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DESCRIPTIONPosterior tibial nerve stimulation (PTNS) is a technique of electrical neuromodulation for the treatment of voiding dysfunction in patients who have failed behavioral and/or pharmacologic therapies. The tibial nerve is assessed using a fine-needle electrode inserted slightly above the ankle, and low-voltage electrical stimulation is delivered. The course of treatment is typically 10–12 weeks of 30-minute weekly sessions.
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.
Voiding dysfunction includes urinary frequency, urgency, incontinence, and nonobstructive retention. Common causes of voiding dysfunction are pelvic floor dysfunction (from pregnancy, childbirth, surgery, etc), 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, etc).
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, 10 Hz frequency) electrical stimulation which 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. PTNS studies have been designed as 30-minute sessions given weekly for 10-12 weeks. Recently, consideration has been given to increasing the frequency of treatments to 3 times per week to speed achievement of desired outcomes. However, an optimal treatment approach has not been identified and the durability of PTNS is uncertain.
PTNS must be distinguished from acupuncture with electrical stimulation. In electrical acupuncture, needles are also inserted just below the skin, but the placement of needles is based on specific theories regarding energy flow throughout the human body. Thus in PTNS, the location of stimulation is directly in the posterior tibial nerve rather than using the theories of energy flow that guide placement of stimulation for acupuncture.
In July 2005, the Urgent® PC Neuromodulation System (Uroplasty, Inc) received 510(k) marketing clearance for percutaneous tibial nerve stimulation to treat patients suffering from urinary urgency, urinary frequency, and urge incontinence. This 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 (K2992069, UroSurge, Inc.).
PTNS was developed as a less-invasive treatment alternative to traditional sacral root 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. PTNS is proposed as an office-based treatment that requires an initial series of 12 treatments followed by a maintenance treatment schedule as determined by the treating physician.
Note: Stimulation of the sacral nerve as a treatment of incontinence is discussed in a separate policy. See Sacral Nerve Stimulation.
Pelvic floor stimulation as a treatment of urinary incontinence refers to electrical stimulation of the pudendal nerve and is addressed in a separate policy. See Incontinence Therapy.
POLICYPosterior tibial nerve stimulation for urinary dysfunction, including but not limited to overactive bladder syndrome, urinary frequency, urgency, incontinence and retention, is considered investigational.
POLICY EXCEPTIONSFederal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
POLICY GUIDELINESInvestigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY9/29/2006: Policy updated
10/7/2008: Policy reviewed, no changes
04/13/2010: Policy description updated. Policy statement unchanged. FEP verbiage added to the Policy Exceptions section.
12/30/2010: Policy statement updated to add "overactive bladder syndrome" to the list of investigational indications.
04/18/2011: Policy reviewed; no changes.
07/12/2012: Policy reviewed; no changes.
SOURCE(S)Blue Cross Blue Shield Association Policy # 7.01.106
CODE REFERENCEThis is not an all-inclusive list of non-covered procedure codes.
All codes billed for this procedure are considered investigational and not eligible for coverage.