Medicare Advantage

Medical Policy

Notification

Sacral Nerve Stimulation (SNS) and Posterior Tibial Nerve Stimulation (PTNS) for the Control of Incontinence

Notification Issue Date:

This policy has been reviewed and reissued to communicate the Company’s continuing position on Sacral Nerve Stimulation (SNS) and Posterior Tibial Nerve Stimulation (PTNS) for the Control of Incontinence.

Title:

Sacral Nerve Stimulation (SNS) and Posterior Tibial Nerve Stimulation (PTNS) for the Control of Incontinence

Policy #:

MA11.028l

Policy

This policy uses coverage criteria primarily based on applicable Medicare statutes, regulations, NCDs, LCDs, CMS manuals and other applicable Medicare coverage documents. In the absence of fully established coverage criteria from these Medicare coverage documents for a specific medical service or item, the criterion/indication/service indicated by an asterisk below (*) is based on internal coverage criteria developed by the Company in consideration of peer-reviewed medical literature, clinical practice guidelines, regulatory status, and/or expert opinion.

SACRAL NERVE STIMULATION

MEDICALLY NECESSARY
Temporary Test Stimulation for the Treatment of Urinary Urge Incontinence, Urinary Urgency-Frequency, Nonobstructive Urinary Retention

Sacral nerve stimulation (SNS) with either percutaneous nerve stimulation or a temporary implanted lead for temporary test stimulation is considered medically necessary and, therefore, covered for the treatment of urinary urge incontinence, urinary urgency-frequency, and nonobstructive urinary retention when all of the following criteria are met:

The individual is an appropriate surgical candidate such that implantation with anesthesia can occur.
There is documented failure of or intolerance to at least two conventional therapies (e.g., behavioral training such as bladder training, prompted voiding, or pelvic muscle exercise training, pharmacologic treatment, and/or surgical corrective therapy).
Urinary incontinence is not related to another neurologic condition (e.g., diabetes with peripheral nerve involvement, detrusor hyperreflexia, multiple sclerosis, spinal cord injury) that is associated with secondary manifestations of urinary urge incontinence, urinary urgency-frequency, or nonobstructive urinary retention.

Permanent Implantation Following a Successful Temporary Test Stimulation for the Treatment of Urinary Urge Incontinence, Urinary Urgency-Frequency, Nonobstructive Urinary Retention

SNS for the permanent placement of the implantable pulse generator (IPG) device is considered medically necessary and, therefore, covered for the treatment of urinary urge incontinence, urinary urgency-frequency, and nonobstructive urinary retention when the following criterion is met:

A successful test stimulation was performed, with either percutaneous nerve stimulation or a temporary implanted lead, resulting in at least a 50 percent reduction in symptoms that had occurred over a period of at least 1 week.

Temporary Test Stimulation for the Treatment of Fecal Incontinence*

SNS with percutaneous nerve stimulation for temporary test stimulation is considered medically necessary and, therefore, covered for the treatment of fecal incontinence when all of the following criteria are met:

The individual is an appropriate surgical candidate such that implantation with anesthesia can occur.
Either of the following is met:
- There is documentation of chronic fecal incontinence of two or more incontinent episodes on average per week with duration greater than 6 months.
- There is documentation of chronic fecal incontinence of two or more incontinent episodes on average per week with duration greater than 12 months after vaginal childbirth.
There is documented failure of or intolerance to conventional therapy (e.g., dietary modification, the addition of bulking and pharmacologic treatment, and/or surgical corrective therapy performed more than 12 months [or 24 months in the case of cancer] previously).
The condition is not related to an anorectal malformation (e.g., congenital anorectal malformation; defects of the external anal sphincter over 60 degrees; visible sequelae of pelvic radiation; active anal abscesses and fistulae) or chronic inflammatory bowel disease.
Fecal incontinence is not related to another neurologic condition (e.g., peripheral neuropathy or complete spinal cord injury).

* Thaha & Abukar (2015); Thin et al. (2013); Tan et al. (2011); Maeda et al. (2011); Tjandra et al. (2008); Leroi et al. (2005)

Permanent Implantation Following a Successful Temporary Test Stimulation for the Treatment of Fecal Incontinence*

SNS for the permanent placement of the IPG device is considered medically necessary and, therefore, covered for the treatment of fecal incontinence when the following criterion is met:

A successful percutaneous test stimulation was performed, resulting in at least a 50 percent reduction in symptoms that occurred over a period of at least 1 week.

*Thaha & Abukar (2015); Thin et al. (2013); Tan et al. (2011); Maeda et al. (2011); Tjandra et al. (2008); Leroi et al. (2005)

EXPERIMENTAL/INVESTIGATIONAL
All other uses of SNS for incontinence control including, but not limited to, the treatment of stress or urge incontinence due to a neurologic condition (e.g., diabetes with peripheral nerve involvement, detrusor hyperreflexia, multiple sclerosis, spinal cord injury), other types of chronic urinary dysfunction, and the treatment of chronic constipation or chronic pelvic pain are considered experimental/investigational and, therefore, not covered because the safety and/or effectiveness cannot be established by review of the available published peer-reviewed literature. *NCD 230.18; Pauwels et al. (2021); Thaha & Abukar (2015); Thomas et al. (2013); Knowles et al. (2012); Zerbib et al. (2017); Dinning et al. (2015)

POSTERIOR TIBIAL NERVE STIMULATION

MEDICALLY NECESSARY
Initial Therapy*

Posterior tibial nerve stimulation (PTNS) delivered in 30-minute sessions once a week for 12 weeks is considered medically necessary for the treatment of urinary urgency, urinary frequency, and urge incontinence when all of the following criteria are met:

There is documented intolerance to or failure of behavioral training (e.g., bladder training, prompted voiding, pelvic muscle exercise training) following an appropriate duration of 8 to 12 weeks without meeting goals.
There is documented failure of or intolerance to at least two anticholinergic drugs, each taken for at least 4 weeks, prior to the PTNS therapy initiation.
The urinary dysfunction is not related to another neurologic condition (e.g., diabetes with peripheral nerve involvement, detrusor hyperreflexia, multiple sclerosis, spinal cord injury).

*Wang et al. (2020); Xiong et al. (2021); Coolen et al. (2021); Ho et al. (2021); Peters et al. (2009); MacDiarmid et al. (2010); Peters et al. (2010); Finazzi-Agrò et al. (2010); Burton et al. (2012); Peters et al. (2013b); Vecchioli-Scaldazza et al. (2013); Gungor Ugurlucan et al. (2013)

Maintenance Therapy*

PTNS maintenance therapy, beyond the initial 12 sessions, is considered medically necessary for the treatment of urinary urgency, urinary frequency, and urge incontinence, at a frequency of up to one session every 1 to 2 months for a maximum of 3 years, when both of the following criteria are met:

There is documented completion and tolerance during the initial PTNS therapy (i.e., first 12 sessions of PTNS)
There is documented improvement (i.e., 50 percent reduction) in symptoms of urinary frequency, nocturia, and/or urinary urgency during the initial PTNS therapy

*Peters et al. (2013a); Peters et al. (2013b); Yoong et al. (2013)

EXPERIMENTAL/INVESTIGATIONAL
Subsequent PTNS maintenance therapy beyond 3 years is considered experimental/investigational and, therefore, not covered because the safety and/or effectiveness of this service cannot be established by review of the available published peer-reviewed literature. *Peters et al. (2013a); Peters et al. (2013b); Yoong et al. (2013)

Implantable PTNS (e.g., ReviTM, eCoinTM, and PROTECT PNS System) for urinary incontinence is considered experimental/investigational and, therefore, not covered because the safety and/or effectiveness of this service cannot be established by review of the available published peer-reviewed literature. *Heesakkers et al. (2017); Heesakkers et al. (2024); Cameron et al. (2024); MacDiarmid et al. (2019); Rogers et al. (2021); ClinicalTrials.gov: NCT02577302

All other uses for PTNS including but not limited to urinary dysfunction related to another neurologic condition (e.g., diabetes with peripheral nerve involvement, detrusor hyperreflexia, multiple sclerosis, spinal cord injury) and fecal incontinence are considered experimental/investigational and, therefore, not covered because the safety and/or effectiveness of this service cannot be established by review of the available published peer-reviewed literature. *Schneider et al (2015); Zonic-Imamovic et al (2019); Sarveazad et al (2019); Luo et al. (2024)

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.

Guidelines

SACRAL NERVE STIMULATION

This policy is consistent with Medicare's coverage criteria for sacral nerve stimulation for the control of urinary incontinence. The Company's payment methodology may differ from Medicare.

There is no Medicare coverage determination addressing sacral nerve stimulation for ​the treatment of fecal incontinence; therefore, the Company policy is applicable. 

POSTERIOR TIBIAL NERVE STIMULATION

This policy is consistent with Medicare's coverage determination for posterior tibial nerve stimulation for the control of urinary incontinence. The Company's payment methodology may differ from Medicare.

