Percutaneous tibial nerve stimulation

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Percutaneous tibial nerve stimulation
Specialty Urology

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.

Contents

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. [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]

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. [6] It appears to work as well as medication, but with fewer side effects. [7] [8]

Fecal incontinence

A meta-review that considered mostly low quality studies found tentative evidence of a benefit for PTNS in fecal incontinence. [9] However, a more recent high quality study however did not identify a benefit. [10]

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.[ citation needed ]

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 [11] ) 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. [12]

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. [13] In a corroborative multi-center study by Govier, et al., 71% of patients achieved success. [12] Additionally, in a study by Shafik, et al., 78% of patients achieved a long-term improvement in faecal incontinence when treated with PTNS. [14]

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. [15]

U.S. reimbursement

Effective January 1, 2011, the PTNS procedure will be billed under the new CPT code 64566, [16] with the descriptor "Posterior tibial neurostimulation, percutaneous needle electrode, single treatment, includes programming." [17]

U.K. NICE guidance

In October 2010, the National Institute for Clinical Excellence (NICE) issued NICE Interventional Procedure Guidance 362 [18] 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.[ citation needed ]

It is thought that further studies on alternative possible treatments, such as home based transcutaneous stimulation, are needed. [19] However, it has proved a viable and successful treatment for many.[ citation needed ]

See also

Related Research Articles

<span class="mw-page-title-main">Interstitial cystitis</span> Medical condition

Interstitial cystitis (IC), a type of bladder pain syndrome (BPS), is chronic pain in the bladder and pelvic floor of unknown cause. It is the urologic chronic pelvic pain syndrome of women. Symptoms include feeling the need to urinate right away, needing to urinate often, and pain with sex. IC/BPS is associated with depression and lower quality of life. Many of those affected also have irritable bowel syndrome and fibromyalgia.

<span class="mw-page-title-main">Urinary incontinence</span> Uncontrolled leakage of urine

Urinary incontinence (UI), also known as involuntary urination, is any uncontrolled leakage of urine. It is a common and distressing problem, which may have a large impact on quality of life. It has been identified as an important issue in geriatric health care. The term enuresis is often used to refer to urinary incontinence primarily in children, such as nocturnal enuresis. UI is an example of a stigmatized medical condition, which creates barriers to successful management and makes the problem worse. People may be too embarrassed to seek medical help, and attempt to self-manage the symptom in secrecy from others.

<span class="mw-page-title-main">Fecal incontinence</span> Inability to refrain from defecation

Fecal incontinence (FI), or in some forms encopresis, is a lack of control over defecation, leading to involuntary loss of bowel contents, both liquid stool elements and mucus, or solid feces. When this loss includes flatus (gas), it is referred to as anal incontinence. FI is a sign or a symptom, not a diagnosis. Incontinence can result from different causes and might occur with either constipation or diarrhea. Continence is maintained by several interrelated factors, including the anal sampling mechanism, and incontinence usually results from a deficiency of multiple mechanisms. The most common causes are thought to be immediate or delayed damage from childbirth, complications from prior anorectal surgery, altered bowel habits. An estimated 2.2% of community-dwelling adults are affected. However, reported prevalence figures vary. A prevalence of 8.39% among non-institutionalized U.S adults between 2005 and 2010 has been reported, and among institutionalized elders figures come close to 50%.

<span class="mw-page-title-main">Transcutaneous electrical nerve stimulation</span> Therapeutic technique

Transcutaneous electrical nerve stimulation is the use of electric current produced by a device to stimulate the nerves for therapeutic purposes. TENS, by definition, covers the complete range of transcutaneously applied currents used for nerve excitation although the term is often used with a more restrictive intent, namely to describe the kind of pulses produced by portable stimulators used to reduce pain. The unit is usually connected to the skin using two or more electrodes which are typically conductive gel pads. A typical battery-operated TENS unit is able to modulate pulse width, frequency, and intensity. Generally, TENS is applied at high frequency (>50 Hz) with an intensity below motor contraction or low frequency (<10 Hz) with an intensity that produces motor contraction. More recently, many TENS units use a mixed frequency mode which alleviates tolerance to repeated use. Intensity of stimulation should be strong but comfortable with greater intensities, regardless of frequency, producing the greatest analgesia. While the use of TENS has proved effective in clinical studies, there is controversy over which conditions the device should be used to treat.

