BlueCross and BlueShield of Montana Medical Policy/Codes
Biofeedback as a Treatment of Urinary Incontinence
Chapter: Mental Health
Current Effective Date: July 18, 2013
Original Effective Date: October 01, 1990
Publish Date: July 18, 2013
Revised Dates: September 1, 2011; August 17, 2012; April 26, 2013
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 pharmacologic treatment, pelvic muscle exercises (PME), bladder training exercises, electrical stimulation, and neuromodulation. Biofeedback, in conjunction with PME, 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 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 physiologic 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 and as a single therapy 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, nonarousing 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 in the form of signals, such as lights or tone, verbal praise, or other auditory or visual stimuli.

The various forms of biofeedback mainly differ 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 EMG biofeedback; these may be used alone or in conjunction with other therapies (e.g., relaxation, behavioral management, medication).

Regulatory Status

A variety of biofeedback devices are cleared for marketing though the U.S. 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”.

Policy

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply.  If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Investigational

Blue Cross and Blue Shield of Montana considers biofeedback experimental, investigational and unproven as a treatment of urinary incontinence.

Rationale

This policy was based on a 1995 Blue Cross Blue Shield Association (BCBSA) Technology Evaluation Center (TEC) Assessment that evaluated biofeedback for the treatment of a number of indications, including urinary incontinence (UI). (1) The Assessment acknowledged several methodologic difficulties that 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.

The 1995 BCBSA TEC 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. This suggests 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.

Another conclusion was that, although there was evidence that feedback on physiologic 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 physiologic process and any health benefits of the intervention. The latter finding underscores the importance of seeking controlled studies showing whether use of biofeedback improves disease-related health outcomes, as opposed to physiologic, intermediate outcomes. Studies also failed to consistently address the durability of effects beyond the initial short-term biofeedback training period.

The specific indication of biofeedback as a treatment of urinary incontinence was re-evaluated in 1997 and 2000 BCBSA TEC Assessments. (2,3) These Assessments focused on the independent contribution of biofeedback as an adjunct to pelvic floor muscular exercises. The 2000 Assessment identified 6 controlled trials that reported outcomes of biofeedback for the treatment of stress incontinence and 1 small nonrandomized study that focused on patients with urge incontinence. In addition, 1 randomized trial investigated biofeedback in men with post-prostatectomy incontinence, a relatively uncommon indication for biofeedback at that time. (4) A total of 30 patients were randomly assigned 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. The TEC Assessment concluded that the trials failed to demonstrate that, for women, the addition of biofeedback is superior to pelvic muscle exercise (PME) alone and that there was insufficient evidence that biofeedback improves health outcomes in men with post-prostatectomy incontinence.

Women with Urinary Incontinence

Since 2000, several additional randomized trials have been published on biofeedback as a treatment of urinary incontinence in women; findings support the conclusions of the TEC assessments. Studies by Aksac and colleagues in 2003 and by Wang and colleagues in 2004 compared pelvic floor muscle exercises (PME) to biofeedback-directed PME and did not find significant improvement in incontinence symptoms when biofeedback was added to PME (5,6). Aukee and colleagues published a study in 2004, also evaluating PME with and without biofeedback, but change in incontinence symptoms was not a primary efficacy outcome. (7) At the 1-year follow-up, there was not a significant difference between groups in the number of women who were assessed as needing surgery for incontinence.

More recently in 2010, Huebner and colleagues in Germany published a study comparing biofeedback-assisted PME with conventional electrical stimulation, biofeedback-assisted PME with dynamic electrical stimulation, and biofeedback-assisted PME alone. (8) With conventional electrical stimulation, the electrical stimulation was applied when the patient was at rest, whereas dynamic electrical stimulation involved applying the stimulation while the patient was actively contracting. The study included 108 women with stress or mixed incontinence. The treatment period was 3 months, at which time 88 of 108 (81.5%) were evaluated. The primary outcome, change in quality of life as measured by the King’s health questionnaire, did not differ significantly among groups. The quality of life scores decreased by a mean of 20.7 points in the group with conventional electrical stimulation, 24.8 points in the group with dynamic electrical stimulation, and 20.2 points in the group with only biofeedback-assisted PME. The groups also did not differ significantly on other outcome measures. This study did not include a group that received PME alone without biofeedback.

