Sacral Nerve Neuromodulation/Stimulation

Número de política: MA 1.033

Effective Date: 1/1/2026

Política

Fecal Incontinence

Criteria A:

A trial period of sacral nerve neuromodulation with either percutaneous nerve stimulation or a temporarily implanted lead may be considered medically necessary in individuals who meet all the following criteria:

1. There is a diagnosis of chronic fecal incontinence of greater than two (2) incontinent episodes on average per week for more than six (6) months or for more than 12 months after vaginal childbirth.
2. There is documented failure or intolerance to conventional conservative therapy (e.g., dietary modification, the addition of bulking and pharmacologic treatment) for at least a sufficient duration to fully assess its efficacy.
3. The individual is an appropriate surgical candidate.
4. The condition is not related to an anorectal malformation (e.g., congenital anorectal malformation) or chronic inflammatory bowel disease.
5. Incontinence is not related to a neurologic condition.
6. The member has not had rectal surgery in the previous 12 months or, in the case of cancer, the individual has not had rectal surgery in the past 24 months.

Criteria B:

Permanent implantation of a sacral nerve neuromodulation device may be considered medically necessary in individuals who meet all the following criteria:

• All of criteria in A.1 through A.6 above are met.
• An initial stimulation period demonstrates at least 50% improvement in symptoms over a period of at least 48 hours.

Sacral nerve neuromodulation is considered investigational in the treatment of chronic constipation or chronic pelvic pain. There is insufficient evidence to support a general conclusion concerning the health outcomes or benefits associated with this procedure.

Referencias cruzadas

• MP 1.134 Percutaneous and Implantable Tibial Nerve Stimulation
• MP 2.064 Biofeedback and Neurofeedback Therapy
• MP 2.064 Pelvic Floor Stimulation as a Treatment of Urinary and Fecal Incontinence

Variaciones del producto

This policy is only applicable to certain programs and products administered by Capital Blue Cross and subject to benefit variations. Consulte la información adicional a continuación.

FEP PPO - Consulte el Manual de Políticas Médicas de FEP.

Descripción/Antecedentes

Treatment of urinary and fecal incontinence, also known as sacral nerve stimulation, is considered when sacral neuromodulation fails for patients with urinary incontinence (urge incontinence, significant symptoms of urgency-frequency, nonobstructive urinary retention) who have failed behavioral (e.g., promoted voiding) and/or pharmacologic therapies.

Sacral nerve neuromodulation involves use of an implantable pulse generator that delivers controlled electrical impulses. This system operates via a test lead that connects to the sacral nerves, most commonly the S3 nerve root. Two external components of the system help control electrical stimulation. A control magnet is used to turn the stimulator on or off. A console programmer is kept by the physician and used to adjust the settings of the pulse generator.

Before implantation of the permanent device, patients undergo an initial testing phase to evaluate potential response to treatment. The first type of testing developed was percutaneous nerve evaluation (PNE). This procedure is done with the patient under local anesthesia, using a test needle to identify the appropriate sacral nerve(s). Once identified, a temporary wire lead is placed adjacent to the sacral nerve and left in place for 4 to 7 days. The lead is connected to an external stimulator, which is carried by patients 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 patients show 50% or greater reduction in symptom frequency, they are deemed eligible for permanent device implantation.

The second type of testing is a 2-stage surgical procedure. In the first stage, a quadripolar-tined lead is implanted through a small incision. The tines help anchor the lead securely at the sacral nerve site. A temporary lead is connected to an external stimulator for 1 to 2 weeks. If patients show at least 50% improvement in symptoms, they proceed to the second stage of surgery, in which a permanent implantable pulse generator is introduced. The 2-stage surgical procedure has been used in various ways. They include its use instead of PNE for patients who failed PNE, patients with inconclusive PNE, or patients who previously had a successful PNE trial.

The permanent device is implanted with the patient 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 on and off by placing the control magnet over the area of the pulse generator for 1 to 2 seconds.

