license. Doing so can well be considered to be practicing medicine without a license. The same can be said for providing a treatment not allowed by your license. All clinicians treating pelvic floor muscle dysfunction should do so only with a referral from a physician able to diagnosis, rule out organic and any other medical problems. Practitioners should then treat and/or refer out, as appropriate to the needs of the client/patient. It is a professional responsibility and legal requirement to refer patients/clients to an appropriate professional (e.g., a physician) to have a diagnosis made that falls outside of the boundaries of common practice for your discipline and/or outside the scope of practice allowed by your license. Care must be taken about what is said or implied during the referral process so as to avoid implying that you have made the diagnosis and to avoid later conflict if the physician were to make a diagnosis different from what you might think it was.

Medical Evaluation

It is important to have an appropriately trained and competent specialty physician such as a urologist or gynecologist conduct a complete medical evaluation to rule out all potential organic causes for the symptoms before treatment is initiated (Glazer 2006). It is important to recognize that for some conditions such as vulvodynia it may be difficult to find a physician, even a gynecologist or urologist, who is familiar with the symptoms or the condition itself (Glazer and Rodke 2002). Patients with vulvodynia often see five or more physicians before finding one who is familiar with the condition (Glazer and Rodke 2002). As such, it may take considerable effort to get a correct diagnosis of a condition such as vulvodynia. The Diagnostic and Statistical Manual, 4th Edition (DSM VI) (APA 2001) did not even include vulvodynia as a diagnostic condition and many physicians are not familiar with it and thus tell patients that it is ‘‘in their head’’ (Glazer and Rodke 2002). To get a diagnosis, appropriate medical examination and physical evaluation may require looking for a specialty clinic such as a vulvar pain clinic or may require working closely with a sympathetic physician who is willing to learn new things. Only after medical clearance and perhaps even a specific prescription by the physician for biofeedback or other behavioral treatment, should a biofeedback practitioner undertake his or her own assessment, collect a baseline, develop a treatment plan, and initiate treatment.

The physician can help ensure that the disorder/problem is one for which biofeedback, pelvic floor muscle exercises, and/or other applied psychophysiological treatments are acceptable treatment options. Physicians can rule out using biofeedback and behavioral interventions when some other medical treatment is indicated, e.g., when there is an organic cause such as a tumor or inflammation best treated with surgery or medications. A compete physical exam, history, and appropriate medical examination and physical evaluation should always precede any urodynamic testing (Dickinson 2006b), and/or any EMG assessment in preparation for treatment of a pelvic floor disorder.

Medical Collaboration

Treating PFDs is an area of practice where it is prudent, practical and perhaps mandatory to first have a physician’s order and possibly collaborate with that physician and/or other professionals such as physical therapists, nurses, and/ or occupational therapists. Doing so, helps ensure that the client/patient gets a correct diagnosis, gets the most appropriate treatment or treatment options presented to him or her, that no harm is done to the patient, and that each professional on the team does his or her part legally, ethically, and professionally. The complexity of some PFDs makes it clear that assessment and treatment by a multidisciplinary team that specializes in treating such conditions is in the best interests of the client.

Honesty and Nondeception

It is important to look carefully at all printed, audio-visual, and other materials for accuracy and honesty. It is easy to inadvertently mislead a client/patient into believing one is a physician when one is not one. For example, if one wears a name tag or has written or audio-visual materials that use the title doctor rather then PhD if one has a PhD, it is easy for clients/patients to assume that one is a medical doctor, especially if a medical doctor introduces a practitioner to a patient by the title doctor without also making clear what the practitioner’s discipline is. Even wearing a white coat can mislead some patients into believing that one is a physician if one operates out of a medical clinic or hospital setting. We all know that white coats and the term doctor before or after our own name enhance our status and we may have even learned to use such factors as part of enhancing the placebo effects of treatment.

