Pelvic Floor Stimulation

PFSinvolves 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 improve urethral closure. In addition, PFS is thought to improve partially denervated urethral and pelvic floor musculature by enhancing the process of reinnervation. Methods of electrical PFS have varied in location (eg, 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. Variations in the amplitude and frequency of the electrical pulse are used to mimic and stimulate the different physiologic mechanisms of the voiding response, depending on the etiology of the incontinence (ie, 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 administered in the physician's office.

Regulatory Status

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 the FDA through the 510(k) process. Predicate devices also used to treat urinary incontinence, including 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) cleared through the FDA 510(k) 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 the FDA. The device is intended to treat male and female urinary and fecal incontinence.

FDA product code: KPI.

Related Policies

• Percutaneous Tibial Nerve Stimulation (Policy #069 in the Surgery Section)
• Sacral Nerve Neuromodulation/Stimulation (Policy #012 in the Treatment Section)

(NOTE: According to UpToDate, "A vaginal insert with a pressure-regulated pump to temporarily occlude the rectum has been shown to reduce incontinence episodes by 50 percent in approximately 80 percent of women at one month. However, studies are needed to evaluate its efficacy in the long-term."

A multicenter, prospective, open-label, 1-year outcome clinical study -LIBERATE- is listed on ClinicalTrials.gov with completion date of March 2018 but results have yet to be posted. NCT02428595.)

For members enrolled in Medicaid and NJ FamilyCare plans, Horizon BCBSNJ applies the above medical policy.

FIDE SNP:

For members enrolled in a Fully Integrated Dual Eligible Special Needs Plan (FIDE-SNP): (1) to the extent the service is covered under the Medicare portion of the member’s benefit package, the above Medicare Coverage statement applies; and (2) to the extent the service is not covered under the Medicare portion of the member’s benefit package, the above Medicaid Coverage statement applies.

[RATIONALE: This policy was created in 1999 and has been updated regularly with searches of the MEDLINE database. The most recent literature update was performed through June 10, 2019.

The urinary incontinence portion of the review was informed by 2 TEC Assessments (2000), one on electrical pelvic floor stimulation (PFS) and the other on magnetic PFS.^1,2,

Evidence reviews assess the clinical evidence to determine whether the use of technology improves the net health outcome. Broadly defined, health outcomes are the length of life, quality of life (QOL), and ability to function-including benefits and harms. Every clinical condition has specific outcomes that are important to patients and managing the course of that condition. Validated outcome measures are necessary to ascertain whether a condition improves or worsens; and whether the magnitude of that change is clinically significant. The net health outcome is a balance of benefits and harms.

To assess whether the evidence is sufficient to draw conclusions about the net health outcome of technology, two domains are examined: the relevance, and quality and credibility. To be relevant, studies must represent one or more intended clinical use of the technology in the intended population and compare an effective and appropriate alternative at a comparable intensity. For some conditions, the alternative will be supportive care or surveillance. The quality and credibility of the evidence depend on study design and conduct, minimizing bias and confounding that can generate incorrect findings. The randomized controlled trial (RCT) is preferred to assess efficacy; however, in some circumstances, nonrandomized studies may be adequate. RCTs are rarely large enough or long enough to capture less common adverse events and long-term effects. Other types of studies can be used for these purposes and to assess generalizability to broader clinical populations and settings of clinical practice.

Electrical PFS for Urinary Incontinence

Clinical Context and Therapy Purpose

The purpose of PFS in patients who have urinary incontinence is to provide a treatment option that is an alternative to or an improvement on existing therapies.

The question addressed in this policy is: Does the use of electrical PFS improve net health outcomes in patients with urinary incontinence?

The following PICOs were used to select literature to inform this review.

Patients

The relevant populations of interest are patients with urinary incontinence. Types of urinary incontinence include stress incontinence, urgency incontinence, and mixed (both stress and urgency).

Urinary incontinence is a common condition and can have a substantial impact on the QOL. Estimates from the National Center for Health Statistics have suggested that, among noninstitutionalized persons 65 years of age and older, 44% have reported issues with urinary incontinence.^3,Urinary incontinence in women is common, with some estimates citing a 50% incidence. Factors that increase a woman's risk include older age, obesity, parity, vaginal delivery, and family history.

Urinary incontinence is less common in men, with estimates ranging from 11% to 34% in men greater than 65 years. Factors that increase a man's risk include older age, prostate disease, urinary tract infection history, impaired activities of daily living, neurologic disease, constipation, diabetes, and sleep apnea.

Interventions

The therapy being considered is electrical PFS for urinary incontinence. In an electrical PFS procedure, a probe delivers electrical pulses to stimulate the pudendal nerve, which activates the pelvic floor musculature. Activation of this musculature is believed to improve urethral closure. Electrical PFS is administered in a physician's office or a physical therapy facility. Patients may also be trained on the use of a PFS system to continue treatments at home.