This evidence review does not address pelvic floor stimulation, which refers to electrical stimulation of the pudendal nerve. Pelvic floor stimulation is addressed separately (see MP 6.024). Also, this review does not address devices that provide direct sacral nerve stimulation in individuals with spinal cord injuries.

Regulatory Status

The InterStim^® Sacral Nerve Stimulation system (Medtronic) was approved by the U.S. Food and Drug Administration (FDA) through the premarket approval process for the indication of urinary and fecal incontinence in patients who have failed or could not tolerate more conservative treatments. The InterStim system was approved for the indications of urinary retention, urgency-frequency, and incontinence in patients who have failed or could not tolerate more conservative treatments.

In 2011, the InterStim^® II system was approved by FDA through the premarket approval process for the treatment of chronic fecal incontinence in patients who have failed or could not tolerate more conservative treatments.

The InterStim device has not been specifically approved by FDA for treatment of chronic pelvic pain.

In 2020, the InterStim™ Micro device was approved by the FDA. This latest generation of the InterStim device does not require recharging and has a battery life of at least 10 years and up to 15 years if used at a low-energy setting.

The InterStim device has not been specifically approved by the FDA for the treatment of chronic pelvic pain.

In 2019, the Axonics^® Sacral Neuromodulation System (Axonics) received premarket approval from the FDA for both fecal incontinence and 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 the Virtis™ Sacral Neuromodulation System (Nuvectra) was approved by the FDA for treatment of urinary retention and symptoms of overactive bladder, including urinary incontinence and significant symptoms of urgency-frequency in patients who have failed more conservative treatments.

FDA product code: EZW.

Fundamento

Summary of Evidence

For individuals with fecal incontinence who have failed conservative treatment who receive sacral nerve stimulation (SNM), the evidence includes randomized controlled trials (RCTs) and systematic reviews. Relevant outcomes are symptoms, morbid events, and treatment-related morbidity. Although relatively small, the available trials had a low risk of bias and demonstrated improvements in incontinence relative to alternatives. The evidence is sufficient to determine that the technology results in a meaningful improvement in net health outcome.

For individuals with constipation who have failed conservative treatment who receive SNM, the evidence includes RCTs and systematic reviews. Relevant outcomes are symptoms, morbid events, and treatment-related morbidity. The available trials have not consistently reported improvements in incontinence with SNM. Additional studies are needed to demonstrate the net benefits of this technology. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals with chronic pelvic pain who receive SNM, the evidence is limited to case series. Relevant outcomes are symptoms, morbid events, and treatment-related morbidity. The evidence is insufficient to determine the effects of the technology on health outcomes.

Definiciones

NA

Exención de responsabilidad

Las políticas médicas de Capital Blue Cross se utilizan para determinar la cobertura de tecnologías, procedimientos, equipos y servicios médicos específicos. Estas políticas médicas no constituyen un consejo médico y están sujetas a cambios según lo exija la ley o la evidencia clínica aplicable de las pautas de tratamiento independientes. Los proveedores que brindan tratamiento son individualmente responsables de los consejos médicos y el tratamiento de los miembros. Estas políticas no son una garantía de cobertura o pago. El pago de las reclamaciones está sujeto a la determinación del programa de beneficios del miembro y la elegibilidad en la fecha del servicio, y a la determinación de que los servicios son médicamente necesarios y apropiados. Final processing of a claim is based upon the terms of contract that applies to the member's benefit program, including benefit limitations and exclusions. Si un proveedor o miembro tiene alguna pregunta sobre esta política médica, debe comunicarse con Servicios para proveedores o Servicios para miembros de Capital Blue Cross.

Coding Information

Note: This list of codes may not be all-inclusive, and codes are subject to change at any time. La identificación de un código en esta sección no denota cobertura, ya que la cobertura está determinada por los términos de la información de beneficios del miembro. Además, no todos los servicios cubiertos son elegibles para un reembolso por separado. Los códigos deben estar en orden numérico.