BENEFIT APPLICATION

SACRAL NERVE STIMULATION AND POSTERIOR TIBIAL NERVE STIMULATION

Subject to the terms and conditions of the applicable Evidence of Coverage, sacral nerve stimulation and posterior tibial nerve stimulation are covered under the medical benefits of the Company’s Medicare Advantage products when the medical necessity criteria listed in this medical policy are met.

However, services that are identified in this policy as experimental/investigational or not covered are not covered because they are not covered by Medicare. Therefore, they are not eligible for reimbursement consideration.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

There are numerous devices approved by the FDA for sacral nerve stimulation system for the control of urinary urge incontinence, urinary urgency-frequency, nonobstructive urinary retention, and fecal incontinence.

There are numerous devices approved by the FDA for posterior tibial nerve stimulation for the control of urinary urge incontinence, urinary urgency-frequency.

Description

Urinary urge incontinence is defined as the involuntary leakage of urine with a sudden strong urge to void due to bladder spasms or contractions with enough force to override the sphincter muscles of the urethra. Nonobstructed urinary retention is defined as the inability to empty the bladder completely without structural obstruction. Nonobstructed urinary retention is usually caused by weak pelvic floor muscles or dysfunction in the neural pathway between the brain and bladder. Urinary urgency-frequency incontinence is defined as a strong and abnormal urge to urinate, resulting in frequent urination without a loss of the feeling of fullness of the bladder.

Fecal incontinence is the unexpected leakage of feces or gas (i.e., flatus) from the rectum. Fecal incontinence can be caused by loss of rectal wall compliance, dysfunction of efferent and afferent neural pathways, dysfunction of central and peripheral nerve systems for the anal sphincter or rectum, and damage to voluntary and involuntary anal sphincter muscles.

Overactive bladder (OAB) syndrome is defined by the International Urogynecological Association (IUGA)/International Continence Society (ICS) as urinary urgency, usually accompanied by frequency and nocturia, with or without urgency urinary incontinence (UUI), in the absence of urinary tract infection or other obvious pathology. Furthermore, most studies for OAB exclude individuals with symptoms related to neurologic conditions.

SACRAL NERVE STIMULATION (SNS) FOR THE CONTROL OF URINARY AND FECAL INCONTINENCE

A sacral nerve stimulator (SNS), also referred to as sacral nerve neuromodulation (SNM) device, is a surgically implanted device (e.g., InterStim® or InterStim II®, Medtronic, Inc; Minneapolis, MN) that is used to manage bladder or rectal function via neural pathways that control bladder or rectal function. An SNS consists of an implantable pulse generator (IPG) that transmits electrical impulses to the sacral nerves through an implanted wire that modulates bladder and rectal function by increasing capacity or improving emptying ability. SNS therapy is indicated for use after conservative measures such as pharmacologic treatments (e.g., anticholinergics, tricyclic antidepressants), behavioral therapy (e.g., timed voiding, controlled fluid intake, pelvic floor muscle training, biofeedback), and/or surgery are ineffective and/or not well tolerated.

SNS consists of both a temporary test stimulation and permanent implantation. A test stimulation is performed prior to permanent placement to establish if permanent implantation will be effective. Individuals must keep a diary to record voiding patterns so that the clinical effectiveness of the device can be properly evaluated.

The test stimulation may be implanted in an outpatient setting under local anesthesia. The appropriate sacral nerve(s) are identified by using a test needle and an attached temporary lead wire. The wire is attached to an external stimulator, which is carried in a pocket or on a belt loop for a trial period of 3 to 5 days. The individual records voiding patterns during the trial period and for 1 week after the wire is removed. Data from the voiding diaries are used to compare the symptoms that are experienced at baseline, during the test phase, and after removal of the wire. The test stimulation must demonstrate at least a 50 percent reduction in symptoms in order for the permanent placement of the stimulator to be medically indicated.

A staged implant test procedure may be required in some individuals if the initial temporary test yields a false-negative finding secondary to migration of the temporary lead. The US Food and Drug Administration (FDA) approved an accurate screening tool, a chronic lead test, for use when the initial temporary test offers inconclusive results. In a staged implant, the permanent lead is surgically inserted and connected to an external pulse generator. The individual returns home for a trial period of 1 to 4 weeks. If the staged implant test is successful (i.e., at least a 50 percent reduction in symptoms), the permanent stage of the procedure is completed with the implantation of the IPG.

The IPG is surgically implanted subcutaneously in the individual's lower abdomen or upper buttock under general anesthesia. A lead is placed next to the identified sacral nerve and is then connected to the neurostimulator by an extension. The professional provider utilizes a console programmer to adjust the device settings and to check neurostimulator information. A hand-held programmer is used to turn the neurostimulator on and off and to adjust the level of stimulation, as prescribed by the professional provider. A control magnet turns the neurostimulator on and off.

PEER-REVIEWED LITERATURE

In 1997, a multicenter, randomized controlled trial (RCT), conducted as part of the FDA approval process, enrolled individuals with severe urinary urge incontinence in whom prior treatments had failed, such as drugs or behavioral therapy. The clinical trial concluded that SNS reduced urinary urge incontinence compared to control individuals. Furthermore, in 1999, the FDA approved the SNS device for the additional indications of urgency-frequency and urinary retention in individuals without mechanical obstruction.

In a long-term follow-up study, van Kerrebroek et al. (2007) reported on a 5-year, prospective, multicenter FDA-regulated trial that evaluated the long-term safety and efficacy of SNS in individuals with refractory urinary urge incontinence, urinary urgency-frequency, and urinary retention. The study enrolled 163 individuals; after undergoing test stimulation, 152 of them underwent SNS implantation. Clinical success was defined as at least a 50 percent improvement of baseline symptoms. At 5-year follow-up after implantation, 68 percent of individuals with urge incontinence, 56 percent with urgency-frequency, and 71 percent with retention had successful outcomes. In 102 individuals, 279 device or therapy-related adverse events were observed. The authors concluded that SNS was a safe and effective modality for providing relief for appropriately selected individuals with urinary urge incontinence, urinary urgency-frequency, and urinary retention cases refractory to other forms of treatment.

Siegel et al. (2015) published results of an industry-sponsored, FDA-mandated, postapproval study known as the InSite for Over Active Bladder (InSite) trial. This RCT compared sacral nerve neuromodulation using a two-stage surgical procedure with standard medical therapy. Study inclusion criteria were a diagnosis of overactive bladder (at least eight voids per day and/or at least two involuntary leaking episodes in 72 hours) and a failed trial of at least one anticholinergic or antimuscarinic medication. Also, there needed to be at least one such medication that had not yet been prescribed. Individuals with neurologic diseases and with primary stress incontinence were excluded. Seventy individuals were allocated to sacral nerve neuromodulation and 77 to standard medical therapy. Of the 70 individuals in the sacral nerve neuromodulation group, 11 elected not to receive test stimulation with the tined lead and eight received the lead but did not receive a full system implant due to lack of response to a 14-day test stimulation period (response was defined as ≥50 percent reduction in average leaks and/or voids). Individuals in the medical treatment group tried the next recommended medication or restarted a discontinued medication. Therapeutic success was defined as at least a 50 percent improvement in average leaks per day or at least a 50 percent improvement in the number of voids per day or a return to fewer than eight voids per day. In intention-to-treat (ITT) analysis, the therapeutic success rate at 6 months was 61 percent in the sacral nerve neuromodulation group and 42 percent in the standard treatment group; the difference between groups was statistically significant (P=0.02). Quality of life at 6 months was a secondary outcome. Several validated quality of life scales were used, and all favored the sacral nerve neuromodulation group compared with the standard treatment group (P<0.002 for all comparisons).

A twelve-month follow-up of the InSite trial was published by Noblett et al. (2016). They analyzed individuals from the SNS group of initial RCT plus additional individuals enrolled and implanted in the interim. A total of 340 individuals underwent test stimulation, 272 underwent implantation, and 255 completed 12 months of follow-up. In a modified completers’ analysis, the therapeutic success rate was 82 percent. This modified completers’ analysis included individuals who were implanted and had either a baseline or 12-month evaluation or withdrew from the trial due to a device-related adverse event or lack of efficacy. In an analysis limited to study completers, the therapeutic response rate was 85 percent. The Noblett et al. analysis did not include data from the control group of individuals receiving only standard medical therapy.

For the treatment of fecal incontinence, Tjandra et al. (2008) published an RCT with 120 individuals with severe fecal incontinence and SNS. Individuals were randomly assigned to receive SNS or best supportive therapy, consisting of pelvic floor exercises with biofeedback, bulking agents, and dietary management with a team of dieticians. Exclusion criteria included neurologic disorders and external anal sphincter defects of more than 120 degrees of the circumference, although a large proportion of the individuals had pudendal neuropathy. Sixty individuals were randomly assigned to SNS, and of these individuals, 90 percent had successful test stimulation. Fifty-three individuals decided to proceed with the implant of the pulse generator. At baseline, the SNS group had an average of 9.5 fecal incontinent episodes per week, and the controls had 9.2. Both groups had an average of 3.3 days per week with fecal incontinence. At 12-month follow-up, fecal incontinent episodes had decreased to one day per week with 3.1 fecal incontinent episodes in the SNS group but had not changed in the control group. Complete continence was achieved in 42 percent of the individuals receiving SNS and 24 percent improved by 75 percent to 99 percent. None of the individuals had worsening of fecal continence.

