| Coverage Policy Manual | |
| Policy #: | 1998162 |
| Category: | Surgery |
| Initiated: | December 1998 |
| Last Review: | June 2023 |
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| Sacral Nerve Stimulation for the Treatment of Urge Urinary Incontinence | |
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| Description: |
Sacral nerve stimulation, also known as sacral nerve neuromodulation (SNM), involves the implantation of a permanent device that modulates the neural pathways controlling bladder function.
Treatment using sacral nerve neuromodulation, also known as indirect sacral nerve stimulation, is one of several alternative modalities for individuals with urinary incontinence (urge incontinence, significant symptoms of urgency-frequency, nonobstructive urinary retention) who have failed behavioral (e.g., prompted voiding) and/or pharmacologic therapies. Urge incontinence is defined as leakage of urine when there is a strong urge to void. Urgency-frequency is an uncontrollable urge to urinate, resulting in very frequent, small volumes. Urgency-frequency is a prominent symptom of interstitial cystitis. Urinary retention is the inability to completely empty the bladder of urine.
The SNM device consists of an implantable pulse generator that delivers controlled electrical impulses. This pulse generator is attached to wire leads that connect to the sacral nerves, most commonly the S3 nerve root. Two external components of the system help control the electrical stimulation. A control magnet is kept by the individual and can be used to turn the device on or off. A console programmer is kept by the physician and used to adjust the settings of the pulse generator.
Prior to implantation of the permanent device, patients undergo a peripheral nerve stimulation test to estimate potential response to SNM. This procedure is done under local anesthesia, using a test needle to identify the appropriate sacral nerve(s). Once identified, a temporary wire lead is inserted through the test needle and left in place for several days. This lead is connected to an external stimulator, which is carried by individuals in their pocket or on their belt. The results of this test phase are used to determine whether patients are appropriate candidates for the permanent device. If individuals show a 50% or greater reduction in incontinence frequency, they are deemed eligible for the permanent device.
The second type of testing is a 2-stage surgical procedure. In the first stage, a quadripolar-tined lead is implanted (stage 1). The testing phase can last as long as several weeks, and if patients show a 50% or greater reduction in symptom frequency, they can proceed to stage 2 of the surgery, which is permanent implantation of the neuromodulation device. The 2-stage surgical procedure has been used in various ways. They include its use instead of percutaneous nerve evaluation, for individuals who failed percutaneous nerve evaluation, for individuals with an inconclusive percutaneous nerve evaluation, or for individuals who had a successful percutaneous nerve evaluation to refine individual selection further.
The permanent device is implanted with the individual under general anesthesia. The electrical leads are placed in contact with the sacral nerve root(s) via an incision in the lower back, and the wire leads are extended through a second incision underneath the skin across the flank to the lower abdomen. Finally, a third incision is made in the lower abdomen where the pulse generator is inserted and connected to the wire leads. Following implantation, the physician programs the pulse generator to the optimal settings for that patient. The patient can switch the pulse generator between on and off by placing the control magnet over the area of the pulse generator for 1–2 seconds.
Regulatory Status
In 1997, the Medtronic Interstim Sacral Nerve Stimulation system received U.S. Food and Drug Administration (FDA) approval for marketing for the indication of urinary urge incontinence in patients who have failed or could not tolerate more conservative treatments. In 1999, the device received FDA approval for the additional indications of urgency-frequency and urinary retention in patients without mechanical obstruction. In 2006, the InterStim II® System (Medtronic) was approved by the FDA through the premarket approval process for the treatment of intractable cases of overactive bladder and urinary retention. The new device is smaller and lighter than the original and is reported to be suited for those with lower energy requirements or small stature. The device also includes updated software and programming options.
In 2019, the Axonics® Sacral Neuromodulation System (Axonics) received premarket approval from the FDA for treatment of urinary retention and symptoms of overactive bladder. This system has a rechargeable battery that has a device life of 15 years after implantation.
In 2023, the Virtis™ Sacral Neuromodulation System (Nuvectra) was approved by the FDA for treatment of urinary retention and symptoms of overactive bladder, including urinary urge incontinence and significant symptoms of urgency-frequency in patients who have failed more conservative treatments.
FDA product code: EZW.
Related policies:
2005004- Sacral Nerve Stimulation for the Treatment of Fecal Incontinence
Note: Pelvic floor stimulation refers to electrical stimulation of the pudendal nerve. This therapy is addressed separately in policy No. 1998147. Sacral nerve stimulation with associated rhizotomy as a treatment of neurogenic bladder (i.e., the Vocare device) is addressed separately in policy #2003003)
Sacral nerve neuromodulation involves several steps identified by the codes listed below.
