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MP 2.01.27 Biofeedback as a Treatment of Urinary Incontinence in Adults

Medical Policy
Section
Medicine 		 Subsection Last Review Status/Date
Reviewed with literature search/7:2009
Issue
7:2009		 Original Policy Date
7/31/97		 Return to Medical Policy Index

Disclaimer

Our medical policies are designed for informational purposes only and are not an authorization, or an explanation of benefits, or a contract.  Receipt of benefits is subject to satisfaction of all terms and conditions of the coverage.  Medical technology is constantly changing, and we reserve the right to review and update our policies periodically.

Description

Urinary Incontinence (UI) is a common condition defined as an involuntary leakage of urine. Women are twice as likely to be affected as men and prevalence increases with age. The severity of incontinence affects quality of life and treatment decisions. The types of urinary incontinence include stress, urge, overflow, functional and post-prostatectomy incontinence. Nonsurgical treatment options may include pharmacological treatment, pelvic muscle exercises (PME), bladder training exercises, electrical stimulation and neuromodulation Biofeedback, in conjunction with pelvic muscle exercises, has been proposed as a treatment modality for stress, urge, mixed and overflow urinary incontinence because it may enhance awareness of body functions and the learning of the pelvic floor exercises. There are several proposed methods of biofeedback which may be employed for the treatment of urinary incontinence including: vaginal cones or weights, perineometers and electromyographic (EMG) systems with vaginal and rectal sensors. Biofeedback is a technique intended to teach patients self-regulation of certain physiologic processes not normally considered to be under voluntary control. The technique involves the feedback of a variety of types of information not commonly available to the patient, followed by a concerted effort on the part of the patient to use this feedback to help alter the physiological process in some specific way. Biofeedback has been proposed as a treatment for a variety of diseases and disorders including anxiety, headaches, hypertension, movement disorders, incontinence, pain, asthma, Raynaud’s disease, and insomnia. Biofeedback training is done either in individual or group sessions, alone, or in combination with other therapies designed to teach relaxation. A typical program consists of 10 to 20 training sessions of 30 minutes each. Training sessions are performed in a quiet, non-arousing environment. Subjects are instructed to use mental techniques to affect the physiologic variable monitored, and feedback is provided for successful alteration of the physiologic parameter. This feedback may be signals such as lights or tone, verbal praise, or other auditory or visual stimuli.

The various forms of biofeedback differ mainly in the nature of the disease or disorder under treatment, the biologic variable that the individual attempts to control and the information that is fed back to the individual. Biofeedback techniques include peripheral skin temperature feedback, blood-volume-pulse feedback (vasoconstriction and dilation), vasoconstriction training (temporalis artery), and electromyographic (EMG) biofeedback; these may be used alone or in conjunction with other therapies (e.g., relaxation, behavioral management, medication).

A variety of biofeedback devices are cleared for marketing though the Food and Drug Administration’s (FDA) 510(k) process. The FDA defines a biofeedback device as “an instrument that provides a visual or auditory signal corresponding to the status of one or more of a patient's physiological parameters (e.g., brain alpha wave activity, muscle activity, skin temperature, etc.) so that the patient can control voluntarily these physiological parameters”.

*Note:Biofeedback as a treatment of headache, chronic pain, miscellaneous applications, and fecal incontinence are addressed in separate policies, Nos. 2.01.29, 2.01.30, 2.01.53, and 2.01.64, respectively.

Policy

Biofeedback is considered investigational as a treatment of urinary incontinence in adults.

Unsupervised home use of biofeedback for treatment of urinary incontinence is investigational.

Policy Guidelines

No applicable information

Benefit Application

BlueCard/National Account Issues

State or federal mandates (e.g., FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.

Biofeedback and biofeedback devices are specifically excluded under many benefit plans. In addition, biofeedback and biofeedback devices are considered behavioral training and education/training in nature, and such services are also specifically excluded under many benefit plans.

Rationale

Several methodologic difficulties arise in assessing biofeedback. For example, most interventions that include biofeedback are multimodal and include relaxation and behavioral instruction, which may have effects separate from those that may occur due to biofeedback. While studies may report a beneficial effect of multimodality treatment, without appropriate control conditions, it is impossible to isolate the specific contribution of biofeedback to the overall treatment effect. For example, relaxation, attention, or suggestion may account for successful results that have been attributed to biofeedback. These effects are nonspecific therapeutic factors, some of which can be considered placebo effects.