Comparators

The following therapies are currently being used to make decisions about urinary incontinence: magnetic PFS or neuromodulation, behavioral therapies (eg, monitoring fluid intake, bladder, and pelvic floor muscle training, diet), and medications. Patients may also be trained on the use of a PFS system to continue treatments at home.

Outcomes

The general outcomes of interest include a reduction in symptoms (eg, number of incontinence episodes) and improvements in QOL and cure rates. Short-term results can be measured at six months.^4, Longer-term follow-up may be necessary to determine if treatment has durable effects.

Study Selection Criteria

Methodologically credible studies were selected using the following principles:

a. To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs;
b. In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.
c. To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.
d. Studies with duplicative or overlapping populations were excluded.

Systematic Reviews

A TEC Assessment (2000) concluded there was insufficient evidence that electrical PFS improved health outcomes compared with placebo or other behavioral therapies in women with stress, urge, or mixed incontinence.^1,

Subsequently, several systematic reviews of the literature with pooled study findings have been published.

In a systematic review and cost-effectiveness analysis published by the U.K. Health Technology Assessment program, Imamura et al (2010) identified 8 RCTs comparing electrical stimulation with no active treatment; a sham control was used in 6 studies.^5, A pooled analysis of findings (all comparison groups combined) did not find a statistically significant difference between groups in cure rate (6% in each group; odds ratio, 1.10; 95% confidence interval [CI], 0.41 to 2.94). A pooled analysis of cure rates from the 5 studies comparing electrical PFS with pelvic floor muscle training did not show a significant difference between groups; the cure rates were 24% and 11%, respectively (odds ratio, 2.65; 95% CI, 0.82 to 8.60). When the comparison was limited to studies evaluating electrical stimulation and no active treatment, there was a higher rate of improvement with electrical stimulation (37% vs 14%; odds ratio, 3.93; 95% CI, 1.43 to 10.8). In studies without a sham intervention group, a placebo effect of electrical stimulation could not be ruled out. Reviewers concluded that there is insufficient evidence to recommend electrical stimulation on a routine basis for the treatment of stress urinary incontinence.

An Agency for Healthcare Research and Quality comparative effectiveness review prepared by Shamliyan et al (2012) identified 9 RCTs evaluating electrical intravaginal stimulation in women with urgency, stress, or mixed incontinence.^6, Eight of the 9 studies were published in 2000 or earlier; nearly all used a sham treatment as the control. A pooled analysis of continence rates in 8 RCTs comparing electrical PFS with no active treatment yielded a relative risk (RR) of 2.86 (95% CI, 1.57 to 5.23). A pooled analysis of the reduction in incontinence symptoms yielded an RR of 2.01 (95% CI, 1.28 to 3.15). Reviewers concluded that a high level of evidence suggested electrical PFS is associated with increased continence rates, and that such stimulation improved urinary incontinence.

Moroni et al (2016) published a systematic review of conservative treatment for stress urinary incontinence.^7, Five trials (total n=221 women) were identified comparing intravaginal electrical PFS with control. There were insufficient data on cure rates (eg, continence rates). A pooled analysis of 4 studies reporting urine quantity with a pad weight test found a significantly greater reduction in pad weight in the treatment vs control groups (mean difference, -9.15; 95% CI, -17.22 to -1.08). A pooled analysis of 2 studies found significantly greater improvement in the incontinence-specific QOL in the electrical PFS group than in the control group (mean difference,= -1.44; 95% CI, -1.94 to -0.95). Three studies were included in a pooled analysis of a number of incontinence episodes; the findings were not reported. Reviewers stated that, among all conservative treatments assessed, evidence was strongest in support of PFS, with or without biofeedback, for treatment of stress urinary incontinence.

Randomized Controlled Trials

Findings of representative RCTs on electrical stimulation for urinary incontinence in women are described next. Goode et al (2003) reported on a trial that randomized 200 women with primarily stress incontinence to 8 weeks of behavioral training, 8 weeks of behavioral training plus home PFS, or self-administered behavioral training alone using a self-help booklet.^8, The main outcomes measures were patient-reported bladder diaries and changes in QOL. Patients in all three groups reported significant reductions in incontinence; there were no significant differences between groups.

Castro et al (2008) published a single-blind RCT comparing treatment with pelvic floor muscle training, electrical PFS, vaginal cones, or a no-treatment control group in women with confirmed urodynamic stress urinary incontinence who did not have urge incontinence.^9, Outcome assessment was blinded but patients were not blinded to treatment group. A total of 118 women were randomized; 17 (14%) women withdrew from the trial. A total of 101 women completed the study and were included in the analysis (26 in the pelvic floor muscle training group, 27 in the electrical stimulation group, 24 in the vaginal cones group, 24 in the untreated group). The primary outcome was the proportion of women with a negative pad test (ie, weight <2 g). At six months, outcomes were similar in the three treatment groups but significantly fewer women in the no-treatment group had a negative pad test. The numbers of women with negative pad tests were 12 (46%) in the pelvic floor muscle training group, 13 (48%) in the electrical stimulation group, 11 (45%) in the vaginal cone group, and 2 (8.0%) in the untreated control group.