Peripheral Nerve Evaluation
Peripheral nerve evaluation to determine candidacy for permanent implantation would be reported using the following codes.
Open Implantation of the Electrode Array
Open implantation of the electrode array, whether as the first stage of the 2-stage implantation procedure, or as the final implantation of the electrode array after a positive percutaneous test, would be reported using the following codes.
Open Implantation of the Neurostimulator
Pulse Generator Open implantation of the neurostimulator pulse generator would be reported using the following codes.
Analysis and Reprogramming of the Implanted Device Some patients will require analysis and reprogramming of the device once implanted.
The following CPT codes may be used. A site of service differential may apply.
Revision or Removal of the Implanted Electrodes or Stimulator
Some patients may require revision or removal of the implanted electrodes or pulse stimulator. The following CPT codes may be used.
Note: HCPCS code L8680 is reported with one unit for each contact point on the implanted lead.
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Policy/ Coverage: |
Effective July 2020
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
Criteria for a Trial Period
A trial period of sacral nerve neuromodulation with either percutaneous nerve stimulation or a temporarily implanted lead meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.in patients who meet all of the following criteria:
Criteria for Permanent Implantation
Permanent implantation of a sacral nerve neuromodulation device meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness. in patients who meet all of the following criteria:
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Other applications of sacral nerve neuromodulation not described above, including but not limited to treatment of stress incontinence or urge incontinence due to a neurologic condition (e.g., detrusor hyperreflexia, multiple sclerosis, spinal cord injury) or other types of chronic voiding dysfunction, do not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
For contracts without primary coverage criteria, other applications of sacral nerve neuromodulation not described above is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Effective Prior to July 2020
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
Sacral nerve neuromodulation meets primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes in patients with at least 1 of the following diagnoses:
Meets all of the following criteria:
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Other applications of sacral nerve neuromodulation not described above, including but not limited to treatment of stress incontinence or urge incontinence due to a neurologic condition (e.g., detrusor hyperreflexia, multiple sclerosis), other types of chronic voiding dysfunction, chronic constipation, or chronic pelvic pain do not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
For contracts without primary coverage criteria, other applications of sacral nerve neuromodulation not described above is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Effective Prior to June 2020
Sacral nerve neuromodulation meets Primary Coverage Criteria that there be scientific evidence of effectiveness in improving health outcomes in patients with urge incontinence, urgency-frequency, and non-obstructive urinary retention that has not responded to prior behavioral and pharmacologic interventions and is not related to a neurologic condition. Patient must have had a successful test stimulation in order to support subsequent permanent implantation.
Other applications of sacral nerve neuromodulation, including but not limited to treatment of stress incontinence or urge incontinence due to a neurologic condition (e.g., detrusor hyperreflexia, multiple sclerosis), other types of chronic voiding dysfunction, chronic constipation, or chronic pelvic pain do not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
For contracts without primary coverage criteria, other applications of sacral nerve neuromodulation, including but not limited to treatment of stress incontinence or urge incontinence due to a neurologic condition (e.g., detrusor hyperreflexia, multiple sclerosis, or spinal cord injury), other types of chronic voiding dysfunction, fecal incontinence, chronic constipation, or chronic pelvic pain are considered investigational. Investigational services are an exclusion in the member certificate of coverage.
Effective prior to June 2012
Sacral nerve neuromodulation may meet Primary Coverage Criteria in patients with urge incontinence, urgency-frequency, and non-obstructive urinary retention that has not responded to prior behavioral and pharmacologic interventions and is not related to a neurologic condition. Patient must have had a successful test stimulation in order to support subsequent permanent implantation.
For contracts without Primary Coverage Criteria language, sacral nerve neuromodulation may be considered medically necessary in patients with urge incontinence, urgency-frequency, and non-obstructive urinary retention that has not responded to prior behavioral and pharmacologic interventions and is not related to a neurologic condition. Patient must have had a successful test stimulation in order to support subsequent permanent implantation.
Other applications of sacral nerve neuromodulation, including but not limited to treatment of stress incontinence or urge incontinence due to a neurologic condition (e.g., detrusor hyperreflexia, multiple sclerosis), other types of chronic voiding dysfunction, fecal incontinence, chronic constipation, or chronic pelvic pain are not covered based on benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
For contracts without primary coverage criteria, other applications of sacral nerve neuromodulation, including but not limited to treatment of stress incontinence or urge incontinence due to a neurologic condition (e.g., detrusor hyperreflexia, multiple sclerosis, or spinal cord injury), other types of chronic voiding dysfunction, fecal incontinence, chronic constipation, or chronic pelvic pain are considered investigational. Investigational services are an exclusion in the member certificate of coverage.