A 1995 TEC Assessment evaluated the use of biofeedback in the treatment of 9 different conditions: anxiety disorders, headaches, hypertension, movement disorders, incontinence, pain, asthma, Raynaud’s disease, and insomnia. (1) The Assessment concluded that while a substantial number of studies reported improvement in the biofeedback group relative to the no-treatment group, there were generally no differences when the isolated effect of biofeedback was compared with relaxation or behavioral therapy alone. The Assessment also concluded that while there was evidence that feedback on physiological processes provides patients with an enhanced ability to control these processes, there was nevertheless no consistent evidence of any relationship between a patient’s ability to exert control over the targeted physiological process and any health benefits of the intervention. This finding underscores the importance of seeking controlled studies showing whether use of biofeedback improves disease-related health outcomes, as opposed to physiological, intermediate outcomes. Studies also failed to consistently address the durability of effects beyond the initial short-term biofeedback training period. The findings that were reviewed suggest that the outcomes of biofeedback relative to no treatment are due to the other components of therapy or to the nonspecific effects of the therapeutic setting and are not a result of the biofeedback training per se.

The specific indication of biofeedback as a treatment of urinary incontinence was re-evaluated in 1997 and 2000 TEC Assessments. (2, 3) These Assessments focused on the independent contribution of biofeedback as an adjunct to pelvic floor muscular exercises. The 1997 TEC Assessment concluded that while the controlled trials that isolated the contribution of biofeedback reported conflicting results, the weight of the evidence suggested no additional benefit for biofeedback above that obtained with pelvic floor muscle exercises alone. (2) All of the trials had low power to detect a small difference in outcomes; therefore, the possibility exists that larger trials with improved statistical power could demonstrate a beneficial effect of biofeedback. However, the TEC Assessment concluded that based on the available data, any such benefit, if present, is likely to be small and may not be clinically significant.

The conclusions of the 2000 TEC Assessment (3) were similar to the 1997 Assessment, i.e., that the evidence is not sufficient to demonstrate an additional benefit for biofeedback above that obtained with pelvic floor muscle exercises (PME) alone:

  1. Six controlled trials reported outcomes of biofeedback for the treatment of stress incontinence. These trials failed to demonstrate that the addition of biofeedback is superior to PME alone. 

    An update of the literature since the 2000 TEC Assessment identified a single report that met study selection criteria for stress urinary incontinence. One small, randomized study compared individual biofeedback plus PME to group physical therapy focusing on PME. (4) Mixed results were reported, with the biofeedback group demonstrating better subjective outcomes and the physical therapy group having slightly better objective outcomes. The results are limited at best and mitigated by possible confounding introduced by individual versus group therapies, the lack of standard outcomes measures (i.e., pad test), and possible bias introduced by a high rate of exclusions from the biofeedback group.
  2. One small, non-randomized study focused on patients with urge incontinence. There was no statistically significant improvement in outcomes for the biofeedback plus PME group as compared to the PME alone group.
    The literature update since 2000 identified no trials on urge incontinence meeting study selection criteria.
  3. One randomized trial investigated biofeedback in men with post-prostatectomy incontinence (5), a relatively uncommon indication for biofeedback at that time. A total of 30 patients were randomized to usual care or usual care plus biofeedback. Both groups improved significantly over time, but there was no difference between groups in the magnitude of improvement.
    Two papers published since the 2000 Assessment have supported the findings of this earlier study. A randomized study of 42 post-prostatectomy patients found no significant difference in outcome between biofeedback plus PME and verbal feedback plus PME. (6) Both groups improved significantly over time. A second randomized trial of 100 patients evaluated a preoperative training program of biofeedback plus PME versus PME alone. (7) Again, both groups improved, but the continence rates as defined by pad test and the rate of continence return were not significantly different between groups. A third study, a randomized controlled trial of 102 post-prostatectomy patients, reported that improvement in both duration and degree of incontinence was significantly better in a group receiving PME plus biofeedback versus placebo. This trial, however, did not evaluate the additive effect of biofeedback. (8)

 

In summary, the literature update did not identify evidence sufficient to alter the 2000 TEC Assessment findings on biofeedback for urge, stress, or post-prostatectomy incontinence.