In a clinical study conducted as part of the FDA approval process, Wexner et al. (2010) evaluated 120 individuals who had an average of 9.4 episodes of fecal incontinence a week. After SNS for a period of 12 months, 88 of 120 individuals had a 50 percent reduction in the number of fecal incontinence episodes, and 43 of 120 individuals achieved full continence of bowel movements. The primary effectiveness endpoint of at least a 50 percent reduction in fecal incontinent episodes at 12 months postimplant in at least 50 percent of the individuals was met. There were no device- or procedure-related deaths or permanent injuries reported in this study. The adverse events seen in the study were consistent with the events seen in the clinical studies for urinary incontinence indications. The authors concluded that SNS using InterStim® therapy was safe and effective in treating individuals with fecal incontinence.

In a meta-analysis, Tan et al. (2011) evaluated randomized trials and observational studies published between 2000 and 2008 on SNS for treating fecal incontinence. They identified 34 studies that reported on at least one of their outcomes of interest and clearly documented how many individuals underwent temporary and permanent SNS. In these 34 studies, 944 individuals underwent temporary SNS and 665 subsequently underwent permanent SNS implantation. There were 279 individuals who did not receive permanent implantation, and of these individuals, 154 were lost to follow-up. Follow-up in the studies ranged from 2 weeks to 35 weeks. In a pooled analysis of findings of 28 studies, there was a statistically significant decrease in fecal incontinence episodes per week with SNS compared with maximal conservative therapy. Fourteen studies reported fecal incontinence scores, and when these results were pooled, there was also a statistically significantly greater improvement in scores with SNS compared with conservative therapy.

For the treatment of fecal incontinence, Thin et al (2013) published a systematic review of randomized trials for treating fecal incontinence. A total of 61 studies met eligibility criteria, including at least 10 individuals, having a clear follow-up interval, and reporting the success rate of therapy based on a 50 percent or greater improvement in fecal incontinence episodes. Only two of the studies were RCTs (Tjandra et al. and Leroi et al.) and 50 were prospective case series. Data from two studies with long-term follow-up could be pooled to calculate median success rates using an intention-to-treat analysis. These median success rates were 63 percent in the short term (no more than 12 months of follow-up), 58 percent in the medium term (12-36 months), and 54 percent in the long term (>36 months). The per-protocol short-, medium-, and long-term success rates were 79 percent, 80 percent, and 84 percent, respectively.

In a multicenter prospective study, Hull et al. (2013) evaluated the long-term results of SNS for severe fecal incontinence. A total of 120 individuals underwent implantation and were followed up at 3, 6, and 12 months, and annually after device implantation. Individuals were assessed with a 14-day diary and fecal incontinence quality-of-life and severity index questionnaires. Therapeutic success was defined as at least a 50 percent improvement over baseline in fecal incontinence episodes per week. Ultimately, 63 percent of the individuals (n=76) completed the minimum follow-up of 5 years. Fecal incontinence episodes per week decreased from a mean of 9.1 at baseline to 1.7 at 5 years, with 89 percent (n=64) having therapeutic success and 36 percent (n=26) having complete continence. Fecal incontinence quality of life scores statistically significantly improved between baseline and 5-year follow-up (P<0.0001). Thirty-five percent of individuals (n=27) required device revision, replacement, or explant. The authors concluded that the therapeutic effect and improved quality of life for fecal incontinence is maintained 5 years after SNS implantation.

A study by Altomare et al. (2015) also reported long-term outcomes (minimum, 60-month follow-up; median, 84-month follow-up) in individuals receiving a sacral nerve stimulator for fecal incontinence. Individuals were identified from a European registry and surveyed. Long-term success was defined as maintaining the temporary stimulation success criteria, i.e., at least 50 percent reduction in the number of fecal incontinence episodes (or fecal incontinence symptom score) at last follow-up, compared with baseline. A total of 272 individuals underwent permanent implantation of a SNS device, and 228 were available for follow-up. A total of 194 (71.3 percent) of the 272 individuals with implants maintained improvement in the long term.

Various professional societies and expert groups have issued guidelines regarding SNS. In 2004, the National Institute for Health and Clinical Excellence (NICE) published separate guidelines on SNS for the treatment of fecal incontinence and urge incontinence/frequency, respectively. NICE determined that the current evidence on the safety and efficacy of SNS for these indications was adequate to support its use. In 2007, NICE published additional guidelines for the management of fecal incontinence in adults which support the use of SNS. In 2007, the Agency for Health Care Research and Quality (AHRQ) published results of a systematic review of several small RCTs to determine the benefit of SNS for urinary incontinence. The evidence from these studies suggested that SNS can improve predominantly urinary urge incontinence in adults, but curative results are not as consistent. In 2019, the AUA updated its guidelines on the diagnosis and treatment of OAB. The guidelines state that sacral neuromodulation may be offered as a third-line treatment in carefully selected individuals with severe refractory symptoms or into those who are not candidates for second-line therapy (e.g., oral antimuscarinics, oral β3-adrenoceptor agonists, transdermal oxybutynin) and are willing to undergo surgery.

The current evidence suggests that SNS may be considered a safe and effective treatment for select individuals with urinary and fecal incontinence who have failed conservative therapies (e.g., pharmacologic and behavioral therapies). There remain concerns about adverse events including device replacement. However, the available published peer-reviewed literature consists of prospective RCTs and meta-analyses which indicate that SNS may result in a reduction in urinary and fecal incontinence episodes. Additionally, at long-term follow-up (e.g., up to 5 years), the therapeutic effects and improvements in quality of life appear to be maintained.

A systematic review by Tutulo et al. (2018) conducted a literature search through December 2017 of RCTs evaluating SNS and PTNS for the treatment of OAB unresponsive to standard medical therapy. Five RCTs were identified. Reviewers concluded that both SNS and PTNS, with success rates ranging from 61 percent to 90 percent and 54 percent to 79 percent, respectively, could be considered effective.

POSTERIOR TIBIAL NERVE STIMULATION FOR THE CONTROL OF URINARY INCONTINENCE

Posterior tibial nerve stimulation (PTNS), also referred to as percutaneous tibial nerve stimulation, is an indirect form of neuromodulation used for the treatment of voiding dysfunction. The posterior tibial nerve is derived from the lumbar-sacral nerves (L4-S3), which innervate the bladder detrusor and pelvic floor. Although the mechanism of action in neuromodulation of the bladder (PTNS) is not fully understood, it is believed that improvements in coordination of the bladder detrusor and sphincter muscles can be achieved through retrograde stimulation of the sacral nerve plexus and restoration of the balance between bladder inhibitory and excitatory control systems.

The procedure involves the placement of a fine-needle electrode above the ankle, near or into the tibial nerve, followed by low-voltage electrical stimulation–producing sensory and/or motor responses. Noninvasive PTNS therapy has also been administered using surface electrodes. PTNS treatment is generally composed of weekly 30 minute sessions for 12 weeks. Successful PTNS treatment is typically defined as the resolution or at least a 50 percent reduction in urinary urge incontinence or urinary urgency-frequency episodes. Regimens including additional PTNS treatments are not well defined and are often tailored to the individual based on symptoms. The current indication cleared by the FDA for PTNS is overactive bladder and associated symptoms of urinary urge incontinence, urinary urgency-frequency.

PEER-REVIEWED LITERATURE
In an industry-sponsored RCT, Peters et al. (2009) compared the effectiveness of PTNS to extended-release tolterodine in 100 adults (50 per group) diagnosed with overactive bladder syndrome (the Overactive Bladder Innovative Therapy Trial [OrBIT]). Of the enrolled individuals, 90 percent were females with symptoms of OAB, with at least eight voids per day. The primary outcome of the 12-week trial was the noninferiority of PTNS compared to extended-release tolterodine in the mean reduction in the number of voids per 24 hours after 12 weeks of treatment. Noninferiority was defined as no more than a 20 percent difference in the mean decrease in voiding episodes. Individuals completed 2-day voiding diaries at baseline and at 12 weeks. Of the 84 individuals that completed the final follow-up, the authors reported decreases in the number of voids per day in both the PTNS and tolterodine groups (2.5 ± 3.9 vs. 2.4 ± 4.0, respectively). The decrease in voiding episodes between groups was not statistically significant (P=0.44). The authors concluded that the data supported noninferiority of PTNS when compared with extended-release tolterodine.

