Percutaneous tibial nerve stimulation#Transcutaneous tibial nerve stimulation

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Percutaneous tibial nerve stimulation (PTNS), also referred to as posterior tibial nerve stimulation, is the least invasive form 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 radical prostatectomy. Outside the United States, PTNS is also used to treat fecal incontinence.

PTNS can be used as a primary therapy. Treatment for overactive bladder and fecal incontinence may begin with pharmacological therapies before PTNS is administered. Unlike the variety of OAB drugs available PTNS is more effective and produces far fewer side-effects.{{cite journal | vauthors = Andersson KE, Chapple CR, Cardozo L, Cruz F, Hashim H, Michel MC, Tannenbaum C, Wein AJ | title = Pharmacological treatment of overactive bladder: report from the International Consultation on Incontinence | journal = Current Opinion in Urology | volume = 19 | issue = 4 | pages = 380–94 | date = July 2009 | pmid = 19448545 | doi = 10.1097/mou.0b013e32832ce8a4 | s2cid = 21857035 | department = review }} Nearly 80% of patients discontinue use (mean of 4.8 months) of drugs within the first year{{cite journal | vauthors = Gopal M, Haynes K, Bellamy SL, Arya LA | title = Discontinuation rates of anticholinergic medications used for the treatment of lower urinary tract symptoms | journal = Obstetrics and Gynecology | volume = 112 | issue = 6 | pages = 1311–8 | date = December 2008 | pmid = 19037041 | doi = 10.1097/aog.0b013e31818e8aa4 | s2cid = 22495238 | department = primary }} with as high as 17% of discontinuation being due to adverse side-effects.{{cite journal | vauthors = Hartmann KE, McPheeters ML, Biller DH, Ward RM, McKoy JN, Jerome RN, Micucci SR, Meints L, Fisher JA, Scott TA, Slaughter JC, Blume JD | title = Treatment of overactive bladder in women | journal = Evidence Report/Technology Assessment | issue = 187 | pages = 1–120, v | date = August 2009 | pmid = 19947666 | pmc = 4781496 | department = review }} 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.{{cite journal | vauthors = Mayer R | title = Neuromodulation--who, what, when, where and why? | journal = The Journal of Urology | volume = 183 | issue = 1 | pages = 17–8 | date = January 2010 | pmid = 19913830 | doi = 10.1016/j.juro.2009.10.053 | department = editorial }}{{cite journal | vauthors = Doggweiler R | title = Will posterior tibial nerve stimulation replace sacral nerve root stimulation as the salvage management of drug resistant urinary urge incontinence? | journal = The Journal of Urology | volume = 184 | issue = 5 | pages = 1835–6 | date = November 2010 | pmid = 20846687 | doi = 10.1016/j.juro.2010.07.012 | department = editorial }}

Medical uses

=Urinary incontinence=

PTNS appears to be effective at improving the number of times a person who has overactive bladder syndrome needs to urinate, although the mechanism for this is unclear.{{cite journal | vauthors = Moossdorff-Steinhauser HF, Berghmans B | title = Effects of percutaneous tibial nerve stimulation on adult patients with overactive bladder syndrome: a systematic review | journal = Neurourology and Urodynamics | volume = 32 | issue = 3 | pages = 206–14 | date = March 2013 | pmid = 22907807 | doi = 10.1002/nau.22296 | s2cid = 9697853 | department = Review }} It appears to work as well as medication, but with fewer side effects.{{cite journal | vauthors = Burton C, Sajja A, Latthe PM | title = Effectiveness of percutaneous posterior tibial nerve stimulation for overactive bladder: a systematic review and meta-analysis | journal = Neurourology and Urodynamics | volume = 31 | issue = 8 | pages = 1206–16 | date = November 2012 | pmid = 22581511 | doi = 10.1002/nau.22251 | s2cid = 35760955 | department = Review }}{{cite journal | vauthors = Peters KM, MacDiarmid SA, Wooldridge LS et al. | title = Randomized trial of percutaneous tibial nerve stimulation versus extended-release tolterodine: results from the overactive bladder innovative therapy trial. | journal = The Journal of Urology | volume = 182 | issue = 3 | pages = 1055–61 | date = September 2009 | pmid = 19616802 | doi = 10.1016/j.juro.2009.05.045 | department = Randomized controlled trial }}