Some trials have reported favorable outcomes with biofeedback plus pelvic floor exercises, but these studies have not examined the incremental effect of adding biofeedback to PME. For example, Burgio and colleagues reported on a study that randomized 197 women to receive either biofeedback-assisted pelvic muscle exercises or drug treatment or placebo. (9) While the biofeedback group reported improved results compared to placebo or drug treatment alone, this study did not isolate the independent contribution of the biofeedback to the pelvic muscle exercises. In a more recent study, Burgio and coworkers (10) used a modified crossover design to evaluate the effects of combining biofeedback-assisted PME and drug treatment. Subjects with urge incontinence were randomized to biofeedback, drug, or placebo groups. Subjects not totally continent or satisfied after 8 weeks of treatment were offered the opportunity to cross over into combined therapy. Although the results showed that combining drug and biofeedback with PME in a stepped program produces added benefits beyond either single therapy, the incremental benefit of adding biofeedback to PME was not addressed. Similarly, McDowell and colleagues reported that outcomes with biofeedback-assisted pelvic muscle exercises were superior to a waiting-list control group. (11) Again, the independent impact of biofeedback on outcomes was not studied.

The focus of both the 1997 and 2000 TEC Assessments (2, 3) contrasts with the 1996 assessment on treatment of incontinence published by the Agency for Healthcare Research and Quality (formerly the Agency for Health Care Policy and Research, AHCPR). (12) While the AHCPR assessment endorsed the use of behavioral therapy as a first-line treatment of incontinence, and identified biofeedback as a component of behavioral therapy, the AHCPR did not specifically evaluate the independent contribution of biofeedback to an overall behavioral approach.

Other evidence-based reviews on the effectiveness of biofeedback for urinary incontinence have generally found limited evidence or no evidence supporting a beneficial effect beyond that offered by PME alone. A Cochrane review conducted in 2000 concluded that formal comparisons of biofeedback-assisted PME versus PME alone consistently suggest that there is no added benefit in women with stress or mixed incontinence. (13) Berghmans and colleagues published a systematic review with qualitative data synthesis. (14) These authors concluded that there was strong evidence to support that the addition of biofeedback to pelvic floor muscle exercises (PME) does not offer additional benefits over PME alone. Weatherall performed a quantitative meta-analysis of the data included in the Berghmans report. (15) This analysis revealed a pooled odds ratio of 2.1 in favor of biofeedback, a result that reached marginal statistical significance.

The Medicare Coverage Advisory Committee (MCAC), Medical/Surgical Procedures Panel, evaluated the effectiveness of biofeedback for urinary incontinence in April 2000. (16) Based strictly on the scientific evidence, the panel concluded that it is not clear that biofeedback adds clinical benefit above and beyond PME alone for stress, urge, or post-prostatectomy incontinence. However, a group that is anecdotally reported to benefit from biofeedback-assisted PME is women who are not able to voluntarily contract their pelvic floor muscles or who fail PME alone, but no reports support this hypothesis. While limited direct empirical evidence was available on whether biofeedback improves outcomes in patients who have failed PME or are unable to perform PME, the Centers for Medicare and Medicaid Services (CMS) felt that coverage was warranted, given the combination of suggestive scientific evidence and broad positive expert testimony. (16)

According to Medicare policy, 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 muscle exercises. Contractors may decide whether or not to cover biofeedback as an initial treatment modality.

2005 Update

A literature search of the MEDLINE database, performed for the period of 2003 through June 2005, did not identify any additional controlled trials that would address the limitations noted above. Therefore, the policy statement is unchanged. Aksac and colleagues reported the results of a trial that randomized 50 patients with stress incontinence to 1 of 3 groups: self-directed PME, biofeedback-directed PME, or no treatment. (17) Outcomes were assessed with pad tests, perineometry, and pelvic floor muscle strength as assessed by digital palpation. The first 2 groups had a significant improvement in outcomes compared to the control (no treatment) group. The biofeedback group had increased strength in the pelvic floor muscles compared to those with self-directed PME, but the clinical significance of this difference is unclear. Two trials investigated the role of biofeedback in post-prostatectomy patients. In a randomized trial, Wille and colleagues reported that the addition of biofeedback did not improve the outcomes compared to PME alone. (18) Parekh and colleagues examined the role of biofeedback-enhanced PME offered both pre- and postoperatively to post-prostatectomy patients. (19) Since this trial did not include PME alone, the contribution of biofeedback cannot be isolated. Aukee and colleagues reported on a study that randomized 35 women with stress incontinence to receive pelvic floor training with or without additional biofeedback. (20) Patients were evaluated after a year; however, during this time 14 of the 35 underwent an incontinence operation, limiting interpretation of the study. Wang and colleagues conducted a study that randomized 103 women with overactive bladder to 1 of 3 arms: pelvic floor exercises, biofeedback-assisted pelvic floor exercises, or electrical stimulation (21). There was a 14% dropout rate in this 12-week study; these results were not included in the statistical analysis. There was no significant difference in reduction in symptoms between the pelvic floor exercise group with or without biofeedback assistance.