Sacral nerve neuromodulation involves several steps:
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| Rationale: |
Literature published since these 2000 was searched in October 2002 to update this policy.
Urge Incontinence.
A multicenter, randomized controlled clinical trial, conducted as part of the U.S. Food and Drug Administration (FDA) approval process, concluded that SNM reduced urge incontinence compared to control patients. This well-designed trial, using standardized clinical and functional status outcomes measurements, enrolled patients with severe urge incontinence who had failed extensive prior treatments. The magnitude of effect (approximately one half of the patients become dry, three quarters experience at least 50% reduction in incontinence) was fairly large, probably at least as great as with surgical procedures, and larger than expected from a placebo effect or from conservative measures such as behavioral therapy or drugs. However, due to the protocol that selects patients who are likely to benefit based on the peripheral nerve evaluation test, this magnitude of effect is overestimated relative to the total pool of patients with refractory urge incontinence. On the other hand, this screening step avoids an invasive procedure and implantation of the SNS device in patients who are less likely to benefit, thus reducing morbidity and unnecessary treatment.
The therapy evaluation test, in which the device is turned off and patients thus serve as their own controls, provided further evidence that the effect on incontinence is due to electrical stimulation, and demonstrates that the effect of SNS is reversible. The cohort analysis of the clinical trial provides some evidence that the effect of SNS is maintained for up to 2 years. There was a high rate of adverse events reported in this clinical trial. Most of the adverse events were minor and reversible; however, approximately one third of patients required surgical revision for pain at the operative sites or migration of the leads. It is not known to what extent these adverse events and the need for surgical revisions may improve as more experience with the device accumulates.
There were inadequate data on other indications for SNS, including treatment of urge incontinence due to neurologic conditions, stress incontinence, or other chronic voiding dysfunctions. An update of the literature since the 1998 Assessment again found insufficient data on these indications. No controlled studies were found for urge incontinence due to neurologic conditions, stress incontinence, or other chronic voiding dysfunctions.
An additional prospective randomized controlled trial of 44 patients with urge incontinence became available after the 1998 Assessment. At 6 months, the implant group showed significantly greater improvement on standardized clinical outcomes, as compared to those receiving conservative therapy. The magnitude of effect was substantial. This study provides further evidence of the beneficial effect of SNS for urinary urge incontinence.
Urinary Urgency/Frequency
Data on Sacral nerve neuromodulation for the treatment of urinary urgency and frequency was reviewed. The data considered in this policy review consisted of 1 published randomized controlled trial, a long-term, single-arm cohort study, and additional data submitted to the FDA as part of the approval process. In the multicenter randomized clinical study of 581 patients with a variety of urinary dysfunctions, 220 had significant urgency-frequency symptoms. After 6 months, 83% of patients with urgency-frequency symptoms reported increased voiding volumes with the same or reduced degree of frequency. At 12 months, 81% of patients had reached normal voiding frequency. Compared to a control group, patients with implants reported significant improvements in quality of life, as evaluated by the SF-36 health survey. There has also been interest in the use of sacral nerve stimulation as a treatment of interstitial cystitis, a condition characterized by painful urinary urgency and frequency. A literature search identified 3 cases series of 15, 20, and 25 patients with interstitial cystitis. These studies reported a decrease in both urgency/frequency and pain. There is no separate policy statement for patients with interstitial cystitis, as they would be considered candidates for sacral neuromodulation therapy based on the presence of urgency and frequency alone.
Urinary Retention
In the randomized clinical study submitted to the FDA as part of the approval process, 177 of 581 patients had urinary retention. Patients with urinary retention reported significant improvements in terms of volume catheterized per catheterization, a decrease in the number of catheterizations per day, and increased total voided volume per day. At 12 months post-implant, 61% of patients had eliminated the use of catheterization. Patients with implants also reported improved quality of life.