MacDiarmid et al. (2010) reported on the 1-year follow-up data for individuals assigned to the PTNS arm of the OrBIT trial and had responded to the initial 12-week course of treatment. During the additional 9 months of follow-up, 33 of the original 35 responders received a mean of 12.1 ± 4.9 treatments, with a mean of 21 days (median, 17 days) between treatments. Voiding diary data were available for 32 of 35 participants at 6 months, and 25 of 35 participants at 12 months. The authors observed a reduction in the average number of voids per day from baseline (original primary outcome of the OrBIT trial) of 3.2 ± 3.7 at 6 months and 2.8 ± 3.7 at 12 months. Secondary outcomes at 12 months, based on 25 voiding diaries, included mean improvements from baseline urge incontinence of -1.6 episodes per day, nocturia episodes of -0.8, and in episodes of moderate-to-severe urgency per day of -3.7. Symptom severity scores for OAB were also statistically significantly improved from 12 weeks to 12 months. The authors concluded that the statistically significant effectiveness of PTNS achieved after 12 weekly treatments to improve frequency, nocturia, urgency, voided volume, and urge incontinence episodes was durable through 12 months of prolonged therapy offered at individualized tapering intervals. The study has the potential for selection bias because the follow-up analysis was restricted to individuals classified as responders to the original course of PTNS.

In a second randomized trial, Peters et al. (2010) assessed the effectiveness of PTNS compared to sham in the treatment of OAB symptoms (the Study of Urgent PC vs Sham Effectiveness in Treatment of Overactive Bladder Symptoms [SUmiT] trial). The multicenter trial enrolled 220 adults with overactive bladder symptoms. Study eligibility criteria included self-reported bladder symptoms lasting at least 3 months, failure of conservative therapy, and a score of at least four on the OAB questionnaire for urgency. Following enrollment, participants were randomly assigned 1:1 to 12 weekly 30-minute PTNS or sham therapy sessions. The sham procedure utilized a blunt instrument to stimulate the location and sensation of electrode placement in active treatment and was previously validated in a separate pilot study conducted by the Peters et al. workgroup. The primary endpoint was to assess the effectiveness of PTNS compared with an inactive sham intervention based on a single-item global response assessment (GRA) variable at 13 weeks. Possible responses to the single-item GRA were that symptoms were markedly worse, moderately worse, mildly worse, the same, slightly improved, moderately improved, or markedly improved. Responders to treatment were defined as individuals reporting moderated or marked improvement in symptoms. The authors reported that the proportion of responders, based on the GRA, was 54.5 percent of individuals in the PTNS group (n=60) and 20.9 percent of individuals in the sham group (n=23), representing a statistically significant difference (P<0.001). No serious device-related adverse events or malfunctions were reported. The authors concluded that this multicenter, double-blinded, randomized, sham-controlled trial provided level I evidence that PTNS was safe and effective in treating OAB symptoms.

In a prospective RCT, Finazzi-Agrò et al. (2010) evaluated the effectiveness of PTNS compared to placebo in individuals with detrusor overactivity (DO) incontinence. The investigators randomly assigned 35 female individuals, refractory to antimuscarinic therapy, to receive 12 30-minute PTNS or placebo sessions. The primary outcome, assessed through completion of a 3-day voiding diary at baseline and following treatment, was percent responders (defined as greater than 50 percent reduction in incontinent episodes). Within the PTNS group, 71 percent of individuals (n=12) were considered responders compared with no responders in the placebo group. Improvements in secondary outcomes, including the number of incontinence episodes, number of voids, voided volume, and incontinence quality of life, were also reported. The investigators concluded that PTNS can be considered an effective treatment for DO with a negligible placebo effect in this specific individual population.

In a systematic review, Burton et al. (2012) evaluated the effectiveness of PTNS in treating OAB symptoms. Relevant RCTs and prospective studies were included in the review, with studies reporting variable initial success rates from 37 to 82 percent for treating OAB symptoms. The authors identified four RCTs comparing PTNS with sham treatment, which showed a statistically significant difference favoring PTNS. Two RCTs compared PTNS with antimuscarinic medication, which showed no statistically significant difference in the change in bladder diary parameters between the treatments. Ten prospective nonrandomized studies were included with varying definitions of success. The authors concluded that there was evidence of significant improvement in OAB symptoms using PTNS, which was comparable to the effect of antimuscarinics. The authors noted that the included studies only considered short-term outcomes after initial treatment. As such, they called for longer term follow-up data.

In a prospective study, Peters et al. (2013) evaluated the effectiveness of PTNS for OAB symptoms after 3 years of therapy. Fifty participants from the SUmiT trial who met the primary effectiveness endpoint after 12 weeks of PTNS treatments were enrolled in this prospective study to assess the long-term outcomes (the STEP trial). Study individuals were prescribed a fixed 14-week tapering protocol followed by a personal treatment plan aimed at sustaining OAB symptom improvement. OAB and quality-of-life questionnaires were completed every 3 months, and 3-day voiding diaries were completed every 6 months where all voiding diary measures were significantly improved. A total of 29 individuals completed the 36-month protocol and received a median of 1.1 treatments per month after a 14-week treatment-tapering protocol. Seventy-seven percent of individuals maintained moderate or marked improvement in OAB at 3-year follow-up. Compared to baseline, median voids per day decreased from 12.0 to 8.7, nighttime voids decreased from 2.7 to 1.7, and urge incontinence episodes decreased from 3.3 to 0.3 (P<0.0001). One individual experienced two mild treatment-related adverse events of bleeding at the needle site during follow-up. The authors concluded that most STEP participants safely sustained OAB symptom improvement to 3 years, with an average of one treatment per month.

In a randomized controlled crossover study, Vecchioli-Scaldazza et al. (2013) compared the effectiveness of solifenacin succinate (SS) with PTNS in women with OAB symptoms. Forty women were randomly assigned into two groups: one SS control group (5 mg for 40 days) and a separate PTNS group (twice weekly for 6 weeks), which included women who subsequently received SS. Voiding diaries, quality-of-life surveys, and individual perception of intensity of urgency questionnaire were performed before and after each treatment. A reduction in the number of daily episodes of urinary urgency, nocturia, and urge incontinence were found with both SS and PTNS group, although the authors noted greater effectiveness in the PTNS group. There was an increase in voided volume in all groups, although individuals in the PTNS group had a greater increase. The authors concluded that the study demonstrated the effectiveness of both SS and PTNS in women with OAB symptoms, with greater improvements found in women who received PTNS.

In a prospective RCT, Gungor Ugurlucan et al. (2013) evaluated the effectiveness of transvaginal electrical stimulation (ES) and PTNS in the treatment of OAB symptoms. A total of 59 women with symptoms of urgency, frequency, and nocturia with or without incontinence were included in the study. Ultimately, 35 individuals received ES (20-minute treatments three times a week for 6 to 8 weeks), while 17 received PTNS (12 30-minute weekly sessions). The authors assessed numerous outcome variables including quality of life parameters, but did not specify primary outcomes or adjust P values for multiple comparisons. From baseline to the end of the treatment period, there were no statistically significant differences in mean change in urgency episodes, nocturia, or incontinence episodes, although there was a statistically significant difference in daytime frequency. The authors concluded that PTNS and ES were both effective in the treatment of OAB, although the proportion of individuals describing themselves as cured was significantly higher in the ES group.

Schneider et al. (2015) published a systematic review on tibial nerve stimulation (transcutaneous and percutaneous) for treating neurogenic lower urinary tract dysfunction. In a literature search through January 2015, 16 studies were identified: four RCTs, nine prospective cohort studies, two retrospective case series, and one case report. Sample sizes of the included studies were small; most included fewer than 50 individuals, and none had a sample size larger than 100 participants. Three of the four RCTs used transcutaneous tibial nerve stimulation (TTNS), and the fourth study, which was conducted in Iran, stated that PTNS was used but did not specify the device. The four RCTs included different study populations: women with neurogenic bladder (n=1), men with neurogenic OAB (n=1), individuals with multiple sclerosis (n=1), and individuals with Parkinson disease (n=1). Comparison interventions were tolterodine, pelvic floor muscle training, lower-limb stretching, and sham (one study each). Pooled analyses were not conducted, and the systematic review mainly discussed intermediate outcomes (e.g., maximum cystometric capacity, maximum detrusor pressure). None of the RCTs reported statistically significant between-group differences in clinical outcome variables (e.g., number of episodes of urgency, frequency, nocturia). The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have fecal incontinence who receive PTNS, the evidence includes several RCTs and systematic reviews. Relevant outcomes are symptoms, change in disease status, functional outcomes, quality of life, and treatment-related morbidity. The available RCTs have not found a clear benefit of PTNS. Neither of the sham-controlled trials found that active stimulation was superior to sham for achieving the primary outcome: an at least a 50 percent reduction in mean weekly fecal incontinence episodes. The larger sham-controlled randomized trial did find a significantly greater decrease in the absolute number of weekly incontinence episodes in the active treatment group, but the overall trial findings did not suggest the superiority of PTNS over sham treatment. A meta-analysis of a single RCT and several observational studies reported that individuals receiving SNS experienced significant benefits compared with individuals receiving PTNS. A post hoc analysis of the larger trial suggested a subset of individuals with fecal incontinence (those without concomitant obstructive defecation) may benefit from PTNS. The evidence is insufficient to determine the effects of the technology on health outcomes.

