Tibial Nerve Stimulation

Policy Number: MA 1.134

Effective Date: 1/1/2026

Policy

Percutaneous tibial nerve stimulation for an initial 12-week course is considered medically necessary for individuals with non-neurogenic urinary dysfunction including overactive bladder who have both:

• Failed behavioral therapy following an appropriate duration of 8 to 12 weeks without meeting treatment goals; AND
• Failed pharmacologic therapy following 4 to 8 weeks of treatment without meeting treatment goals (see policy guidelines).

Maintenance therapy using monthly percutaneous tibial nerve stimulation is considered medically necessary for individuals following a 12-week initial course of percutaneous tibial nerve stimulation that resulted in improved urinary dysfunction meeting treatment goals.

Percutaneous tibial nerve stimulation is considered investigational for all other indications including, but not limited to, the following:

• Neurogenic bladder dysfunction; OR
• Fecal incontinence

There is insufficient evidence to support a general conclusion concerning the health outcomes or benefits associated with this procedure for these indications.

Subcutaneous tibial nerve stimulation delivered by an implantable neuromodulator system (e.g., eCoin®) is considered investigational for all indications, including individuals with non-neurogenic urinary dysfunction including overactive bladder. There is insufficient evidence to support a general conclusion concerning the health outcomes or benefits associated with this procedure.

Transcutaneous tibial nerve stimulation (e.g., Vitality System) is considered investigational for individuals with urinary incontinence and urinary urgency. There is insufficient evidence to support a general conclusion concerning the health outcomes or benefits associated with this procedure.

Cross-References

• MP 1.033 Sacral Nerve Neuromodulation/Stimulation and Pelvic Floor Stimulation for Urinary Incontinence
• MP 1.099 Periurethral Bulking Agents as Treatment of Vesicoureteral Reflux
• MP 2.066 Biofeedback and Neurofeedback Therapy
• MP 2.069 Electromyography (EMG) (Needle and Non-Needle) of the Anal or Urethral Sphincter
• MP 6.050 Percutaneous Electrical Nerve Stimulation (PENS) and Percutaneous Neuromodulation Therapy (PNT)

Product Variations

This policy is only applicable to certain programs and products administered by Capital Blue Cross and subject to benefit variations. Please see additional information below.

FEP PPO – Refer to FEP Medical Policy Manual.

Description/Background

Voiding Dysfunction

Common causes of non-neurogenic voiding dysfunction are pelvic floor neuromuscular changes (e.g., from pregnancy, childbirth, surgery), inflammation, medication (e.g., diuretics, anticholinergics), obesity, and psychogenic factors. Overactive bladder is a non-neurogenic voiding dysfunction characterized by urinary frequency, urgency, urge incontinence, and nonobstructive retention.

Neurogenic bladder dysfunction is caused by neurologic damage in patients with multiple sclerosis, spinal cord injury, detrusor hyperreflexia, or diabetes with peripheral nerve involvement. The symptoms include overflow incontinence, frequency, urgency, urge incontinence, and retention.

Treatment

Approaches to the treatment of incontinence differentiate between urge incontinence and stress incontinence. Conservative behavioral management such as lifestyle modification (e.g., dietary changes, weight reduction, fluid management, smoking cessation) along with pelvic floor exercises and bladder training are part of the initial treatment of overactive bladder symptoms and both types of incontinence. Pharmacotherapy is another option, and different medications target different symptoms. Some individuals experience mixed incontinence.

Policy Guidelines

If behavioral therapies and pharmacotherapy are unsuccessful, percutaneous tibial nerve stimulation (PTNS), sacral nerve stimulation, or botulinum toxin may be recommended.

Percutaneous Tibial Nerve Stimulation

The current indication cleared by the U.S. Food and Drug Administration (FDA) for PTNS is overactive bladder and associated symptoms of urinary frequency, urinary urgency, and urge incontinence.

