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Clinical Policy Title: Pelvic floor stimulation for incontinence

Clinical Policy Number: 13.02.02

Effective Date: July 1, 2016

Initial Review Date: April 27, 2016

Most Recent Review Date: April 10, 2018

Next Review Date: April 2019

Related policies:

CP# 13.03.02 Surgical and invasive treatments for overactive bladder syndrome.

CP# 08.01.06 Cecostomy for fecal incontinence.

CP# 08.02.04 Injectable bulking agents—fecal incontinence.

ABOUT THIS POLICY: Prestige Health Choice has developed clinical policies to assist with making coverage determinations. Prestige Health

Choice’s clinical policies are based on guidelines from established industry sources, such as the Centers for Medicare & Medicaid Services (CMS), state regulatory agencies, the American Medical Association (AMA), medical specialty professional societies, and peer-reviewed professional literature. These clinical policies along with other sources, such as plan benefits and state and federal laws and regulatory requirements, including any state- or plan-specific definition of “medically necessary,” and the specific facts of the particular situation are considered by Prestige Health Choice when making coverage determinations. In the event of conflict between this clinical policy and plan benefits and/or state or federal laws and/or regulatory requirements, the plan benefits and/or state and federal laws and/or regulatory requirements shall control. Prestige Health Choice’s clinical policies are for informational purposes only and not intended as medical advice or to direct treatment. Physicians and other health care providers are solely responsible for the treatment decisions for their patients. Prestige Health Choice’s clinical policies are reflective of evidence-based medicine at the time of review. As medical science evolves, Prestige Health Choice will update its clinical policies as necessary. Prestige Health Choice’s clinical policies are not guarantees of payment.

Coverage policy

Prestige Health Choice considers the use of pelvic floor stimulation using non-implanted electrical

devices for the treatment of urinary or fecal incontinence to be investigational/experimental and

therefore, not medically necessary.

Prestige Health Choice considers the use of pelvic floor stimulation using extracorporeal magnetic

innervation for the treatment of urinary incontinence to be investigational/experimental and therefore,

not medically necessary.

For Medicare members only:

Prestige Health Choice considers the use of pelvic floor stimulation using non-implanted electrical

Policy contains:

Urinary incontinence.

Fecal incontinence.

Extracorporeal magnetic innervation.

Non-implantable pelvic floor electrical stimulation.

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devices to be clinically proven and, therefore, medically necessary for the treatment of stress and/or

urge urinary incontinence in cognitively intact patients who have failed a documented trial of pelvic

muscle exercise training.

A failed trial of PME training is defined as no clinically significant improvement in urinary continence

after completing four weeks of an ordered plan of pelvic muscle exercises to increase periurethral

muscle strength (CMS, 2006).

Limitations:

Coverage determinations are subject to benefit limitations and exclusions as delineated by the state

Medicaid authority. The Florida Medicaid website may be accessed at

http://ahca.myflorida.com/Medicaid/.

All other uses of pelvic floor stimulation using non-implanted electrical devices and extracorporeal

magnetic innervation are not medically necessary.

Alternative covered services:

Behavioral training.

Biofeedback.

Bladder neck support prosthesis (pessary).

Bladder training.

Diet modification.

Pelvic floor muscle training.

Pharmacotherapy (e.g., oxybutynin, tolterodine, darifenacin, solifenacin, fesoterodine, and

trospium).

Weight loss and exercise.

Background

Incontinence is a significant health problem in the United States and worldwide. Estimates of prevalence

of urinary incontinence vary widely due to inconsistencies in the definitions and differences in

populations studied, but urinary incontinence has a significant impact on the quality of life. Urinary

incontinence is more common in women than men, and older women experience it more often than

younger women. Stress urinary incontinence is the predominant type of urinary incontinence in women

and urge urinary incontinence is the predominant type in men, with the exception of urinary

incontinence related to radical prostatectomy, in which stress urinary incontinence predominates (Wu,

2014; Markland, 2011). Urinary incontinence in men and women is caused by bladder dysfunction,

sphincter dysfunction, or both. Clinical presentation varies depending on the underlying mechanism

causing or contributing to urinary incontinence.

