Posterior Tibial Nerve Stimulation
© Blue Cross and Blue Shield of Montana
Current Effective Date:
March 27, 2013
Original Effective Date:
December 18, 2009
March 27, 2013
June 1, 2011; June 11, 2012; March 27, 2013
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).
Posterior tibial nerve stimulation (PTNS) is a technique of electrical neuromodulation used for treating voiding dysfunction. Altering the function of the posterior tibial nerve with 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. 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 (10mA, 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 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.).
BCBSMT considers all other uses of PTNS are considered experimental, investigational and unproven, including but not limited to:
- Continued therapy after initial 12 weeks when no improvement is seen;
- Continued therapy after 1 year of maintenance therapy;
- Stress incontinence;
- Interstitial cystitis;
- Neurogenic bladder due to neurologic impairment (e.g., spinal cord injury, multiple sclerosis, Alzheimers disease, Parkinsons disease, stroke, etc.);
- Obstructive urinary retention.
Federal mandate prohibits denial of any drug, device or biological product fully approved by the FDA as investigational for the Federal Employee Program (FEP). In these instances coverage of these FDA-approved technologies are reviewed on the basis of medical necessity alone.
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, Carrico D, Burks F. Validation of a sham for percutaneous tibial nerve stimulation (PTNS). Neurourol Urodyn 2009; 28(1):58-61.
- 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):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.
- Modified Extension Study to the SUmiT Trial: evaluation of long term therapy with percutaneous tibial nerve stimulation (PTNS) for overactive bladder syndrome (STEP). NCT00928385. Available online at: www.ClinicalTrials.gov . Last accessed October 2010.
- 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.
- 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 (In press, Tab to be determined).
- American College of Obstetricians and Gynecologists (ACOG). Urinary incontinence in women. ACOG Practice Bulletin, no. 63. Available online at the National Guideline Clearinghouse website, www.guideline.gov (Last accessed December 2010).
- Posterior Tibial Nerve Stimulation for Voiding Dysfunction. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (2011 January) 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.|