In 2010, the Cochrane Collaboration published a systematic review of trials on pelvic floor muscle training for urinary incontinence in women. (9) Several of the trials included biofeedback as part of the intervention. However, the Cochrane review did not include an analysis that specifically focused on the efficacy of pelvic floor muscle training with and without biofeedback and did not comment on the efficacy of biofeedback in their conclusions.

Men with Post-prostatectomy Urinary Incontinence

In 2007, a systematic review of pelvic floor muscle training to improve urinary incontinence after radical prostatectomy was published. (10) The review discussed 3 studies (281 men) that focused on the value of biofeedback over written/verbal instructions for pelvic floor exercises. 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.

Two trials have evaluated the combination of biofeedback and electrical stimulation in men with post-prostatectomy incontinence. In 2009, Mariotti and colleagues conducted a randomized controlled trial (RCT) in Italy comparing a program of pelvic floor electrical stimulation and electromyographic (EMG) biofeedback (2 sessions weekly for 6 weeks) to written/verbal instructions for PMEs. (11) All 60 patients (30 per group) completed the study through the 6-month follow-up. The mean time to regain continence was significantly shorter in the treatment group (8.0 weeks) than the control group (13.9 weeks, p=0.003). The continence rate was significantly higher in the treatment group beginning at the 4-week visit and continuing through the 20-week visit at which time 29 of 30 (96.7%) in the treatment group and 18 of 30 (60%) in the control group were continent. The difference in the rate of continence was not statistically significantly different at the final, 6-month visit at which time 29 patients in the treatment group continued to be continent compared to 20 of 30 (66.7%) in the control group. In this study, the effect of biofeedback without electrical stimulation compared to written/verbal instructions to perform pelvic floor muscle exercises was not evaluated.

In 2011, Goode and colleagues published the results of a randomized trial comparing behavioral therapy alone to behavioral therapy in combination with biofeedback and pelvic floor electrical stimulation. (12) The trial included 208 men with UI persisting at least 1 year after radical prostatectomy. Men with pre-prostatectomy incontinence were excluded. Participants were randomized to 1 of 3 groups; 8 weeks of behavioral therapy (pelvic floor muscle training and bladder control exercises) (n=70), behavioral therapy plus biofeedback and electrical stimulation (n=70), and a delayed-treatment control group (n=68). The biofeedback and electrical stimulation intervention, called “behavior-plus,” consisted of in-office electrical stimulation with biofeedback using an anal probe and daily home pelvic floor electrical stimulation. After 8 weeks, patients in the 2 active treatment groups were given instructions for a maintenance program of pelvic floor exercises and fluid control and were followed up at 6 and 12 months. The primary efficacy outcome was reduction in the number of incontinent episodes at 8 weeks, as measured by a 7-day bladder diary. A total of 176 of 208 (85%) randomized men completed the 8 weeks of treatment. In an intention-to-treat analysis of the primary outcome, the mean reduction in incontinent episodes was 55% (28 to 13 episodes per week) in the behavioral therapy group, 51% (26 to 12 episodes per week) in the behavior-plus group, and 24% (25 to 20 episodes per week) in the control group. The overall difference between groups was statistically significant (p=0.001), but the behavior-plus intervention did not result in a significantly better outcome than behavioral therapy alone. Findings were similar on other outcomes. For example, at the end of 8 weeks, there was a significantly higher rate of complete continence in the active treatment groups (11 of 70, 16% in the behavior group and 12 of 70, 17% in the behavior-plus group) than the control group (4 of 68, 6%), but the group receiving biofeedback and electrical stimulation did not have a significantly higher continence rate than the group receiving behavioral therapy alone.

The two trials had mixed findings. Mariotti et al. (2009) found a beneficial effect of the combined intervention of biofeedback and electrical stimulation, whereas the Goode et al. (2011) study did not find a benefit compared to behavioral therapy alone. Both studies were limited in that they did not isolate the effect of biofeedback, and thus the independent effect of biofeedback on outcomes cannot be determined.