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Fecal incontinence affects one in eight community adults with equal distribution among genders. The

factors most commonly reported to be associated with FI include increasing age, diarrhea, chronic

illness, and urinary incontinence (Ng, 2015; Bharucha, 2015).

Treatment depends on the type of incontinence. For urinary incontinence, treatment options include

pelvic floor muscle training; physical therapies (e.g., vaginal cones); behavioral therapies (e.g., bladder

training); mechanical devices (e.g., continence pessaries); drug therapies (e.g., anticholinergics and

duloxetine) and surgical interventions, such as sling procedures and colposuspension (Imamura, 2013).

For fecal incontinence, nonsurgical treatment options include biofeedback, lifestyle and dietary

modifications, bowel habit interventions, pelvic floor muscle training, rectal irrigation, and drug therapy.

When noninvasive options fail, minimally invasive and surgical therapies may be considered (Bharucha,

2015).

Pelvic floor stimulation using non-implanted electrical or magnetic devices has been proposed as a

nonsurgical option for the treatment of urinary and fecal incontinence. While the precise mechanism of

action of pelvic floor electrical stimulation in humans is unclear, the therapeutic intent is to stimulate

the pudendal nerve to activate the pelvic floor musculature, which may lead to improved urethral

closure. In addition, it may improve partially denervated urethral and pelvic floor muscles through the

process of re-innervation.

Pelvic floor electrical stimulation refers to the use of non-implanted electrodes, either adhesive pads

placed on the skin near the vagina and anus, or a tampon-shaped device placed intra-vaginally or intra-

anally, to deliver variable rates of electrical current to the pelvic floor musculature. Depending on the

etiology of incontinence, pelvic floor electrical stimulation applies variations in electrical pulse

amplitude and frequency to mimic and stimulate different physiologic mechanisms of the voiding

response. Methods of pelvic floor electrical stimulation vary in location (e.g., vaginal or rectal), stimulus

frequency, 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. Initial training occurs in an outpatient or office setting, followed

by home treatment with a rented or purchased pelvic floor stimulator. As of January 16, 2016, the U.S.

Food and Drug Administration (FDA) has given marketing clearance to 65 pelvic floor electrical

stimulation devices (Class II, product code KPI) for the treatment of urinary and fecal incontinence

(Hayes, 2016).

Extracorporeal magnetic innervation delivers nerve impulses to the pelvic floor area to increase

muscular contractions in an attempt to improve bladder control. The FDA has approved one device, the

NeoControl® Pelvic Floor Therapy System for the treatment of urinary incontinence in women

(Neotonus, North Attleboro, MA; Class II, product code KPI). The system consists of a control unit and

treatment chair. The chair's therapeutic head generates pulsed magnetic fields that stimulate the

perineal tissues, nerves, and muscles, reportedly increasing contractions and improving circulation. The

treatment is typically performed twice a week, with each session lasting approximately 20 minutes. A

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complete course of treatment may take eight weeks or more depending on the condition of the pelvic

floor muscles when therapy is started.

Searches

Prestige Health Choice searched PubMed and the databases of:

UK National Health Services Centre for Reviews and Dissemination.

Agency for Healthcare Research and Quality’s National Guideline Clearinghouse and other

evidence-based practice centers.

The Centers for Medicare & Medicaid Services (CMS).

We conducted searches on February 14, 2018. Search terms were: "urinary incontinence/therapy",

"fecal incontinence/therapeutic use", "fecal incontinence/therapy", "electric stimulation therapy" and

"pelvic floor."

We included:

Systematic reviews, which pool results from multiple studies to achieve larger sample sizes

and greater precision of effect estimation than in smaller primary studies. Systematic

reviews use predetermined transparent methods to minimize bias, effectively treating the

review as a scientific endeavor, and are thus rated highest in evidence-grading hierarchies.

