On October 6, 2000 the Health Care Financing Administration (HCFA) announced that it was initiating a national policy for coverage of biofeedback treatments of urinary incontinence (UI). This is a significant development both for physicians already using biofeedback and for those contemplating adding conservative therapies to their practice.
On October 6, 2000 the Health Care Financing Administration (HCFA) announced that it was initiating a national policy for coverage of biofeedback treatments of urinary incontinence (UI). This is a significant development both for physicians already using biofeedback and for those contemplating adding conservative therapies to their practice.
HCFA's announcement is the latest event in a clinical trend that began in 1988, when the National Institutes of Health (NIH) held a consensus conference concerned with UI as a health care issue. The NIH conference concluded that, as a general rule for the staging of treatment, the least invasive method should be tried first. In 1992, biofeedback and other conservative therapies received additional support when the Agency for Health Care Policy and Research (AHCPR) published its Clinical Practice Guidelines for the Treatment of UI. The 1996 edition of the AHCPR Guidelines gave its highest strength of evidence for biofeedback combined with strategies for urge in the treatments of stress, urge, and mixed UI.[1]
In 1998, the need for more widespread use of conservative therapies was reinforced by a National Association for Continence membership survey that revealed:
Conservative Treatment
Conservative treatment includes many techniques that are used in designing individualized treatment plans for patients with pelvic muscle dysfunction (PMD) (Table 1). PMD includes disorders of the bowel and bladder affected by a nonefficient functioning of the pelvic floor muscles (levator ani) (Table 2). Biofeedback is the primary technique used in treating PMD, and should be viewed as an adjunct to medical practice. Biofeedback training is a tool for physicians to enhance total patient care, and it is a tool for patients, guided by a clinician, to learn physiological control. Biofeedback should only be recommended for patients after an appropriate medical diagnostic work-up.
Table 1. Behavioral Techniques
Table 2. PMD Treatment Applications
Biofeedback from Kegels to Beyond
In the late 1940s Dr. Arnold Kegel felt that there was another way to treat urinary incontinence besides surgery. He developed a vaginal pressure perineometer. The woman inserted the perineometer and performed repetitive contractions and relaxations of the pelvic floor muscles. This was technically biofeedback. Dr. Kegel only prescribed pelvic muscle exercises with the use of instrumentation.[2] Kegel exercises have continued to be prescribed but without the use of instrumentation. Unfortunately many patients are unable to perform an isolated contraction and up to 25% will promote urinary incontinence with their efforts.
Biofeedback training by surface electromyography (sEMG) for incontinence and other related pelvic muscle dysfunctions is a group of therapeutic procedures that includes verbal instructions, focused attention, feedback, and motor skills learning. It utilizes an electronic instrument to accurately measure, process and 'feedback' to the patient and clinician data in the form of visual and/or auditory signals. This information has educational and reinforcing characteristics about the muscle activity. The knowledge of muscle activity allows the patient and clinician to adjust existing motor patterns by reeducating the muscle or muscle groups for efficient muscle function and voluntary control. sEMG uses surface electrodes to noninvasively monitor aggregated muscle activity for the purpose of functional evaluations and rehabilitation.
The CIRCON Orion Platinum biofeedback instrument (Figure 1) gives clinicians the capabilities of providing multi-modality biofeedback training. Multi-modality biofeedback provides the opportunity to monitor up to four channels of sEMG, peripheral temperature, and respiration. Four channels of sEMG will allow clinicians to do pelvic muscle profiling for female patients with complex PMD. The four channels include monitoring the sEMG signals from an internal vaginal sensor, and an anal sensor recording from the deep and subcutaneous branches of the external anal sphincter and accessory muscle (abdominal).
ControlWorks, the software platform for the Orion Platinum, provides a robust collection of evaluation/training protocols, including the Beyond Kegels® protocols. Documentation is designed to meet criteria for reimbursement, including trend analysis from sEMG data and the voiding diary.
The Beyond Kegels protocols incorporate the action of the pelvic muscle force field as described by Hulme.[3] This pelvic muscle force field includes the following muscles: 1) obturator internus; 2) pelvic diaphragm (levator ani); 3) urogenital diaphragm; 4) external urinary and anal sphincters; and 5) hip adductors. The Beyond Kegel protocol combines external hip rotation and internal hip rotation exercises to facilitate action of the pelvic and urogenital diaphragm muscles within the pelvic muscle force field. Research by Hulme and Nevin compared Kegel exercises alone to the Beyond Kegels exercise protocol. Their research indicated a 46% decrease in the number of weeks to obtain continence (average 6.5 weeks compared to 3.5 weeks).[4]
Temperature and respiration feedback is used along with physiological quieting for quieting the autonomic nervous system. This is useful in setting the resting tone of striated muscles, which is determined largely by the muscle spindle gamma bias within each muscle fiber bundle. Diaphragmatic breathing and hand warming are also used in quieting the autonomic nervous system innervation in urge incontinence, urgency/ frequency, and in pain.
Essential Ingredients for Successful Biofeedback Training
Biofeedback training requires the same ingredients necessary for training of any complex skill: clear goals, rewards for goals, sufficient time and practice for learning, proper instructions, variety of training techniques, and feedback of information. There must be an active and positive interaction between the patient and clinician. The patient must be cognitively intact, able to understand the rationale for training, and able to process the positive expectations and motivation. The choice of the clinician providing the training is paramount to the success of the biofeedback program.
Summary
Biofeedback training is an adjunct to medical practice and a mechanism to provide nurse-generated income. It may be used alone or in combination with medications or surgery. There is generally an 80% success rate or higher and no side effects. The HCFA decision to amend Coverage Issues Manual 35-27 includes the following:
"Biofeedback therapy is covered for the treatment of stress and/or urge incontinence in patients who failed a documented trial of pelvic muscle exercise training or who are unable to perform pelvic muscle exercises. Contractors may decide whether or not to cover biofeedback as an initial treatment modality."
Incorporating biofeedback training into medical practices enhances total patient care and improves patients' quality of life.
References
1. Clinical Practice Guidelines Update: Urinary Incontinence in Adults. Rockville, MD: Agency for Health Care Policy and Research; 1996.
2. Kegel AH. Progressive resistance exercises in the functional restoration of the perineal muscles. Am J Obstet Gynecol. 1948; 56:238-248.
3. Hulme J. Beyond Kegels: Fabulous Four Exercises to Prevent and Treat Incontinence. Missoula, MT: Phoenix Publishing, 1997.
4. Hulme J. Research in Geriatric Urinary Incontinence: Pelvic Muscle Force Field. Topics in Geriatric Rehab 2000; 16:1.
Dr. Rackley is on staff at the Section of Voiding Dysfunction and Female Urology, and Director of the Pelvic Floor Re-education Center, at the Urological Institute, Cleveland Clinic Foundation.
Linda West is a clinical consultant for SRS Medical, and is certified in biofeedback and perineometry.
®Beyond Kegels is a U.S. registered trademark of Phoenix Publishing
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