| Coverage Policy Manual | |
| Policy #: | 1998147 |
| Category: | Medicine |
| Initiated: | August 2017 |
| Last Review: | May 2023 |
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| Electrical and/or Magnetic Stimulation, Pelvic Floor Muscles-Adult Urinary and Fecal Incontinence | |
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| Description: |
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.
Background
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. The intent of the intervention is to stimulate the pudendal nerve to activate the pelvic floor musculature; it is thought that activation of these muscles will 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 (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. 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 type of etiology of 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 delivered in the physician’s office.
PFS was first proposed as a treatment for urinary incontinence and later also proposed as a treatment for fecal incontinence. Incontinence, especially urinary, is a common condition and can have a substantial impact on quality of life. Nonsurgical treatment options for incontinence may include pharmacologic therapy, pelvic floor muscle exercises, bowel or bladder training exercises, electrical stimulation, and neuromodulation.
Regulatory Status
Several electrical stimulators have been cleared by the U.S. Food and Drug Administration (FDA). In 2006, the MyoTrac Infiniti™ (Thought Technology Ltd.) and in 2015, the ApexM (InControl Medical), nonimplanted electrical stimulator for treating urinary incontinence, was 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 Inc.). In 2011, the itouch Sure Pelvic Floor Exerciser (Tenscare, U.K.) was cleared for marketing. This product is being marketed in the U.S. as EmbaGYN® by Everett Laboratories (Chatham, NJ).
In 2000, the NeoControl® Pelvic Floor Therapy System (Neotonus Inc.) 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 Medicine; Brookfield, WI), a nonimplantable device that provides electrical stimulation and/or biofeedback via manometry, was cleared by FDA. The device is intended for the treatment of male and female urinary and fecal incontinence.
FDA produce code: KPI
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Policy/ Coverage: |
Effective May 2022
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Electrical or magnetic stimulation of the pelvic floor muscles (pelvic floor stimulation) as a treatment for urinary or fecal incontinence does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
For members with contracts without primary coverage criteria, electrical or magnetic stimulation of the pelvic floor muscles (pelvic floor stimulation) as a treatment for urinary or fecal incontinence is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Effective prior to May 2022
Electrical or magnetic stimulation of the pelvic floor muscles (pelvic floor stimulation) as a treatment for urinary or fecal incontinence is not covered based on benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
For contracts without primary coverage criteria, electrical or magnetic stimulation of the pelvic floor muscles (pelvic floor stimulation) as a treatment for urinary or fecal incontinence is considered investigational. Investigational services specific contract exclusions in most member benefit certificates of coverage.
Effective prior to May 2014
Electrical or magnetic stimulation of the pelvic floor muscles (pelvic floor stimulation) as a treatment for urinary incontinence is not covered based on benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
For contracts without primary coverage criteria, electrical or magnetic stimulation of the pelvic floor muscles (pelvic floor stimulation) as a treatment for urinary incontinence is considered investigational. Investigational services are an exclusion in the member certificate of coverage.
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| Rationale: |
Electrical Pelvic Floor Stimulation
The Policy reviewed the published peer-reviewed literature focusing on the safety and effectiveness of electrical pelvic floor stimulation compared to placebo and compared to other forms of behavioral therapies including pelvic floor muscle exercises and the use of vaginal cones. The specific etiologies of stress incontinence, urge incontinence, and post-prostatectomy incontinence were considered.
In October 2002, a review of the literature published since the prior review identified few new reports and those identified do not change the policy statement.
Two studies investigated the use of electrical pelvic floor stimulation in patients with stress incontinence. Neither study provides evidence supporting a beneficial effect of SNS for stress incontinence. One small, randomized double-blind study of 27 patients compared a new pattern of electrical stimulation with sham stimulation. The electrical stimulation group showed statistically greater improvement on the quality of life measure, but no between-group differences were observed in other outcome parameters, including pad testing. A second randomized trial of 60 women compared the effectiveness of electrical stimulation plus biofeedback with pelvic floor exercise. The electrical stimulation-biofeedback group performed better than the pelvic floor exercise group. The paper, however, did not report key clinical outcomes, i.e., improvement and cure as measured by voiding diaries or pad testing. More importantly, due to the combined therapy of electrical stimulation and biofeedback, the independent effect of electrical stimulation was not evaluated.
