Percutaneous tibial nerve stimulation

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Percutaneous tibial nerve stimulation (PTNS), also referred to as posterior tibial nerve stimulation, is the least invasive forms of neuromodulation used to treat overactive bladder (OAB) and the associated symptoms of urinary urgency, urinary frequency and urge incontinence. These urinary symptoms may also occur with interstitial cystitis and following a post-radical prostatectomy. Outside the United States, PTNS is also used to treat fecal incontinence.

PTNS can be used as a primary therapy. However, treatment for Overactive Bladder and Fecal Incontinence begins with conservative therapies including pharmacology. There are a variety of OAB drugs available that generally produce similar overall efficacy and side-effects.[1] Nearly 80% of patients discontinue use (mean of 4.8 months) of drugs within the first year[2] with as high as 17% of discontinuation being due to adverse side-effects.[3] Neuromodulation is emerging as an effective modality to treat patients who are not successful with conservative methods and its demonstrated efficacy has been the topic of multiple publications.[4][5]

PTNS is delivered using the Urgent PC Neuromodulation System available from Uroplasty, Inc., Minnetonka, MN.

Procedure[edit]

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, 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.[6]

Research and market approval[edit]

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.[7] In a corroborative multi-center study by Govier, et al., 71% of patients achieved success.[8] Additionally, in a study by Shafik, et al., 78% of patients achieved a long-term improvement in faecal incontinence when treated with PTNS.[9]

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, the only PTNS device commercially available today.

Clinical publications[edit]

Urinary incontinence[edit]

Since the introduction of PTNS, more than 30 published studies in peer reviewed journals have consistently demonstrated PTNS efficacy in reducing OAB symptoms in 60 – 80% of patients. Of specific clinical importance are two randomized controlled trials (RCT) [10][11] and one publication that represents a long term follow-up of a subset of patients of a 12-week trial.[12]

Multicenter RCT Trial of PTNS and Drug Therapy (OrBIT Trial) [13][14][edit]

The Overactive Bladder Innovative Therapy (OrBIT) trial was a multicenter, randomized controlled trial comparing the effectiveness of PTNS to extended-release tolterodine. A total of 100 adults with urinary frequency were randomized to 12 weeks of PTNS treatment or 4 mg daily extended-release tolterodine. Both groups had statistically significant reductions in urgency, frequency, urge incontinence, urge severity and nighttime voids. In addition, there was an 80% subjective response to PTNS compared to a 55% response to drugs (12 week Global Response Assessment). The 12-month portion of this trial assessed the sustained therapeutic effects of PTNS in subjects with OAB through 1 year of therapy. 73% of patients who responded to treatment continued treatment for 1 year and were able to sustain improvement with a treatment every 21 days. Investigators concluded that the efficacy of PTNS achieved after 12 weeks of therapy was statistically significant for improvement in frequency, nocturia, urgency, voided volume, and urge incontinence episodes from baseline and was durable through 12 months of continued therapy at varied intervals.

Multicenter RCT Trial Comparing PTNS to Sham (SUmiT Trial) [15][edit]

The Study of Urgent PC vs. Sham Effectiveness in Treatment of Overactive Bladder Symptoms (SUmiT) was a multicenter, double-blind, randomized, controlled trial comparing the efficacy of PTNS to sham through 12 weeks of therapy. PTNS demonstrated statistical superiority with 55% of PTNS subjects responding to treatment compared to 21% of sham subjects (p<0.001) The validated sham treatment was conducted with a Streitberger needle to simulate the sensation of the needle electrode insertion and two TENS surface electrodes were placed at the bottom of the patient’s foot to imitate the PTNS treatment sensation. Data were collected from GRA questionnaires and patient voiding diaries. The investigators concluded the study results provide strong scientific evidence that PTNS provides a significant therapeutic effect in the treatment of overactive bladder symptoms.

Fecal incontinence[edit]

Clinical support for the use of PTNS in fecal incontinence continues to grow. A subset (28) of the subjects in the SUmit trial were also diagnosed with fecal incontinence. 15 of these subjects received weekly PTNS and 13 subjects received sham therapy. 45.5% of PTNS subjects were moderately or markedly improved whereas only 18.2% of sham subjects were moderately or markedly improved.[16]

The efficacy of PTNS for fecal incontinence is reinforced in other prospective, multicenter studies. Boyle, et al. reports that 68% of subjects improved with median incontinence episodes per week from changing from 4 to 0 (p<0.0001).[17]

In another muticenter study, 59% of subjects had a >50% decrease in incontinence episodes.[18]

U.S. reimbursement[edit]

Effective January 1, 2011, the PTNS procedure will be billed under the new CPT code 64566,[19] with the descriptor “Posterior tibial neurostimulation, percutaneous needle electrode, single treatment, includes programming.[20]

U.K. NICE guidance[edit]

In October 2010, the National Institute for Clinical Excellence (NICE) issued NICE Interventional Procedure Guidance 362[21] 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[edit]

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 PTNS 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 (external stimulation) PTNS 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).[22] The study concludes that transcutaneous PTNS has a positive impact and an overall reduction in bladder weakness symptoms, supporting its use as a first line intervention.