In 2017, the American Gastroenterological Association issued an expert review and clinical practice update on surgical interventions and device-aided therapy for the treatment of fecal incontinence. The update stated that until further evidence is available, percutaneous tibial nerve stimulation should not be used for managing fecal incontinence in clinical practice.

For individuals who have non-neurogenic urinary dysfunction including OAB and have failed behavioral and pharmacologic therapy who receive an initial course of PTNS, the evidence includes randomized sham-controlled trials, RCTs with an active comparator, and systematic reviews. Relevant outcomes are symptoms, change in disease status, functional outcomes, quality of life, and treatment-related morbidity. The Sham Effectiveness in Treatment of Overactive Bladder Symptoms (SUmiT) and the OrBIT trials are two key industry-sponsored RCTs. Systematic reviews that included these and other published trials have found short-term reductions in voiding dysfunction with PTNS. The largest, highest quality study was the double-blinded, sham-controlled SUmiT trial, which reported a statistically significant benefit of PTNS versus sham at 12 weeks. In an additional, small sham-controlled trial, a 50 percent reduction in urge incontinent episodes was attained in 71 percent of PTNS group compared with 0 percent in the sham group. The nonblinded OrBIT trial found that PTNS was noninferior to medication therapy at 12 weeks. Adverse events were limited to local irritation effects. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

For individuals who have OAB syndrome that has failed behavioral and pharmacologic therapy who respond to an initial course of PTNS who receive maintenance PTNS, the evidence includes observational studies and systematic reviews. Relevant outcomes are symptoms, change in disease status, functional outcomes, quality of life, and treatment-related morbidity. The SUmiT and the OrBIT trials each included extension studies that followed up individuals who responded to the initial course of PTNS and continued to receive periodic maintenance therapy. There is variability in the interval between and frequency of maintenance treatments, and an optimal maintenance regimen remains unclear. There are up to 36 months of observational data available, reporting that there is a durable effect for some of these individuals. Although comparative data are not available after the initial 12-week treatment period, the observational data support a clinically meaningful benefit for use in individuals who have already failed behavioral and pharmacologic therapy and who respond to the initial course of PTNS. PTNS may allow such individuals to avoid more invasive interventions. Adverse events appear to be limited to local irritation for both short- and long-term PTNS use. The published evidence supports a meaningful improvement in the net health outcome. Evidence reported through clinical input further supports that this use provides a clinically meaningful improvement in net health outcomes and is consistent with generally accepted medical practice. Typical regimens schedule maintenance treatments every four to six weeks. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

For individuals who have neurogenic bladder dysfunction who receive PTNS, the evidence includes several RCTs and a systematic review of RCTs and observational data. Relevant outcomes are symptoms, change in disease status, functional outcomes, quality of life, and treatment-related morbidity. Only a few RCTs evaluating tibial nerve stimulation for treating neurogenic bladder have been published to date, and all but one performed transcutaneous stimulation rather than PTNS. Studies varied widely in factors such as study populations and comparator interventions. Study findings have not reported that tibial nerve stimulation significantly reduced incontinence symptoms and improved other outcomes. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have fecal incontinence who receive PTNS, the evidence includes several RCTs and systematic reviews. Relevant outcomes are symptoms, change in disease status, functional outcomes, quality of life, and treatment-related morbidity. The available RCTs have not found a clear benefit of PTNS. Neither of the sham-controlled trials found that active stimulation was superior to sham for achieving the primary outcome, at least a 50 percent reduction in mean weekly fecal incontinence episodes. The larger sham-controlled randomized trial did find a significantly greater decrease in the absolute number of weekly incontinence episodes in the active treatment group, but the overall trial findings did not suggest the superiority of PTNS over sham treatment. A meta-analysis of a single RCT and several observational studies reported that individuals receiving SNS experienced significant benefits compared with individuals receiving PTNS. A post hoc analysis of the larger trial suggested a subset of individuals with fecal incontinence (those without concomitant obstructive defecation) may benefit from PTNS. The evidence is insufficient to determine the effects of the technology on health outcomes.

Implantable Posterior Tibial Nerve Stimulation (PTNS)

Revi^TM

Revi (formally known as Renova iStim) [BlueWind Medical, Ltd.] received class II de novo status by U.S. Food and Drug Administration (FDA) for marketing in the United States August 16, 2023 and was CE (Conformité Européenne) marked in June 2016. It is a implantable tibial nerve modulation (iTNM) device featuring a leadless, battery-less implant that is inserted under the fascia via a minimally invasive open procedure at the tibial neurovascular bundle. The device is approximately 3 cm in length and 3 mm in diameter and includes an electrode and a receiver (pulse generator). A wearable control unit, programmed by the clinician, provides wireless stimulation to the implant.

Clinicaltrials.gov reports a crossover assignment RCT is currently recruiting (NCT06217328), and the literature includes three prospective, single-arm studies from the OASIS clinical trial (NCT03596671). The first study followed participants for 6 months and collected data on voids/day, volume voided/day, urgency assessment, leaking episodes/day, pads used/day, and leak severity. Clinical success was defined as a ≥50% reduction in the number of leaks/day or number of voids/day or number of episodes with degree of urgency >2 or a return to <8 voids/day on a 3 day diary. Thirty-four of the 36 implanted participants completed the study; of these, 71% experienced clinical success at 6 months. All parameters’ relative changes from baseline to each follow-up visit were statistically significant (p < 0.05) except for leaks severity at 1 month. Seventeen subjects (17/36, 47%) experienced adverse events during the study, which included implant site pain (13.9%), suspected infection (22.2%), and procedural wound complications (8.3%) (Heesakkers et al., 2017).

Of the 34 participants, 20 consented to continuation in the 3-year follow-up study. The primary long-term study endpoint was to evaluate the safety profile based on incidence of serious adverse events (system and/or procedure related), which was measured by the impact and frequency of serious adverse events. The full study is inaccessible (must pay to read). Referring to the abstract, the results reported secondary endpoints which included clinical success rate, not the long-term safety profile measures; therefore, conclusions cannot be drawn in this assessment about Renova’s (Revi’s) long-term safety.

The most recent study from the OASIS trial was published April 2024. The primary efficacy and safety endpoints were the proportion of responders to therapy ( ≥ 50% improvement on average number of urgency-related incontinence episodes) and incidence of adverse events from implantation to 12-month post-activation. A total of 151 participants were implanted; 144 and 140 completed the 6- and 12-month visits, respectively. Six and 12-months post-activation, 76.4% and 78.4% of participants, respectively, were responders to therapy in an intent-to-treat analysis. Six device-related AEs were reported in six participants (4.0%), with all events related to pain with stimulation/implant. Sixteen procedure-related AEs occurred in 16 participants (10.6%), of which 10 (6.6%) were wound-related (7 wound complications, 2 infections, and 1 dehiscence). The remaining 6 procedure-related AEs included numbness after surgery, swollen foot, pain, erythroderma/skin rash, cellulitis, and allergic reaction to preoperative medications. An independent clinical events committee (CEC) reviewed and adjudicated AEs for severity, seriousness, and relatedness to the procedure or device and classified all AEs as anticipated (Heesakkers et al., 2024).

A ≥50% reduction in symptom severity is often employed by researchers to define clinical success; however, the AUA/SUFU 2024 guidelines identified the discordance between the research defined success parameter of ≥50% improvement and what people with OAB are seeking. They continue to state, “It is difficult to counsel patients with data being focused on such a low bar for treatment success. This is perhaps a sign that we have much work to do to better define this problem” (Cameron et al. 2024). The proportion of participants with severe OAB severity scores were not reported in any of the OASIS studies. Studies should include participants with high severity because they may experience a different impact from the device. Additionally, the authors did not operationalize what “severe” OAB symptoms were in the OASIS studies. Only the 2024 study operationalized leak severity as a secondary endpoint: Severity of leaks was defined on a scale from 0 to 3; (0) none: no leakage, (1) drops: damp, few drops only, (2) small: wet underwear or pad, and (3) large/severe: soaked or emptied bladder, but average number of severe/large urgency-related incontinence episodes (another secondary endpoint) was not operationalized.

The AUA/SUFU practice guidelines offer a moderate recommendation (Grade A) for neuromodulation as a subsequent therapy; “[individuals] with OAB who have an inadequate response to, or have experienced intolerable side effects from, pharmacotherapy or behavioral therapy, clinicians should offer sacral neuromodulation, percutaneous tibial nerve stimulation, and/or intradetrusor botulinum toxin injection. Based on the guidelines literature review on Implantable tibial nerve stimulation which concludes, “the literature on implantable tibial nerve stimulators is limited by a lack of studies providing a direct comparison to other OAB treatment modalities or placebo, and therefore a recommendation specific to these implantable systems is not provided”: the recommendation for percutaneous tibial nerve stimulation as a subsequent therapy does not extend to Revi.