Altering the function of the posterior tibial nerve with PTNS is believed to improve voiding function and control. The mechanism of action is believed to be retrograde stimulation of the lumbosacral nerves (L4-S3) via the posterior tibial nerve located near the ankle. The tibial nerve innervates control of the bladder detrusor and pelvic floor.

Administration of PTNS consists of inserting a needle above the medial malleolus into the posterior tibial nerve followed by the application of low-voltage (10 mA, 1-10 Hz) frequency electrical stimulation that produces sensory and motor responses and is designed to block afferent and efferent pathways or training of reflex arcs. Noninvasive PTNS has been developed with transcutaneous or surface electrodes. The recommended course of treatment is an initial series of 12 weekly office-based treatments followed by an individualized maintenance treatment schedule.

PTNS is less invasive than traditional sacral nerve neuromodulation (see cross-reference MP 1.033), which has been successfully used to treat urinary dysfunction but requires implantation of a permanent device. In sacral nerve neuromodulation, an implantable pulse generator that delivers controlled electrical impulses is attached to wire leads that connect to the sacral nerves, most commonly the S3 nerve root that modulates the neural pathways controlling bladder function.

PTNS has also been proposed as a treatment for non-neurogenic and neurogenic bladder syndromes and fecal incontinence.

Subcutaneous Tibial Nerve Stimulation

The current indication approved by the FDA for subcutaneous tibial nerve stimulation (STNS) is urgency urinary incontinence in individuals who are intolerant or who have had an inadequate response to more conservative therapies or who have undergone a surgical failure of PTNS. STNS is administered through an eCoin® leadless battery-powered implant placed near the tibial nerve. STNS offers a less invasive alternative to traditional sacral nerve neuromodulation by providing therapy through an automated leadless implant without the need for chronic outpatient PTNS treatment sessions.

Transcutaneous Tibial Nerve Stimulation

The current indication approved by the FDA for transcutaneous tibial nerve stimulation (TTNS) (Vitality System) is for the treatment of individuals with bladder conditions of urge urinary incontinence and urinary urgency. The device consists of a stimulator that is worn on the ankle and delivers electrical signals to the tibial nerve. This is typically an at-home treatment.

Regulatory Status

In 2005, the Urgent® PC Neuromodulation System was the initial PTNS device cleared for marketing by FDA through the 510(k) process to treat patients suffering from urinary frequency, urinary urgency, and urge incontinence. Additional percutaneous tibial nerve stimulators have been cleared for marketing through the 510(k) process. They are listed in Table 1.

The devices are not FDA-cleared for other indications, such as the treatment of fecal incontinence.

Wireless technology is evolving for the treatment of overactive bladder. In March 2022, the eCoin® Peripheral Neuromodulation 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 urgency urinary incontinence (P200038; FDA Product Code: GPT).

Table 1. FDA-Cleared Percutaneous Tibial Nerve Stimulators (FDA Product Code: NAM)

Rationale

Summary of Evidence

For individuals who have non-neurogenic urinary dysfunction including overactive bladder 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 SUmiT and the OrBIT trials are 2 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 vs sham at 12 weeks. In an additional, small sham-controlled trial, a 50% reduction in urge incontinent episodes was attained in 71% of PTNS group compared with 0% 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 overactive bladder 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 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 patients. While 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. Typical regimens schedule maintenance treatments every 4-6 weeks. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

For individuals who have non-neurogenic urinary dysfunction including overactive bladder and who have failed behavioral and pharmacologic therapy or who have responded to an initial course of PTNS and then receive subcutaneous tibial nerve stimulation (STNS), the evidence includes single-arm studies. Relevant outcomes are symptoms, change in disease status, functional outcomes, quality of life, and treatment-related morbidity. The pivotal open-label, single-arm study leading to FDA-approval of the subcutaneously implanted, wireless eCoin tibial nerve stimulation system demonstrated a 68% response rate at 48 weeks of follow-up which surpassed a performance goal of 40%. However, the certainty of the evidence is limited by the lack of comparator group and a lower response rate observed during the COVID-19 pandemic. Additionally, the FDA noted that the performance goal was identified after patients had already been implanted. An ongoing post-approval study may elucidate the certainty of benefit, including safety of reimplantation given battery lifespan concerns. The evidence is insufficient to determine that the technology results in an 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% 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 patients receiving sacral nerve simulation experienced significant benefits compared with patients receiving PTNS. A post hoc analysis of the larger trial suggested a subset of patients 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.

