mp-201
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Pelvic Floor Stimulation as a Treatment of Urinary and Fecal Incontinence

Policy Number: MP-201

Latest Review Date: August 2021

Category:  DME                                                                    

Policy Grade: A

POLICY:

Electrical or magnetic stimulation of the pelvic floor muscles (pelvic floor stimulation) as treatment for urinary or fecal incontinence is considered investigational.

DESCRIPTION OF PROCEDURE OR SERVICE:

Pelvic floor stimulation (PFS) is proposed as a nonsurgical treatment option for women and men with urinary incontinence. This approach involves either electrical stimulation of pelvic floor musculature or extracorporeal pulsed magnetic stimulation. Electrical stimulation of the pelvic floor is also proposed as a treatment of fecal incontinence.

Pelvic Floor Stimulation

PFS involves electrical stimulation of pelvic floor muscles using either a probe wired to a device for controlling the electrical stimulation or, more recently, extracorporeal electromagnetic (also called magnetic) pulses. Stimulation of the pudendal nerve to activate the pelvic floor musculature may lead to improved urethral closure. In addition, PFS is thought to improve partially denervated urethral and pelvic floor musculature by enhancing the process of reinnervation. The methods of electrical PFS have varied in location (e.g., vaginal, rectal), stimulus frequency, stimulus intensity or amplitude, pulse duration, pulse to rest ratio, treatments per day, number of treatment days per week, length of time for each treatment session, and overall time period for device use between clinical and home settings. Variation in the amplitude and frequency of the electrical pulse is used to mimic and stimulate the different physiologic mechanisms of the voiding response, depending on the etiology of the incontinence, i.e., either detrusor instability, stress incontinence, or a mixed pattern. Magnetic PFS does not require an internal electrode; instead, patients sit fully clothed on a specialized chair with an embedded magnet.

Patients receiving electrical PFS may undergo treatment in a physician’s office or physical therapy facility, or patients may undergo initial training in a physician’s office followed by home treatment with a rented or purchased pelvic floor stimulator. Magnetic PFS may be delivered in the physician’s office.

Note: Stimulation of the sacral nerve as a treatment of incontinence is discussed separately (see Medical Policy #159 Sacral Nerve Modulation/Stimulation).

KEY POINTS:

This policy is updated regularly with searches of the PubMed database. The most recent literature was reviewed through July 1, 2021.

SUMMARY OF EVIDENCE:

For individuals who have urinary incontinence who receive electrical PFS, the evidence includes systematic reviews of RCTs. Relevant outcomes are symptoms, change in disease status, quality of life, and treatment-related morbidity. Findings from systematic reviews have not found that electrical PFS used to treat urinary incontinence in women consistently improves the net health outcome compared with placebo or other conservative treatments. Moreover, meta-analyses of RCTs have not found a significant benefit of electrical PFS in men with postprostatectomy incontinence compared with a control intervention. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have fecal incontinence who receive electrical PFS, the evidence includes RCTs and systematic reviews. Relevant outcomes are symptoms, change in disease status, quality of life, and treatment-related morbidity. Among the RCTs that have evaluated electrical PFS as a treatment for fecal incontinence only 1 trial was sham-controlled, and it did not find that electrical stimulation improved the net health outcome. Systematic reviews of RCTs have not found that electrical stimulation is superior to control interventions for treating fecal incontinence. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have urinary incontinence who receive magnetic PFS, the evidence includes RCTs and a systematic review. Relevant outcomes are symptoms, quality of life and treatment-related morbidity. A systematic review of RCTs on magnetic PFS for urinary incontinence in women concluded that the evidence was insufficient due to the small number of trials with short-term follow-up, methodological limitations and heterogeneity in patient populations, interventions and outcome reporting. One RCT evaluating magnetic stimulation for treatment of men with postprostatectomy urinary incontinence reported short term results favoring magnetic PFS; however, the trial was small and lacked a sham comparator. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have fecal incontinence who receive magnetic PFS, the evidence includes no RCTs or non-RCTs. Relevant outcomes are symptoms, quality of life and treatment-related morbidity. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

PRACTICE GUIDELINES AND POSITION STATEMENTS:

American Urological Association

In 2019, the American Urological Association published guidelines on diagnosis and management of overactive bladder. Electrical PFS and magnetic PFS were not mentioned as recommended first-, second- or third-line treatment options.

Joint guidelines issued in 2019 by the AUA and the Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction (SUFU) on management of post-prostatectomy urinary incontinence do not specifically address electrical or magnetic PFS as treatment options. Pelvic floor muscle training/exercise is recommended as first-line treatment for post-prostatectomy incontinence.