Guidelines based on systematic reviews.

Economic analyses, such as cost-effectiveness, and benefit or utility studies (but not simple

cost studies), reporting both costs and outcomes — sometimes referred to as efficiency

studies — which also rank near the top of evidence hierarchies.

Findings

The National Institute for Health and Care Excellence recommends against the routine use of electrical

stimulation of women with overactive bladder syndrome, alone or in combination with pelvic floor

muscle training. The group does recommend that pelvic floor electrical stimulation be considered in

women who cannot actively contract pelvic floor muscles in order to aid motivation and adherence to

therapy (NICE, 2013).

The European Association of Urology recommended pelvic floor electrical stimulation as an adjunct to

behavioral therapy in patients with urgency urinary incontinence. The Association does not recommend

pelvic floor electrical stimulation as monotherapy for stress urinary incontinence, or extracorporeal

magnetic innervation for the treatment of urinary incontinence or overactive bladder in adult women

(EAU, 2015).

The American Society of Colon and Rectal Surgeons recommended dietary management, medical

management and biofeedback as first-line nonsurgical treatments for patients with fecal incontinence

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and some preserved voluntary sphincter contraction, but made no mention of pelvic floor electrical

stimulation in the guideline (Paquette, 2015).

The American College of Physicians guideline on the nonsurgical management of urinary incontinence in

women did not mention either pelvic floor electrical stimulation or extracorporeal magnetic innervation

in its 2014 recommendations of nonsurgical management of urinary incontinence in women (Qaseem,

2014).

The most recent systematic (Cochrane) review for non-implanted pelvic floor electrical stimulation for

stress urinary incontinence included 56 trials, 18 of which did not report a primary outcome of cure or

improvement. The review found that pelvic floor electrical stimulation is probably more effective than

placebo, but could not determine if electrical stimulation is as effective as pelvic floor muscle training or

other active treatments. The low or very low quality of evidence limits any confidence in results

(Stewart, 2017).

This systematic review was published a year after another such review by the same Cochrane research

team. The earlier review included 63 trials, 44 of which lacked a primary outcome of cure or

improvement. Some evidence documented pelvic floor electrical stimulation was more effective than

pelvic floor muscle training, but whether it was more effective than placebo was unclear. Low quality of

evidence made it difficult to present results with confidence (Stewart, 2016).

A Hayes review assessed 15 randomized controlled trials, including 11 of women with stress urinary

incontinence and three of men following a prostatectomy. The study concluded that a moderate-sized

body of low-quality evidence exists showing benefits to some women with stress urinary incontinence,

and a limited amount of low-quality evidence shows improved outcomes in men after radical

prostatectomy (Hayes, 2016).

Other systematic reviews include:

Thirteen studies assessed efficacy of biofeedback and/or pelvic floor electrical stimulation

for adult fecal incontinence (young mothers and elderly men and women needing second-

line treatment). It concluded that these therapies combined were consistently superior to

either as monotherapy, using moderate-to-high quality evidence (Vonthein, 2013).

In an Agency for Healthcare Research and Quality review of 63 studies, adding

electrostimulation to pelvic floor muscle training did not improve effectiveness (severity and

quality of life) among patients with fecal incontinence in 2 -3 months (Forte, 2016).

Nine trials found pelvic floor electrical stimulation increased continence rates more than did

placebo, but only one in nine treated women achieved continence (Shamilyan, 2012).

Fifty-five trials (n = 6,608 women with stress urinary incontinence) evaluated efficacy of five

interventions; pelvic floor electrical stimulation was less effective than biofeedback and

pelvic floor muscle training, and no more effective than placebo (Imamura, 2010).

Thirty-seven studies (n = 1058 women with stress urinary incontinence) documented

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electrical stimulation improved quality of life more than placebo, but results of individual

studies were inconsistent (Moroni, 2016).