Fecal Incontinence
A literature search identified 4 cases series of 15, 16, 20, and 23 patients, respectively, with fecal incontinence who were treated with sacral neuromodulation as an alternative to anal sphincter surgery. All series included patients with a variety of etiologies of fecal incontinence, including obstetric injury, spinal cord injury, prior surgery, or idiopathic incontinence. While sacral neuromodulation for urinary disorders focuses on patients with urinary tracts that appear to be structurally intact but functionally impaired, in contrast, the majority of patients with fecal incontinence have structural impairment of the anal sphincter. Similar to patients with urinary incontinence, placement of the permanent device was preceded by implantation of a temporary electrode to assess treatment effect. However, 3 of the case series on fecal incontinence focus only on those receiving the permanent implant, so it is unknown how many patients were initially evaluated. One case series reported that 20 of 23 patients responded to the temporary electrode and progressed to permanent implantation. In general, the case series reported improvements in episodes of incontinence and improvements in quality of life in those undergoing permanent implantation. There were also improvements in objective measures, such as anal sphincter resting pressure. The longest follow-up was 24 months. These small case series provide inadequate data to permit scientific conclusions. The trials of patients with urinary incontinence have typically included an arm in which symptoms were evaluated with the device turned off in a blinded manner to evaluate a placebo effect. No such component was included in these case series of fecal incontinence.
Constipation
Two small case series were identified that focused on patients with slow transit constipation. While both reported promising results, these case series of 4 and 8 patients, respectively, are inadequate to permit scientific conclusions.
Chronic Pelvic Pain
Siegel and colleagues reported on a case series of 10 patients with chronic pelvic pain. Their research interest was prompted by the concomitant decrease in pain reported by patients receiving sacral neuromodulation for urinary disorders. The authors did not detail the etiology of the pain syndromes in their case series, but reported that 9 of the 10 patients had a decrease in pain. These data are inadequate to permit scientific conclusions.
2012 Update
A literature search was conducted using the MEDLINE database. There was no new information that would prompt a change in the coverage statement.
A 2011 series by Groen and colleagues in The Netherlands was identified (Groen, 2011). A total of 60 patients had at least 5 years of follow-up after SNM for refractory idiopathic urge urinary incontinence. Success was defined as at least a 50% decrease in the number of incontinent episodes or pads used per day. The success rate was 52 of 60 (87%) at 1 month and gradually decreased to 37 (62%) at 5 years. The number of women who were completely continent was 15 (25%) at 1 month and 9 (15%) at 5 years. At the 5-year follow-up, SNM was still used by 48/60 (80%) women. A total of 57 adverse events were reported in 32 of 60 (53%) patients. The most frequent adverse events were hardware-related or pain or discomfort. There were a total of 23 reoperations in 15 patients. In most cases, pain problems were managed conservatively.
2013 Update
A literature search was conducted using the MEDLINE database through May 2013. There was no new information identified that would prompt a change in the coverage statement.
2014 Update
A literature search conducted through May 2014 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
Ongoing and Unpublished Clinical Trials
InSite for Over Active Bladder (InSite - OAB) (NCT00547378)( MedtronicNeuro, 2014): This randomized open-label trial is comparing the safety and efficacy of sacral neuromodulation using the InterStim device to standard medical therapy in patients with overactive bladder who failed at least 1 previous medication. Patients will be followed for 5 years. The primary efficacy outcomes, change in overactive bladder symptoms at 6 months, were published in 2014 (Seigel, 2014). The primary safety outcome, safety of the tined lead, will be reported at 5 years. The estimated study completion date is November 2016.
Refractory Overactive Bladder: Sacral NEuromodulation v. BoTulinum Toxin Assessment (ROSETTA) (NCT01502956): This randomized, open-label trial is comparing the safety and efficacy of sacral neuromodulation (InterStim) with injections of botulinum toxin A for the treatment of refractory urge urinary incontinence. Patients will be followed for 24 months; primary outcomes are changes in urge incontinence symptoms at 6 months. The estimated study completion date is December 2016.
Chronic Pelvic Pain
A 2013 systematic review of studies on nerve stimulation for chronic pelvic pain did not identify any RCTs on SNS for treatment of chronic pelvic pain or bladder pain (Tirlapur, 2013). The published evidence is limited to case series. For example, in 2012 Martelluci et al reported on 27 patients with chronic pelvic pain (at least 6 months) who underwent testing for SNM implantation. After a 4-week temporary stimulation phase, 16 of 27 patients (59%) underwent implantation of an InterStim device. In the 16 implanted patients, mean pain on a visual analogue scale was 8.1 before implantation and 2.1 at the 6- and 12-month follow-ups. An earlier study by Siegel et al reported on 10 patients and stated that 9 of the 10 experienced a decrease in pain with SNS stimulation (Seigel, 2001).