One double-blind randomized controlled study compared the effects of electrical stimulation with sham treatment in 68 patients with urge incontinence due to detrusor overactivity. Reported outcomes suggested a beneficial treatment effect with electrical stimulation. Based on patient diary, 19% of patients receiving active treatment versus 3% of patients receiving sham treatment were cured, while 81% of active patients versus 32% of sham patients were improved. These differences were statistically significant. The study did not report the more objective pad testing, and given the inconclusive or conflicting results reported in the two earlier studies, additional evidence is needed from well-designed trials to determine the benefits of electrical stimulation for urge incontinence.
The updated literature review identified no new studies investigating the use of electrical stimulation with post-prostatectomy patients.
The Agency for Healthcare Research and Quality (formerly the Agency for Health Care Policy and Research, AHCPR) published a 1996 practice guideline on the treatment of incontinence. This guideline concluded that PFS significantly reduces urinary incontinence in women with stress incontinence and may be effective in men and women with detrusor instability and mixed incontinence. The strength of evidence was rated a “B,” meaning that the recommendation was supported by scientific evidence from properly designed and implemented clinical series that support the guideline statement. The AHCPR summary of findings suggested that PFS may be effective when augmented with other pelvic muscle therapies, but further research is needed to determine the efficacy of PFS used alone or in combination with other treatments for urinary incontinence.
The policy was based on analysis of randomized controlled trials, as opposed to the “clinical series” used in the AHCPR guideline. Evidence from clinical series tends to overestimate treatment effect. These studies do not account for placebo effects or for dropouts by using intent-to-treat analysis. Clinical trials are needed to control for the effects of bias and to demonstrate the efficacy of PFS. In addition, since the AHCPR guideline was published in 1996, additional randomized controlled clinical trials have been published that failed to validate the effectiveness of PFS.
Magnetic Pelvic Floor Stimulation
In 2000, minimal data regarding these devices were available and no randomized trials had isolated and validated the effectiveness of the treatment. Galloway and colleagues presented the results of a multicenter prospective trial in 83 patients with stress urinary incontinence. Patients were treated for 20 minutes twice a week for 6 weeks. A total of 66% of patients were either dry or using no more than one pad per day after a 3-month follow-up. The conclusion was that the preliminary results require confirmation in randomized trials.
In October 2002, review of the literature published since the 2000 identified no published full-length peer-reviewed papers reporting the results of a randomized trial. Galloway and colleagues reported an update on the multicenter prospective trial that included 111 women with stress urinary incontinence. A total of 47 women completed 6-month follow-up testing; 38 patients were completely dry or used less than 1 pad per day (81%). Pad use was reduced in 33 patients (70%). Nevertheless, lacking a control group, the influence of patient selection bias on these outcomes cannot be ruled out.
Uncontrolled pilot studies on electromagnetic pelvic floor stimulation reported as abstracts provide inadequate evidence of improved outcomes to alter previous Blue Cross Blue Shield Association Technology Evaluation Center Assessment conclusions. One unpublished preliminary report provided by the device manufacturer reported the results of a double-blind randomized trial comparing pelvic floor electromagnetic stimulation with sham treatment for women with stress urinary incontinence. All patients also underwent pelvic floor muscle training. Patients were treated for 20 minutes 3 times a week over 6 weeks. No difference was observed between the two groups for any overall parameter at 8 weeks, however, a significant treatment effect was seen in the subgroup of patients with poor pelvic floor tone at baseline.
In summary, the available data are insufficient to alter the conclusions of the Policy Statement on electromagnetic pelvic floor stimulation.
2007 Update
A search of the MEDLINE database was performed for the period of February 2006 through July 2007 did not identify any evidence that would change the coverage statement. One randomized double-blind study compared effective and sham intravaginal electrical stimulation in 40 women with mixed urinary incontinence (Amaro et al, 2006). Both groups showed significant improvements in subjective and objective measurements following three 20-minute treatments per week over a 7 week period, but no differences were observed between effective and sham stimulation. Another study assessed the efficacy of magnetic stimulation in 74 patients with urge incontinence, urgency/frequency, stress incontinence, mixed incontinence and defecation problems (Voorham-van der Zalm et al, 2006). Extracorporeal magnetic stimulation did not improve any of the outcome measures except for one domain on the King’s Health Questionnaire.