Six randomized controlled trials (n=544 men) in a Cochrane study found electrical

stimulation reduced incontinence significantly greater than placebo six months after

treatment started, but not after 12 months. Adding electrical stimulation to pelvic floor

muscle training did not significantly change reduction in urinary incontinence, i.e., 63 versus

61 percent, and showed a significantly greater rate of adverse events, i.e., 17 versus 2

percent (Berghmans, 2013).

A total of 30 randomized clinical trials reviewed mostly intravaginal electrical stimulation,

which effectively treated urge urinary incontinence, but reported contradictory data

regarding stress and mixed incontinence (Schreiner, 2013).

Four studies of 210 post-prostatectomy males treated for six to 12 months with pelvic floor

muscle training with or without pelvic floor electrical stimulation found a non-significant

(three percent) difference in risk ratio (Zhu, 2012).

Ninety-six randomized controlled trials and three systematic reviews found pelvic floor

electrical stimulation did not resolve urinary incontinence in women (Shamilyan, 2008).

An randomized controlled trial of 208 men ages 51 – 84 with incontinence post-prostatectomy found

that mean incontinence episodes per week after eight weeks of treatment decreased from 28 to 13

after behavioral therapy alone, and a similar reduction of 26 to 12 after behavioral therapy plus pelvic

floor electrical stimulation; these reductions were better than controls (25 to 21), but adding pelvic floor

electrical stimulation to behavioral therapy did not improve outcomes (Goode, 2011).

A recent study of 60 women with overactive bladder syndrome found pelvic floor electrical stimulation

did not reduce daily micturitions and nocturnia episodes as effectively as percutaneous tibial nerve

stimulation (Scaldazza, 2017).

The multiple systematic reviews discussed here do not address any long-term effects of pelvic floor

electrical stimulation, while limited evidence of effectiveness has prevented any cost-effectiveness

studies to date.

Few journal articles have been published on efficacy of extracorporeal magnetic innervation. A

systematic review of 11 studies (n=1028 men) treated after radical prostatectomy observed that

extracorporeal magnetic innervation and electrical stimulation were found to be initially (within 1-2

months) more effective than pelvic floor muscle training within 1 – 2 months in one trial, but there were

no significant differences existed between groups after three months. Subjects assigned to pelvic floor

muscle training achieved continence faster than those who were not (MacDonald, 2007).

One study that followed 137 women treated for stress and urge urinary incontinence with

extracorporeal magnetic innervation found that 47 percent were dry after six months, but with high

recurrence after three years (Doganay, 2010). Another study of 30 women with stress urinary

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incontinence treated with extracorporeal magnetic innervation found 77.8 percent were cured or

improved after three months, a figure that was unchanged for one year; however, a gradual decrease

occurred in the second year (Hoscan, 2008). A Hayes review of 22 studies found a similar pattern of any

improvements not lasting past the short term (Hayes, 2015).

Policy updates:

A total of five peer-reviewed references were added to this policy in February 2018.

A total of 1 guideline/other and 11 peer-reviewed references were added to this policy in April 2017.

Summary of clinical evidence:

Citation Content, Methods, Recommendations

Stewart (2017)

PFES for women with stress

urinary incontinence or

urgency predominant mixed

urinary incontinence

Key points:

Cochrane review of 56 trials (n=3781) of women with stress urinary incontinence or

urgency predominant mixed urinary incontinence.

Eighteen trials did not report subjective cure, improvement of SUI or incontinence-

specific quality of life.

Electronic stimulation more effective than no treatment (moderate quality evidence)

No difference in cure or improvement for PFES vs. PFMT (RR 0.85) PFMT + ES vs.

PFMT alone (RR 1.10) or ES versus vaginal cones (RR 1.09); evidence is low quality.

Stewart (2016)

PFES for adults with

overactive bladder

Key points:

Cochrane review of 63 trials (n = 4,424) of adults treated for overactive bladder with

PFES.

44 of 63 trials did not have outcomes of perception of cure or improvement.

Moderate-quality evidence indicated PFES was better than pelvic floor muscle training

(RR = 1.60), drug treatment (RR = 1.20), and placebo (RR = 2.26) for perception of

improvement.