2006 Update

A literature review update for the period of June 2005 through July 2006 did not identify any additional controlled trials that would address the limitations noted above. Therefore, the policy statement is unchanged.

2007-2008 Update

A search of the MEDLINE database was performed for the period of August 2006 through December 2007. A systematic review of pelvic floor muscle training to improve urinary incontinence after radical prostatectomy discussed 3 studies (281 men) that focused on the incremental value of biofeedback over written/verbal PME. (22) Although PME appeared to reduce the time to recover continence compared to no training, there was no evidence for an advantage of training with biofeedback over written/verbal instructions. An incremental improvement with biofeedback-PME or a combination of biofeedback-PME plus neuromuscular electrical stimulation was reported in a small study (10 subjects per group) of patients with multiple sclerosis; interpretation of the study results is limited due to the small group size and an imbalance in baseline measures following randomization. (23) A subsequent randomized study by the same group (74 patients with multiple sclerosis) reported that the addition of neuromuscular electrical stimulation (with biofeedback training) resulted in 85% incontinence reduction, compared to a 47% incontinence reduction in the control group trained only with biofeedback. (24) No evidence was identified that would alter the conclusions reached above; the policy statement is unchanged.

2009 Update

A search of the MEDLINE database was performed for the period December 2007 through December 2008. The literature search did not identify any new high quality clinical trials that address biofeedback for the treatment of urinary incontinence. Thus, the evidence base reviewed above is unchanged.

Technology Assessments and Systematic Reviews

In October 2006, National Institute for Health and Clinical Excellence (NICE) (25) issued their guideline on the management of urinary incontinence in women. NICE states that “perineometry or pelvic floor electromyography as biofeedback should not be used as a routine part of pelvic floor muscle training”, but that “electrical stimulation and/or biofeedback should be considered in women who cannot actively contract pelvic floor muscles in order to aid motivation and adherence to therapy.” This conclusion regarding use of biofeedback is based on expert opinion.

An Evidence Report/Technology Assessment, Prevention of Urinary and Fecal Incontinence in Adults (26), based on research conducted by the Minnesota Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville was issued in December 2007.

The research objectives were to assess the prevalence of and risk factors for urinary incontinence (UI) and fecal incontinence (FI) in adults in long-term care (LTC) settings and in the community, the effectiveness of diagnostic methods to identify adults at risk and patients with incontinence, and to review the effectiveness of clinical interventions to reduce the risk of incontinence. The Report executive summary section titled “Effects of Clinical Interventions on UI”, includes the authors’ overview of the evidence on the clinical effectiveness of interventions including biofeedback for various UI conditions in adult females and males. The following are excerpts from the report that include biofeedback;

  • Clinical interventions for primary prevention of UI in pregnant women were examined in 8 large randomized controlled trials (RCTs) with more than 100 women and one smaller trial; pelvic floor muscle training with biofeedback and electrostimulation started at 9 weeks after vaginal delivery resulted in continence 10 times more often compared to usual care at 10 months of follow-up.
  • Clinical interventions for primary prevention of UI in males with urological diseases were examined in 12 randomized controlled trials, 2 of 8 trials with continence outcomes, reported significant benefit after pelvic floor muscle training with biofeedback compared to usual care; the highest continence rate (99 percent) was reported in a large, well designed RCT of early pelvic floor muscle training and biofeedback in participants who had radical retropubic prostatectomy for localized prostate cancer at one year of follow-up with a small significant relative benefit compared to usual care; continence rates in the control groups were more than 60 percent across other RCTs with no statistically significant differences compared to active treatments. The comparative effectiveness of pelvic floor muscle training compared to usual care in males after different treatment options for prostate cancer requires future confirmation in well-designed RCTs.
  • Pelvic floor muscle training for secondary prevention of UI found weak evidence suggesting beneficial effects of behavioral interventions on UI in females; pelvic floor muscle training combined with biofeedback were sensitive to one small RCT with a two-month follow-up.

