Percutaneous tibial nerve stimulation

Urinary incontinence

PTNS appears to be effective at improving the number of times a person needs to urinate who has overactive bladder syndrome. It appears to work as well as medication but to have less side effects.

Fecal incontinence

A review that looked at mostly low quality studies found tentative evidence of benefit. A more recent high quality study however did not find benefit in fecal incontinence.

Procedure

A patient sits comfortably with the treatment leg elevated. A fine needle electrode is inserted into the lower, inner aspect of the leg, slightly cephalad/rostral to the medial malleolus. As the goal is to send stimulation through the tibial nerve, it is important to have the needle electrode near (but not on) the tibial nerve. A surface electrode (grounding pad) is placed over the medial aspect of the calcaneus on the same leg. The needle electrode is then connected to an external pulse generator which delivers an adjustable electrical pulse that travels to the sacral plexus via the tibial nerve. Among other functions, the sacral nerve plexus regulates bladder and pelvic floor function.

With correct placement of the needle electrode and level of electrical impulse, there is often an involuntary toe flex or fan, or an extension of the entire foot. However, for some patients, the correct placement and stimulation may only result in a mild sensation in the ankle area or across the sole of the foot.

The treatment protocol requires once-a-week treatments for 12 weeks, 30 minutes per session. Many patients begin to see improvements by the 6th treatment. Patients who respond to treatment may require occasional treatments (~ once every 3 weeks) to sustain improvements.

PTNS is a low-risk procedure. The most common side-effects with PTNS treatment are temporary and minor, resulting from the placement of the needle electrode. They include minor bleeding, mild pain and skin inflammation.

Research and market approval

The methodology was first invented by Dr. Marshall Stoller at UCSF Medical Center, San Francisco, and was first known as the SANS protocol.

In 2000, Dr. Stoller reported that 98 patients were treated with the SANS device with an approximate 80% success rate in treating urge incontinence syndrome, including urgency and frequency. In a corroborative multi-center study by Govier, et al., 71% of patients achieved success. Additionally, in a study by Shafik, et al., 78% of patients achieved a long-term improvement in faecal incontinence when treated with PTNS.

Regulatory clearances were based on these data. A PTNS device received FDA-clearance for urinary urgency, urinary frequency and urge incontinence in 2000; in 2010, the clearance was updated to include Overactive Bladder (OAB). A PTNS device received the CE mark for urinary urgency, urinary frequency and urge incontinence and fecal incontinence in 2005.

Since 2005, Uroplasty has marketed the Urgent PC Neuromodulation System. In 2015, Medtronic acquired Advanced Uro-Solutions for its PTNS therapy, and began marketing the NURO PTNM System in 2016

U.S. reimbursement

Effective January 1, 2011, the PTNS procedure will be billed under the new CPT code 64566, with the descriptor "Posterior tibial neurostimulation, percutaneous needle electrode, single treatment, includes programming."

U.K. NICE guidance

In October 2010, the National Institute for Clinical Excellence (NICE) issued NICE Interventional Procedure Guidance 362 supporting the use of Percutaneous Tibial Nerve Stimulation (PTNS) as a routine treatment for Overactive Bladder syndrome. Highlights of the NICE guidance include: Evidence shows that PTNS is effective in reducing symptoms in the short and medium term.

There are no major safety concerns.

It can be offered routinely as a treatment option for people with overactive bladder provided that doctors are sure that the patients understand what is involved and agree to the treatment and that the results of the procedure are monitored.

A NICE guidance for fecal incontinence is currently under review.

Transcutaneous tibial nerve stimulation

Recent studies have been carried out to demonstrate the efficacy of transcutaneous tibial nerve stimulation with the use of external electrodes. Electrodes are applied near to the ankle where the tibial/sural nerve is located. It is believed that the electrical stimulation can penetrate the skin delivering tibial nerve stimulation in the same way, but without the need for a needle electrode. A study carried out by Glasgow Caledonian University reported that based on 7 case series 48–68% of patients treated via transcutaneous tibial nerve stimulation (external stimulation) saw a marked improvement or cure of their bladder irregularities (varying forms of incontinence). This is in contrast to the 60–80% success rate for treating overactive bladder using the percutaneous method (use of a needle stimulator). The study concludes that transcutaneous tibial nerve stimulation has a positive impact and an overall reduction in bladder weakness symptoms, supporting its use as a first line intervention.

Transcutaneous tibial nerve stimulation is also believed to be an effective treatment for fecal incontinence (FI). In a survey carried out by Gut (an international peer-reviewed journal for health professionals and researchers in gastroenterology and hepatology) it was found that 45% of their subjects receiving transcutaneous PTNS saw more than a 50% reduction in weekly episodes of faecal incontinence.

It is thought that further studies on alternative possible treatments, such as home based transcutaneous stimulation, are needed. However, it has proved a viable and successful treatment for many.