Abdelbary et al (2015) published a 3-group RCT evaluating women with overactive bladder and treated with electrical PFS, local vaginal estrogen treatment, or a combination of both interventions.^4, The trial included 315 women (105 women per group). Electrical PFS was administered using a vaginal probe. At six-months follow-up, there were statistically significant differences among the three groups in outcomes that included the number of voids per day, the number of incontinence episodes, the number of urgency episodes, and the QOL score (p<0.001 for each outcome). In a post hoc analysis, there was more improvement in the electrical PFS group than in the estrogen-only group for all key variables. The combined treatment group had better results than the estrogen-only group on several outcomes, but not voiding frequency per day, the number of incontinence episodes, or QOL.

Men With Postprostatectomy Urinary Incontinence

Systematic Reviews

Several systematic reviews of RCTs have been published. A Cochrane review by Berghmans et al (2013) identified 6 RCTs on electrical PFS with nonimplanted electrodes for postprostatectomy urinary incontinence in men.^10, The trials varied by intervention used, study protocols, study populations, and outcome measures. In a pooled analysis of 4 RCTs comparing the combination of electrical stimulation and pelvic floor muscle exercises with pelvic floor muscle exercises alone, there was no statistically significant difference between groups in the proportion of men with urinary incontinence at 3 months (RR=0.93; 95% CI, 0.82 to 1.06). Findings from studies evaluating electrical PFS alone were not pooled.

Zhu et al (2012) conducted a meta-analysis and reported similar findings for electrical PFS to treat postprostatectomy urinary incontinence.^11, Reviewers identified 4 RCTs (total n=210 men) that provided sufficient data on clinical outcomes. A pooled analysis of data from 3 trials did not find a statistically significant benefit of electrical PFS on continence levels compared with controls within 3 months of prostatectomy (RR=1.21; 95% CI, 0.96 to 1.54). Similarly, a pooled analysis of data from all 4 trials did not show a statistically significant benefit of electrical PFS on continence levels 6 to 12 months after prostatectomy (RR=1.03: 95% CI, 0.88 to 1.20).

Randomized Controlled Trials

Representative trials of men with postprostatectomy urinary incontinence include the RCT by Goode et al (2011) comparing behavioral therapy alone with behavioral therapy plus biofeedback and electrical PFS.^12, The trial included 208 men with urinary incontinence persisting at least 1 year after radical prostatectomy. Men with preprostatectomy incontinence were excluded. Participants were randomized to 1 of 3 groups: 8 weeks of behavioral therapy (pelvic floor muscle training plus bladder control exercises; n=70), behavioral therapy plus biofeedback and electrical stimulation (n=70), and a delayed-treatment control group (n=68). The biofeedback plus electrical stimulation intervention (called "behavior-plus") consisted of in-office electrical stimulation with biofeedback using an anal probe and daily home electrical PFS. After 8 weeks, patients in the 2 active treatment groups were given instructions for a maintenance program of pelvic floor exercises and fluid control; they were then given follow-up at 6 and 12 months. The primary efficacy outcome was a reduction in the number of incontinent episodes at eight weeks, as measured by a seven-day bladder diary. A total of 176 (85%) of 208 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% (from 26 to 12 episodes per week) in the behavior-plus group, and 24% (from 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 for other outcomes. For example, at the end of 8 weeks, there was a significantly higher rate of complete continence in the active treatment groups (11/70 [16%] in the behavior group vs 12/70 [17%] in the behavior-plus group) than in the control group (4/68 [6%]); however, the group receiving biofeedback and electrical PFS did not have a significantly higher continence rate than the group receiving behavioral therapy alone. The trial did not isolate the effect of electrical PFS, and the combined behavior-plus intervention did not result in better outcomes than behavioral therapy alone.

Yamanishi et al (2010) published findings of an RCT comparing electrical stimulation with a sham control group.^13, This trial, conducted in Japan, was double-blinded; in it, 56 men with severe postprostatectomy urinary incontinence were randomized to active (n=26) or sham (n=30) electrical PFS. All the men performed pelvic floor muscle training. Active or sham electrical PFS was performed until incontinence was resolved or until the end of the study at 12 months. Forty-seven patients (22 in the active stimulation group, 25 in the sham group) completed the trial. The continence rate (defined as loss of ≤8 g of urine during a 24-hour pad test) was the primary efficacy outcome. There was a statistically higher rate of continence at 1, 3, and 6 months in the active stimulation group than in the sham group but the between-group difference was not statistically significant at 12 months. The numbers of men reported as continent in the active electrical PFS group were 8 (36%), 14 (63%), 18 (81%), and 19 (86%) at 1, 3, 6, and 12 months, respectively. Corresponding rates in the sham group were 1 (4%), 4 (16%), 11 (44%), and 17 (86%), respectively. Differences in the amount (number of grams) of daily leakage as measured by 24-hour pad tests differed significantly between groups at 1 month; however, the difference disappeared at the 12-month follow-up. For example, after 1 month, the mean amount of leakage was 210 grams in the active treatment group and 423 grams in the sham group (p>0.05). Change in the amount of daily leakage from baseline differed significantly between groups at 1 month (-528 g in the active treatment group vs -257 g in the sham group, p<0.01) but not at the other follow-up time points.