The authors in discussing evidence limitations concluded that the applicability of clinical interventions that demonstrated significant improvement in incontinence was restricted to the sampled population groups. Whether these effective interventions would result in the same clinical benefit in other populations requires future research.

A systematic review of randomized, controlled trials of non-surgical treatments for urinary incontinence in women was conducted for the AHRQ evidence report. (27) This review examined 96 RCTs and 3 systematic reviews to synthesize evidence on the management of urinary incontinence in women. The studies included women with stress and urge urinary incontinence, overactive bladder with urge incontinence, or minimal urinary incontinence. The studies did not explicitly exclude women with other types of urinary incontinence; therefore, the effects of the treatments can be applied to women with mixed urinary incontinence. Study quality was analyzed using the following criteria: participant selection; length and loss of follow-up; use of intention-to treat principle; masking of the treatment status; randomization scheme; adequacy of randomization and allocation concealment; and justification of sample sizes. The efficacy of the clinical interventions was analyzed from the trials that compared active treatment to placebo, regular care, or no active treatments. The comparative effectiveness of the interventions was analyzed from the trials with active controls, long-term follow-up, adequate sample size and intention-to treat analysis. The evidence reviewed included 22 clinical intervention comparative trials with biofeedback in conjunction with pelvic floor muscle training. The overall strength of the evidence in these 22 studies was deemed low.

Nineteen RCTs (n =2,441) included pelvic floor muscle training with biofeedback compared with active interventions (education, bladder training, medical device, medications). The authors concluded continence and improvement rates did not differ when two active treatments were compared. Three RCTs (n =179) included pelvic floor muscle training with biofeedback and bladder training compared with regular care. The authors concluded that pelvic floor training with biofeedback and bladder training improved but did not resolve UI. In conclusion, the studies of behavioral interventions including pelvic floor muscle training and biofeedback relied largely on convenience samples that involved recruiting participants in the clinics while few studies reported population-based recruitment. Selection criteria varied for the same interventions and some clinical trials reported statistically significant differences at baseline among the treatment groups despite randomization. Pooling analysis was questionable due to clinical and methodologic differences across the studies and previous systematic reviews. Despite extensive efforts to standardize outcomes, assessment for urinary incontinence in the included studies measured a variety of outcomes.

In conclusion, despite both CMS and NICE guidance supporting biofeedback-assisted PME for women unable to voluntarily contract their pelvic floor muscles, no published evidence supports these hypotheses. Future research is needed to determine the comparative effectiveness of available treatments, including biofeedback.

No published evidence supports the unsupervised home use of biofeedback for treatment of urinary incontinence.

Clinical Input Received through Physician Medical Societies and Academic Medical Centers

In response to requests, input was received through 4 Physician Specialty Societies and 2 Academic Medical Centers while this policy was under review. While the various Physician Specialty Societies and Academic Medical Centers may collaborate with and make recommendations during this process, through the provision of appropriate reviewers, input received does not represent an endorsement or position statement by the Physician Specialty Societies or Academic Medical Centers, unless otherwise noted. The clinical input was variable. Several reviewers commented about the lack of data (e.g., those who can not do pelvic exercises) as well as the inability to separate from the available literature the contribution of biofeedback to overall outcomes in many studies.

Summary

Therefore, the policy remains unchanged; biofeedback as a treatment for urinary incontinence is considered investigational due to insufficient evidence to permit conclusions concerning the impact of this procedure on net health outcomes. Specifically the value of adding biofeedback to a program of pelvic muscle exercises has not been demonstrated.

Physician Specialty Society Guidelines and Position Statements

In December 2007, NIH convened a Consensus Development Conference; Prevention of Fecal and Urinary Incontinence and subsequently released a statement. (28) Included in this statement was the following regarding pelvic floor muscle training and biofeedback: …”Pelvic floor muscle training and biofeedback are effective in preventing and reversing some pregnancy-related fecal and urinary incontinence for the first year after delivery. There is insufficient research on the sustained long-term benefits of pelvic floor muscle training or biofeedback on preventing fecal or urinary incontinence.”