For individuals who have urge urinary incontinence and urinary urgency who receive transcutaneous tibial nerve stimulation, the evidence includes an RCT and a nonrandomized study. Relevant outcomes are symptoms, change in disease status, functional outcomes, quality of life, and treatment-related morbidity. The results of the available studies did not show a clear benefit of transcutaneous tibial nerve stimulation. The RCT showed statistically significant improvements in the primary outcome measure. However, the primary outcome was a composite score of patient reported outcomes. A secondary analysis on individual symptoms showed no significant difference between the active therapy arm and the sham arm for voids or urgency leaks. The nonrandomized open-label, single-arm study showed statistically significant improvements in daily voids, incontinence episodes, and urgency episodes. However, minimal clinically important differences were not reported for these outcomes. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Additional Information

2018 Input

Clinical input was sought to help determine whether the use of maintenance PTNS for individuals with non-neurogenic urinary dysfunction including overactive bladder who have failed behavioral and pharmacologic therapy and respond to an initial course of PTNS would provide a clinically meaningful improvement in the net health outcome and whether the use is consistent with generally accepted medical practice. In response to requests, clinical input was received from 3 physician respondents identified by specialty societies.

For individuals with non-neurogenic urinary dysfunction including overactive bladder who have failed behavioral and pharmacologic therapy and respond to an initial course of PTNS, clinical input supports this use provides a clinically meaningful improvement in net health outcome and indicates this use is consistent with generally accepted medical practice.

Definitions

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.

Urinary Retention is the inability to completely empty the bladder of urine.

Disclaimer

Capital Blue Cross’ medical policies are used to determine coverage for specific medical technologies, procedures, equipment, and services. These medical policies do not constitute medical advice and are subject to change as required by law or applicable clinical evidence from independent treatment guidelines. Treating providers are solely responsible for medical advice and treatment of members. These policies are not a guarantee of coverage or payment. Payment of claims is subject to a determination regarding the member’s benefit program and eligibility on the date of service, and a determination that the services are medically necessary and appropriate. Final processing of a claim is based upon the terms of contract that applies to the members’ benefit program, including benefit limitations and exclusions. If a provider or a member has a question concerning this medical policy, please contact Capital Blue Cross’ Provider Services or Member Services.

Coding Information

Note: This list of codes may not be all-inclusive, and codes are subject to change at any time. The identification of a code in this section does not denote coverage as coverage is determined by the terms of member benefit information. In addition, not all covered services are eligible for separate reimbursement. The codes need to be in numerical order.

The following tibial nerve stimulation devices are considered investigational; therefore, not covered:

^*These codes may be used for the Protect PNS device which has not been FDA approved

Covered when medically necessary, for treatment of non-neurogenic urinary dysfunction via percutaneous tibial nerve stimulation devices:

References

1. Wang M, Jian Z, Ma Y, et al. Percutaneous tibial nerve stimulation for overactive bladder syndrome: a systematic review and meta-analysis. Int Urogynecol J. Dec 2020; 31(12): 2457-2471. PMID 32681345
2. Xiong SC, Peng L, Hu X, et al. Effectiveness and safety of tibial nerve stimulation versus anticholinergic drugs for the treatment of overactive bladder syndrome: a meta-analysis. Ann Palliat Med. Jun 09 2021. PMID 34118839
3. Coolen RL, Groen J, Scheepe JR, et al. Transcutaneous Electrical Nerve Stimulation and Percutaneous Tibial Nerve Stimulation to Treat Idiopathic Nonobstructive Urinary Retention: A Systematic Review. Eur Urol Focus. Oct22 2020. PMID 33268327
4. 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. Jun 2021; 40(5):1078-1088. PMID 33973670
5. Tutolo M, Ammirati E, Heesakkers J, et al. Efficacy and Safety of Sacral and Percutaneous Tibial Neuromodulation in Non-neurogenic Lower Urinary Tract Dysfunction and Chronic Pelvic Pain: A Systematic Review of the Literature. Eur Urol. Mar 2018; 73(3): 406-418. PMID 29336927
6. Tutolo M, Ammirati E, Van der Aa F. What Is New in Neuromodulation for Overactive Bladder?. Eur Urol Focus. Jan 2018; 4(1): 49-53. PMID 29773501
7. Stewart F, Gameiro LF, El Dib R, et al. Electrical stimulation with non-implanted electrodes for overactive bladder in adults. Cochrane Database Syst Rev. Dec 09 2016; 12: CD010098. PMID 27935011
8. Burton C, Sajja A, Latthe PM. Effectiveness of percutaneous posterior tibial nerve stimulation for overactive bladder: a systematic review and meta-analysis. Neurourol Urodyn. Nov 2012; 31(8): 1206-16. PMID 22581511
9. 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. Nov 2012; 23(11): 1591-7. PMID 22411208
10. Moossdorff-Steinhauser HF, Berghmans B. Effects of percutaneous tibial nerve stimulation on adult patients with overactive bladder syndrome: a systematic review. Neurourol Urodyn. Mar 2013; 32(3): 206-14. PMID 22907807
11. Gaziev G, Topazio L, Iacovelli V, et al. Percutaneous Tibial Nerve Stimulation (PTNS) efficacy in the treatment of lower urinary tract dysfunctions: a systematic review. BMC Urol. Nov 25 2013; 13: 61. PMID 24274173
12. Shamliyan T, Wyman J, Kane RL. Nonsurgical Treatments for Urinary Incontinence in Adult Women: Diagnosis and Comparative Effectiveness (Comparative Effectiveness Review No. 36). Rockville, MD: Agency for Healthcare Research and Quality; 2012.
13. Finazzi-Agro E, Petta F, Sciobica F, et al. Percutaneous tibial nerve stimulation effects on detrusor overactivity incontinence are not due to a placebo effect: a randomized, double-blind, placebo controlled trial. J Urol. Nov 2010;184(5): 2001-6. PMID 20850833
14. 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. Apr 2010;183(4): 1438-43. PMID 20171677
15. Peters K, Carrico D, Burks F. Validation of a sham for percutaneous tibial nerve stimulation (PTNS). Neurourol Urodyn. 2009; 28(1): 58-61. PMID 18671297
16. 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. Jun 2013; 189(6): 2194-201. PMID 23219541
17. Vecchioli-Scaldazza C, Morosetti C. Effectiveness and durability of solifenacin versus percutaneous tibial nerve stimulation versus their combination for the treatment of women with overactive bladder syndrome: a randomized controlled study with a follow-up of ten months. Int Braz J Urol. Jan-Feb 2018; 44(1): 102-108. PMID 29064651
18. Boudaoud N, Binet A, Line A, et al. Management of refractory overactive bladder in children by transcutaneous posterior tibial nerve stimulation: A controlled study. J Pediatr Urol. Jun 2015; 11(3): 138.e1-10. PMID 25979217
19. 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.PMID 23171636