American College of Obstetricians and Gynecologists (ACOG):
2016 Update
A literature search conducted through May 2016 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
Noblett and colleagues published a twelve-month follow-up of the Insite trial (Noblett, 2014). The analysis included patients included in the SNS group of initial RCT plus additional patients enrolled and implanted in the interim. A total of 340 patients 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%. This modified completers’ analysis included patients 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%. The Noblett analysis did not include data from the control group of patients receiving only standard medical therapy.
American Urological Association
In 2014, the American Urological Association issued an updated guideline on diagnosis and treatment of overactive bladder (AUA, 2015). The guideline states that sacral neuromodulation may be offered as a third-line treatment in carefully selected patients with severe refractory symptoms or in those who are not candidates for second-line therapy (eg, oral anti-muscarinics, oral 3-adrenoceptor agonists or transdermal oxybutynin) and are willing to undergo surgery
2017 Update
A literature search conducted through May 2017 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
URINARY INCONTINENCE
Amundsen and colleagues reported on a RCT comparing intra-detrusor injection of onabotulinumtoxinA (n=192) with SNM (n=189) in women with refractory urgency urinary incontinence, defined least 1 supervised behavioral or physical therapy intervention and the use of a minimum of 2 anticholinergics (or inability to tolerate or contraindications to the medication) (Amundsen, 2016). In intention-to-treat analysis, patients in onabotulinumtoxinA-treated patients had greater reductions in urge incontinence per day in SNM-treated patients: 3.9 vs 3.3/ day (mean difference: 0.63; 95% CI 0.13 to 1.14, P=0.01). OnabotulinumtoxinA -treated patients had greater reductions in some overactive bladder-related quality of life questionnaire related measures, although the clinical meaningfulness of the changes was uncertain. Patients in the onabotulinumtoxinA-treated group were more likely to have urinary tract infections (UTIs, 35% vs 11%; risk difference -23%, 95% CI -33% to -13%, P<0.001).
2018 Update
A literature search conducted using the MEDLINE database through May 2018 did not reveal any new information that would prompt a change in the coverage statement.
2019 Update
A literature search was conducted through May 2019. There was no new information identified that would prompt a change in the coverage statement.
2020 Update
A literature search was conducted through May 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 May 2021. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
A 2018 guideline on urinary incontinence from the Association makes the following statements (EUA, 2018):
"Sacral nerve neuromodulation is more effective than continuation of failed conservative treatment for cure of urge urinary incontinence [UUI], but no sham controls have been used."
"Sacral nerve neuromodulation is not more effective than OnabotulinumA toxin 200 U injection at 6 months."
"In those patients who have been implanted, at long-term, 50% improvement of UUI is maintained in at least 50% of patients and 15% may remain cured."
"The use of tined, permanent electrodes in a staged approach results in more patients receiving the final implant than occurs with temporary test stimulation."
The guideline also gives a strong recommendation for offering sacral nerve modulation to "patients who have UUI refractory to antimuscarinic therapy."
Of note, the 2018 guideline was reprinted in 2020 and will be updated in full for 2021 under the European Association of Urology Guidelines on Non-neurogenic Female Lower Urinary Tract Symptoms.
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through May 2022. No new literature was identified that would prompt a change in the coverage statement.
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through May 2023. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Chartier-Kastler et al published 3-year results from a prospective, observational, multicenter study from France (SOUNDS) (Chartier-Kastler, 2022). Patients with overactive bladder (N=229) underwent InterStim implantation (either a first device or a replacement) and were followed for a mean of 33.7 ± 3.7 months. During the 3-year follow-up, average daily voids and leaks were significantly reduced (all p<.05) and response (defined as ≥50% reduction in voids per day or return to normal voiding frequency) ranged from 72% to 86%. Quality of life scores were improved at all study visits. About half of the patients experienced adverse events, which were mostly minor, but surgical revision was required in 33% of patients. Lack of a control arm may limit the clinical applicability of these results.
Pezella et al published an observational, single-arm, multicenter study (ARTISAN-SNM) of the Axonics system in 129 patients with urinary urgency incontinence (Pezzella, 2021). After 2 years, 93% of the 121 patients that remained in the study met the criteria for response, which was defined as a ≥50% reduction in urge incontinence episodes. Freedom from urge incontinence episodes (100% reduction) occurred in 37% of patients. Average number of incontinence episodes per day decreased from 5.6 ± 0.3 at baseline to 1.0 ± 0.3 at 2 years (p<.0001). No serious device-related adverse events occurred.