2009 Update
A search of the MEDLINE database was performed through March 2009. The literature search did not identify any new high quality trials that address pelvic floor stimulation for the treatment of urinary incontinence.
In 2006, the National Institute for Health and Clinical Excellence (NICE) issued their guideline on the management of urinary incontinence in women. NICE states that “perineometry or pelvic floor electromyography as biofeedback should not be used as a routine part of pelvic floor muscle training”, but that “electrical stimulation and/or biofeedback should be considered in women who cannot actively contract pelvic floor muscles in order to aid motivation and adherence to therapy.” This conclusion was based on expert opinion.
In 2008, the Agency for Healthcare Research and Quality (AHRQ) published a systematic review of randomized controlled trials of non-surgical treatments for urinary incontinence. Twelve randomized controlled trials did not show that magnetic or electrical stimulation cured or improved urinary incontinence in women better than sham stimulation or pelvic muscle training. Two of the 12 trials assessed continence at 6 months or more follow-up failed to show statistically significant benefit from electrical stimulation compared with continence services or medications. Other randomized controlled trials did not demonstrate significant benefit of electrical stimulation compared with pelvic floor exercises, biofeedback-assisted training or placebo.
McClurg et colleagues published results of a randomized controlled trial conducted in the United Kingdom comparing neuromuscular stimulation to EMG biofeedback and pelvic floor muscle training in patients diagnosed with multiple sclerosis with urinary tract dysfunction. Group 1 received pelvic floor muscle training, electromyography biofeedback and placebo neuromuscular electrical stimulation. Group 2 received pelvic floor muscle training, electromyography biofeedback and active neuromuscular electrical stimulation. At the end of 9 weeks the mean number of incontinence episodes were reduced in Group 2 by 85% where Group 1 had a reduction of 47%.
In December 2007, the National Institutes of Health convened a Consensus Development Conference: Prevention of Fecal and Urinary Incontinence. A statement was released which stated, “ Inconsistent low-level evidence from twelve randomized controlled trials did not show that magnetic or electrical stimulation cure or improved urinary incontinence in women better than did sham stimulation or pelvic floor muscle training.”
Therefore, the policy remains unchanged as the evidence does not support the effectiveness of pelvic floor stimulation for the treatment of urinary incontinence.
2012 Update
This policy is being updated with a literature search conducted using the MEDLINE database through April 2012. There was no new literature identified that would prompt a change in the coverage statement. The following is a summary of the identified relevant published literature.
Electrical Pelvic Floor Stimulation
Women with urinary incontinence
In 2010, the Health Technology Assessment program in the U.K. published a review of studies on non-surgical treatments for women with stress urinary incontinence (Imamura, 2010). The investigators identified 8 RCTs comparing electrical stimulation to no active treatment; a sham control was used in 6 of the studies. A pooled analysis of study findings (all comparison groups combined) did not find a statistically significant difference between groups in cure rate, which was 6% in each group (odds ratio [OR]: 1.10, 95% confidence interval [CI]: 0.41 to 2.94). Moreover a pooled analysis of cure rates from the 5 studies comparing electrical stimulation to pelvic floor muscle training did not show a significant difference between groups; the cure rates were 24% and 11%, respectively (OR: 2.65, 95% CI: 0.82 to 8.60). When the comparison was limited to studies comparing electrical stimulation to no active treatment, there was a higher rate of improvement with electrical stimulation (37% versus 14%, OR: 3.93, 95% CI: 1.43 to 10.8). The latter analysis may have been subject to the placebo effect. The authors of the systematic review concluded that there is insufficient evidence to recommend electrical stimulation on a routine basis for treatment of stress urinary incontinence.
Men with post-prostatectomy urinary incontinence
In 2012, a Cochrane review was published on conservative management of post-prostatectomy urinary incontinence (Campbell, 2012). Three RCTs were identified that evaluated electrical stimulation compared to no stimulation or sham stimulation for postoperative treatment of incontinence. In a pooled analysis, the short-term (3-month) rate of incontinence was lower in the group that received electrical stimulation than in the control group (76% vs. 90%, respectively). The pooled risk ratio (RR) is 0.84 (95% CI: 0.74 to 0.94). There were too few data to evaluate the long-term impact of electrical stimulation on rates of incontinence. In addition, one trial was identified on prevention of urinary incontinence after radical prostatectomy; there were insufficient data to pool findings on preventative use of electrical pelvic floor stimulation.
