Posterior Tibial Nerve Stimulation
© Blue Cross and Blue Shield of Montana
Current Effective Date:
March 15, 2014
Original Effective Date:
December 18, 2009
January 15, 2014
June 1, 2011; June 11, 2012; March 27, 2013; January 15, 2014
Altering the function of the posterior tibial nerve with posterior tibial nerve stimulation (PTNS) is believed to improve voiding function and control. While the posterior tibial nerve is located near the ankle, it is derived from the lumbar-sacral nerves (L4-S3), which control the bladder detrusor and perineal floor. Voiding dysfunction includes urinary frequency, urgency, incontinence, and nonobstructive retention. Common causes of voiding dysfunction are pelvic floor dysfunction (e.g., from pregnancy, childbirth, surgery), inflammation, medication (e.g., diuretics and anticholinergics), obesity, psychogenic factors, and disease (e.g., multiple sclerosis, spinal cord injury, detrusor hyperreflexia, diabetes with peripheral nerve involvement).
The procedure for PTNS consists of the insertion of 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 (i.e., a tickling sensation and plantar flexion or fanning of all toes). Noninvasive PTNS has also been delivered with 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, which has been successfully used in the treatment of urinary dysfunction but requires implantation of a permanent device. In sacral root 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.
In July 2005, the Urgent® PC Neuromodulation System (Uroplasty, Inc.) received 510(k) marketing clearance from the U.S. Food and Drug Administration (FDA) for percutaneous tibial nerve stimulation to treat patients suffering from urinary urgency, urinary frequency, and urge incontinence. The device was cleared as a class II ‘‘nonimplanted, peripheral nerve stimulator for pelvic floor dysfunction” because it was considered to be substantially equivalent to the previously cleared percutaneous Stoller afferent nerve system (PerQ SANS System) in 2001 (K992069, UroSurge, Inc.).
04.92, 596.51, 788.20-788.29, 788.30-788.39, 788.41, 788.63
N32.81, N39.41-N39.498, R33.0–R33.9, R35.0, R39.15, 01HY3MZ
- Peters K, MacDiarmid SA, Wooldridge LS et al. Randomized trial of percutaneous tibial nerve stimulation versus extended-release tolterodine: results from the overactive bladder innovative therapy trial. J Urol 2009; 182(3-Jan):1055-61.
- MacDiarmid SA, Peters KM, Shobeiri SA et al. Long-term durability of percutaneous tibial nerve stimulation for the treatment of overactive bladder. J Urol 2010; 183(1):234-40.
- Peters KM, Carrico DJ, Perez-Marrero P et al. Randomized trial of percutaneous tibial nerve stimulation versus sham efficacy in the treatment of overactive bladder syndrome: results from the SUmiT trial. J Urol 2010; 183(4):1438-43.
- Peters K, Carrico D, Burks F. Validation of a sham for percutaneous tibial nerve stimulation (PTNS). Neurourol Urodyn 2009; 28(1):58-61.
- Peters KM, Carrico DJ, MacDiarmid SA et al. Sustained therapeutic effects of percutaneous tibial nerve stimulation: 24-month results of the STEP study. Neurourol Urodyn 2013; 32(1):24-9.
- 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 2012 [Epub ahead of print].
- 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 2010; 184(5):2001-6.
- Schreiner L, dos Santos TG, Knorst MR et al. Randomized trial of transcutaneous tibial nerve stimulation to treat urge urinary incontinence in older women. Int Urogynecol J 2010; 21(9):1065-70.
- 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.
- 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 [Epub ahead of print].
- Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Percutaneous tibial nerve stimulation for the treatment of voiding dysfunction. TEC Assessments 2010; Volume 25, Tab 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 2012; 31(8):1206-16.
- Levin PJ, Wu JM, Kawasaki A et al. The efficacy of posterior tibial nerve stimulation for the treatment of overactive bladder in women: a systematic review. Int Urogynecol J 2012; 23(11):1591-7.
- Moossdorff-Steinhauser HF, Berghmans B. Effects of percutaneous tibial nerve stimulation on adult patients with overactive bladder syndrome: a systematic review. Neurourol Urodyn 2013; 32(3):206-14.
- Shamliyan T, Wyman J, Kane RL. Nonsurgical Treatments for Urinary Incontinence in Adult Women: Diagnosis and Comparative Effectiveness. Rockville (MD) 2012.
- Yoong W, Ridout AE, Damodaram M et al. Neuromodulative treatment with percutaneous tibial nerve stimulation for intractable detrusor instability: outcomes following a shortened 6-week protocol. BJU Int 2010; 106(11-Jan):1673-6.
- Yoong W, Shah P, Dadswell R et al. Sustained effectiveness of percutaneous tibial nerve stimulation for overactive bladder syndrome: 2-year follow-up of positive responders. Int Urogynecol J 2012 [Epub ahead of print].
- Gobbi C, Digesu GA, Khullar V et al. Percutaneous posterior tibial nerve stimulation as an effective treatment of refractory lower urinary tract symptoms in patients with multiple sclerosis: preliminary data from a multicentre, prospective, open label trial. Mult Scler 2011; 17(12):1514-9.
- De Seze M., Raibaut P, Gallien P et al. Transcutaneous posterior tibial nerve stimulation for treatment of the overactive bladder syndrome in multiple sclerosis: results of a multicenter prospective study. Neurourol Urodyn 2011; 30(3):306-11.
- American Urological Association (AUA) and Society of Urodynamics FPMURS. Diagnosis and treatment of overactive bladder (non-neurogenic) in adults/AUA/SUFU guideline. Available online at: www.guideline.gov . Last accessed April, 2013.
- American College of Obstetricians and Gynecologists (ACOG). Urinary incontinence in women. ACOG Practice Bulletin, no. 63. Available online at: www.guideline.gov . Last accessed March, 2013.
- Percutaneous posterior tibial nerve stimulation for overactive bladder syndrome. National Institute for Health and Clinical Excellence (NICE) Guidance 362, October 2010. Available at: www.nice.org.uk . Last accessed October 2014.
- Posterior Tibial Nerve Stimulation for Voiding Dysfunction. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (May 2013) Surgery 7.01.106.
||Policy reviewed no change to policy statement or coding; Updated rationale and references.|
||Policy updated with literature review. References 8-11 added; other references renumbered. Neurogenic bladder added to list of investigational indications. Clinical input added.|
||Policy title changed from "Posterior Tibial Nerve Stimulation for Voiding Dysfunction" to "Posterior Tibial Nerve Stimulation." Policy statement changed from investigational to include medically necessary indications. Removed CPT codes 97014 and 97032.|
||Document updated with literature review. The following was added to Coverage: 1) If the patient has shown continued improvement from the first year of treatments with PTNS for OAB, continued PTNS therapy may be considered medically necessary when administered once every 3 weeks to maintain symptom improvement in responders for an additional 12 months, for up to a maximum of 36 months total; 2) Continued PTNS therapy after 12 months when improvement is not sustained, and/or PTNS therapy beyond 36 months are considered experimental, investigational and/or unproven.|