Nocturia is defined by the International Continence Society (ICS) as “the complaint that the individual has to wake at night one or more times for voiding .” The term is derived from Latin nox, night, and Greek [τα] ούρα, urine. Causes are varied and can be difficult to discern. Although not every patient needs treatment, most people seek treatment for severe nocturia, waking up to void more than 2–3 times per night.

<span class="mw-page-title-main">Darifenacin</span> Medication for urinary incontinence

Darifenacin is a medication used to treat urinary incontinence due to an overactive bladder. It was discovered by scientists at the Pfizer research site in Sandwich, UK under the identifier UK-88,525 and used to be marketed by Novartis. In 2010, the US rights were sold to Warner Chilcott for US$400 million.

Neurogenic bladder dysfunction, or neurogenic bladder, refers to urinary bladder problems due to disease or injury of the central nervous system or peripheral nerves involved in the control of urination. There are multiple types of neurogenic bladder depending on the underlying cause and the symptoms. Symptoms include overactive bladder, urinary urgency, frequency, incontinence or difficulty passing urine. A range of diseases or conditions can cause neurogenic bladder including spinal cord injury, multiple sclerosis, stroke, brain injury, spina bifida, peripheral nerve damage, Parkinson's disease, or other neurodegenerative diseases. Neurogenic bladder can be diagnosed through a history and physical as well as imaging and more specialized testing. Treatment depends on underlying disease as well as symptoms and can be managed with behavioral changes, medications, surgeries, or other procedures. The symptoms of neurogenic bladder, especially incontinence, can have a significant impact on quality of life.

<span class="mw-page-title-main">Overactive bladder</span> Condition where a person has a frequent need to urinate

Overactive bladder (OAB) is a common condition where there is a frequent feeling of needing to urinate to a degree that it negatively affects a person's life. The frequent need to urinate may occur during the day, at night, or both. Loss of bladder control may occur with this condition. Overactive bladder affects approximately 11% of the population and more than 40% of people with overactive bladder have incontinence. Conversely, about 40% to 70% of urinary incontinence is due to overactive bladder. Overactive bladder is not life-threatening, but most people with the condition have problems for years.

<span class="mw-page-title-main">Sacral nerve stimulator</span>

A sacral nerve stimulator is a small device usually implanted in the buttocks of people who have problems with bladder and/or bowel control. This device is implanted in the buttock and connected to the sacral nerve S3 by a wire. The device uses sacral nerve stimulation to stop urges to defecate and urinate by sending signals to the sacral nerve. The patient is able to control their bladder and/or bowel via an external device similar to a remote control.

Sacral nerve stimulation, also termed sacral neuromodulation, is a type of medical electrical stimulation therapy.

Lower urinary tract symptoms (LUTS) refer to a group of clinical symptoms involving the bladder, urinary sphincter, urethra and, in men, the prostate. The term is more commonly applied to men—over 40% of older men are affected—but lower urinary tract symptoms also affect women. The condition is also termed prostatism in men, but LUTS is preferred.

Urogynecology or urogynaecology is a surgical sub-specialty of urology and gynecology.

<span class="mw-page-title-main">Urodynamic testing</span> Assessment of bladder and urethra performance

Urodynamic testing or urodynamics is a study that assesses how the bladder and urethra are performing their job of storing and releasing urine. Urodynamic tests can help explain symptoms such as:

<span class="mw-page-title-main">Underactive bladder</span> Bladder syndrome

Underactive bladder syndrome (UAB) describes symptoms of difficulty with bladder emptying, such as hesitancy to start the stream, a poor or intermittent stream, or sensations of incomplete bladder emptying. The physical finding of detrusor activity of insufficient strength or duration to ensure efficient bladder emptying is properly termed "detrusor underactivity" (DU). Historically, UAB and DU have been often used interchangeably, leading to both terminologic and pathophysiologic confusion.

In fecal incontinence (FI), surgery may be carried out if conservative measures alone are not sufficient to control symptoms. There are many surgical options described for FI, and they can be considered in 4 general groups.

Treatments for overactive bladder are therapies used to treat overactive bladder or related conditions, such as urinary incontinence and frequent urination. Behavioral modification and medications are commonly used to treat this condition.

<span class="mw-page-title-main">Serlopitant</span> Chemical compound

Serlopitant (INN, codenamed VPD-737) is a drug which acts as an NK1 receptor antagonist. It was assessed in clinical trials for the treatment of urinary incontinence and overactive bladder, but while it was superior to placebo it provided no advantage over existing approved drugs, and was not approved for further development for this indication. Serlopitant is now undergoing clinical trials for the treatment of chronic pruritus (itch)

<span class="mw-page-title-main">Surgery for benign prostatic hyperplasia</span> Type of surgery

If medical treatment is not effective, surgery may need to be performed for benign prostatic hyperplasia.