Representative trials are described in the following section:
In 2010, Yamanishi and colleagues published findings of a study comparing electrical stimulation to a sham control group (Yamanishi, 2010). This trial, conducted in Japan, was a double-blind trial in which 56 men with severe post-prostatectomy urinary incontinence were randomized to receive active (n=26) or sham (n=30) electrical stimulation. All men performed pelvic floor muscle training. Active or sham electrical stimulation was performed until incontinence was resolved or until the end of the study at 12 months. A total of 47 patients (22 in the active stimulation group and 25 in the sham group) completed the 12-month study. The continence rate, defined as loss of 8 gm or less of urine during a 24-hour pad test, was the primary efficacy outcome. There was a statistically significantly higher rate of continence at 1, 3, and 6 months in the active stimulation group compared to the sham group, but the difference between groups was not statistically significant at 12 months. Rates of continence in the active electrical stimulation 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%). Findings of the 24-hour pad tests were also reported in several other ways. Differences in the amount (number of grams) of daily leakage were not significantly different between groups at any follow-up time point. For example, after 1 month, the mean amount of leakage was 210 gm in the active treatment group and 423 in the sham group, p>0.05. Change in the amount of daily leakage from baseline differed significantly between groups at 1 month (-528 gm in the active treatment group and -257 gm in the sham group, p<0.01) but not at the other follow-up time points.
In 2010, Goode and colleagues published the results of a randomized trial comparing behavioral therapy alone to behavioral therapy in combination with biofeedback and pelvic floor electrical stimulation (Goode, 2011). The trial included 208 men with urinary incontinence persisting at least 1 year after radical prostatectomy. Men with pre-prostatectomy incontinence were excluded. Participants were randomized to one of 3 groups; 8 weeks of behavioral therapy (pelvic floor muscle training and bladder control exercises) (n=70), behavioral therapy plus biofeedback and electrical stimulation (n=70), and a delayed-treatment control group (n=68). The biofeedback and electrical stimulation intervention, called “behavior-plus”, consisted of in-office electrical stimulation with biofeedback using an anal probe and daily home pelvic floor electrical stimulation. After 8 weeks, patients in the 2 active treatment groups were given instructions for a maintenance program of pelvic floor exercises and fluid control and were followed up at 6 and 12 months. The primary efficacy outcome was reduction in the number of incontinent episodes at 8 weeks, as measured by a 7-day bladder diary. A total of 176 of 208 (85%) randomized men completed the 8 weeks of treatment. In an ITT 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 significantly significant (p=0.001), but the behavior-plus intervention did not result in a significantly better outcome than behavioral therapy alone. Findings were similar on other outcomes. For example, at the end of 8 weeks, there was a significantly higher rate of complete continence in the active treatment groups (11 of 70, 16% in the behavior group and 12 of 70, 17% in the behavior-plus group) than the control group (4 of 68, 6%), but the group receiving biofeedback and electrical stimulation did not have a significantly higher continence rate than the group receiving behavioral therapy alone. The study did not isolate the effect of pelvic floor electrical stimulation. However, the combined intervention of biofeedback and electrical stimulation along with behavioral therapy did not result in better outcomes than behavioral therapy alone.
In 2009, Mariotti and colleagues published a study from Italy that evaluated the effect of a combination of electrical stimulation and biofeedback compared to a no treatment control (Mariotti, 2009). Sixty men (30 in each group) were randomized to 12 sessions (twice a week for 6 weeks) that consisted of 15 minutes of biofeedback followed by 20 minutes of electrical stimulation using an InCare anal probe. The intervention began 7 days after catheter removal. The primary outcome was continence defined as pad weight gain during a 24-hour period of 2 grams or less. All participants completed the intervention and were available for follow-up. Beginning at the second visit (2 weeks after starting treatment) and continuing through the 6-month follow-up, a significantly higher proportion of men in the intervention group was continent compared to the control group. For example, the number of continent participants at 3 months was 24 (80%) in the intervention group and 10 (33.3%) in the control group; at 6 months the number of continent men was 29 (96.7%) in the intervention group and 20 (66.7%) in the control group. In addition to the inability to isolate the effect of electrical stimulation in this combined intervention, there may have been a placebo effect, since a no-treatment control was used rather than a sham intervention.