Similarly, Blok et al reported 2-year results of the prospective RELAX-OAB study that evaluated the Axonics system in 51 patients with overactive bladder (Blok, 2020). Response to treatment was defined as a ≥50% reduction in voids or leaks or a return to normal voiding frequency (<8 voids per day), and was assessed 1 month after implantation. Forty patients were followed for the full 2 years. Of these, 30 patients had met the criteria for response at 1 month and 27 were still responders after 2 years. No serious device-related adverse events occurred.
In 2018, the International Continence Society published a best practice statement on the use of sacral neuromodulation (Goldman, 2018). The authors specified that the guideline recommendations applied primarily to the Interstim device and may or may not be applicable to future devices that have become available since that time. For both urinary and bowel disorders, first-line interventions include behavioral therapy, physical therapy, and medical management. Sacral neuromodulation can be offered to patients who fail or have an intolerance to first-line interventions. The guideline also states that sacral neuromodulation is appropriate for interstitial cystitis, bladder pain syndrome, Fowler's syndrome, voiding dysfunction, and nonobstructive urinary retention. However, there was a lack of evidence supporting the use of sacral neuromodulation for chronic pelvic pain unrelated to any of the aforementioned etiologies. For constipation, sacral neuromodulation should only be considered for patients who have had symptoms for at least 1 year, whose symptoms cannot be attributed to a mechanically correctable cause, and when conservative treatment has failed. Contraindications to sacral neuromodulation include lack of response during a therapeutic trial and pregnancy. Relative contraindications may include severe or rapidly progressive neurologic disease, abnormal sacral anatomy, anticipated need for magnetic resonance imaging below the head, and spinal cord injury.
In 2020, NICE issued guidance on the Axonics sacral neuromodulation system for treating refractory overactive bladder (NICE, 2020). The guidance states that the Axonics system should be considered an option for people with refractory overactive bladder. Similarly, 2004 guidance states that use of sacral nerve stimulation for urge incontinence and symptoms of urgency/frequency is supported by evidence of efficacy and safety (NICE, 2004).
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| References: |
American College of Obstetricians and Gynecologists.(2005) Urinary incontinence in women. Obstet Gynecol 2005; 105(6):1533-45. American Urological Association (AUA).(2015) Guideline on Diagnosis and Treatment of Overactive Bladder. 2014; https://www.auanet.org/education/guidelines/overactive-bladder.cfm. Bemelmans BLH, Munday AR, Craggs MD.(1999) Neuromodulation by implant for treating lower urinary tract symptoms and dysfunction. Eur Urol 1999; 36:81-91. Blok B, Van Kerrebroeck P, de Wachter S, et al.(2020) Two-year safety and efficacy outcomes for the treatment of overactive bladder using a long-lived rechargeable sacral neuromodulation system. Neurourol Urodyn. Apr 2020; 39(4): 1108-1114. PMID 32243625 Bosch JL, Groen J.(1995) Sacral (S3) segmental nerve stimulation as a treatment for urge incontinence in patients with detrusor instability: Results of chronic electrical stimulation using an implantable neural prosthesis. J Urol 1995; 154:504-507. Bosch JL, Groen J.(1996) Treatment of refractory urge incontinence with sacral spinal nerve stimulation in multiple sclerosis patients. Lancet 1996; 348:717-719. Bosch JL, Groen J.(2000) Sacral nerve neuromodulation in the treatment of patients with refractory motor urge incontinence: long term result of a prospective longitudinal study. J Urol 2000; 163:1219-1222. Brazzelli M, Murray A, Fraser C.(2006) Efficacy and safety of sacral nerve stimulation for urinary urge incontinence: a systematic review. J Urol 2006; 175(3 pt 1):835-41. Chartier-Kastler E, Normand LL, Ruffion A, et al.(2022) Sacral Neuromodulation with the InterStim System for Overactive Bladder: 3-Year Results from the French Prospective, Multicenter, Observational SOUNDS Study. Eur Urol Focus. Sep 2022; 8(5): 1399-1407. PMID 34334342 Comiter CV.