National Institute for Health and Clinical Excellence (NICE)

The National Institute for Health and Care Excellence (2019) issued guidance on the management of urinary incontinence in women. NICE stated that electrical stimulation, alone or as an adjunct to pelvic floor muscle training, should not be routinely used to treat women with overactive bladder. NICE guidance further stated: “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.” Magnetic PFS is not mentioned.

NICE (2007) issued guidance on the management of fecal incontinence in adults. (This guidance was last reviewed by NICE in 2018.) The document stated that that the evidence on electrical stimulation for treatment of fecal incontinence was inconclusive. NICE recommended that patients who continue to have episodes of fecal incontinence after initial treatment be considered for specialized management, which may include electrical PFS. Magnetic PFS is not mentioned.

American College of Physicians

In 2014, the American College of Physicians issued guidelines on the nonsurgical management of urinary incontinence. Electrical pelvic floor stimulation was not discussed.

American Society of Colon and Rectal Surgeons

In 2015, the American Society of Colon and Rectal Surgeons issued an evidence-based guideline using GRADE methodology on treatment of fecal incontinence. Dietary interventions, medical management and biofeedback were the only non-surgical treatment options recommended for fecal incontinence.

 

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Pelvic floor stimulation (PFS), pelvic floor muscle exercises (PME), detrusor instability, stress incontinence, urinary incontinence, electrical stimulation, magnetic stimulation, Fecal incontinence, InTone®MV, EmbaGYN®, NeoControl® Pelvic Floor Therapy System, MyoTrac Infiniti™, itouch Sure Pelvic Floor Exerciser, InCare® PRS, Pathway™ CTS 2000

APPROVED BY GOVERNING BODIES:

Several electrical stimulators have been cleared by the U.S. Food and Drug Administration (FDA). In 2006, the MyoTrac Infiniti™ (Thought Technology) and in 2015, the ApexM (InControl Medical), nonimplanted electrical stimulators for treating urinary incontinence, were cleared for marketing by FDA through the 510(k) process. Predicate devices also used to treat urinary incontinence, include the Pathway™ CTS 2000 (Prometheus Group) and the InCare® PRS (Hollister). In 2011, the itouch Sure Pelvic Floor Exerciser (TensCare) was cleared for marketing. This product is being marketed in the United States as EmbaGYN® (Everett Laboratories).

In 2000, the NeoControl® Pelvic Floor Therapy System (Neotonus) was approved by FDA through the premarket approval process for treating urinary incontinence in women. This device, formerly known as the Neotonus Model 1000 Magnetic Stimulator, provides noninvasive electromagnetic stimulation of pelvic floor musculature. The magnetic system is embedded in a chair seat; patients sit on the chair fully clothed and receive the treatment. The magnetic fields are controlled by a separate power unit.

In 2014, the InTone®MV (InControl Medical), a nonimplantable device that provides electrical stimulation and/or biofeedback via manometry, was cleared by FDA. The device is intended to treat male and female urinary and fecal incontinence.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP contracts: FEP does not consider investigational if FDA approved and will be reviewed for medical necessity.

CURRENT CODING:

CPT:

53899  Unlisted procedure, urinary system
97014 

Physical medicine and rehabilitation-Application of a modality that does not require direct (one-on-one) contact by the provider; electrical  stimulation (unattended)

97032

Application of a modality that requires direct (one-on-one) patient contact by the  provider; Application of a modality to one or more areas; electrical stimulation (manual), each 15 minutes.

             

HCPCS  

E0740   Non-implanted pelvic floor electrical stimulator, complete system
G0283 

Electrical stimulation (unattended), to one or more areas for indications(s) other than wound care, as part of a therapy plan of care

REFERENCES:

  1. Abdelbary AM, El-Dessoukey AA, Massoud AM, et al. Combined vaginal pelvic floor electrical stimulation (pfs) and local vaginal estrogen for treatment of overactive bladder (OAB) in perimenopausal females. Randomized controlled trial (RCT). Urology. Sep 2015; 86(3):482-486.
  2. American Urological Association. Diagnosis and Management of Overactive Bladder (Non-Neurogenic) in Adults. 2014; //www.auanet.org/common/pdf/education/clinical-guidance/Overactive-Bladder.pdf. Accessed September 14, 2016.
  3. Berghmans B, Hendriks E, Bernards A et al. Electrical stimulation with non-implanted electrodes for urinary incontinence in men. Cochrane Database Syst Rev 2013; 6:CD001202.
  4. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Pelvic floor electrical stimulation in the treatment of urinary incontinence in adults. 2000; Volume 15, Tab 2.
  5. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Magnetic stimulation in the treatment of urinary incontinence in adults. 2000; Volume 15, Tab 8.
  6. Campbell SE, Glazener C, Hunter KF et al. Conservative management for postprostatectomy urinary incontinence. Cochrane Database Syst Rev 2012; (1):CD001843.
  7. Cohen-Zubary N, Gingold-Belfer R, Lambort I, et al. Home electrical stimulation for women with fecal incontinence: a preliminary randomized controlled trial. Int J Colorectal Dis. Jan 27 2015.
  8. European Association of Urology. Incontinence in men: Guidelines on urinary incontinence. Available online at: //www.guidelines.gov.
  9. Goode PS, Burgio KL, Johnson TM et al. Behavioral therapy with or without biofeedback and pelvic floor electrical stimulation for persistent postprostatectomy incontinence. JAMA 2011; 305(2):151-9.
  10. Gorina Y, Schappert S, Bercovitz A, et al. Prevalence of incontinence among older Americans. Vital Health Stat 3. Jun 2014(36):1-33.
  11. Gormley EA, Lightner DJ, Burgio KL, et al. Diagnosis and Treatment of Non-Neurogenic Overactive Bladder (OAB) in Adults: AUA/SUFU Guideline. 2014; https://www.auanet.org/guidelines/overactive-bladder-(oab)- (aua/sufu-guideline-2012-amended- 2014). Accessed August 27, 2019
  12. Imamura M, Abrams P, Bain C et al. Systematic review and economic modeling of the effectiveness and cost-effectiveness of non-surgical treatments for women with stress urinary incontinence. Health Technology Assessment 2010; Volume 14, No. 40. Available online at: //www.hta.ac.uk/1612.
  13. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
  14. Lightner DJ, Gomelsky A, Souter L, et al. Diagnosis and Treatment of Overactive Bladder (Non-Neurogenic) in Adults:AUA/SUFU Guideline Amendment 2019. J Urol. Sep 2019; 202(3): 558-563.
  15. Lim R, Lee SW, Tan PY, et al. Efficacy of electromagnetic therapy for urinary incontinence: A systematic review. Neurourol Urodyn. Nov 2015; 34(8):713-722.
  16. Lucas MG, Bosch RJ, Burkhard FC et al. EAU guidelines on assessment and nonsurgical management of urinary incontinence. Eur Urol 2012; 62(6):1130-42.
  17. Moroni RM, Magnani PS, Haddad JM, et al. Conservative treatment of stress urinary incontinence: a systematic review with meta-analysis of randomized controlled trials. Rev Bras Ginecol Obstet. Feb 2016; 38(2):97-111.
  18. Myo Trac Infiniti 510(k) Summary. //www.accessdata.fda.gov.
  19. Nambiar AK, Bosch R, Cruz F, et al. EAU guidelines on assessment and nonsurgical management of urinary incontinence. Eur Urol. Apr 2018; 73(4):596-609.
  20. National Institute for Health and Clinical Excellence (NICE). Urinary Incontinence: The Management of Urinary Incontinence in Women. 2013; //www.nice.org.uk/guidance/cg171/chapter/1-recommendations#/neurostimulation. Accessed July 7, 2021.
  21. National Institute for Health and Care Excellence (NICE) Guideline. Urinary Incontinence and Pelvic Organ Prolapse in Women:Management. NICE Guideline. 2019. https://www.nice.org.uk/guidance/ng123. Accessed July 7,2021.
  22. NeoControl Pelvic Floor Therapy System 510(k) Summary. www.accessdata.fda.gov.
  23. National Institute for Health and Clinical Excellence (NICE). Urinary Incontinence in Women: Management [CG171]. 2015; //www.nice.org.uk/guidance/cg171. Accessed June 22, 2020.
  24. National Institute for Health and Care Excellence (NICE) Guideline. Urinary Incontinence and Pelvic Organ Prolapse in Women: Management. NICE Guideline. 2019. Accessed June 22, 2020. https://www.nice.org.uk/guidance/ng123
  25. Quaseem A, Dallas P, Faciea M, et al. Nonsurgical Management of Urinary Incontinence in Women: A Clinical Practice Guideline from the American College of Physicians. Ann Intern Med 2014; 161 (6) 429-440. 2014.
  26. Sandhu JS, Breyer B, Comiter C, et al. Incontinence after Prostate Treatment: AUA/SUFU Guideline. J Urol. Aug 2019; 202(2):369-378.
  27. Schwandner T, Konig IR, Heimerl T et al. Triple target treatment (3T) is more effective than biofeedback alone for anal incontinence: the 3T-AI study. Dis Colon Rectum 2010; 53(7):1007-16.
  28. Schwandner T, Hemmelmann C, Heimerl T et al. Triple-target treatment versus low-frequency electrostimulation for anal incontinence: a randomized, controlled trial. Dtsch Arztebl Int 2011; 108(39):653-60.
  29. Sciarra A, Viscuso P, Arditi A, et al. A biofeedback-guided programme or pelvic floor muscle electric stimulation can improveearly recovery of urinary continence after radical prostatectomy: A meta-analysis and systematic review. Int J Clin Pract. Apr 022021: e14208.
  30. Shamliyan T, Wyman J, Kane R. Agency for Healthcare Research and Quality (AHRQ): Nonsurgical Treatments for Urinary Incontinence in Adult Women: Diagnosis and Comparative Effectiveness. 2012. Available online at: //effectivehealthcare.ahrq.gov/ehc/products/169/834/urinary-incontinence-treatment-report-130909.pdf. Last accessed March, 2014.
  31. Stewart F, Berghmans B, Bo K, et al. Electrical stimulation with non-implanted devices for stress urinary incontinence in women. Cochrane Database Syst Rev. Dec 22 2017; 12: CD012390.
  32. Vonthein R, Heimerl T, Schwandner T et al. Electrical stimulation and biofeedback for the treatment of fecal incontinence: a systematic review. Int J Colorectal Dis 2013; 28(11):1567-77.
  33. Wallis MC, Davies EA, Thalib L et al. Pelvic static magnetic stimulation to control urinary incontinence in older women: a randomized controlled trial. Clin Med Res 2012: 10(1):7-14.
  34. Yamanishi T, Homma Y, Nishizawa O et al. Multicenter, randomized, sham-controlled study on the efficacy of magnetic stimulation for women with urgency urinary incontinence. Int J Urol 2013.
  35. Yamanishi T, Mizuno T, Watanabe M et al. Randomized, placebo controlled study of electrical stimulation with pelvic floor muscle training for severe urinary incontinence after radical prostatectomy. J Urol. 2010; 184(5):2007-12.
  36. Zhu YP, Yao XD, Zhang SL et al. Pelvic floor electrical stimulation for postprostatectomy urinary incontinence: a meta-analysis. Urology 2012; 79(3):552-5.