Practitioners should not, deliberately or inadvertently, mislead patients into thinking he or she is something he or she is not. Practitioners should make clear what their degree, discipline, and/or title are in all correspondence, written and audio-visual materials, name tags, and labels on office doors. A name plate on ones desk that is clearly visible to a client seated before the desk and a name tag that clearly reads, e.g., Sarah Ellis, PhD, Psychologist is much clearer and less misleading then a name tag that reads, Dr. Sarah Ellis.

It is also important to correct errors made by other health care practitioners, media personnel, or others who introduce us in ways that could be misleading. For example, if a psychologist was introduced to a patient by a gynecologist as Dr. X, when in fact; the person was not an MD but rather possessed a PhD degree, it would be important to make clear to the patient that one is not a physician but rather that ones degree is in psychology. It is important to be sensitive to misleading statements and to correct them whenever possible.

Summary of Tentative Ethical Practice Guidelines for the Assessment and Treatment of Pelvic Floor Disorders

Competence

Practitioners should practice only in those areas in which they are competent unless appropriately supervised. They should be prepared to demonstrate to others (e.g., licensing board or ethics committee) that they are competent in all of the knowledge and skills needed before undertaking or providing assessment and/or treatment for any specific PFD. Competence should be demonstrable based on education, training, experience (supervised and unsupervised), and continuing education (Striefel 2004a). Licensing and/or certification in a health care field in the state in which one practices, along with BCIA certification in Pelvic Muscle Dysfunction Biofeedback, are two ways of demonstrating that one has had the specific education, training, and supervised experience necessary for acquiring these credentials. Credentials by themselves are not necessarily indicators of ones competence to treat a specific disorder. Practitioners are responsible for providing services only in areas in which they are competent.
Licensing and certification by themselves are not necessarily evidence of competence in a specific area or of continued competence, especially if several years have lapsed since licensing or certification first occurred. Practitioners should remain current on the clinical and research literature related to the assessments and treatments that they provide, should know the level of support for each, the potential risks, benefits, and side effects for each, how to deal with side effects if they occur, and any other information needed to avoid harming those they serve and for facilitating positive outcomes from treatments provided.

Practitioners should also remain current on all relevant laws, ethical principles, and practice guidelines and standards, e.g., the ethical principles and practice guidelines and standards, if any, for their discipline, AAPB (2003; Striefel 2004a), and BCIA. Practitioners have an ethical obligation to abide by all relevant ethical principles, practice guidelines and standards, laws, and other applicable rules and regulations. The public does expect professionals to adhere to a higher standard of practice then it does other people they know.

Medical Clearance and Cooperation

Unless appropriately licensed as a physician or otherwise allowed by law to make a diagnosis of a pelvic floor disorder, a practitioner will not make a diagnosis or undertake the assessment or treatment of a pelvic floor disorder until such time as a medical clearance and/or referral has been received. This means that all self referrals with possible PFDs will be referred to an appropriately specialized physician (e.g., urologist, gynecologist) for a diagnosis, the ruling out of all organic causes for the problem, and an indication that biofeedback, and/or other applied psychophysiological or behavioral assessments and treatments are not contraindicated. When a patient is referred by a physician for treatment where a diagnosis has not yet been made and where it seems likely that the patient has a pelvic floor disorder, a discussion will be held with the physician (with client consent) and the client referred to a specialty physician for medical clearance as previously described if making the diagnosis is outside of the particular physician’s areas of competence and a need for a diagnosis exists.

Some educational dialogue with the referring physician may be necessary to work out issues of scope of practice, competence, appropriateness of behavioral, applied psychophysiological, or biofeedback treatments. Establishing a good rapport and working relationship with physicians is generally in the client/patient’s best interest. Only after medical clearance should a biofeedback practitioner undertake his or her own assessment, collect a baseline, develop a treatment plan, and initiate treatment.

