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Percutaneous tibial nerve stimulation (PTNS) is one of the least invasive forms of neurostimulation, currently used to treat the urinary urgency, urinary frequency and urge incontinence associated with a variety of urologic conditions including overactive bladder (OAB), and interstitial cystitis. Outside the United States, PTNS is also used to treat fecal incontinence.

Contents

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 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, roughly 30 minutes per session. On-going therapy may be required for some patients.

PTNS is a low-risk procedure and is generally not associated with serious adverse events. Patients may experience mild bleeding or transient mild pain at the stimulation site.[1]

Research and development

The methodology was first invented by Dr. Marshall Stoller at UCSF Medical Center, San Francisco, and was first known as the SANS protocol. Dr. Stoller's goal was to create an alternative to the more invasive sacral neuromodulation devices. Thus, rather than requiring an incision and placement of electrodes in the sacrum, PTNS utilizes the nerve root (S3) but at a location much closer to the surface of the skin, slightly above the ankle.

In 2000, Dr. Stoller reported that 100 patients were treated with the SANS device with an approximate 80% success rate in treating urge incontinence syndrome, including urgency and frequency.[2] In a corroborative multi-center study by Govier, et al., 71% of patients achieved success. [3] Additionally, in a study by Shafik, et al., 78% of patients achieved a long-term improvement in faecal incontinence when treated with PTNS.[4] Several additional studies have been published, which on average, reinforce a patient response rate of just over 70%.[5]

PTNS has faced challenges in the industrial sector. The first company to attempt to market Dr. Stoller's device was called Urosurge, based in the USA. After conducting an international product launch in London, the company went out of business. Both UCSF & Dr. Stoller then attempted to find another company to carry on their work, to no avail. Another company, Cystomedix, purchased the intellectual property from UroSurge and attempted to market the device. In Dec. 2004, Uroplasty acquired Cystomedix and subsequently redesigned the product. [6] Uroplasty currently offers the only PTNS device available today, which they call Urgent PC Neuromodulation System.

See also

References

  1. ^ Govier, F.E., Litwiller, S., Nitti, V., Kreder, K.J., Jr., & Rosenblatt, P. (2001). Percutaneous afferent neuromodulation for the refractory overactive bladder: Results of a multi-center study Journal of Urology. 165. pp. 1193–1198.  
  2. ^ Dr. Marshall Stoller's Guest Lecture On IC Network
  3. ^ Govier, F.E., Litwiller, S., Nitti, V., Kreder, K.J., Jr., & Rosenblatt, P. (2001). Percutaneous afferent neuromodulation for the refractory overactive bladder: Results of a multi-center study Journal of Urology. 165. pp. 1193–1198.  
  4. ^ Shafik, A., Ahmed, I., El-Sibai, O., & Mostafa, R.M. (2003). "Percutaneous peripheral neuromodulation in the treatment of fecal incontinence". Eur Surg Res 35 (2): 103–107.  
  5. ^ Martinson, M (2008). Meta-Analysis of PTNS for Urinary Disorders. Sponsored by Uroplasty, Inc.
  6. ^ Uroplasty Press Release Announcing Cystomedix Acquisition

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