Conclusions: There are a few small RCTs evaluating electrical pelvic floor muscle stimulation as a treatment of post-prostatectomy urinary incontinence in men that report improvements on some outcomes with electrical stimulation. A pooled analysis of RCTs found there was a short-term benefit of electrical PFS, but there were insufficient data to evaluate the long-term effect. These studies are limited by failure to isolate the effect of electrical simulation and/or lack of a sham comparison or comparison to an accepted treatment. High-quality RCTs are needed that report on longer-term outcomes in order to determine the efficacy of electrical stimulation for this patient population.
Magnetic Pelvic Floor Stimulation
Women with urinary incontinence
In 2012, Wallis and colleagues in Australia published a single-blind RCT comparing magnetic PFS to a sham intervention in 122 women at least 60-years-old who had urinary incontinence for 6 months or more (Wallis, 2012). Magnetic stimulation was provided via an undergarment that had 15 magnetic disks of 800 to 1,200 Gauss each sewn into the cotton bands on the outside of the garment. For the sham intervention, the undergarments were the same, but the magnets were replaced by inert metal disks of the same size and weight. Women were instructed to wear the undergarments at least 6 consecutive hours during the day and at least 6 hours at night. Outcomes were reported after 12 weeks of garment use. A total of 101/122 (83%) of women completed at least 4 weeks of the intervention and provided data for the efficacy analysis. At 12 weeks, the study did not find any statistically significant differences between groups on any of the efficacy outcomes, which included frequency of incontinence severity and quality-of-life measures. For example, the median change in frequency of incontinence episodes (time period not specified) was 0.75 in the magnetic stimulation group and 0.5 in the sham group, p=0.68. The magnetic undergarments used in this study do not appear to be approved by the FDA for treating urinary incontinence.
2013 Update
A search of the MEDLINE database through August 2013 did not reveal any new literature that would prompt a change in the coverage statement. A systematic review (Zhu, 2012) and clinical guideline (Lucas, 2012) which support the coverage statement were identified.
In 2012, Zhu and colleagues published a systematic review focusing on pelvic floor electrical stimulation used to treat post-prostatectomy urinary incontinence (Zhu, 2012). The authors identified 4 RCTs with 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 stimulation on continence levels compared to control within 3 months of prostatectomy (risk ratio [RR]: 1.21; 95% CI: 0.96-1.54). Similarly, a pooled analysis of data from all 4 trials did not show a statistically significant benefit of electrical stimulation on continence levels 6-12 months after prostatectomy (RR: 1.03: 95% CI: 0.88-1.20).
Also, in 2012, the European Association of Urology (EAU) published clinical guidelines on the management of urinary incontinence (Lucas, 2012). The guidelines do not recommend treatment or urinary incontinence with electrical stimulation using surface electrodes alone, and do not recommend treatment with magnetic stimulation.
2014 Update
Electrical Pelvic Floor Stimulation
Men with postprostatectomy urinary incontinence
Several systematic reviews of RCTs have been published. A 2013 Cochrane review by Berghmans et al identified 6 RCTs on electrical stimulation with nonimplanted electrodes for postprostatectomy urinary incontinence in men (Berghmans. 2013). The trials varied in the intervention used, the study protocols, the study populations and the 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 not a 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 of studies evaluating electrical stimulation alone were not pooled.
In summary, there are a few small RCTs evaluating electrical pelvic floor muscle stimulation as a treatment of postprostatectomy urinary incontinence in men. These studies reported improvements on some outcomes with electrical stimulation, but tended to be limited by failure to isolate the effect of electrical simulation and/or lack of a sham comparison or comparison with an accepted treatment. Three pooled analyses of RCTs were identified; 1 did not find a significantly significant benefit of electrical stimulation when added to pelvic floor muscle exercises, a second found a short-term benefit of electrical stimulation compared with no stimulation or sham and the third did not find a short- or long-term benefit of electrical stimulation compared with any control condition. This review does not prompt a change in the coverage statement.