Revi has been proposed and investigated as an intervention that may serve as a therapeutic option post-failures of established alternatives aimed to treat overreactive bladder. However, reliable data addressing the clinical usefulness of tibial nerve stimulation through Revi are yet to be presented in peer-reviewed publications. The studies did not categorize participants by baseline severity—this is needed because individuals with severe OAB may benefit differently than individuals with mild or moderate OAB. We do not how efficacious Revi is for these subpopulations. These data are needed to evaluate if subfascial stimulation results in objective and sizeable reduction of various symptoms in populations with overactive bladder pathology. Additionally, professional societies do not offer recommendations for implantable neurostimulation systems due to lack of evidence. The current evidence is insufficient to determine Revi has an improvement in net health outcomes.

eCoin^TM

In March 2022, the eCoin Peripheral Neurostimulator System (Valencia Technologies Corporation) became the first subcutaneous tibial nerve stimulation implant approved by the FDA through the premarket authorization (PMA) process for individuals with UUI. The evidence includes single-arm, open-label studies.

A 2019 feasibility study by MacDiarmid et al. enrolled 46 participants with refractory UUI. In an intent-to-treat analysis, participants experienced a reduction in median daily incontinent episodes from 4.2 at baseline to 1.7 at 3 months (P=0.001). A 12-month follow- up study published by Gilling et al. (2021) reported the median number of UUI episodes per day was maintained at 1.7.

Rogers et al. (2021) evaluated the safety and efficacy of the wireless eCoin device in a single-arm, open-label trial at 15 US sites. A total of 132 participants with refractory (failed ≥1 second- or third-line therapy) overactive bladder were included in the intention-to-treat analysis; 120 participants completed the primary endpoint. The majority of individuals were female (98%) and 26% had received prior PTNS therapy. The primary efficacy endpoint was the percentage of subjects experiencing a 50% or greater improvement in UUI episodes as measured by a 3-day voiding diary 48 weeks after device activation. Sixty-nine percent of participants were responders at 24 weeks, 70% at 36 weeks, and 68% at 48 weeks. Twenty-one percent of participants reported 100% response at 48 weeks. Responder rates differed pre- and peri-pandemic, but this influence was not explored. A different performance goal was established after participants had already been implanted: the null hypothesis—the percentage of responders less than or equal to 40%—was tested against the alternative hypothesis—the percentage greater than 40%. The authors state the performance goal was based on Interstim SNM data. It is inappropriate to alter the performance goal after the trial has already begun. During the study, eight patients total were explanted: four due to related adverse events (three infection, one contact dermatitis), three for an MRI need, and one for device failure. One subject was revised for device dislocation. The study observed the need to re-implant the device after only 1 year. Consequently, the FDA requested a post-approval study to confirm the results of the pivotal study.

A 2022 follow-up study to the MacDiarmid et al. (2019) paper included 23 participants who were reimplanted with an eCoin device after 1 year with a second-generation device. According to the clinical trial, the primary efficacy endpoint was change from baseline in UUI episodes as measured by a 3-day voiding journal 12 weeks after device activation. After reimplantation and activation of the new study device, the median number of UUI episodes decreased from 3.3 episodes at baseline to 1.3 at 12 weeks (P<0.001). No serious device-related adverse events were reported.

Limitations include lack of well-designed studies with sufficient follow-up time. Also, additional studies confirming the efficacy results of eCoin are needed. The post-approval study requested by the FDA is still ongoing. The evidence is insufficient to determine whether eCoin improves net health outcomes.

Protect PNS System

Protect PNS System (PROTECT) is a neurostimulation device that integrates the two components required for nerve stimulation into a miniaturized, single component device. PROTECT consists of a percutaneous implanted pulse generator (pIPG) constructed of a flexible integrated circuit board and an embedded receiver encased in tubing containing four electrodes and fixation tines. This single-device pIPG is placed adjacent to the posterior tibial nerve to treat overactive bladder (OAB) symptoms such as refractory urge incontinence.

Two clinical trials are underway: the PROTECT trial (NCT02577302), which is a prospective, randomized, controlled, multicenter study comparing sacral nerve stimulator, Interstim System, to PROTECT; and the IDE-approved GUARDIAN trial (NCT04589507-G200227), which is a prospective, randomized, controlled, multicenter study comparing PROTECT to traditional medical management for OAB. The primary endpoint of the PROTECT Trial is a 50% or greater reduction in number of incontinence episodes associated with urgency at the 3-month visit, with additional measurements assessed at 14 days, 1, 6, 9, and 12 months.

Limitations of this primary endpoint are also noted for the implantable posterior tibial nerve stimulators eCoin and Revi. A 50% or greater reduction in symptom severity is often employed by researchers to define clinical success; however, the AUA/SUFU 2024 guidelines identified the discordance between the research-defined success parameter of 50% or greater improvement and what people with OAB are seeking. They continue to state, “It is difficult to counsel patients with data being focused on such a low bar for treatment success. This is perhaps a sign that we have much work to do to better define this problem" (Cameron et al. 2024).

It would be beneficial for the clinical trials to stratify the severity of urinary urgency incontinence as “mild", “moderate", or “severe" to determine if the effect of PROTECT is clinically meaningful for those with severe urinary incontinence. Additionally, Interstim has a minimum of 5 years of follow-up and percutaneous tibial nerve stimulation has 3 years of follow-up. Studies reporting long-term outcomes for PROTECT will be needed to determine the durability of treatment benefit.

The AUA/SUFU practice guideline offers a moderate recommendation (Grade A) for neuromodulation as a subsequent therapy; “[individuals] with OAB who have an inadequate response to, or have experienced intolerable side effects from, pharmacotherapy or behavioral therapy, clinicians should offer sacral neuromodulation, percutaneous tibial nerve stimulation, and/or intradetrusor botulinum toxin injection." Based on the guideline's literature review on implantable tibial nerve stimulation that concludes, “the literature on implantable tibial nerve stimulators is limited by a lack of studies providing a direct comparison to other OAB treatment modalities or placebo, and therefore a recommendation specific to these implantable systems is not provided," the recommendation for percutaneous tibial nerve stimulation as a subsequent therapy does not extend to PROTECT.

The aggregation of evidence on implantable PTNS systems for the treatment of OAB remains insufficient to draw definitive conclusions about their ability to improve the OAB symptoms in the worst sufferers or the devices' durability of treatment effect.

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Gungor Ugurlucan F, Onal M, Aslan E, et al. Comparison of the effects of electrical stimulation and posterior tibial nerve stimulation in the treatment of overactive bladder syndrome. Gynecol Obstet Invest. 2013;75(1):46-52.

Haylen BT, de Ridder D, Freeman RM, et al. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Int Urogynecol J. 2010;21(1):5-26.

Hassouna MM, Siegel SW, Nyeholt AA, et al. Sacral neuromodulation in the treatment of urgency-frequency symptoms: a multicenter study on efficacy and safety. J Urol. 2000;163(6):1849-1854.

Heesakkers JPFA, Digesu GA, van Breda J, Van Kerrebroeck P, Elneil S. A novel leadless, miniature implantable Tibial Nerve Neuromodulation System for the management of overactive bladder complaints. Neurourol Urodyn. 2017;37(3):1060-1067. doi:10.1002/nau.23401.

Heesakkers JPFA, Toozs-Hobson P, Sutherland SE, et al. A prospective study to assess the effectiveness and safety of the BlueWind System in the treatment of patients diagnosed with urgency urinary incontinence. Neurourol Urodyn. Published online April 18, 2024. doi:10.1002/nau.25477.

Herbison GP, Arnold EP. Sacral neuromodulation with implanted devices for urinary storage and voiding dysfunction in adults. Cochrane Database Syst Rev. 2009;(2):CD004202.

Ho FCS, He C, Yao HH, et al. Efficacy of sacral neuromodulation and percutaneous tibial nerve stimulation in the treatment of chronic nonobstructive urinary retention: A systematic review. Neurourol Urodyn. 2021;40(5):1078-1088.

Holzer B, Rosen HR, Novi G, et al. Sacral nerve stimulation in patients with severe constipation. Dis Colon Rectum. 2008;51(5):524-529.

Horrocks EJ, Chadi SA, Stevens NJ, et al. Factors associated with efficacy of percutaneous tibial nerve stimulation for fecal incontinence, based on post-hoc analysis of data from a randomized trial. Clin Gastroenterol Hepatol. 2017;15(12):1915-1921.e2.

Horrocks EJ, Thin N, Thaha MA, et al. Systematic review of tibial nerve stimulation to treat faecal incontinence. Br J Surg. 2014;101(5):457-468.

Hull T, Giese C, Wexner SD, et al. Long-term durability of sacral nerve stimulation therapy for chronic fecal incontinence. Dis Colon Rectum. 2013;56(2):234-245.

Jones CA, Nyberg L. Epidemiology of interstitial cystitis. Urology.1997;49(5A Suppl):2-9.

Kamm MA, Dudding TC, Melenhorst J, et al. Sacral nerve stimulation for intractable constipation. Gut. 2010;59:333-340.

Kaaki B, English S, Gilling P, et al. Six-Month Outcomes of Reimplantation of a Coin-Sized Tibial Nerve Stimulator for the Treatment of Overactive Bladder Syndrome With Urgency Urinary Incontinence. Female Pelvic Med Reconstr Surg. 2022;28(5):287-292. doi:10.1097/SPV.0000000000001105.