Not clear if PFES better than placebo for urgency urinary incontinence.

Low-quality evidence (n = 51) that PFES added to pelvic floor muscle training was

superior than when PFES was not added.

Hayes (2016)

PFES as treatment of UI

Key points:

Systematic review of 15 RCTs; 11 RCTs evaluated PFES in 895 women with SUI and

308 women with UUI, and three RCTs evaluated PFES in 258 men with SUI following

radical retropubic prostatectomy (RRP).

Overall quality: low. Heterogeneity in patient populations, specific treatment protocols,

and comparators and short follow-up.

PFES appears to be safe and well tolerated in the short term. Most common adverse

effects were pain or discomfort with the electrical stimulation.

For women with SUI or UUI or men with UUI, PFES offers limited benefit at best.

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Citation Content, Methods, Recommendations

The optimal number of sessions or duration of treatment is unclear.

European Association of

Urology (2015)

Guidelines on UI

Key points:

Evidence synthesis of two health technology assessments and three systematic

reviews, comprising 15 trials that used different comparison methods.

Overall quality: low. Heterogeneous stimulation parameters, treatment regimens and

outcome parameters.

Most evidence on PFES refers to women with SUI.

No evidence found for electromagnetic stimulation.

In adults with UI, conflicting evidence of effectiveness of PFES versus sham stimulation

or pharmacotherapy, and whether PFES adds to the benefit of PFMT alone.

Vonthein (2013)

PFES and/or biofeedback

(BF) for FI

Key points:

Systematic review and meta-analysis of 13 RCTs comparing BF alone or in

combination with PFES; PFES alone to other treatments. Two populations represented

were 1) young mothers and 2) predominately elderly men and women in need of a

second-line conservative treatment and no obvious need for surgery.

Overall quality: moderate to high quality. Heterogeneity with respect to spectrum of

patients and treatment protocols, poor reporting of technological details and safety

outcomes.

No trial showed superiority of control, BF alone or PFES alone when compared with BF

+ PFES. Superiority of BF + PFES over any monotherapy was demonstrated in several

trials.

High-quality evidence suggests AM-MF PFES plus electromyography BF is the best

second-line treatment for FI.

Shamliyan (2012)

For the Agency for

Healthcare Research and

Quality

Nonsurgical treatments for

UI in community-dwelling

women

Key points:

Systematic review of nine RCTs of intra-vaginal PFES and five RCTs of ExMI.

Overall quality: high for PFES, low to moderate for ExMI. Poor adherence.

PFES increased continence rate, improved SUI and improved quality of life compared

to sham.

For UUI, MUI, or overactive bladder (OAB), comparable outcomes between PFES as

monotherapy or combination therapy versus other nonsurgical treatments or

pharmacological treatments.

ExMI improved UI but did not increase urinary continence more than sham stimulation.

Evidence of improved quality of life was low.

References

Professional society guidelines/other:

Lucas MG, Bedretdinova D, Berghmans LC, et al. Guidelines on urinary incontinence. European

Association of Urology. March, 2015. http://uroweb.org/wp-content/uploads/20-Urinary-

Incontinence_LR1.pdf. Accessed February 14, 2018.

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National Collaborating Centre for Women’s and Children’s Health. Urinary incontinence: the

management of urinary incontinence in women. London: National Institute for Health and Care

Excellence (NICE). 2013. Clinical guideline no. 171.

https://www.guideline.gov/summaries/summary/47099/urinary-incontinence-the-management-of-

urinary-incontinence-in-women?q=pelvic+floor+electrical+stimulation. Accessed February 14, 2018.

National Institute of Diabetes and Digestive and Kidney Diseases website. Fecal incontinence.

http://www.niddk.nih.gov/health-information/health-topics/digestive-diseases/fecal-

incontinence/Pages/facts.aspx. Accessed February 14, 2018.