Section Summary: Electrical PFS for Urinary Incontinence

A majority of RCTs on electrical PFS for treatment of women with urinary incontinence have been published before 2001. Meta-analyses of RCTs have had inconsistent findings on the impact of electrical intravaginal stimulation on urinary incontinence in women compared with sham treatment.

There are a few small RCTs evaluating electrical PFS as a treatment of postprostatectomy urinary incontinence in men. These studies have reported improvements in some outcomes with electrical PFS but also have limitations, such as failure to isolate the effect of electrical PFS; and/or failure to find a sham comparator or an accepted treatment comparator. Three pooled analyses of RCTs were identified: one did not find a statistically significant benefit of electrical PFS when added to pelvic floor muscle exercises; a second found a short-term benefit of electrical PFS compared with no stimulation or sham; and the third did not find a short- or long-term benefit of electrical PFS compared with any control condition.

Electrical PFS for Fecal Incontinence

Clinical Context and Therapy Purpose

The purpose of PFS in patients who have fecal incontinence is to provide a treatment option that is an alternative to or an improvement on existing therapies.

The question addressed in this policy is: Does the use of electrical PFS improve net health outcomes in patients with fecal incontinence?

The following PICOs were used to select literature to inform this review.

Patients

The relevant populations of interest are patients with fecal incontinence. Fecal incontinence can have a substantial impact on the QOL. Estimates from the National Center for Health Statistics have suggested that among noninstitutionalized persons, 65 years of age or older, 17% have reported issues with fecal incontinence. Risk factors for fecal incontinence are similar in men and women: older age, diarrhea, fecal urgency, urinary incontinence, and diabetes.

Interventions

The therapy being considered is electrical PFS for fecal incontinence. Electrical PFS is administered in a physician's office or a physical therapy facility. Patients may also be trained on the use of a PFS system to continue treatments at home.

Comparators

The following therapies are currently being used to make decisions about fecal incontinence: Nonsurgical treatment options for incontinence may include pharmacologic therapy, bowel training exercises, magnetic stimulation. Behavioral therapies including pelvic floor muscle training and diet.

Outcomes

The general outcomes of interest include a reduction in symptoms (eg, number of incontinence episodes) and improvements in QOL and cure rates. Electrical PFS therapy generally continues for six-eight weeks.^14,15,

Study Selection Criteria

Methodologically credible studies were selected using the following principles:

a. To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs;
b. In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.
c. To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.
d. Studies with duplicative or overlapping populations were excluded.

A systematic review by Vonthein et al (2013) searched for studies on the impact of biofeedback and/or electrical PFS for treating fecal incontinence in adults.^16, They identified 13 RCTs that used one or both of these treatments and reported health outcomes (eg, remission or response rates using validated scales). A pooled analysis of trial results did not find statistically significant differences in rates of remission when comparing electrical PFS with a control intervention (RR=0.47; 95% CI, 0.13 to 1.72). A pooled analysis of studies comparing electrical PFS plus biofeedback with electrical PFS alone found a significantly higher rate of remission with the combination intervention (RR=22.97; 95% CI, 1.81 to 291.69). The latter analysis focused on the efficacy of biofeedback and not electrical PFS. Additionally, the confidence interval was very wide, indicating an imprecise estimate of the treatment effect. The Vonthein et al (2013) review included only 2 RCTs on electrical PFS^17,18, that were published after a Cochrane review (below). These two trials included the combination of amplitude-modulated medium-frequency stimulation and biofeedback. Electrical PFS was not evaluated in the absence of biofeedback.

A Cochrane review by Hosker et al (2007) identified 4 RCTs evaluating electrical stimulation as a treatment of fecal incontinence in adults.^19, One trial was sham-controlled, another compared electrical PFS with levatorplasty, and two used electrical PFS as an adjunct treatment. Reviewers did not pool study findings; they concluded that there is insufficient evidence to draw conclusions on the efficacy of electrical PFS for treating fecal incontinence.

