Clinical Policy: Posterior Tibial Nerve Stimulation for Voiding Dysfunction

Reference Number: CP.MP.133
Date of Last Revision: 07/25

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See Important Reminder at the end of this policy for important regulatory and legal information.

Description

Posterior tibial nerve stimulation (PTNS), also known as peripheral tibial nerve stimulation, is a minimally invasive form of electrical neuromodulation used to treat overactive bladder (OAB) syndrome and associated symptoms of urinary urgency, urinary frequency, and urge urinary incontinence.¹ This policy describes the medical necessity requirements for posterior tibial nerve stimulation.

IV. It is the policy of health plans affiliated with Centene Corporation that there is insufficient evidence in the published peer-reviewed literature to support the use of implantable tibial nerve stimulation for the treatment of urinary voiding dysfunction.

Background

The term “voiding dysfunction” has been used to refer to urinary incontinence, urinary retention, and symptoms of urinary frequency and urgency. Overactive bladder (OAB) is a specific type of voiding dysfunction that includes any of the following symptoms: urinary frequency, urinary urgency, urge incontinence, and nocturia.² OAB can significantly impact quality of life including physical function, sexual function, and social interactions. Treatments for OAB include lifestyle changes, bladder training, pelvic floor muscle training and anticholinergic (anti-muscarinic) drugs.³

Clinical Policy

Posterior Tibial Nerve Stimulation for Voiding Dysfunction

Posterior tibial nerve stimulation (PTNS) involves indirect modulation of the specific nerve that controls bladder function (i.e., the sacral nerve plexus) via stimulation of the posterior tibial nerve accessed just above the ankle. This minimally invasive form of neuromodulation consists of insertion of a 34-gauge needle electrode approximately five centimeters (cm) cephalad to the medial malleolus and two cm posterior to the tibia near the tibial nerve. A surface electrode is placed on the medial aspect of the foot. The needle electrode is connected via a lead wire to a low-voltage electrical stimulator. Stimulation is administered at a current level of 0.5 to nine milliamperes (mA) at 20 hertz (Hz) and continues for 30 minutes. Initial treatment regimens typically consist of 12 weekly sessions, with responders exhibiting some symptom improvement after six to eight sessions. Maintenance treatment sessions may be required to sustain the response to treatment.⁴

Several implantable tibial nerve neuromodulation systems, including a battery-less leadless, miniature implantable device, are currently under investigation for the management of OAB, however, evidence is still limited on their benefits and efficacy at this time.

National Institute for Health and Care Excellence (NICE)

According to NICE, current evidence demonstrates that PTNS for OAB syndrome is effective in reducing symptoms in the short term and medium term. Per NICE guidance, PTNS for OAB syndrome does not have major safety concerns, and the use of this procedure should comply with standard protocols for consent, audit, and clinical governance.³

A NICE guidance on urinary incontinence in women does not recommend the “routine” use of PTNS to treat OAB. Rather, they recommend PTNS for OAB for the following²:

• There has been a multidisciplinary team (MDT) review, and
• Conservative management including OAB drug treatment has not worked adequately, and
• The woman does not want botulinum toxin A or percutaneous sacral nerve stimulation.

American Urological Association

Clinicians may offer PTNS as third-line treatment in a carefully selected patient population, characterized by moderately severe baseline incontinence and frequency and willingness to comply with the PTNS protocol. Patients must also have the resources to make frequent office visits both during the initial treatment phase and to obtain maintenance treatments in order to achieve and maintain treatment effects.¹ The most common protocol is the application of 30 minutes of stimulation once a week for 12 weeks (the trial duration; for continued benefit, weekly stimulation would have to continue).¹,⁴,⁶

Studies to date evaluating PTNS for the treatment of OAB conclude there is evidence of benefit, although most studies have been small and report short-term outcomes after 12 weeks of treatment. A small study of 33 PTNS responders who continued therapy for six to12 months reported excellent durability after 12 months.⁷ Another small study reported sustained safety and efficacy of PTNS for the treatment of OAB symptom control over 24 months with initial success after 12 weekly treatments, followed by a 14-week prescribed tapering protocol and a personalized treatment plan with an average of 1.3 treatments per month.⁸

Clinical Policy

Posterior Tibial Nerve Stimulation for Voiding Dysfunction

Coding Implications