Covered when medically necessary:

Referencias

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2. Thaha MA, Abukar AA, Thin NN, et al. Sacral nerve stimulation for faecal incontinence and constipation in adults. Cochrane Database Syst Rev. Aug 24 2015; 2015(8): CD004464. PMID 26299888
3. 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. Oct 2013; 100(11): 1430-47. PMID 24037562
4. Tan E, Ngo NT, Darzi A, et al. Meta-analysis: sacral nerve stimulation versus conservative therapy in the treatment of faecal incontinence. Int J Colorectal Dis. Mar 2011; 26(3): 275-94. PMID 21279370
5. Maeda Y, Matzel K, Lundby L, et al. Postoperative issues of sacral nerve stimulation for fecal incontinence and constipation: a systematic literature review and treatment guideline. Dis Colon Rectum. Nov 2011; 54(11): 1443-60. PMID 21979192
6. Vollebregt PF, Goh YL, Chan CL, et al. Clinical effectiveness of subsensory sacral neuromodulation in adults with faecal incontinence: the SUBSoNIC crossover RCT and mechanistic study. Southampton (UK): National Institute for Health and Care Research; November 2024.
7. Tjandra JJ, Chan MK, Yeh CH, et al. Sacral nerve stimulation is more effective than optimal medical therapy for severe fecal incontinence: a randomized, controlled study. Dis Colon Rectum. May 2008; 51(5): 494-502. PMID 18278532
8. 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. Nov 2005; 242(5): 662-9. PMID 16244539
9. Wexner SD, Coller JA, Devroede G, et al. Sacral nerve stimulation for fecal incontinence: results of a 120-patient prospective multicenter study. Ann Surg. Mar 2010; 251(3): 441-9. PMID 20160636
10. Mellgren A, Wexner SD, Coller JA, et al. Long-term efficacy and safety of sacral nerve stimulation for fecal incontinence. Dis Colon Rectum. Sep 2011; 54(9): 1065-75. PMID 21825885
11. Hull T, Giese C, Wexner SD, et al. Long-term durability of sacral nerve stimulation therapy for chronic fecal incontinence. Dis Colon Rectum. Feb 2013; 56(2): 234-45. PMID 23303153
12. Altomare DF, Giuratrabocchetta S, Knowles CH, et al. Long-term outcomes of sacral nerve stimulation for faecal incontinence. Br J Surg. Mar 2015; 102(4): 407-15. PMID 25644687
13. Leo CA, Thomas GP, Bradshaw E, et al. Long-term outcome of sacral nerve stimulation for faecal incontinence. Colorectal Dis. Dec 2020; 22(12): 2191-2198. PMID 32954658
14. Desprez C, Damon H, Meurette G, et al. Ten-year Evaluation of a Large Retrospective Cohort Treated by Sacral Nerve Modulation for Fecal Incontinence: Results of a French Multicenter Study. Ann Surg. Apr 01 2022; 275(4): 735-742. PMID 32740249
15. De Meyere C, Nuytens F, Parmentier I, et al. Five-year single center experience of sacral neuromodulation for isolated fecal incontinence or fecal incontinence combined with low anterior resection syndrome. Tech Coloproctol. Sep 2020; 24(9): 947-958. PMID 32556866
16. 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. Feb 2022; 74(1): 185-191. PMID 34982410
17. Jottard K, Van den Broeck S, Komen N, et al. Treatment of Fecal Incontinence With a Rechargeable Sacral Neuromodulation System: Efficacy, Clinical Outcome, and Ease of Use-Six-Month Follow-Up. Neuromodulation. Oct 2021; 24(7): 1284-1288. PMID 33107663
18. Katuwal B, Thorsen A, Kochar K, et al. Outcomes and efficacy of magnetic resonance imaging-compatible sacral nerve stimulator for management of fecal incontinence: A multi-institutional study. World J Radiol. Feb 28 2024; 16(2): 32-39. PMID 38455883
19. 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. PMID 34599572