Randomized Controlled Trials

Representative RCTs published are described next. An RCT by Cohen-Zubary et al (2015) allocated 42 women with fecal incontinence to 6 weeks of electrical stimulation (n=22) or biofeedback training (n=20).^14, Biofeedback sessions were conducted in-clinic and electrical PFS sessions at home following an initial training in-clinic. Thirty-six (86%) women completed the trial and were included in the analysis; the analysis was not intention-to-treat. The trial's primary endpoints were an improvement in frequency of fecal, urine, and gas incontinence, assessed using visual analog scale scores. There were no statistically significant differences between groups for the primary outcomes. The mean visual analog scale score (standard deviation) for solid stool incontinence at baseline in the stimulation group was 2.9 (2.8), which decreased to 0.9 (0.9) at follow-up. In the biofeedback group, the baseline visual analog scale score was 1.1 (2.1) and 0.3 (0.5) at follow-up. The between-group difference for this outcome was not statistically significant. For within-group changes, the electrical stimulation group improved significantly on solid stool incontinence-but not on liquid stool or gas incontinence-and the biofeedback group did not improve significantly on any of the fecal incontinence outcomes.

Norton et al (2006) in the U.K. published a sham-controlled randomized trial that included 90 adults with fecal incontinence.^15, Patients used a home electric PFS device for eight weeks. Patients allocated to active treatment had the stimulation set at 35 Hz, with a 0.5-second ramped pulse. The sham stimulator looked identical but stimulation was set at 1 Hz below the level tested for therapeutic effect. Patients were blinded to the treatment group; although nurses who trained patients on device use were not. The primary outcome was patient self-report of efficacy, using a rating scale ranging from -5 to +5 to indicate symptom change. Seventy (78%) of the 90 patients completed the trial. In an intention-to-treat analysis (assigning patients who dropped out a value of 0), there was no statistically significant difference between groups in patient ratings of symptom change. On a scale of -5 to +5, there was a median rating of 0 in each group (p=0.92). In a completer analysis, the median change in symptoms was 2 in the active treatment group and 1 in the sham group (p=0.74). Groups did not differ significantly on other secondary outcomes such as the frequency of urge or passive incontinence after treatment.

Section Summary: Electrical PFS for Fecal Incontinence

Several RCTs have evaluated electrical stimulation for treating fecal incontinence. Only one was sham-controlled, and it did not find that active stimulation produced better results than sham stimulation. Systematic reviews of RCTs have not found that electrical stimulation is superior to control interventions for treating fecal incontinence.

Magnetic PFS for Urinary Incontinence

Clinical Context and Therapy Purpose

The purpose of magnetic PFS in patients who have urinary incontinence is to provide a treatment option that is an alternative to or an improvement on existing therapies.

The question addressed in this policy is: Does the use of magnetic PFS improve net health outcomes in patients with urinary incontinence?

The following PICOs were used to select literature to inform this review.

Patients

The relevant populations of interest are patients with urinary incontinence. Types of urinary incontinence include stress incontinence, urgency incontinence, and mixed (both stress and urgency). Urinary incontinence in women is common, with some estimates citing a 50% incidence. Factors that increase a woman's risk include older age, obesity, parity, vaginal delivery, and family history. Urinary incontinence is less common in men, with estimates ranging from 11% to 34% in men greater than 65 years. Factors that increase a man's risk include older age, prostate disease, urinary tract infection history, impaired activities of daily living, neurologic disease, constipation, diabetes, and sleep apnea.

Interventions

The therapy being considered is magnetic PFS for urinary incontinence. The mechanism of action of a magnetic PFS procedure is similar to the electrical procedure, though using magnetic pulses to activate the pelvic floor musculature. The magnetic pulses are delivered without a probe, with patients sitting fully clothed in a specialized chair with an embedded magnet. Magnetic PFS is administered in a physician's office or a physical therapy facility. Patients may also be trained on the use of a rental PFS system to continue treatments at home.

Comparators

The following therapies are currently being used to make decisions about urinary incontinence: electrical PFS and behavioral therapies (eg, monitoring fluid intake, pelvic floor muscle training, diet), and medications.

Outcomes

The general outcomes of interest include a reduction in symptoms (eg, number of incontinence episodes) and improvements in QOL and cure rates. Treatment is for approximately eight weeks, and follow-up is generally at up to six months.

Women

Systematic Reviews

A systematic review of RCTs on magnetic stimulation for the treatment of urinary incontinence was published by Lim et al (2015).^20, Reviewers identified 8 blinded sham-controlled trials (total n=484 patients). Treatment protocols (eg, frequency, duration of magnetic PFS) varied among trials. The primary outcome was cure rate; only one trial reported this outcome, so data were not pooled. A meta-analysis of 3 studies reporting improvements in the continence rates found significantly greater improvement in the treatment group than in the sham group (RR=2.29; 95% CI, 1.60 to 3.29). Due to the variability across trials in types of incontinence treated and/or outcome reporting, data were not pooled for other outcomes. Reviewers noted that the evidence was limited by low-quality trials with short-term follow-up.