Paquette IM, Varma MG, Kaiser AM, Steele SR, Rafferty JF. The American Society of Colon and Rectal

Surgeons' Clinical Practice Guideline for the Treatment of Fecal Incontinence. Dis Colon Rectum. 2015;

58(7):623 – 36.

Qaseem A, Dallas P, Forciea MA, 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 –

40.

Shamliyan T WJ, Kane RL. Nonsurgical Treatments for Urinary Incontinence in Adult Women: Diagnosis

and Comparative Effectiveness [Internet]. Rockville (MD): Agency for Healthcare Research and Quality

(AHRQ) (US); 2012 Apr. (Comparative Effectiveness Reviews, No. 36.) AHRQ website.

http://www.ncbi.nlm.nih.gov/books/NBK92960/. Accessed February 14, 2018.

Peer-reviewed references:

Berghmans B, Hendriks E, Bernards A, de Bie R, Omar MI. Electrical stimulation with non-implanted

electrodes for urinary incontinence in men. Cochrane Database Syst Rev. 2013 Jun 6;(6):CD001202. doi:

10.1002/14651858.CD001202.pub5.

Bharucha AE, Dunivan G, Goode PS, et al. Epidemiology, pathophysiology, and classification of fecal

incontinence: state of the science summary for the National Institute of Diabetes and Digestive and

Kidney Diseases (NIDDK) workshop. Am J Gastroenterol. 2015;110(1):127 – 36.

Doganay M, Kilic S, Yilmaz N. Long-term of extracorporeal magnetic innervations in the treatment of

women with urinary incontinence: results of 3-year follow-up. Arch Gynecol Obstet. 2010;282(1):49 – 53.

Forte ML, Andrade KE, Butler M (eds.), et al. Treatments for Fecal Incontinence [Internet]. Rockville

(MD): Agency for Healthcare Research and Quality (US); 2016 Mar. Report No.: 15(16)-EHC037-EF.

AHRQ Comparative Effectiveness Reviews.

Goode PS, Burgio KL, Johnson TM 2nd, et al. Behavioral therapy with or without biofeedback and pelvic

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floor electrical stimulation for persistent postprostateceomy incontinence: a randomized controlled

trial. JAMA. 2011;305(2):151 – 59.

Hayes Inc., Hayes Medical Technology Report. Pelvic Floor Electrical Stimulation for the Treatment of

Urinary Incontinence. Lansdale, PA. Hayes Inc. February 26, 2016.

Hayes Inc. Medical Technology Directory. Extracorporeal magnetic stimulation for urinary incontinence.

Lansdale PA: Hayes, Inc. February 24, 2015.

Hoscan MB, Dilmen C, Perk H, et al. Extracorporeal magnetic inervation for the treatment of stress

urinary incontinence: results of two-year follow-up. Urol Int. 2008;81(2):167 – 72.

Imamura M, Jenkinson D, Wallace S, et al. Conservative treatment options for women with stress

urinary incontinence: clinical update. Br J Gen Pract. 2013;63(609):218 – 20.

Imamura M, Abrams P, Bain C, et al. Systematic review and economic modelling of the effectiveness and

cost-effectiveness of non-surgical treatments for women with stress urinary incontinence. Health

Technol Assess. 2010;14(40):1 – 188.

Jerez-Roi J, Souza DL, Espelt A, Costa-Marin M, Belda-Molina AM. Pelvic floor electrostimulation in

women with urinary incontinence and/or overactive bladder syndrome: a systematic review. Actas Urol

Esp. 2013;37(7):429 – 44.

MacDonald R, Fink HA, Huckabay C, Monga M, Wilt TJ. Pelvic floor muscle training to improve urinary

incontinence after radical prostatectomy: a systematic review of effectiveness. BJU Int. 2007;100(1):76-

81.

Markland AD, Richter HE, Fwu CW, Eggers P, Kusek JW. Prevalence and trends of urinary incontinence in

adults in the United States, 2001 to 2008. J Urol. 2011;186(2):589 – 93.