POLICY HISTORY:

Medical Policy Group, August 2006 (2)

Medical Policy Administration Committee, October 2006

Available for comment October 6-November 20, 2006

Medical Policy Group, February 2009 (4)

Medical Policy Group, March 2011 (2)

Medical Policy Group, January 2012 (2): Updated Key Points and References

Medical Policy Group, October 2012 (2): Updated Key Points and References

Medical Policy Group, April 2013 (2): Updated Description, Key Points and References

Medical Policy Panel, April 2014 (4)/span>

Medical Policy Group, July 2014 (4): Title changed to include fecal incontinence, Policy changed to include indication for fecal incontinence, Approved governing bodies, Key Words, Key Points and References updated.

Medical Policy Administration Committee, August 2014

Available for comment July 29 through September 11, 2014

Medical Policy Panel, April 2015

Medical Policy Group, April 2015 (6): Updates to Key Points and References; no change to policy statement.

Medical Policy Panel, October 2016

Medical Policy Group, November 2016 (6): Updates to Key Points, Practice Guidelines, Governing Bodies, Key Words, and References. No change to policy intent.

Medical Policy Group, December 2016: 2017 Annual Coding Update.  Updated verbiage for revised HCPCS code E0740

Medical Policy Panel, August 2017

Medical Policy Group, September 2017 (6): Updates to Key Points, removed old policy statement. ,/span>

Medical Policy Panel, September 2018

Medical Policy Group, September 2018 (6): Updates to Description, Key Points, Practice Guidelines, Governing Bodies, Coding (G0283) and References.

Medical Policy Panel, August 2019

Medical Policy Group, August 2019 (6): Updates to Description, Key Points and Practice Guidelines.

Medical Policy Panel, August 2020

Medical Policy Group, August 2020 (6): Updates to Key Points, Practice Guidelines and References.

Medical Policy Panel, August 2021

Medical Policy Group, August 2021 (6): Updates to Key Points, Practice Guidelines and References. Policy statement updated to remove “not medically necessary,” no change to policy intent.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

 

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

     4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic

        or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.