Randomized Controlled Trials

Yamanishi et al (2014) published an industry-sponsored evaluation of magnetic PFS provided to women with urinary urgency using an armchair-type stimulator.^21, The device was produced by a Japanese company and does not have the Food and Drug Administration approval. Patients received active (n=101) or sham (n=50) stimulation, 2 times a week for 6 weeks. The level of stimulation was tailored to each patient's maximum tolerable intensity; sham stimulation was set at a lower level than active treatment. Because noises differed between the two procedures, patients were isolated from the sounds to maintain blinding. Study personnel were not blinded. A total of 143 (95%) of 151 patients were included in the efficacy analysis. The primary endpoint was a change in the number of urinary incontinence episodes per week, as reported in a patient diary. The decrease in the weekly number (standard deviation) of incontinence episodes was 13 (11) in the active treatment group compared with 9 (13) in the sham group (p=0.038). Patients in the active stimulation group had significantly better results on some secondary outcomes (eg, number of urgency episodes per 24 hours) but not others (eg, number of voids per 24 hours).

A sham-controlled randomized trial evaluating magnetic PFS using the NeoControl chair did not find evidence that PFS improved outcomes. In this trial by Gilling et al (2009) in New Zealand, sham treatment involved inserting a thin aluminum plate in the chair to prevent penetration of the magnetic field.^22, The trial included 70 women, 35 in each group, with stress or mixed urinary incontinence. Both groups received three treatment sessions per week for six weeks. There was no significant difference between the active and sham treatment groups for the primary outcome measure, change from baseline in the 20-minute pad test result to 8 weeks after the start of treatment (2 weeks after finishing treatment). At 8 weeks, the mean change in the 20-minute pad test was 20.1 mL in the treatment group and 7.5 mL in the control group. The groups also did not differ significantly in the 20-minute pad weight or QOL measure at the 6-month follow-up. Data from 29 (83%) women in the active treatment group and 26 (74%) women in the sham group were available at 6 months; all participants appear to be included in the 8-week outcomes analysis.

Men With Postprostatectomy Urinary Incontinence

One RCT was identified on magnetic PFS for treating postprostatectomy urinary incontinence. Yokoyama et al (2004) reported findings from a 3-arm randomized trial.^23, Thirty-six men (12 in each group) were randomized to extracorporeal magnetic PFS (NeoControl chair), functional electrical PFS, or pelvic floor exercises. The primary outcome was pad weight testing for up to six months after the one-month treatment period. At one month after catheter removal, pad weight was significantly lower in the electrical PFS group than in the control group; at two months after catheter removal, pad weight was significantly lower in the magnetic PFS group compared with the control group; and, beginning at three months after catheter removal, there were no significant differences across arms in pad weight. Additionally, there were no significant differences between groups in QOL measurements at any follow-up point. The trial lacked a sham magnetic stimulation group and therefore a placebo effect cannot be ruled out as an explanation for the short-term reduction in pad weight in the magnetic PFS treatment group.

Section Summary: Magnetic PFS for Urinary Incontinence

A systematic review of RCTs evaluating the use of 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, methodologic limitations, and heterogeneity in terms of patient populations, interventions, and outcome reporting.

One RCT evaluated magnetic PFS for the treatment of men with postprostatectomy urinary incontinence. There was a greater improvement in pad weight at two months in the magnetic PFS group than in the pelvic floor muscle exercises group but there were no significant differences between groups beginning at three months. Other outcomes also did not favor the magnetic PFS group.

Magnetic PFS for Fecal Incontinence

Clinical Context and Therapy Purpose

The purpose of PFS in patients who have fecal incontinence is to provide a treatment option that is an alternative to or an improvement on existing therapies.

The question addressed in this policy is: Does the use of magnetic PFS improve net health outcomes in patients with fecal incontinence?

The following PICOs were used to select literature to inform this review.

Patients

The relevant populations of interest are patients with fecal incontinence. Risk factors for fecal incontinence are similar in men and women: older age, diarrhea, fecal urgency, urinary incontinence, and diabetes. For women, current and past use of hormone therapy is an added risk factor. Fecal incontinence can have a substantial impact on the QOL. Estimates from the National Center for Health Statistics have suggested that among noninstitutionalized persons, 65 years of age or older, 17% have reported issues with fecal incontinence.

Interventions

The therapy being considered is magnetic PFS for fecal incontinence. The mechanism of action of a magnetic PFS procedure is similar to the electrical procedure, though using magnetic pulses to activate the pelvic floor musculature. The magnetic pulses are delivered without a probe, with patients sitting fully clothed in a specialized chair with an embedded magnet. Magnetic PFS is administered in a physician's office or a physical therapy facility. Patients may also be trained on the use of a rental PFS system to continue treatments at home.

Comparators

The following therapies are currently being used to make decisions about fecal incontinence: Nonsurgical treatment options for incontinence may include pharmacologic therapy, bowel training exercises, and electrical stimulation. Behavioral therapies including pelvic floor muscle training and diet. Patients may also be trained on the use of a rental PFS system to continue treatments at home.

The general outcomes of interest include a reduction in symptoms (eg, number of incontinence episodes) and improvements in QOL and cure rates.