Transcutaneous PTNS is also believed to be an effective treatment for faecal 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.[23]

It is thought that further studies on alternative possible treatments, such as home based transcutaneous stimulation, are needed.[24] However, it has proved a viable and successful treatment for many.

See also[edit]

External links[edit]

References[edit]

  1. ^ Andersson, KE, Chapple, CR, Cardozo L et al. (2009). "Pharmacological treatment of overactive bladder: report from the International Consulation on Incontinence". Current Opinion in Urology 19: 380. 
  2. ^ Gopal M, Haynes K, Bellamy SL, Arya LA. (2008). "Discontinuation rates of anticholinergic medications used for the treatment of lower urinary tract symptoms.". Obstet Gynecol 112: 1311–8. 
  3. ^ Hartmann KE, McPheeters ML, Biller DH, et al. Treatment of overactive bladder in women. AHRQ Evidence Report/Technology Assessment No. 187. (Prepared by the Vanderbilt Evidence-based Practice Center under Contract No. 290-2007-10065-I). AHRQ Publication No. 09-E017. Accessed Oct 25, 2010 at http://www.ncbi.nlm.nih.gov/bookshelf/br.fcgi?book=erta187.
  4. ^ Mayer, R. (2010). "Neuromodulation – Who, what, when, where and why.". J Urol 183: 17–18. 
  5. ^ Doggwiler, R. (2010). "Will Posterior Tibial Nerve Stimulation Replace Sacral Nerve Root Stimulation as the Salvage Management of Drug Resistant Urinary Urge Incontinence.". J Urol 184: 1835–86. 
  6. ^ 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: 1193–1198. 
  7. ^ Dr. Marshall Stoller's Guest Lecture On IC Network
  8. ^ 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: 1193–1198. 
  9. ^ 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. 
  10. ^ Peters, K.M. (2009). "Randomized trial of percutaneous tibial nerve stimulation versus extended-release tolterodine: Results from the Overactive Bladder Innovative Therapy Trial". J Urol 182: 1055–1061. 
  11. ^ Peters, K.M., et al. (2010). "Randomized trial of percutaneous tibial nerve stimulation versus sham efficacy in the treatment of overactive bladder syndrome: results from the SUmiT Trial.". J Urol 183: 1438–1443. 
  12. ^ MacDiarmid, S.A. et al. (2010). "Long-term durability of percutaneous tibial nerve stimulation for the treatment of overactive bladder.". J Urol 183: 234–240. 
  13. ^ Peters, K.M. (2009). "Randomized trial of percutaneous tibial nerve stimulation versus extended-release tolterodine: Results from the Overactive Bladder Innovative Therapy Trial". J Urol 182: 1055–1061. 
  14. ^ MacDiarmid, S.A. et al. (2010). "Long-term durability of percutaneous tibial nerve stimulation for the treatment of overactive bladder.". J Urol 183: 234–240. 
  15. ^ Peters, K.M., et al. (2010). "Randomized trial of percutaneous tibial nerve stimulation versus sham efficacy in the treatment of overactive bladder syndrome: results from the SUmiT Trial.". J Urol 183: 1438–1443. 
  16. ^ Peters, K.M., et al. (2010). "Randomized trial of percutaneous tibial nerve stimulation versus sham efficacy in the treatment of overactive bladder syndrome: results from the SUmiT Trial.". J Urol 183: 1438–1443. 
  17. ^ Boyle, D.J., et al. (2010). "Percutaneous tibial nerve stimulation for the treatment of urge faecal incontinence.". Dis Colon Rectum 53 (4): 432–7. 
  18. ^ Govaert, B. et al (2010). "A prospective multicenter study to investigate percutaneous tibial nerve stimulation for the treatment of faecal incontinence.". Colorectal Disease 12: 1236–41. 
  19. ^ CPT copyright 2009 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.
  20. ^ http://www.uroplasty.com/view/files/pressRelease/Uroplasty%20Inc%20CPT%20Code%20and%20RVU%20FINAL.pdf
  21. ^ National Institute for Clinical Excellence. Percutaneous Posterior Tibial Nerve stimulation for overactive bladder symptoms. Guidance issue date 27 October 2010. http://guidance.nice.org.uk/IPG362
  22. ^ Glasgow Caledonian University: A Pilot Trial of Transcutaneous Posterior Tibial Nerve Stimulation for Bladder and Bowel Dysfunction in Older Adults in Residential Care; https://www.rcn.org.uk/__data/assets/pdf_file/0017/512234/2013_RCN_research_6.3.2.pdf; http://www.kegel8.co.uk/articles/pelvic-floor-exercise/tibial-nerve-stimulation.html
  23. ^ Gut 2011;60:A157-A158 doi:10.1136/gut.2011.239301.334; http://www.kegel8.co.uk/articles/pelvic-floor-exercise/tibial-nerve-stimulation.html
  24. ^ Percutaneous tibial nerve stimulation (PTNS) efficacy in the treatment of lower urinary tract dysfunctions: a systematic review by Gabriele Gaziev, Luca Topazio, Valerio Iacovelli, Anastasios Asimakopoulos, Angela DiSanto, Cosimo De Nunzio, Enrico Finazzi BMC Urology 2013, 13:61 doi:10.1186/1471-2490-13-61; http://www.kegel8.co.uk/articles/pelvic-floor-exercise/tibial-nerve-stimulation.html