(2003) Sacral neuromodulation for the symptomatic treatment of refractory interstitial cystitis: a prospective study. J Urol 2003; 169:1369-73. Couillard DR, Webster GD.(1995) Detrusor instability. Urol Clin N Am 1995; 22:593-612. Dijkema HE, Weil EHJ, Mijs PT, et al.(1993) Neuromodulation of sacral nerves for incontinence and voiding dysfunctions. Eur Urol 1993; 24:72-76. Elabbady AA, Hassouna MM, Elhilali MM.(1994) Neural stimulation for chronic voiding dysfunctions. J Urol 1994; 152:2076-2080. European Association of Urology (EUA).(2018) EUA guidelines on urinary incontinence in adults. 2018. https://uroweb.org/guideline/urinary-incontinence/. Accessed March 5, 2021.\ Fantl JA, Newman DK, Colling J, et al.(1996) Urinary incontinence in adults: acute and chronic management. AHCPR Clinical practice guideline; # 2 update 1996. FDA.(1999) Medtronic® Interstim® System for Urinary Control. http://www.fda.gov/cdrh/pdf/P970004S004.html. Accessed November 1 1999. FDA.(2001) Premarket approval decisions for August 2001. http://www.fda.gov/cdrh/pma/pmaaug01.html. Accessed October 25, 2001. FDA.(2001) Safety alert. http://www.fda.gov/cdrh/pmajun01.html.Accessed July 12, 2001. Ganio E, Luc AR, et al.(2001) Sacral nerve stimulation for treatment of fecal incontinence. Dis Colon Rectum 2001; 44:619-31. Ganio E, Ratto C, et al.(2001) Neuromodulation for fecal incontinence: outcome in 16 patients with definitive implant. Dis Colon Rectum 2001; 44:965-70. Goldman HB, Lloyd JC, Noblett KL, et al.(2018) International Continence Society best practice statement for use of sacral neuromodulation. Neurourol Urodyn. Jun 2018; 37(5): 1823-1848. PMID 29641846 Grimby A, Milsom I, Molander U, et al.(1993) The influence of urinary incontinence on the quality of life of elderly women. Age Aging 1993; 22:82-89. Groen J, Blok BF, Bosch JL.(2011) Sacral neuromodulation as treatment for refractory idiopathic urge urinary incontinence: 5-year results of a longitudinal study in 60 women. J Urol. 2011; 186(3):954-9. Hassouna MM, Siegel SW, Lycklama AAB, et al.(2000) Sacral Nerve Stimulation Study Group. Sacral Neuromodulation in the treatment of urgency-frequency symptoms: a multicenter study on efficacy and safety. J Urol 2000; 163:1849-1854. Janknegt RA, Hassouna MM, Siegel SW, et al.(2001) Long-term effectiveness of Sacral Nerve Stimulation for refractory urge incontinence. Eur Urol 2001; 139:101-106. Jonas U, Fowler CJ, Chancellor MB, et al.(2001) Efficacy of sacral nerve stimulation for urinary retention: results 18 months after implantation. J Urol 2001; 165:15-19. Kenefick NJ, Nicholls RJ, et al.(2002) Permanent sacral nerve stimulation for treatment of idiopathic constipation. Br J Surg 2002; 89:882-88. Kenefick NJ, Vaizey CJ, et al.(2002) Medium term results of permanent sacral nerve stimulation for faecal incontinence. Br J Surg 2002; 89:896-901. Koldewijn EL, Rosier PFWM, Meuleman EJH.(1994) Predictors of success with neuromodulation in lower urinary tract dysfunction: Results of trial stimulation in 100 patients. J Urol 1994; 152:2071-2075. Koziol JA, Clark DC, Gittes RF, et al.(1993) The natural history of interstitial cystitis: a survey of 374 patients. J Urol 1993; 149:465-469. Lam GW, Foldsprang A, Elving LB, et al.(1992) Social context, social abstention, and problem recognition correlated with adult female urinary incontinence. Dan Med Bull 1992; 39:565-570. Leroi AM, Parc Y, Lehur PA, et al.(2005) Efficacy of sacral nerve stimulation for fecal incontinence; results of a multicenter double-blind crossover study. Ann Surg 2005; 242(5):662-9. Lloyd SN, Lloyd SM, Rogers K, et al.(1992) Is there still a place for prolonged bladder distension. Br J Urol 1992; 70:382-386. Maher CF, Carey MP, et al.(2001) Percutaneous sacral nerve root neuromodulation for intractable interstitial cystitis. J Urol 2001; 165:884-6. Malouf AJ, Wiesel PH, et al.(2002) Short-term effects of sacral nerve stimulation for idiopathic slow transit constipation. World J Surg 2002; 26:166-70. Medical coverage policy decisions. Sacral nerve stimulation for treatment of urge urinary incontinence. http://www.hcfa.gov/quality/8b3-v3.htm. Accessed July 3, 2001. National Institute for Health and Care Excellence (NICE).