Women with urinary incontinence
The AHRQ-funded comparative effectiveness review identified 9 RCTs evaluating electrical intravaginal stimulation in women with urgency, stress or mixed incontinence Shamliyan, 2012). Eight of the 9 studies were published in 2000 or earlier; nearly all used a sham treatment as the control condition. A pooled analysis of continence rates in 8 RCTs comparing electrical stimulation with no active treatment yielded a relative risk (RR) of 2.86 (95% CI, 1.57 to 5.23). A pooled analysis of improvement in incontinence symptoms yielded an RR of 2.01 (95% CI, 1.28 to 3.15). The AHRQ report concluded that a high level of evidence suggests that electrical stimulation is associated with increased continence rates and improvement in urinary incontinence.
In summary, multiple RCTs have been published, mainly before 2001. Meta-analyses have had mixed findings on the impact of electrical intravaginal stimulation on urinary incontinence in women compared with sham treatment. This review does not prompt a change in the coverage statement.
Individuals with fecal incontinence
In 2007, a Cochrane review identified 4 RCTS evaluating electrical stimulation as a treatment of fecal incontinence in adults (Hosker, 2007). One trial was sham-controlled, 1 compared electrical stimulation with levatorplasty, and 2 used electrical stimulation as an adjunct treatment. The Cochrane investigators did not pool study findings, and they concluded that there is insufficient evidence to draw conclusions on the efficacy of electrical stimulation for treating fecal incontinence.
More recently, a 2013 systematic review by Vonthein et al searched for studies on the impact of biofeedback and/or electrical stimulation for treating fecal incontinence in adults (Vonthein, 2013). The authors identified 13 RCTs that used 1 or both of these treatments and reported health outcomes eg, remission or response rates using validated scales. A pooled analysis of study results did not find a statistically significantly higher rate of remission when electrical stimulation was compared with a control intervention (RR=0.47; 95% CI, 0.13 to 1.72). A pooled analysis of studies comparing the combination of electrical stimulation and biofeedback with electrical stimulation 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 stimulation. Also, the confidence interval was very wide, indicating an imprecise estimate of treatment effect. The Vonthein study included only 2 RCTs on electrical stimulation that were published after the Cochrane review, just described (Schwandner, 2010; Schwandner, 2011). These 2 studies both included the combination of amplitude-modulated medium-frequency stimulation and biofeedback. Electrical stimulation was not evaluated in the absence of biofeedback.
Only 1 sham-controlled RCT has been published on electrical stimulation for fecal incontinence. This study, published by Norton et al in 2006, was conducted in the U.K and included 90 adults (Norton, 2006). Patients used a home electric stimulation device for 8 weeks. Those allocated to active treatment had 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 that is hypothesized to have a therapeutic effect. Patients were blinded to treatment group; although nurses who trained patients on device use were not blinded. The primary outcome was patient self-report of efficacy, using a rating scale ranging from -5 to +5 to indicate symptom change. Seventy of the 90 patients (78%) completed the study. In an ITT 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; again, the difference between groups was not statistically significant (p=0.74). Moreover, groups did not differ significantly on other secondary outcomes such as the frequency of urge or passive incontinence after treatment.
In summary, several RCTs have been published evaluating electrical stimulation for treating fecal incontinence. Only 1 of these was sham-controlled, and this study did not find that active stimulation produced better results than sham stimulation. Systematic reviews of RCTs have not found that electrical stimulation was superior to control interventions for treating fecal incontinence. Coverage statement changed to address fecal incontinence.
2015 Update
A literature search conducted through April 2015 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
A 2015 RCT from Israel randomized 42 women with fecal incontinence to 6 weeks of electrical stimulation (n=22) or biofeedback training (n=20) (Cohen. 2015). Biofeedback sessions were conducted in-clinic and electrical stimulation sessions occurred in the home following an initial training in-clinic. A total of 36 women (86%) completed the study and were included in the analysis; the analysis was not ITT. The study’s primary end points were improvement in frequency of fecal, urine, and gas incontinence, assessed by VAS scores. There were no statistically significant differences between groups in the primary study outcomes. For example, the mean VAS for solid stool incontinence at baseline in the electrical stimulation group was 2.9 ± 2.8, and this decreased to 0.9 ± 0.9 at follow-up. In the biofeedback group, the baseline VAS was 1.1 ± 2.1 and 0.3 ± 0.5 at follow-up. The p value for the between-group differences in this outcome was not statistically significant. For within-group changes, the electrical stimulation group improved significantly on solid stool incontinence but not liquid stool or gas incontinence, and the biofeedback group did not improve significantly on any of the fecal incontinence outcomes.