20. Pilkington SA, Emmett C, Knowles CH, et al. Surgery for constipation: systematic review and practice recommendations: Results V: Sacral Nerve Stimulation. Colorectal Dis. Sep 2017; 19 Suppl 3: 92-100. PMID 28960926
21. Thomas GP, Dudding TC, Rahbour G, et al. Sacral nerve stimulation for constipation. Br J Surg. Jan 2013; 100(2): 174-81. PMID 23124687
22. Knowles CH, Thin N, Gill K, et al. Prospective randomized double-blind study of temporary sacral nerve stimulation in patients with rectal evacuatory dysfunction and rectal hyposensitivity. Ann Surg. Apr 2012; 255(4): 643-9. PMID 22418005
23. Zerbib F, Siproudhis L, Lehur PA, et al. Randomized clinical trial of sacral nerve stimulation for refractory constipation. Br J Surg. Feb 2017; 104(3): 205-213. PMID 27779312
24. Dinning PG, Hunt L, Patton V, et al. Treatment efficacy of sacral nerve stimulation in slow transit constipation: a two-phase, double-blind randomized controlled crossover study. Am J Gastroenterol. May 2015; 110(5): 733-40. PMID 25895520
25. Kamm MA, Dudding TC, Melenhorst J, et al. Sacral nerve stimulation for intractable constipation. Gut. Mar 2010; 59(3): 333-40. PMID 20207638
26. Maeda Y, Lundby L, Buntzen S, et al. Sacral nerve stimulation for constipation: suboptimal outcome and adverse events. Dis Colon Rectum. Jul 2010; 53(7): 995-9. PMID 20551750
27. 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. Aug 2013; 92(8): 881-7. PMID 23710833
28. Martellucci J, Naldini G, Carriero A. Sacral nerve modulation in the treatment of chronic pelvic pain. Int J Colorectal Dis. Jul 2012; 27(7): 921-6. PMID 22203519
29. Siegel S, Paszkiewicz E, Kirkpatrick C, et al. Sacral nerve stimulation in patients with chronic intractable pelvic pain. J Urol. Nov 2001; 166(5): 1742-5. PMID 11586214
30. Greig J, Mak Q, Furrer MA, et al. Sacral neuromodulation in the management of chronic pelvic pain: A systematic review and meta-analysis. Neurourol Urodyn. Apr 2023; 42(4): 822-836. PMID 36877182
31. Baxter C, Kim JH. Contrasting the percutaneous nerve evaluation versus staged implantation in sacral neuromodulation. Curr Urol Rep. Sep 2010; 11(5): 310-4. PMID 20535593
32. 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. Sep 2011; 30(7): 1249-52. PMID 21404317
33. 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. Dec 2002; 90(9): 840-5. PMID 12460343
34. Wald A, Bharucha AE, Cosman BC, et al. ACG clinical guideline: management of benign anorectal disorders. Am J Gastroenterol. Aug 2014; 109(8): 1141-57; (Quiz) 1058. PMID 25022811
35. Wald A, Bharucha AE, Limketkai B, et al. ACG Clinical Guidelines: Management of Benign Anorectal Disorders. Am J Gastroenterol. Oct 01 2021; 116(10): 1987-2008. PMID 34618700
36. ACOG Practice Bulletin No. 210: Fecal Incontinence. Obstet Gynecol. Apr 2019; 133(4): e260-e273. PMID 30913197
37. Bordeianou, L. G., Thorsen, A. J., Keller, D. S., et al. The American Society of Colon and Rectal Surgeons Clinical Practice Guidelines for the Management of Fecal Incontinence. 2023. Diseases of the colon and rectum, 66(5), 647-661. https://doi.org/10.1097/DCR.0000000000002776
38. 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. Jun 2016; 59(6): 479-92. PMID 27145304
39. Alavi K, Thorsen AJ, Fang SH, et al. The American Society of Colon and Rectal Surgeons Clinical Practice Guidelines for the Evaluation and Management of Chronic Constipation. Dis Colon Rectum. Oct 01 2024; 67(10): 1244-1257. PMID 39250791
40. Chronic Pelvic Pain: ACOG Practice Bulletin, Number 218. Obstet Gynecol. Mar 2020; 135(3): e98-e109. PMID 32080051

Historial de políticas

• MA 1.033
• 9/10/2025 Creation of policy.