(2004) Sacral nerve stimulation for urge incontinence and urgency-frequency. IPG64. https://www.nice.org.uk/guidance/ipg64. June 23, 2004. Accessed February 22, 2023. National Institute for Health and Care Excellence (NICE).(2020) Axonics sacral neuromodulation system for treating refractory overactive bladder [MTG50]. 2020; https://www.nice.org.uk/guidance/mtg50. Accessed February 15, 2023. Noblett K, Siegel S, Mangel J, et al.(2014) Results of a prospective, multicenter study evaluating quality of life, safety, and efficacy of sacral neuromodulation at twelve months in subjects with symptoms of overactive bladder. Neurourol Urodyn. Dec 24 2014. PMID 25546568 Payne CK, Whitmore KE, et al.(2001) Sacral neuromodulation in patients with interstitial cystitis: a multicenter clinical trial. Neurourol Urodyn 2001; 20:554-5. Pezzella A, McCrery R, Lane F, et al.(2021) Two-year outcomes of the ARTISAN-SNM study for the treatment of urinary urgency incontinence using the Axonics rechargeable sacral neuromodulation system. Neurourol Urodyn. Feb 2021; 40(2): 714-721. PMID 33508155 Position Statement Regarding Sacral Nerve Stimulation for Urinary Incontinence. Am Urological Association. http://www.auanet.org/govaffairs/dc_update/index.cfm?contented=51&categoryid=9. Accessed November 1 2000. Rosen HR, Urbaz C, et al.(2001) Sacral nerve stimulation as a treatment for fecal incontinence. Gastroenterology 2001; 121:536-41. Sacral nerve stimulation: urge incontinence. Blue Cross Blue Shield Association Technology Evaluation Center Assessment; T-18 1998. Sacral nerve stimulation: urinary urgency/frequency. 2000 Blue Cross Blue Shield Association Technology Evaluation Center Assessment; Tab 7. Schmidt RA, Jonas U, Oleson KA, et al.(1999) Sacral nerve stimulation for treatment of refractory urinary urge incontinence. J Urol 1999; 62:352-357. Shaker HS, Hassouna M.(1998) Sacral Nerve Root Neuromodulation: an Effective Treatment for Refractory Urge Incontinence. J Urol 1998; 159:1516-1519. Siegel S, Noblett K, Mangel J et al.(2014) Results of a prospective, randomized, multicenter study evaluating sacral neuromodulation with InterStim therapy compared withstandard medical therapy at 6-months in subjects with mild symptoms of overactive bladder. Neurourol Urodyn 2014. Siegel S, Paszkiewicz E, et al.(2001) Sacral nerve stimulation in patient with chronic intractable pelvic pain. J Urol 2001; 166:1742-5. Siegel SW, Catanzaro F, Dijkema HE, et al.(2000) Long-term results of a multicenter study on sacral nerve stimulation for treatment of urinary urge incontinence, urgency-frequency, and retention. Urology 2000; 56:87-91. Siegel SW.(1992) Management of voiding dysfunction with an implantable neuroprosthesis. Urol Clin N Am 1992; 19:163-170. Sponsored by MedtronicNeuro.(2007) InSite for Over Active Bladder (InSite - OAB) (NCT00547378). Available online at: www.guideline.gov. Last accessed March, 2014. Sponsored by the NICHD Pelvic Floor Disorders Network.(2011) Refractory Overactive Bladder: Sacral NEuromodulation v. BoTulinum Toxin Assessment (ROSETTA) (NCT01502956). ). Available online at: www.guideline.gov. Last accessed March, 2014. Tirlapur SA, Vlismas A, Ball E et al.(2013) Nerve stimulation for chronic pelvic pain and bladder pain syndrome: a systematic review. Acta Obstet Gynecol Scand 2013; 92(8):881-7. Urinary Incontinence Guideline Panel.(1992) Urinary incontinence in adults: clinical practice guideline. AHCPR 1992. Weil EHJ, Ruiz-Cerdá JL, Eerdmans PHA, et al.(1998) Clinical results of sacral neuromodulation for chronic voiding dysfunction using unilateral sacral foramen electrodes. World J Urol 1998; 16:313-321. Weil Ehm Ruiz-Cerda JL, et al.(2000) Sacral root neuromodulation in the treatment of refractory urinary urge incontinence: a prospective randomized clinical trial. Eur Urol 2000; 37:161-71. Weinberger MW.(1995) Conservative treatment of urinary incontinence. Clin Ob Gyn 1995; 38:175-188. |
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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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