Children with Dysfunctional Elimination Syndrome

In 2010, Palmer published an article with an overview of bladder control and pediatric voiding dysfunction. The author addresses biofeedback and concludes that biofeedback has been shown to be very effective in children to correct  incontinence secondary to dysfunctional voiding, as well as in treating giggle incontinence and to help resolve vesicoureteral reflux. (18)

In 2008, Kaye and Palmer published an article evaluating the efficacy of biofeedback with and without animation in treating dysfunctional voiding and urinary symptoms.  The comparison reported included 120 girls with urinary complaints and exhibited dysfunctional voiding on electromyography uroflow.  The authors noted their comparison included the last 60 cases of biofeedback using electromyography tracing alone (non-animated) were compared with the first 60 cases using the Urostym Pediflow program (animated). The evaluation of the 2 groups included improvement in post-void residual volume after treatment, and time to resolution of symptoms and dysfunctional voiding. Results reported included the following: Dysfunctional voiding resolved in 95% of patients in both groups. Post-void residual reduction was similar, namely from 35% to 9% of pre-void volume in the nonanimated group, and from 28% to 8% in the animated group. Children in the animated biofeedback group achieved success in significantly fewer sessions (3.6) than those undergoing nonanimated biofeedback (7.6, t test p <0.05).  The authors concluded that in spite of their proved experience with nonanimated biofeedback systems and inexperience with an animated system, animated biofeedback systems yielded similar results in a significantly shorter time. Animated and nonanimated biofeedback is efficacious in the treatment of dysfunctional voiding and its symptoms. (19)

In 2011, a published article from Kajbafzadeh, Sharifi-Rad et al. assessed the efficacy of animated biofeedback in children with dysfunctional elimination syndrome.  Eighty children were randomly assigned to two groups to undergo either conservative therapy or animated biofeedback.  Group A had 40 patients and were treated with animated biofeedback along with pelvic floor muscles exercises and behavioral modification (hydration, high fiber diet, scheduled voiding).  Group B had 40 patients and were treated with behavioral modification only. Results reported by the authors included animated biofeedback therapy was more efficient than nonbiofeedback management with regards to objective and subjective voiding problems and bowel dysfunction.(p<0.05).  The following conclusions were indicated by the authors animated biofeedback effectively treats bowel and voiding dysfunction in children with dysfunctional voiding. Pelvic floor muscle exercises coordinate breathing and pelvic floor muscle contractions, and are beneficial in improving bowel dysfunction. (20)

Desantis et al, conducted a literature search to analyze if biofeedback was an effective method to treat children less than 18 years of age for dysfunctional elimination syndrome.  The authors noted articles were retrieved for data abstraction and quality assessment.  Primary outcomes were urinary tract infections (UTIs) and daytime incontinence.  Twenty-seven studies were evaluated (1 random controlled trial [RCT], and 26 case-series).  The authors results indicated the pooled estimate showed 83% (95% CI: 79%-86%) and 80% (95% CI: 76%-85%) improvement in UTI and daytime incontinence respectively.  Although not statistically significant, the RCT favored biofeedback over standard therapy.  The authors of the article indicated in their conclusions that biofeedback is an effective, non-invasive method of treating dysfunctional elimination syndrome, and approximately 80% of children benefited from this treatment. Also noted in the conclusion was, most reports were of low level of evidence and studies of more solid design such as RCT should be conducted. (21)

Although the results reported in these studies are encouraging, they involve small numbers of patients and only one study was an RCT.  Therefore, the evidence at this time is insufficient to consider coverage of biofeedback for urinary incontinence in children.

Summary

There is insufficient evidence to determine the incremental effects of biofeedback on health outcomes in women with stress and/or urge incontinence and men with post-prostatectomy incontinence. Specifically the value of adding biofeedback to a program of pelvic muscle exercises has not been demonstrated. Studies on combined electrical stimulation and biofeedback have shown mixed results but have not isolated the effect of biofeedback on outcomes. No published evidence supports the unsupervised home use of biofeedback for treatment of UI. Thus, biofeedback for the treatment of UI, whether as part of an outpatient program or unsupervised in the home, is considered experimental, investigational and unproven.