Moroni RM, Magnani PS, Haddad JM, Castro Rde A, Brito LG. Conservative treatment of stress urinary

incontinence: a systematic review with meta-analysis of randomized controlled trials. Rev Bras Ginecol

Obstet. 2016;38(2):97 – 111.

Ng KS, Sivakumaran Y, Nassar N, Gladman MA. Fecal incontinence: community prevalence and

associated factors – a systematic review. Dis Colon Rectum. 2015;58(12):1194 – 1209.

Scaldazza CV, Morosetti C, Giampieretti R, Lorenzetti R, Baroni M. Percutaneous tibial nerve stimulation

versus electrical stimulation with pelvic floor muscle training for overactive blader syndrome in women:

results of randomized controlled study. Int Braz J Urol. 2017;43(1):121 – 26.

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Schreiner L, Santos TG, Souza AB, Nygaard CC, Silva Filho IG. Electrical stimulation for urinary

incontinence in women: a systematic review. Int Braz J Urol. 2013;39(4):454 – 64.

Shamilyan TA, Kane RL, Wyman J, Wilt TJ. Systematic review: randomized, controlled trials of

nonsurgical treatments for urinary incontinence in women. Ann Intern Med. 2008;18;459 – 73.

Stewart F, Gameiro LF, El Dib R, Gameiro MO, Kapoor A, Amaro JL. Electrical stimulation with non-

implanted electrodes for overactive bladder in adults. Cochrane Database Syst Rev. 2016;12:CD010098.

Doi: 10.1002/14651858.CD010098.pub4.

Stewart F, Berghmans B, Bo K, Glazener CM. Electrical stimulation with non-implanted devices for stress

urinary incontinence in women. Cochrane Database Syst Rev. 2017 Dec 22;12:CD012390. doi:

10.1002/14651858.CD012390.pub2.

Vonthein R, Heimerl T, Schwandner T, Ziegler A. Electrical stimulation and biofeedback for the treatment

of fecal incontinence: a systematic review. Int J Colorectal Dis. 2013; 28(11): 1567 – 77.

Wu JM, Vaughan CP, Goode PS, et al. Prevalence and trends of symptomatic pelvic floor disorders in U.S.

women. Obstet Gynecol. 2014; 123(1): 141 – 48.

Zhu YP, Yao XD, Zhang SL, Dai B, Ye DW. Pelvic floor electrical stimulation for postprostatectomy urinary

incontinence: a meta-analysis. Urology. 2012;79(3):552 – 55.

CMS National Coverage Determinations (NCDs):

230.8 Non-Implantable Pelvic Floor Electrical Stimulator. CMS website. Effective October 19, 2006.

https://www.cms.gov/medicare-coverage-database/details/ncd-

details.aspx?NCDId=231&ncdver=2&CoverageSelection=Both&ArticleType=All&PolicyType=Final&s=All&

KeyWord=pelvic+floor+electrical+stimulator&KeyWordLookUp=Title&KeyWordSearchType=And&bc=gA

AAACAAAAAAAA%3d%3d&. Accessed February 14, 2018.

Local Coverage Determinations (LCDs):

None.

Commonly submitted codes

Below are the most commonly submitted codes for the service(s)/item(s) subject to this policy. This is

not an exhaustive list of codes. Providers are expected to consult the appropriate coding manuals and

bill accordingly.

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CPT Code Description Comments

53899 Extracorporeal magnetic innervation (Unlisted procedure, urinary system)

97014 Application of a modality to one or more areas; electrical stimulation unattended

97032 Application of a modality to one or more areas; electrical stimulation (manual),

each 15 minutes, requiring direct patient contact by the provider

ICD-10 Code Description Comments

N39.3 Stress incontinence (female) (male)

N39.41-N39.498 Other specified urinary incontinence (code range)

R15.0-R15.9 Fecal incontinence (code range)

R32 Unspecified urinary incontinence

HCPCS

Level II Code Description Comments

E0740 Incontinence treatment system; pelvic floor stimulator, monitor, sensor and/or

trainer