Outcomes

The general outcomes of interest include a reduction in symptoms (eg, number of incontinence episodes) and improvements in QOL and cure rates. Treatment is for approximately eight weeks, and follow-up is generally at up to six months.

No studies were identified that evaluated magnetic PFS as a treatment of fecal incontinence.

Section Summary: Magnetic PFS for Fecal Incontinence

Current evidence is insufficiently robust to draw conclusions about the efficacy of magnetic PFS to treat fecal incontinence.

Summary of Evidence

For individuals who have urinary incontinence who receive electrical PFS, the evidence includes RCTs and systematic reviews. The relevant outcomes are symptoms, change in disease status, QOL, and treatment-related morbidity. Findings from multiple RCTs 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. Meta-analyses of these RCTs have also reported inconsistent findings. 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 the effects of the technology on health outcomes.

For individuals who have fecal incontinence who receive electrical PFS, the evidence includes RCTs and systematic reviews. The relevant outcomes are symptoms, change in disease status, QOL, and treatment-related morbidity. Among the RCTs that have evaluated electrical PFS as a treatment for fecal incontinence only one 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 the effects of the technology on health outcomes.

For individuals who have urinary incontinence who receive magnetic PFS, the evidence includes RCTs and a systematic review. The relevant outcomes are symptoms, change in disease status, QOL, 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 following factors: a low number of trials with short-term follow-up, methodologic limitations, as well as heterogeneity in patient populations, interventions, and outcomes reported. One RCT evaluating magnetic stimulation for treating 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 the effects of the technology on health outcomes.

For individuals who have fecal incontinence who receive magnetic PFS, the evidence includes no RCTs or non-RCTs. The relevant outcomes are symptoms, change in disease status, QOL, and treatment-related morbidity. The evidence is insufficient to determine the effects of the technology on health outcomes.

SUPPLEMENTAL INFORMATION

Practice Guidelines and Position Statements

American Urological Association

The American Urological Association (2014) published guidelines on the diagnosis and management of overactive bladder.^24, Neither electrical pelvic floor stimulation (PFS) nor magnetic PFS was mentioned as recommended first-, second-, or third-line treatment options.

National Institute for Health and Care Excellence

The NICE (2019) issued guidance on the management of urinary incontinence in women.^25,The 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. The 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.

The NICE (2007) issued guidance on the management of fecal incontinence in adults.^26, (This guidance was last reviewed by NICE in 2014.) The document stated that that the evidence on electrical stimulation for treatment of fecal incontinence was inconclusive. The 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

The American College of Physicians (2014) issued guidelines on the nonsurgical management of urinary incontinence.^27, Electrical PFS and magnetic PFS were not discussed.

U.S. Preventive Services Task Force Recommendations

Not applicable.

Ongoing and Unpublished Clinical Trials

Some currently unpublished trials that might influence this review are listed in Table 1.

Table 1. Summary of Key Trials

NCT No.	Trial Name	Planned Enrollment	Completion Date
Unpublished
NCT02599831	Efficacy of Electrical Pudendal Nerve Stimulation for Patients with Postprostatectomy Incontinence	96	Aug 2017 (completed)
NCT01924728a	A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Investigate the Effects of Transpelvic Magnetic Stimulation (Using QRS®-1010 PelviCenter) in Patients with Stress Urinary Incontinence	120	Feb 2016 (completed)

NCT: national clinical trial.

^a Denotes industry-sponsored or cosponsored trial.]
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Horizon BCBSNJ Medical Policy Development Process:

This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.

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Index:
Pelvic Floor Stimulation as a Treatment of Urinary and Fecal Incontinence and Dynamic Rectal Control System as a Treatment of Fecal Incontinence
Pelvic Floor Stimulation as a Treatment of Urinary and Fecal Incontinence
Electrical Stimulation of the Pelvic Floor Muscles
Electromagnetic Pulsed Stimulation
Extracorporeal Electromagnetic Pulsed Stimulation
Magnetic Stimulation of the Pelvic Floor Muscles
NeoControl Pelvic Floor Therapy System
Incontinence, Urinary, Pelvic Floor Stimulation
Incontinence, Fecal, Pelvic Floor Stimulation
Pulsed Electromagnetic Stimulation
Urinary Incontinence, Pelvic Floor Stimulation
Neotonus Muscle Stimulator System
Pathway CTS 2000
Pathway STM-10 Pelvic Floor Stimulator
Liberty PFS-200
Fecal Incontinence, Pelvic Floor Stimulation
MyoTrac Infiniti™
EmbaGYN®
InTone®MV
InTone MV
Dynamic Rectal Control System as a Treatment of Fecal Incontinence
Rectal Control System as a Treatment for Fecal Incontinence
Fecal Incontinence, Dynamic Rectal Control System
Incontinence, Fecal, Dynamic Rectal Control System
Eclipse System
Vaginal Bowel Control Therapy for Fecal Incontinence

References:
1. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Pelvic floor electrical stimulation in the treatment of urinary incontinence in adults. TEC Assessments. 2000;Volume 15:Tab 2.

2. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Magnetic stimulation in the treatment of urinary incontinence in adults. TEC Assessments. 2000;Volume 15:Tab 8.

3. Gorina Y, Schappert S, Bercovitz A, et al. Prevalence of incontinence among older Americans. Vital Health Stat 3. Jun 2014(36):1-33. PMID 24964267

4. 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. PMID 26135813

5. 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. Aug 2010;14(40):1-188, iii-iv. PMID 20738930

6. Shamliyan T, Wyman J, Kane R. Nonsurgical Treatments for Urinary Incontinence in Adult Women: Diagnosis and Comparative Effectiveness (Comparative Effectiveness Review 36). Rockville, MD: Agency for Healthcare Research and Quality; 2012.

7. 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. PMID 26883864

8. Goode PS, Burgio KL, Locher JL, et al. Effect of behavioral training with or without pelvic floor electrical stimulation on stress incontinence in women: a randomized controlled trial. Jama. Jul 16 2003;290(3):345-352. PMID 12865375

9. Castro RA, Arruda RM, Zanetti MR, et al. Single-blind, randomized, controlled trial of pelvic floor muscle training, electrical stimulation, vaginal cones, and no active treatment in the management of stress urinary incontinence. Clinics (Sao Paulo). Aug 2008;63(4):465-472. PMID 18719756

10. Berghmans B, Hendriks E, Bernards A, et al. Electrical stimulation with non-implanted electrodes for urinary incontinence in men. Cochrane Database Syst Rev. Jun 6 2013;6(6):CD001202. PMID 23740763

11. Zhu YP, Yao XD, Zhang SL, et al. Pelvic floor electrical stimulation for postprostatectomy urinary incontinence: a meta-analysis. Urology. Mar 2012;79(3):552-555. PMID 22386394

12. Goode PS, Burgio KL, Johnson TM, 2nd, et al. Behavioral therapy with or without biofeedback and pelvic floor electrical stimulation for persistent postprostatectomy incontinence: a randomized controlled trial. JAMA. Jan 12 2011;305(2):151-159. PMID 21224456

13. 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. Nov 2010;184(5):2007-2012. PMID 20850831

14. 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. Apr 2015;30(4):521-528. PMID 25619464

15. Norton C, Gibbs A, Kamm MA. Randomized, controlled trial of anal electrical stimulation for fecal incontinence. Dis Colon Rectum. Feb 2006;49(2):190-196. PMID 16362803

16. 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. Nov 2013;28(11):1567-1577. PMID 23900652

17. 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. Jul 2010;53(7):1007-1016. PMID 20551752

18. 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. Sep 2011;108(39):653-660. PMID 22013492

19. Hosker G, Cody JD, Norton CC. Electrical stimulation for faecal incontinence in adults. Cochrane Database Syst Rev. Jul 18 2007(3):CD001310. PMID 17636665

20. 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. PMID 25251335

21. 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. Apr 2014;21(4):395-400. PMID 24118165

22. Gilling PJ, Wilson LC, Westenberg AM, et al. A double-blind randomized controlled trial of electromagnetic stimulation of the pelvic floor vs sham therapy in the treatment of women with stress urinary incontinence. BJU Int. May 2009;103(10):1386-1390. PMID 19154474

23. Yokoyama T, Nishiguchi J, Watanabe T, et al. Comparative study of effects of extracorporeal magnetic innervation versus electrical stimulation for urinary incontinence after radical prostatectomy. Urology. Feb 2004;63(2):264-267. PMID 14972468

24. 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

25. National Institute for Health and Care Excellence (NICE) Guideline. Urinary Incontinence and Pelvic Organ Prolapse in Women: Management. NICE Guideline. 2019. Accessed June 13, 2019. https://www.nice.org.uk/guidance/ng123

26. National Institute for Health and Care Excellence (NICE). Faecal incontinence in adults: management [CG49]. 2007; https://www.nice.org.uk/guidance/cg49. Accessed August 27, 2019.

27. 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. Sep 16 2014;161(6):429-440. PMID 25222388

28. Centers for Medicare & Medicaid Services (CMS). CMS Manual System: Pub 100-03 Medicare National Coverage Determinations; Transmittal 48. 2006; https://www.cms.gov/medicare-coverage-database/details/ncd- details.aspx?NCDId=231&ncdver=2&NCAId=61&TAId=10&SearchType=Advanced&CoverageSelection=Both&N CSelection=NCA%257CCAL%257CNCD%257CMEDCAC%257CTA%257CMCD&ArticleType=Ed%257CKey%2 57CSAD%257CFAQ&PolicyType=Final&s=All&KeyWord=Incontinence&KeyWordLookUp=Title&KeyWordSearc hType=Exact&CptHcpcsCode=E0740&kq=true&bc=IAAAACAAQAAA&. Accessed August 27, 2019.

Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)

CPT*

53899

A4563
E0740