Knowles CH, Horrocks EJ, Bremner SA, et al. Percutaneous tibial nerve stimulation versus sham electrical stimulation for the treatment of faecal incontinence in adults (CONFIDeNT): a double-blind, multicentre, pragmatic, parallel-group, randomised controlled trial. Lancet. 2015;386(10004):1640-8.

Lee UJ, Scott VC, Rashid R, et al. Defining and managing overactive bladder: disagreement among the experts. Urology. 2013;81(2):257-262.

Leo CA, Thomas GP, Bradshaw E, et al. Long-term outcome of sacral nerve stimulation for faecal incontinence. Colorectal Dis. 2020;22(12): 2191-2198.

Leo CA, Thomas GP, Hodgkinson JD, et al. Randomized pilot study: anal inserts versus percutaneous tibial nerve stimulation in patients with fecal incontinence. Dis Colon Rectum. 2021;64(4):466-474.

Leong RK, De Wachter SG, Nieman FH, et al. PNE versus 1st stage tined lead procedure: a direct comparison to select the most sensitive test method to identify patients suitable for sacral neuromodulation therapy. Neurourol Urodyn. 2011;30(7):1249-1252.

Leroi AM, Parc Y, Lehur PA, et al. Efficacy of sacral nerve stimulation for fecal incontinence: results of a multicenter double-blind crossover study. Ann Surg. 2005;242(5):662-669.

Levin PJ, Wu JM, Kawasaki A, et al. The efficacy of posterior tibial nerve stimulation for the treatment of overactive bladder in women: a systematic review. Int Urogynecol J. 2012;23(11):1591-1597.

Lightner DJ, Gomelsky A, Souter L, et al. Diagnosis and treatment of overactive bladder (non-neurogenic) in adults: AUA/SUFU Guideline Amendment 2019. J Urol. 2019;202(3):558-563.

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MacDiarmid SA, Staskin DR, Lucente V, et al. Feasibility of a Fully Implanted, Nickel Sized and Shaped Tibial Nerve Stimulator for the Treatment of Overactive Bladder Syndrome with Urgency Urinary Incontinence. J Urol. 2019;201(5):967-972. doi:10.1016/j.juro.2018.10.017.

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Paquette IM, Varma MG, Kaiser AM, et al. The American Society of Colon and Rectal Surgeons' Clinical Practice Guideline for the Treatment of Fecal Incontinence. Dis Colon Rectum. 2015;58(7):623-636.

Paquette IM, Varma M, Ternent C, et al. The American Society of Colon and Rectal Surgeons' Clinical Practice Guideline for the Evaluation and Management of Constipation. Dis Colon Rectum. 2016;59(6):479-492.

Pauwels N, Willemse C, Hellemans S, et al. The role of neuromodulation in chronic functional constipation: a systematic review. Acta Gastroenterol Belg. 2021;84(3):467-476.

Perissinotto MC, D'Ancona CA, Lucio A, et al. Transcutaneous tibial nerve stimulation in the treatment of lower urinary tract symptoms and its impact on health-related quality of life in patients with Parkinson disease: a randomized controlled trial. J Wound Ostomy Continence Nurs. 2015;42(1):94-99.

Peters K, Carrico D, Burks F. Validation of a sham for percutaneous tibial nerve stimulation (PTNS). Neurourol Urodyn. 2009;28(1):58-61.

Peters KM, Carrico DJ, MacDiarmid SA, et al. Sustained therapeutic effects of percutaneous tibial nerve stimulation: 24-month results of the STEP study. Neurourol Urodyn. 2013;32(1):24-29.

Peters KM, Carrico DJ, Perez-Marrero RA, et al. Randomized trial of percutaneous tibial nerve stimulation versus sham efficacy in the treatment of overactive bladder syndrome: results from the SUmiT trial. J Urol. 2010;183:1438-1443.

Peters KM, Carrico DJ, Wooldridge LS, et al. Percutaneous tibial nerve stimulation for the long-term treatment of overactive bladder: 3-year results of the STEP study. J Urol. 2013;189(6):2194-2201.

Peters KM, MacDiarmid SA, Wooldridge LS, et al. Randomized trial of percutaneous tibial nerve stimulation versus extended release tolterodine: results from the Overactive Bladder Innovative Therapy trial. J Urol. 2009:182:1055-1061.

Picciariello A, Rinaldi M, Dibra R, et al. Ageing with sacral nerve modulation for fecal incontinence: how many patients get benefit after more than 10 years? Updates Surg. 2022;74(1):185-191.

Pilkington SA, Emmett C, Knowles CH, et al. Surgery for constipation: systematic review and practice recommendations: Results V: Sacral Nerve Stimulation. Colorectal Dis. 2017;19 Suppl 3:92-100.

Preyer O, Umek W, Laml T, et al. Percutaneous tibial nerve stimulation versus tolterodine for overactive bladder in women: a randomised controlled trial. Eur J Obstet Gynecol Reprod Biol. 2015;191:51-56.

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Scheepens WA, Van Koeveringe GA, De Bie RA, et al. Long-term efficacy and safety results of the two-stage implantation technique in sacral neuromodulation. BJU Int. 2002;90(9):840-845.

Schneider MP, Gross T, Bachmann LM, et al. Tibial nerve stimulation for treating neurogenic lower urinary tract dysfunction: a systematic review. Eur Urol. 2015;68(5):859-867.

Schreiner L, dos Santos TG, Knorst MR, et al. Randomized trial of transcutaneous tibial nerve stimulation to treat urge urinary incontinence in older women. Int Urogynecol J. 2010;21(9):1065-1070.

Sethi PS, Peters KM. A First-In-Human Feasibility Study of a New Implantable Tibial Nerve Stimulator for Overactive Bladder Syndrome. Neuromodulation. Published online March 1, 2025. doi:10.1016/j.neurom.2025.01.013

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Simillis C, Lal N, Qiu S, et al. Sacral nerve stimulation versus percutaneous tibial nerve stimulation for faecal incontinence: a systematic review and meta-analysis. Int J Colorectal Dis. 2018;33(5):645-648.

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Tirlapur SA, Vlismas A, Ball E et al. Nerve stimulation for chronic pelvic pain and bladder pain syndrome: a systematic review. Acta Obstet Gynecol Scand. 2013;92(8):881-887.

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Thin NN, Horrocks EJ, Hotouras A, et al. Systematic review of the clinical effectiveness of neuromodulation in the treatment of faecal incontinence. Br J Surg. 2013;100(11):1430-1447.

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Coding

CPT Procedure Code Number(s)

MEDICALLY NECESSARY

64561

64566

64581

64585

64590

64595

95970

95971

95972

0786T

0787T

0788T

0789T

EXPERIMENTAL/INVESTIGATIONAL

0988T

0989T

THE FOLLOWING CODE IS USED TO REPRESENT PERCUTANEOUS IMPLANTATION OR REPLACEMENT OF THE PROTECT PNS SYSTEM

0587T

THE FOLLOWING CODE IS USED TO REPRESENT REVISION OR REMOVAL OF THE PROTECT PNS SYSTEM

0588T

THE FOLLOWING CODE IS USED TO REPRESENT ELECTRONIC ANALYSIS WITH SIMPLE PROGRAMMING OF THE PROTECT PNS SYSTEM

0589T

THE FOLLOWING CODE IS USED TO REPRESENT ELECTRONIC ANALYSIS WITH COMPLEX PROGRAMMING OF THE PROTECT PNS SYSTEM

0590T

THE FOLLOWING CODE IS USED TO REPRESENT OPEN INSERTION OR REPLACEMENT OF THE INTEGRATED NEUROSTIMULATION eCOIN SYSTEM

0816T

THE FOLLOWING CODE IS USED TO REPRESENT REVISION OR REMOVAL OF THE INTEGRATED NEUROSTIMULATION eCOIN SYSTEM

0818T

THE FOLLOWING CODE IS USED TO REPRESENT OPEN INSERTION OR REPLACEMENT OF THE INTEGRATED NEUROSTIMULATION REVI SYSTEM

0817T

THE FOLLOWING CODE IS USED TO REPRESENT REVISION OR REMOVAL OF THE INTEGRATED NEUROSTIMULATION REVI SYSTEM

0819T

ICD - 10 Procedure Code Number(s)

N/A

ICD - 10 Diagnosis Code Number(s)

SACRAL NERVE STIMULATION (SNS) [CPT 64561, 64581 ] IS MEDICALLY NECESSARY WITH ANY OF THE FOLLOWING DIAGNOSIS CODES:

N31.8 Other neuromuscular dysfunction of bladder

N31.9 Neuromuscular dysfunction of bladder, unspecified

N32.81 Overactive bladder

N36.44 Muscular disorders of urethra

N39.41 Urge incontinence

N39.42 Incontinence without sensory awareness

N39.43 Post-void dribbling

N39.44 Nocturnal enuresis

N39.45 Other specified urinary incontinence

N39.46 Mixed incontinence

N39.490 Overflow incontinence

N39.498 Other specified urinary incontinence

R15.0 Incomplete defecation

R15.1 Fecal smearing

R15.2 Fecal urgency

R15.9 Full incontinence of feces

R30.1 Vesical tenesmus

R32 Unspecified urinary incontinence

R33.0 Drug induced retention of urine

R33.8 Other retention of urine

R33.9 Retention of urine, unspecified

R35.0 Frequency of micturition

R39.11 Hesitancy of micturition

R39.14 Feeling of incomplete bladder emptying

R39.15 Urgency of urination

R39.81 Functional urinary incontinence

R39.89 Other symptoms and signs involving the genitourinary system

R39.9 Unspecified symptoms and signs involving the genitourinary system

POSTERIOR TIBIAL NERVE STIMULATION (PTNS) [CPT 64566 ] IS MEDICALLY NECESSARY WITH ANY OF THE FOLLOWING DIAGNOSIS CODES:

N32.81 Overactive bladder

N36.44 Muscular disorders of urethra

N39.41 Urge incontinence

N39.42 Incontinence without sensory awareness

N39.43 Post-void dribbling

N39.44 Nocturnal enuresis

N39.45 Other specified urinary incontinence

N39.46 Mixed incontinence

N39.490 Overflow incontinence

N39.498 Other specified urinary incontinence

R30.1 Vesical tenesmus

R32 Unspecified urinary incontinence

R35.0 Frequency of micturition

R39.11 Hesitancy of micturition

R39.14 Feeling of incomplete bladder emptying

R39.15 Urgency of urination

R39.81 Functional urinary incontinence

R39.89 Other symptoms and signs involving the genitourinary system

R39.9 Unspecified symptoms and signs involving the genitourinary system

HCPCS Level II Code Number(s)

MEDICALLY NECESSARY

A4290 Sacral nerve stimulation test lead, each

C1767 Generator, neurostimulator (implantable), nonrechargeable

C1778 Lead, neurostimulator (implantable)

C1787 Patient programmer, neurostimulator

C1883 Adaptor/extension, pacing lead or neurostimulator lead (implantable)

C1894 Introducer/sheath, other than intracardiac electrophysiological, nonlaser

C1897 Lead, neurostimulator test kit (implantable)

L8678 Electrical stimulator supplies (external) for use with implantable neurostimulator, per month

L8679 Implantable neurostimulator, pulse generator, any type

L8680 Implantable neurostimulator electrode, each

L8685 Implantable neurostimulator pulse generator, single array, rechargeable, includes extension

L8686 Implantable neurostimulator pulse generator, single array, nonrechargeable, includes extension

L8687 Implantable neurostimulator pulse generator, dual array, rechargeable, includes extension

L8688 Implantable neurostimulator pulse generator, dual array, nonrechargeable, includes extension

Revenue Code Number(s)

N/A

MPMiscCodesNarrativesPub

Coding and Billing Requirements

Cross Reference

Policy History

Revisions From MA11.028l:

01/21/2026	The policy has been reviewed and reissued to communicate the Company’s continuing position on Sacral Nerve Stimulation (SNS) and Posterior Tibial Nerve Stimulation (PTNS) for the Control of Incontinence.
01/01/2026	Inclusion of a policy in a Code Update memo does not imply that a full review of the policy was completed at this time. This policy has been identified for the CPT code update, effective 01/01/2026. The following codes have been added to this policy as experimental/investigational: 0988T 0989T

Revisions From MA11.028k:

05/28/2025	This policy has been reissued in accordance with the Company's annual review process.
10/01/2024	This version of the policy will become effective 10/01/2024. The following criteria have been added to this policy: Implantable posterior tibial nerve stimulation (e.g., eCoin, Revi, the PROTECT PNS System) as experimental/investigational The following CPT codes have been added to the policy: 0587T, 0588T, 0589T, 0590T The following HCPCS code has been removed from this policy: E0736

Revisions From MA11.028j:

04/01/2024

This policy has been identified for the HCPCS code update, effective 04/01/2024.

The following HCPCS Code has been added to this policy as Experimental/Investigational:

E0736

Revisions From MA11.028i:

01/02/2024

This policy has been identified for the CPT code update, effective 01/02/2024.

The following CPT Codes have been added to this policy as Medically Necessary: 0786T, 0787T, 0788T, 0789T

The following CPT Codes have been added to this policy as Experimental/Investigational: 0816T, 0817T, 0818T, 0819T

Revisions From MA11.028h:

01/01/2024	Effective 01/01/2024 this policy applies to New Jersey Medicare Advantage (MA) lines of business.
05/03/2023	This policy has been reviewed and reissued to communicate the Company’s continuing position on sacral nerve stimulation (SNS) and posterior tibial nerve stimulation (PTNS) for the control of incontinence.
04/01/2023	This policy has been identified for the HCPCS code update, effective 04/01/2023. The following HCPCS Code has been added to this policy: L8678 Electrical stimulator supplies (external) for use with implantable neurostimulator, per month

Revisions From MA11.028g:

06/29/2022	This policy has been reissued in accordance with the Company's annual review process.
01/01/2022	This policy has been identified for the CPT code update effective 01/01/2022. The CPT code narrative has been revised in this policy for the following code: 64581

Revisions From MA11.028f:

06/07/2021

This version of the policy will become effective 06/07/2021.

The following qualification was made for sacral nerve stimulation (SNS):

Permanent implantation- duration criteria for successful test stimulation

The following policy criteria have been revised for posterior tibial nerve stimulation (PTNS):

Documented intolerance to or failure of behavioral training
Urinary dysfunction not related to another neurologic condition
PTNS Experimental/Investigational statement to include examples (such as but not limited to)
Language clarification: frequency limits for maintenance therapy

The following ICD-10 CM codes have been deleted from this policy:

N31.8 Other neuromuscular dysfunction of bladder
N31.9 Neuromuscular dysfunction of bladder, unspecified
R33.0 Drug induced retention of urine
R33.8 Other retention of urine
R33.9 Retention of urine, unspecified
R39.2 Extrarenal uremia

The following HCPCS codes have been deleted from this policy:
L8681 Patient programmer (external) for use with implantable programmable neurostimulator pulse generator, replacement only

L8689 External recharging system for battery (internal) for use with implantable neurostimulator, replacement only
L8695 External recharging system for battery (external) for use with implantable neurostimulator, replacement only

Revisions From MA11.028e:

12/18/2019	This policy has been reviewed and reissued to communicate the Company’s continuing position on Sacral Nerve Stimulation (SNS) and Posterior Tibial Nerve Stimulation (PTNS) for the Control of Incontinence.
01/01/2019	This policy has been identified for the CPT code update effective 01/01/2019. The following CPT code narratives have been revised in this policy: 95970, 95971, 95972

Revisions From MA11.028d:

08/15/2018

This policy has been reissued in accordance with the Company's annual review process.

12/15/2017

This version of the policy will become effective 12/15/2017.
This policy was updated to communicate the Company’s continuing position on Sacral Nerve Stimulation (SNS) and Posterior Tibial Nerve Stimulation (PTNS) for the Control of Incontinence.

The intent of the policy remains unchanged however the following policy criteria have been revised for SNS with percutaneous nerve stimulation for temporary test stimulation: documentation of chronic fecal incontinence was changed from three or more incontinent episodes to two or more incontinent episodes.

The frequency of PTNS maintenance therapy, beyond the initial 12 sessions for the treatment of urinary urgency, urinary frequency, and urge incontinence was changed from a frequency of up to one session every month for up to two years, to a frequency of up to one session every one to two months for up to three years with a maximum of 45 sessions per lifetime

The following criteria have been deleted from this policy for PTNS initial therapy:

There is documented failure of or intolerance to behavioral training (e.g., bladder training, prompted voiding, pelvic muscle exercise training).

The following ICD-10 CM code has been removed from this policy:
N39.3 Stress incontinence (female) (male)

Revisions From MA11.028c:

01/06/2017

This version of the policy will become effective 01/06/2017.

The following codes were added:

CPT/HCPCS: C1787,C1894
ICD 10: N31.9,N39.43 ,N39.44 ,N39.45, N39.490, N39.498.

Revisions From MA11.028b:

01/01/2016

This version of the policy will become effective 01/01/2016. The code narrative for CPT code 95972 has been revised, and the CPT code 95973 has been deleted.

Revisions From MA11.028a:

07/01/2015

Revised policy number MA11.028a will become effective 07/01/2015.

The medical necessity criteria for the permanent implantation of an implantable pulse generator (IPG) following a successful temporary test stimulation has been updated; specifically, the two week time period requirement for the trial of a temporary implant before the placement of a permanent implant has been removed

Revisions From MA11.028:

01/01/2015

This is a new policy.

12/8/2014, the policy Notification was revised to include 1/1/2015 CPT coding updates. The CPT section of the Coding table was updated as follows:

95972 narrative revised

Version Effective Date:

10/1/2024

Version Issued Date:

10/1/2024

Version Reissued Date:

1/21/2026