=Fecal incontinence=

A meta-review that considered mostly low quality studies found tentative evidence of a benefit for PTNS in fecal incontinence.{{cite journal | vauthors = Thomas GP, Dudding TC, Rahbour G, Nicholls RJ, Vaizey CJ | title = A review of posterior tibial nerve stimulation for faecal incontinence | journal = Colorectal Disease | volume = 15 | issue = 5 | pages = 519–26 | date = May 2013 | pmid = 23216902 | doi = 10.1111/codi.12093 | s2cid = 29161476 | department = review }} However, a more recent high quality study however did not identify a benefit.{{cite journal | vauthors = Knowles CH, Horrocks EJ, Bremner SA, Stevens N, Norton C, O'Connell PR, Eldridge S | title = Percutaneous tibial nerve stimulation versus sham electrical stimulation for the treatment of faecal incontinence in adults (CONFIDeNT): a double-blind, multicentre, pragmatic, parallel-group, randomised controlled trial | journal = Lancet | volume = 386 | issue = 10004 | pages = 1640–8 | date = October 2015 | pmid = 26293315 | doi = 10.1016/S0140-6736(15)60314-2 | s2cid = 29321045 | collaboration = CONFIDeNT study group | department = review }}

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.{{cn|date=February 2022}}

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 (about once every three weeks or as needed{{cite web |url=https://medicalaffairs.ucsf.edu/sites/g/files/tkssra856/f/wysiwyg/ahpPrivileges/Stoller%20Afferent%20Nerve%20Stimulator%20%28SANS%29%28Adult,%20Peds%29.pdf |archive-url=https://web.archive.org/web/20230719054820/https://medicalaffairs.ucsf.edu/sites/g/files/tkssra856/f/wysiwyg/ahpPrivileges/Stoller%20Afferent%20Nerve%20Stimulator%20%28SANS%29%28Adult,%20Peds%29.pdf |archive-date=19 Jul 2023 |title=Stoller Afferent Nerve Stimulator |url-status=live}}) 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.{{cite journal | vauthors = Govier FE, Litwiller S, Nitti V, Kreder KJ, Rosenblatt P | title = Percutaneous afferent neuromodulation for the refractory overactive bladder: results of a multicenter study | journal = The Journal of Urology | volume = 165 | issue = 4 | pages = 1193–8 | date = April 2001 | pmid = 11257669 | doi = 10.1016/s0022-5347(05)66469-5 | department = primary }}

Research and market approval

The methodology was first invented by Marshall Stoller at UCSF Medical Center, San Francisco, and was first known as the SANS (Stoller Afferent Nerve Stimulator) protocol.

In 2000, 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.Dr. Marshall Stoller's Guest Lecture On IC Network{{vs|date=August 2018}} 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.{{cite journal | vauthors = Shafik A, Ahmed I, El-Sibai O, Mostafa RM | title = Percutaneous peripheral neuromodulation in the treatment of fecal incontinence | journal = European Surgical Research | volume = 35 | issue = 2 | pages = 103–7 | year = 2003 | pmid = 12679620 | doi = 10.1159/000069399 | s2cid = 21082372 | department = primary }}

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.{{cite web | title = Medtronic Unveils NURO System in US for Overactive Bladder | url = https://www.zacks.com/stock/news/211973/medtronic-unveils-nuro-system-in-us-for-overactive-bladder | publisher = Zacks Investment Research }}

U.S. reimbursement

Effective January 1, 2011, the PTNS procedure will be billed under the new CPT code 64566,CPT copyright 2009 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.{{citation needed|date=August 2018}} with the descriptor "Posterior tibial neurostimulation, percutaneous needle electrode, single treatment, includes programming."{{cite press release |title=Uroplasty, Inc. Announces CPT(R) Category I Code and Associated Reimbursement Value for Posterior Tibial Nerve Stimulation |publisher=Uroplasty |date=November 3, 2010 |url=https://www.biospace.com/article/releases/uroplasty-inc-announces-cpt-r-category-i-code-and-associated-reimbursement-value-for-posterior-tibial-nerve-stimulation-/ |access-date=August 29, 2018 }}

U.K. NICE guidance

In October 2010, the National Institute for Clinical Excellence (NICE) issued NICE Interventional Procedure Guidance 362{{cite web | publisher = U.K. National Institute for Clinical Excellence. | title = Percutaneous Posterior Tibial Nerve stimulation for overactive bladder symptoms. | date = 27 October 2010 | url = http://guidance.nice.org.uk/IPG362 }} 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

{{see also|Transcutaneous electrical 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.{{citation needed|date=August 2018}}

It is thought that further studies on alternative possible treatments, such as home based transcutaneous stimulation, are needed.{{cite journal | vauthors = Gaziev G, Topazio L, Iacovelli V, Asimakopoulos A, Di Santo A, De Nunzio C, Finazzi-Agrò E | title = Percutaneous Tibial Nerve Stimulation (PTNS) efficacy in the treatment of lower urinary tract dysfunctions: a systematic review | journal = BMC Urology | volume = 13 | pages = 61 | date = November 2013 | pmid = 24274173 | pmc = 4222591 | doi = 10.1186/1471-2490-13-61 | department = review | doi-access = free }} However, it has proved a viable and successful treatment for many.{{citation needed|date=August 2018}}

See also

References

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