Practice Guidelines and Position Statements
The NICE guidelines were updated in 2013 (NICE, 2013). Recommendations specific to electrical stimulation for urinary incontinence did not change.
In 2014, the American College of Physicians issued guidelines on the nonsurgical management of urinary incontinence (Quaseem, 2014). Electrical pelvic floor stimulation was not discussed.
2016 Update
A literature search conducted through April 2016 did not reveal any new information that would prompt a change in the coverage statement.
2017 Update
A literature search conducted through April 2017 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
Moroni and colleagues published a systematic review of conservative treatment of stress urinary incontinence (Moroni, 2016). Five trials (total N=221 women) were identified comparing intravaginal electrical stimulation versus 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 significantly greater reduction in pad weight in the treatment versus control groups (mean difference [MD], -9.15; 95% CI, -17.22 to -1.08). A pooled analysis of 2 studies found significantly greater improvement in incontinence-specific quality of life (QOL) in the electrical PFS group than in the control group (MD = -1.44; 95% CI, -1.94 to -0.95). Three studies were included in a pooled analysis of number of incontinence episodes; findings of this meta-analysis were not reported. The reviewers stated that, among all conservative treatments assessed, evidence was strongest in support of pelvic floor muscle stimulation, with or without biofeedback, for treatment of stress urinary incontinence.
Abdelbary and colleagues published a 3-group RCT in women with overactive bladder comparing electrical PFS, local vaginal estrogen treatment, and a combination of both interventions (Abdelbary, 2015). The trial included 315 women, 105 per group. Electrical stimulation was administered using a vaginal probe. At 6-month followup, there were statistically significant differences among the 3 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, improvement was better 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.
MAGNETIC PFS FOR URINARY INCONTINENCE
A systematic review of RCTs on magnetic stimulation for treatment of urinary incontinence was published by Lim and colleagues (Lim, 2015). The reviewers identified 8 blinded sham-controlled trials (total N=484 patients). Treatment protocols (eg, frequency, duration of electrical stimulation) varied among trials. The primary outcome was cure rate; only 1 trial reported this outcome, so data were not pooled. A meta-analysis of 3 studies reporting improvement in the continence rate found significantly greater improvement in the treatment versus 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 also not pooled for other outcomes. The reviewers noted that the evidence was limited by low quality trials with short-term follow-up.
MAGNETIC PFS FOR FECAL INCONTINENCE
No studies were identified that evaluated magnetic PFS as a treatment of fecal incontinence.
SUMMARY OF EVIDENCE
For individuals who have urinary incontinence who receive electrical pelvic floor stimulation, the evidence includes randomized controlled trials (RCTs) and systematic reviews. Relevant outcomes are symptoms, quality of life and treatment-related morbidity. Findings from multiple RCTs have not found that electrical PFS used to treat urinary incontinence in women consistently improved the net health outcome compared with placebo or other conservative treatments. Meta-analyses of these RCTs have had mixed findings. Moreover, meta-analyses of RCTs have not found benefit of significant electrical PFS in men with Post prostatectomy 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. Relevant outcomes are symptoms, quality of life and treatment-related morbidity. Several RCTs have been published evaluating electrical PFS used to treat fecal incontinence. Only 1 trial was sham-controlled, and this did not find that electrical stimulation improved the net health outcome. Systematic reviews of RCTs have not found that electrical stimulation was 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. 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 terms of patient populations, interventions and outcome reporting. There was only 1 RCT evaluating magnetic stimulation for treatment of men with post prostatectomy urinary incontinence. 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. Relevant outcomes are symptoms, quality of life and treatment-related morbidity. The evidence is insufficient to determine the effects of the technology on health outcomes.
ONGOING AND UNPUBLISHED CLINICAL TRIALS
A search of the MEDLINE database was performed through April 2017. The literature search did not identify any new high quality trials that address pelvic floor stimulation for the treatment of urinary incontinence.
May 2018
A literature search conducted using the MEDLINE database through April 2018 did not reveal any new information that would prompt a change in the coverage statement.