Medicare National Coverage

This policy (29) applies to biofeedback therapy rendered by a practitioner in an office or other facility setting. Biofeedback is covered for the treatment of stress and/or urge incontinence in cognitively intact patients who have failed a documented trial of pelvic muscle exercise (PME) training. Biofeedback is not a treatment, per se, but a tool to help patients learn how to perform PME. Biofeedback-assisted PME incorporates the use of an electronic or mechanical device to relay visual and/or auditory evidence of pelvic floor muscle tone, in order to improve awareness of pelvic floor musculature and to assist patients in the performance of PME. A failed trial of PME training is defined as no clinically significant improvement in urinary incontinence after completing 4 weeks of an ordered plan of pelvic muscle exercises to increase periurethral muscle strength. Contractors may decide whether or not to cover biofeedback as an initial treatment modality. Home use of biofeedback therapy is not covered.
 

References:

  1. 1995 TEC Assessments; Tab 25.
  2. 1997 TEC Assessments; Tab 23.
  3. 2000 TEC Assessments; Tab 3.
  4. Pages IH, Jahr S, Schaufele MK et al. Comparative analysis of biofeedback and physical therapy for treatment of urinary stress incontinence in women. Am J Phys Med Rehabil 2001; 80(7): 494-502.
  5. Franke JJ, Gilbert WB, Grier J et al. Early post-prostatectomy pelvic floor biofeedback. J Urol 2000; 163(1):191-3.
  6. Floratos DL, Sonke GS, Rapidou CA et al. Biofeedback vs. verbal feedback as learning tools for pelvic muscle exercises in the early management of urinary incontinence after radical prostatectomy. BJU Int 2002; 89(7):714-9.
  7. Bales GT, Gerber GS, Minor TX et al. Effect of preoperative biofeedback/pelvic floor training on continence in men undergoing radical prostatectomy. Urology 2000; 56(4):627-30.
  8. Van Kampen M, De Weerdt W, Van Poppel H et al. Effect of pelvic-floor re-education on duration and degree of incontinence after radical prostatectomy: a randomised controlled trial. Lancet 2000; 355(9198):98-102.
  9. Burgio KL, Locher JL, Goode PS et al. Behavioral vs. drug treatment for urge urinary incontinence in older women: a randomized controlled trial. JAMA 1998; 280(23):1995-2000.
  10. Burgio KL, Locher JL, Goode PS. Combined behavioral and drug therapy for urge incontinence in older women. J Am Geriatr Soc 2000; 48(4):370-4.
  11. McDowell BJ, Engberg S, Serbia S et al. Effectiveness of behavioral therapy to treat incontinence in homebound older adults. J Am Geriatr Soc 1999; 47(3):309-18.
  12. Fantl JA, Newman DK, Colling J et al. Urinary incontinence in adults: acute and chronic management. Clinical practice guideline, No. 2, 1996 update. Rockville, MD. Agency for Health Care Policy and Research, Public Health Service, U.S. Department of Health and Human Services, 1996.
  13. Hay-Smith EJ, Bo K, Berghamans LC et al. Pelvic floor muscle training for urinary incontinence in women (Cochrane Review). In: The Cochrane Library, Issue 3, 2002.
  14. Berghmans LC, Hendriks HJ, Bo K et al. Conservative treatment of stress urinary incontinence in women: a systematic review of randomized clinical trials. Br J Urol 1998; 82(2):181-91.
  15. Weatherall M. Biofeedback or pelvic floor muscle exercises for female genuine stress incontinence and sexual function after anatomic radical prostatectomy: a meta-analysis of trials identified in a systematic review. BJU Int 1999; 83(9):1015-6.
  16. Centers for Medicare and Medicaid Services. Medicare Coverage Policy: Biofeedback for urinary incontinence (#CAG-00020N). Decision Memorandum. October 6, 2000. Available online at http://cms.hhs.gov/coverage/8b3-x.asp.
  17. Aksac B, Aki S, Karan A et al. Biofeedback and pelvic floor exercises for the rehabilitation of urinary stress incontinence. Gynecol Obstet Invest 2003; 56(1):23-7.
  18. Wille S, Sobottka A, Heidenreich A et al. Pelvic floor exercises, electrical stimulation and biofeedback after radical prostatectomy: results of a prospective randomized trial. J Urol 2003; 170(2 pt 1):490-3.
  19. Parekh AR, Feng MI, Kirages D et al. The role of pelvic floor exercises on post-prostatectomy incontinence. J Urol 2003; 170(1):130-3.
  20. Aukee P, Immonen P, Laaksonen DE et al. The effect of home biofeedback training on stress incontinence. Acta Obstet Gynecol Scand 2004; 83(10):973-7.
  21. Wang AC, Wang YY, Chen MC. Single-blind, randomized trial of pelvic floor muscle training, biofeedback-assisted pelvic floor muscle training, and electrical stimulation in the management of overactive bladder. Urology 2004; 63(1):61-6.
  22. MacDonald R, Fink HA, Huckabay C et al. Pelvic floor muscle training to improve urinary incontinence after radical prostatectomy: a systematic review of effectiveness. BJU Int 2007; 100(1):76-81.
  23. McClurg D, Ashe RG, Marshall K et al. Comparison of pelvic floor muscle training, electromyography biofeedback, and neuromuscular electrical stimulation for bladder dysfunction in people with multiple sclerosis: a randomized pilot study. Neurourol Urodyn 2006; 25(4):337-48.
  24. McClurg D, Ashe RG, Lowe-Strong AS. Neuromuscular electrical stimulation and the treatment of lower urinary tract dysfunction in multiple sclerosis- A double blind, placebo controlled, randomised clinical trial. Neurourol Urodyn 2007 Aug 17; [Epub ahead of print]
  25. National Institute for Health and Clinical Excellence (NICE). Urinary incontinence: the management of urinary incontinence in women. Guideline 40; October 2006. Available at: www.nice.org.uk
  26. Shamliyan T, Wyman J, Bliss DZ et al. Prevention of urinary and fecal incontinence in adults. Evid Rep Technol Assess (Full Rep) 2007; (161):1-379. AHRQ Publication No. 08-E003.
    Available at:     www.ahrq.gov
  27. Shamliyan TA, Kane RL, Wyman J et al. Systematic review: randomized, controlled trials of nonsurgical treatments for urinary incontinence in women. Ann Intern Med 2008; 148(6):459-73.
  28. NIH state-of-the-science conference statement on prevention of fecal and urinary
    incontinence in adults. NIH Consens State Sci Statements 2007; 24(1):1-37.
  29. Centers for Medicare and Medicaid Services. National coverage decision for biofeedback therapy for the treatment of urinary incontinence. Available at: http://www.cms.hhs.gov/mcd/viewncd.asp?ncd_id=30.1.1&ncd_version=1&basket=ncd%3A30%2E1%2E1%3A1%3ABiofeedback+Therapy+for+the+Treatment+of+Urinary+Incontinence

