Overactive bladder (OAB) syndrome is defined as an urgency to void with or without incontinence. There are two main types of incontinence: stress urinary incontinence (SIU) and urgency urinary incontinence (UUI). UUI is defined as the involuntary loss of urine associated with urgency. First line therapy for OAB may include behavioral treatments such as bladder training, urge control techniques, pelvic muscle training, caffeine reduction, fluid management and dietary changes. Behavioral therapies may be combined with pharmacological management such as antimuscarinic agents or oral β3-adrenoceptor agonists. Conservative treatment options may be unsuccessful in alleviating symptoms; second line treatment options may include incontinence surgery, onabotulinumtoxin A bladder injections and various neuromodulation techniques.

Posterior tibial nerve stimulation is a technique of electrical neuromodulation used primarily for treating urinary dysfunction. Altering the function of the posterior tibial nerve is believed to improve urinary function and control. Although 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.

Percutaneous tibial nerve stimulation (PTNS) involves the insertion of a fine-needle electrode above the ankle into the posterior tibial nerve followed by the application of low-voltage electrical stimulation. The Urgent^® PC Neuromodulation System has been cleared for marketing by the U.S. Food and Drug Administration (FDA) for percutaneous tibial nerve stimulation to treat patients diagnosed with overactive bladder (OAB) and experiencing associated symptoms of urinary urgency, urinary frequency, and urge incontinence.

Subcutaneous tibial nerve stimulation (STNS) is administered through a coin-sized leadless battery-powered implant. STNS offers a less invasive alternative to traditional percutaneous nerve neuromodulation and offers a convenient delivery system for automated treatments without the need for chronic outpatient PTNS treatment sessions. The eCoin^® Peripheral Neurostimulator System is the first subcutaneous tibial nerve stimulation (STNS) implant approved by the FDA through the premarket authorization (PMA) process for individuals with urgency urinary incontinence. The FDA requires post approval study (PAS) of eCoin^® as a condition of continued approval.

Transcutaneous tibial nerve stimulation (TTNS) is a form of neuromodulation involving the use of electrical impulses to address urinary symptoms. Two electrodes are placed on the medial ankle overlying the posterior tibial nerve, and specific parameters are set on the TENS machine by a physiotherapist. Patients then use TTNS at home daily for 12 weeks, for 30 minutes each session. The ZIDA Wearable Neuromodulation System is a neuromodulation system approved by the FDA through the premarket authorization (PMA) process, for the treatment of patients with an overactive bladder (OAB) and associated urinary symptoms. The ZIDA System is a home-use neuromodulation system that is designed to deliver non-invasive access to the sacral nerve plexus through transcutaneous electrical stimulation of the posterior tibial nerve.

I.    Percutaneous posterior tibial nerve stimulation may be considered MEDICALLY NECESSARY AND APPROPRIATE for the treatment of urinary dysfunction (i.e., incontinence, urgency frequency, and non- obstructive urinary retention) in patients who meet ALL the following criteria:

• Absence of neurologic disease associated with detrusor hyperreflexia; AND
• Absence of outlet obstruction; AND
• Symptoms have resulted in significant disability (e.g., the frequency and/or severity of leakages are limiting the patient's ability to work or participate in activities outside the home); AND
• Trial and failure of conservative forms of treatment, including BOTH of the following: 
  • Behavioral therapy (e.g., bladder training, bladder control strategies, pelvic floor muscle training, fluid management) following 12 weeks of treatment without meeting treatment goals; AND 
  • Pharmacologic therapy following 8 weeks of treatment without meeting treatment goals OR inability to tolerate pharmacologic therapy.

II.   The use of percutaneous posterior tibial nerve stimulation for any other indication is considered EXPERIMENTAL/INVESTIGATIVE due to a lack of clinical evidence demonstrating an impact on improved health outcomes.

III. Posterior tibial nerve stimulation by any other means (e.g., subcutaneous, transcutaneous, implantable) is considered EXPERIMENTAL/INVESTIGATIVE for all indications due to a lack of clincial evidence demonstrating an impact on improved health outcomes.