20. 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. Aug 2015; 191: 51-6. PMID 26073262
21. Vecchioli-Scaldazza C, Morosetti C, Berouz A, et al. Solifenacin succinate versus percutaneous tibial nerve stimulation in women with overactive bladder syndrome: results of a randomized controlled crossover study. Gynecol Obstet Invest. 2013; 75(4): 230-4. PMID 23548260
22. 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. Sep 2010; 21(9): 1065-70. PMID 20458465
23. Peters KM, Macdiarmid SA, Wooldridge LS, et al. Randomized trial of percutaneous tibial nerve stimulation versusextended-release tolterodine: results from the overactive bladder innovative therapy trial. J Urol. Sep 2009; 182(3):1055-61. PMID 19616802
24. MacDiarmid SA, Peters KM, Shobeiri SA, et al. Long-term durability of percutaneous tibial nerve stimulation for the treatment of overactive bladder. J Urol. Jan 2010; 183(1): 234-40. PMID 19913821
25. Schneider MP, Gross T, Bachmann LM, et al. Tibial Nerve Stimulation for Treating Neurogenic Lower Urinary Tract Dysfunction: A Systematic Review. Eur Urol. Nov 2015; 68(5): 859-67. PMID 26194043
26. Monteiro ES, de Carvalho LB, Fukujima MM, et al. Electrical stimulation of the posterior tibialis nerve improves symptoms of poststroke neurogenic overactive bladder in men: a randomized controlled trial. Urology. Sep 2014;84(3): 509-14. PMID 25168524
27. 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. Jan-Feb 2015; 42(1): 94-9. PMID 25549314
28. Gaspard L, Tombal B, Opsomer RJ, et al. [Physiotherapy and neurogenic lower urinary tract dysfunction in multiple sclerosis patients: a randomized controlled trial]. Prog Urol. Sep 2014; 24(11): 697-707. PMID 25214451
29. Eftekhar T, Teimoory N, Miri E, et al. Posterior tibial nerve stimulation for treating neurologic bladder in women: a randomized clinical trial. Acta Med Iran. 2014; 52(11): 816-21. PMID 25415813
30. Zonic-Imamovic M, Imamovic S, Cickusic A, et al. Effects of Treating an Overactive Urinary Bladder in Patients with Multiple Sclerosis. Acta Med Acad. Dec 2019; 48(3): 271-277. PMID 32124625
31. Welk B, McKibbon M. A randomized, controlled trial of transcutaneous tibial nerve stimulation to treat overactive bladder and neurogenic bladder patients. Can Urol Assoc J. Jul 2020; 14(7): E297-E303. PMID 32017693
32. Sarveazad A, Babahajian A, Amini N, et al. Posterior Tibial Nerve Stimulation in Fecal Incontinence: A SystematicReview and Meta-Analysis. Basic Clin Neurosci. Sep-Oct 2019; 10(5): 419-431. PMID 32284831
33. Tan K, Wells CI, Dinning P, et al. Placebo Response Rates in Electrical Nerve Stimulation Trials for Fecal Incontinence and Constipation: A Systematic Review and Meta-Analysis. Neuromodulation. Dec 2020; 23(8): 1108-1116. PMID 31889364
34. 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. May 2018; 33(5): 645-648. PMID 9470730
35. Edenfield AL, Amundsen CL, Wu JM, et al. Posterior tibial nerve stimulation for the treatment of fecal incontinence:a systematic evidence review. Obstet Gynecol Surv. May 2015; 70(5): 329-41. PMID 25974730
36. Horrocks EJ, Thin N, Thaha MA, et al. Systematic review of tibial nerve stimulation to treat faecal incontinence. Br J Surg. Apr 2014; 101(5): 457-68. PMID 24446127
37. George AT, Kalmar K, Sala S, et al. Randomized controlled trial of percutaneous versus transcutaneous posterior tibial nerve stimulation in faecal incontinence. Br J Surg. Feb 2013; 100(3): 330-8. PMID 23300071
38. 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. Oct 24 2015; 386(10004): 1640-8. PMID 26293315
39. 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. Dec 2017; 15(12): 1915-1921.e2. PMID 28647458