 

Codes

Number

Description
CPT  90875-90876 Individual psychophysiological therapy incorporating biofeedback training by any modality (face-to-face with the patient), with psychotherapy (e.g., insight oriented, behavior modifying, or supportive psychotherapy); code range
90901  Biofeedback training by any modality 
  90911  Biofeedback training, perineal muscles, anorectal, or urethral sphincter, including EMG and/or manometry 
ICD-9 Procedure  89.21  Urinary manometry 
  89.23  Urethral sphincter electromyogram 
  93.08  EMG 
  94.39  Other individual psychotherapy (biofeedback) 
ICD-9 Diagnosis    Investigational for all codes 
HCPCS  E0746  Electromyography (EMG), biofeedback device 
Type of Service  Medicine 
Place of Service  Outpatient 

Index

Biofeedback
Biofeedback, Urinary Incontinence in Adults
EMG Biofeedback

Policy History

Date Action Reason
7/31/97 Add to Medicine section New policy
01/30/98 Replace policy Reviewed with changes; expanded rationale; no change in policy coverage
04/01/98 Replace policy Biofeedback policy separated into 3 policies
08/18/00 Replace policy Policy updated with reference to 2000 TEC Assessment; policy statement unchanged
12/15/00 Replace policy Benefits application section revised to include information regarding BlueCard or National Account
12/18/02 Replace policy Policy updated with literature search; no change in policy statement. References added
07/15/04 Replace policy Policy updated with literature search; no change in policy statement. References added
08/17/05 Replace policy Policy updated with literature search; no change in policy statement. References 20 and 21 added
10/10/06 Replace policy Policy updated with literature search for the period of June 2005 through July 2006; no change in policy statement.
02/14/08 Replace Policy Policy updated with literature search; references 22-24 added; no change in policy statement
07/09/09 Replace policy Policy updated with literature search December 2007 through December 2008; clinical input reviewed; addition to policy statement for unsupervised home use of biofeedback is investigational; references 25-29 added.

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