2019 Update
Annual policy review completed with a literature search using the MEDLINE database through April 2019. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Practice Guidelines and Position Statements
European Association of Urology
The latest version of the European Association of Urology clinical guidelines on the assessment and nonsurgical management of urinary incontinence was published in 2018 (Nambiar, 2018). The following statements were made on electrical PFS and magnetic PFS:
“Do not offer electrical stimulation with surface electrodes (skin, vaginal, anal) alone for the treatment of stress urinary incontinence.” (strong recommendation)
“Do not offer magnetic stimulation for the treatment of urinary incontinence or overactive bladder in women.” (strong recommendation)
2020 Update
A literature search was conducted through April 2020. There was no new information identified that would prompt a change in the coverage statement.
2021 Update
Annual policy review completed with a literature search using the MEDLINE database through April 2021. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
A 2017 Cochrane review evaluated the effect of PFS on self-reported incontinence (Stewart, 2017). The review found no difference between PFS and pelvic floor muscle training (PFMT) in likelihood of cure of stress incontinence at 6 months based on the results of 4 RCTs (N = 143; RR 0.51, 95% CI 0.15 to 1.63). There was also no difference between groups in adverse event rates based on an imprecise estimate (RR 5.00, 95% CI 0.25 to 99). Quality of life was not reported. The same review included studies comparing PFS + PFMT versus PFMT alone, finding no difference between groups in incontinence rates based on 3 trials (N = 99; RR 0.76, 95% CI 0.38 to 1.52). The review found a small benefit of PFS + PFMT on incontinence-related quality of life when compared with PFMT alone (SMD -0.77, 95% CI -1.11 to -0.42). The review deemed the evidence for PFS alone or in combination with PFMT versus PFMT inconclusive for incontinence and quality of life outcomes.
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through April 2022. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Sciarra et al conducted meta-analyses comparing the effect of PFS with pelvic floor muscle training and biofeedback on urinary incontinence in men following radical prostatectomy (Sciarra, 2021). The review included 5 RCTs of PFS, the most recent of which was published in 2018. PFS devices, frequency and duration varied among the trials. At 3 months, the effect size for continence recovery (based on pad-free event rate) was 0.57 (95% CI, 0.46 to 0.69) for PFS, 0.40 (95% CI, 0.30 to 0.49) for pelvic floor muscle training and 0.54 (95% CI, 0.32 to 0.75) for biofeedback (p=.01 for both PFS and biofeedback versus pelvic floor muscle training). At 6 and 12 months, PFS effect sizes were 0.78 (95% CI, 0.59 to 0.98) and 0.82 (95% CI, 0.65 to 0.99) and there was no longer a statistically significant difference between any treatment group and rate of continence recovery.
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 (Sandhu, 2019).
In 2015, the American Society of Colon and Rectal Surgeons issued an evidence-based guideline using GRADE methodology on treatment of fecal incontinence (Paquette, 2015). Dietary interventions, medical management and biofeedback were the only non-surgical treatment options recommended for fecal incontinence.
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through April 2023. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Leonardo et al published a systematic review and meta-analysis of 8 RCTs (N=562) which evaluated the comparative effectiveness of biofeedback‐assisted pelvic floor muscle training (PFMT) versus PFS versus a control group (PFMT alone, bladder training, or lifestyle recommendations only) in women with overactive bladder (Leonardo, 2022). Outcomes assessed included quality of life, number of episodes of incontinence, and number of patients who improved or were cured. The PFS group exhibited significant differences in quality of life (mean difference, 7.41; 95% confidence interval [CI], 7.90 to 12.92; p=.008), episodes of incontinence (mean difference, -1.33; 95% CI, -2.50 to -0.17; p=.02), and the number of patients who improved or were cured (risk ratio, 1.46; 95% CI, 1.14 to 1.87; p=.003) compared to the control group. The biofeedback-assisted PFMT group did not have significant differences in any of these outcomes compared to the control group. Limitations of the study include high heterogeneity for some analyses and differences in the qualitative and quantitative assessments utilized in the included RCTs which limits the direct comparability among the studies.
In 2021, the American College of Gastroenterology issued guidelines on the management of benign anorectal disorders (Wald, 2021). In the section on fecal incontinence, PFS is not mentioned as a treatment option.
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Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
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