Informed Consent

Practitioners should take care to obtain full and meaningful informed consent on all of the factors that a reasonable person would want to be informed about before undergoing pelvic floor assessment or treatment. This informed consent should not fall below the expected standard of care for one’s discipline or that of AAPB if one is using biofeedback or other applied psychophysiological approaches to assessment and/or treatment (Striefel 2004a). At minimum, informed consent should include: limits of confidentiality; fees, billing, insurance limitations, and collection procedures; major treatment options, level of clinical and research support for each, potential risks, benefits, and side effects of each, and the rationale for proposing to use a specific treatment approach; information on the approach to assessment and treatment, what level of appropriate touch may be involved, sensor placement, safety and prevention of infection issues; protection of client privacy, modesty, and sense of decency; client right to withhold or withdraw consent; and the client’s right to ask questions at any time and have them answered (Striefel 2004a). See the earlier section on ‘‘Standards of Dress and Touch’’ for more specific guidance.

Clients should not be asked to consent to procedures that violate a federal or state law, an ethical principle, or a practice guideline or standard (Striefel 2007d). For example, it is unethical and illegal for a practitioner to obtain consent to forms of touch that are outside of the scope of practice for members of a specific discipline. Having clients undress, attaching or inserting sensors on the genitalia, breasts, or other parts of the body that would be considered a violation of a client’s right to privacy and modesty by a specific discipline is unethical and probably illegal (Striefel 2007d).

Practitioners should remember that in most states touching a client without permission, e.g., to attach sensors even on public areas of the body, can be considered assault (Striefel 2007d). One should not assume that a client has given consent just because he or she does not object at the time. Some clients are shy and unlikely to confront a professional, but may well be offended and take legal action later or file an ethics complaint if they feel they or their rights were violated. Medical practitioners have long practiced risk management when conducting physical exams of opposite gender clients by having a second person, often of the same gender as the client present during such examinations. It avoids misunderstandings. Many practitioners conducting pelvic floor treatment invite the client to bring someone they trust with them to all sessions, even though many clients do not do so. If a practitioner palpates muscles in acceptable areas of the body (i.e., within the scope of practice for his or her discipline) where there might be any question of appropriateness, it is expected that to remain within the minimal acceptable standards of practice that the practitioner will explain the reason for doing so and will ensure that he or she has the client’s informed consent for doing so. Having a second person present who is the same gender as the patient is prudent, and is a way of avoiding problems and questions about the appropriateness of any touch that occurs. In addition, the presence of a witness decreases the probability that a practitioner will behave inappropriately. Practitioners will carefully document the content and process for obtaining informed consent. Informed consent is not a one time event, but rather is ongoing from first contact to termination of treatment.

Practitioners are expected to know and abide by standards set by the Office of Safety and Health Administration (OSHA) (Striefel 2007d). This includes, but is not limited to: the universal precautions about blood borne pathogens and for preventing infections, such as using sterile sensors, wearing gloves if one is likely to come in contact with bodily fluids (e.g., handling a sensor that was inserted in the vaginal canal or if abrading the skin), washing ones hands between clients, and disinfecting the client treatment space and all of the equipment therein. Practitioners should not become complacent in adhering to the relevant OSHA standards. Practitioners have an ethical and legal duty to avoid infecting themselves, their family, or other patients. It is prudent to practice as if one is not sure if a specific client has an infection, sexually transmitted disease, or is HIV positive. Prevention is good practice.

Licensing Laws

Every state has its own approach to how it goes about licensing or certifying health care professionals. Some states do not license or certify members of all health care professions. It is important for all practitioners who wish to assess and/or treat PFDs to be familiar with and abide by any and all relevant state licensing and/or certification laws. Practitioners should be familiar not only with the laws for their own discipline but also the laws for any other discipline that might restrict or prohibit certain activities. Most commonly this would be the licensing law for physicians.

Acknowledgements
Some of the content of this article was previously published by S. Striefel (2006). Thanks are expressed to AAPB and Alliance Communications Group (now called Allen Press Publishing Services) for permission to reprint that material within this article. The authors would also like to thank Susan J. Middaugh, PhD for her timely and thoughtful review of this article.

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Keywords : PFD EMG

Source : Appl Psychophysiol Biofeedback (2008) 33:181–193

A Proposed Set of Ethical Practice Guidelines in the Assessment and Treatment of Pelvic Floor Disorders

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