Practice Guidelines and Position Statements

In 2007, the National Institutes of Health (NIH) convened a Consensus Development Conference, Prevention of Fecal and Urinary Incontinence and subsequently released a statement. (13) 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.”

In 2007, the Agency for Healthcare Research and Quality (AHRQ) issued an Evidence Report/Technology Assessment, Prevention of Urinary and Fecal Incontinence in Adults, based on research conducted by the Minnesota Evidence-based Practice Center (EPC). (14,15). The report’s 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 in one small RCT with a 2-month follow-up.

In 2006, National Institute for Health and Clinical Excellence (NICE) (16) issued a 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.” The conclusion regarding use of biofeedback is based on expert opinion.

Coding

Disclaimer for coding information on Medical Policies

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps. 

ICD-9 Codes

94.39.  Experimental, investigational and unproven for all codes.

ICD-10 Codes
GZC9ZZZ.  Experimental, investigational and unproven for all codes.
Procedural Codes: 90875, 90876, 90901, 90911, E0746
References
  1. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Biofeedback. TEC Assessments 1995; Volume 10, Tab 25.
  2. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Biofeedback in the Treatment of Adult Urinary Incontinence. TEC Assessments 1997; Volume 12, Tab 23.
  3. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Biofeedback in the Treatment of Urinary Incontinence in Adults. TEC Assessments 2000; Volume 15, Tab 3.
  4. Franke JJ, Gilbert WB, Grier J et al. Early post-prostatectomy pelvic floor biofeedback. J Urol 2000; 163(1):191-3.
  5. 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.
  6. 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.
  7. 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.
  8. Huebner M, Riegel K, Hinninghofen H et al. Pelvic floor muscle training for stress urinary incontinence: A randomized, controlled trial comparing different conservative therapies. Physiother Res Int 2010 [Epub ahead of print].
  9. Dumoulin C, Hay-Smith J. Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women. Cochrane Database Syst Rev 2010; (1):CD005654.
  10. 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.
  11. Mariotti G, Sciarra A, Gentilucci A et al. Early recovery of urinary continence after radical prostatectomy using early pelvic floor electrical stimulation and biofeedback associated treatment. J Urol 2009; 181(4):1788-93.
  12. Goode PS, Burgio KL, Johnson TM et al. Behavioral therapy with or without biofeedback and pelvic floor electrical stimulation for persistent postprostatecomy incontinence. JAMA 2011; 305(2):151-9.
  13. 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.
  14. 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 online at: http://www.ahrq.gov . Last accessed June 2012.
  15. Shamliyan T, 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.
  16. National Institute for Health and Clinical Excellence (NICE). Urinary incontinence: the management of urinary incontinence in women. Guideline 40; October 2006. Available online at: http://www.nice.org.uk . Last accessed June 2012.
  17. Biofeedback as a Treatment of Urinary Incontinence in Adults. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (2011 July) Medicine 2.01.27.
  18. Palmer LS.  Biofeedback in the management of urinary continence in children.  Curr Urol Rep.  2010 Mar; 11(2): 122-7.
  19. Kaye JD, and Palmer LS.  Animated biofeedback yields more rapid results than nonanimated biofeedback in the treatment of dysfunctional voiding in girls.  J Urol. 2008 Jul; 180(1):300-5.
  20. Kajbafzadeh AM, Sharifi-Rad, et al.  Animated biofeedback; an ideal treatment for children with dysfunctional elimination syndrome.  J Urol. 2011 Dec; 186(6): 2379-84.
  21. Desantis DJ, Leonard MP, Preston MA,  et al. Effectiveness of biofeedback for dysfunctional elimination syndrome in pediatrics: a systematic review.  J Pediatr Urol 2011 Jun;7(3): 342-8.
History
September 2009 Previously part of Biofeedback Policy
September 2011 Updated policy rationale and references. No change in coding or policy statement.
August 2012 Policy updated with literature search through May 2012. References 2, 3, 4 and 6 added; other references renumbered. No change in policy statements.
April 2013 Policy formatting and language revised.  Policy statement unchanged.  Title changed from "Biofeedback as a Treatment of Urinary Incontinence in Adults" to "Biofeedback as a Treatment of Urinary Incontinence".
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Biofeedback as a Treatment of Urinary Incontinence