40. Thin NN, Taylor SJ, Bremner SA, et al. Randomized clinical trial of sacral versus percutaneous tibial nerve stimulation in patients with faecal incontinence. Br J Surg. Mar 2015; 102(4): 349-58. PMID 25644291
41. 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. Apr 01 2021; 64(4): 466-474. PMID 33399411
42. Sanagapalli S, Neilan L, Lo JYT, et al. Efficacy of Percutaneous Posterior Tibial Nerve Stimulation for the Management of Fecal Incontinence in Multiple Sclerosis: A Pilot Study. Neuromodulation. Oct 2018; 21(7): 682-687. PMID 29575432
43. 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. Sep 2019; 202(3): 558-563. PMID 31039103
44. Gormley EA, Lightner DJ, Faraday M, et al. Diagnosis and treatment of overactive bladder (non-neurogenic) in adults: AUA/SUFU guideline amendment. J Urol. May 2015;193(5):1572-1580. PMID 25623739
45. ACOG Practice Bulletin No. 155: Urinary Incontinence in Women. Obstet Gynecol. Nov 2015; 126(5): e66-e81.PMID 26488524
46. Bharucha AE, Rao SSC, Shin AS. Surgical Interventions and the Use of Device-Aided Therapy for the Treatment of Fecal Incontinence and Defecatory Disorders. Clin Gastroenterol Hepatol. Dec 2017; 15(12): 1844-1854. PMID
47. Lukacz, E. Female urinary incontinence: Treatment. In: UpToDate Online Journal [serial online]. Waltham, MA: UpToDate; updated July 13, 2022
48. van Breda HMK, Martens FMJ, Tromp J, Heesakkers JPFA. A New Implanted Posterior Tibial Nerve Stimulator for the Treatment of Overactive Bladder Syndrome: 3-Month Results of a Novel Therapy at a Single Center. J Urol. 2017 Jul;198(1):205-210. PMID: 28189576.
49. MacDiarmid S, Staskin DR, Lucente V, Kaaki B, English S, Gilling P, Meffan P, Clark M, Sand PK, Sen SK, Rovner E. 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 May;201(5):967-972. PMID: 31009968.
50. Gilling P, Meffan P, Kaaki B, et al. Twelve-month Durability of a Fully-implanted, Nickel-sized and Shaped Tibial Nerve Stimulator for the Treatment of Overactive Bladder Syndrome with Urgency Urinary Incontinence: A Single-Arm, Prospective Study. Urology. Nov 2021; 157: 71-78. PMID 34048826
51. Kaaki B, English S, Gilling P, Meffan P, Lucente V, MacDiarmid S, 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 May 1;28(5):287-292 PMID: 35536667
52. Rogers A, Bragg S, Ferrante K, Thenuwara C, Peterson DKL. Pivotal Study of Leadless Tibial Nerve Stimulation with eCoin® for Urgency Urinary Incontinence: An Open-Label, Single Arm Trial. J Urol. 2021Aug;206(2):399-408 PMID: 33797291
53. United States Food and Drug Administration (FDA). PMA database. P200036. ECoin® Peripheral Neurostimulator. 2022 July.
54. Ginsberg DA, Boone TB, Cameron AP et al: The AUA/SUFU Guideline on Adult Neurogenic Lower Urinary Tract Dysfunction: Treatment and Follow-up. J Urol 2021; 206: 1106.
55. Tudor KI, Seth JH, Liechti MD, et al. Outcomes following percutaneous tibial nerve stimulation (PTNS) treatment for neurogenic and idiopathic overactive bladder. Clin Auton Res. 2020;30(1):61-67. doi:10.1007/s10286-018-0553-8
56. Luo C, Wei D, Pang K, et al. Is percutaneous tibial nerve stimulation (PTNS) effective for fecal incontinence (FI) in adults compared with sham electrical stimulation? A meta-analysis. Tech Coloproctol. Feb 24 2024; 28(1): 37. PMID 38401006
57. Cameron AP, Chung DE, Dielubanza EJ, et al. The AUA/SUFU guideline on the diagnosis and treatment of idiopathic overactive bladder. J Urol. Published online April 23, 2024. doi:10.1097/JU.0000000000003985.

Policy History

• MA 1.134
• 8/8/2025 Policy creation.
• 12/11/2025 Administrative update. Added new codes 0988T and 0989T. Effective 01/01/2026.