<span class="mw-page-title-main">Vibegron</span> Medication

Vibegron, sold under the brand name Gemtesa, is a medication for the treatment of overactive bladder. Vibegron is a selective beta-3 adrenergic receptor agonist.

Prof Clare Fowler CBE is a British physician and academic who created the subspecialty of uro-neurology, a medical field that combines urology and neurology. This work was done at the Institute of Neurology, University College London, where she is an emeritus professor.

References

  1. ↑ Andersson KE, Chapple CR, Cardozo L, Cruz F, Hashim H, Michel MC, Tannenbaum C, Wein AJ (July 2009). "Pharmacological treatment of overactive bladder: report from the International Consultation on Incontinence". review. Current Opinion in Urology. 19 (4): 380–94. doi:10.1097/mou.0b013e32832ce8a4. PMID   19448545. S2CID   21857035.
  2. ↑ Gopal M, Haynes K, Bellamy SL, Arya LA (December 2008). "Discontinuation rates of anticholinergic medications used for the treatment of lower urinary tract symptoms". primary. Obstetrics and Gynecology. 112 (6): 1311–8. doi:10.1097/aog.0b013e31818e8aa4. PMID   19037041. S2CID   22495238.
  3. ↑ Hartmann KE, McPheeters ML, Biller DH, Ward RM, McKoy JN, Jerome RN, Micucci SR, Meints L, Fisher JA, Scott TA, Slaughter JC, Blume JD (August 2009). "Treatment of overactive bladder in women". review. Evidence Report/Technology Assessment (187): 1–120, v. PMC   4781496 . PMID   19947666.
  4. ↑ Mayer R (January 2010). "Neuromodulation--who, what, when, where and why?". editorial. The Journal of Urology. 183 (1): 17–8. doi:10.1016/j.juro.2009.10.053. PMID   19913830.
  5. ↑ Doggweiler R (November 2010). "Will posterior tibial nerve stimulation replace sacral nerve root stimulation as the salvage management of drug resistant urinary urge incontinence?". editorial. The Journal of Urology. 184 (5): 1835–6. doi:10.1016/j.juro.2010.07.012. PMID   20846687.
  6. ↑ Moossdorff-Steinhauser HF, Berghmans B (March 2013). "Effects of percutaneous tibial nerve stimulation on adult patients with overactive bladder syndrome: a systematic review". Review. Neurourology and Urodynamics. 32 (3): 206–14. doi:10.1002/nau.22296. PMID   22907807. S2CID   9697853.
  7. ↑ Burton C, Sajja A, Latthe PM (November 2012). "Effectiveness of percutaneous posterior tibial nerve stimulation for overactive bladder: a systematic review and meta-analysis". Review. Neurourology and Urodynamics. 31 (8): 1206–16. doi:10.1002/nau.22251. PMID   22581511. S2CID   35760955.
  8. ↑ Peters KM, MacDiarmid SA, Wooldridge LS, et al. (September 2009). "Randomized trial of percutaneous tibial nerve stimulation versus extended-release tolterodine: results from the overactive bladder innovative therapy trial". Randomized controlled trial. The Journal of Urology. 182 (3): 1055–61. doi:10.1016/j.juro.2009.05.045. PMID   19616802.
  9. ↑ Thomas GP, Dudding TC, Rahbour G, Nicholls RJ, Vaizey CJ (May 2013). "A review of posterior tibial nerve stimulation for faecal incontinence". review. Colorectal Disease. 15 (5): 519–26. doi:10.1111/codi.12093. PMID   23216902. S2CID   29161476.
  10. ↑ Knowles CH, Horrocks EJ, Bremner SA, Stevens N, Norton C, O'Connell PR, Eldridge S, et al. (CONFIDeNT study group) (October 2015). "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". review. Lancet. 386 (10004): 1640–8. doi:10.1016/S0140-6736(15)60314-2. PMID   26293315. S2CID   29321045.
  11. ↑ "Stoller Afferent Nerve Stimulator" (PDF). Archived (PDF) from the original on 19 July 2023.
  12. 1 2 Govier FE, Litwiller S, Nitti V, Kreder KJ, Rosenblatt P (April 2001). "Percutaneous afferent neuromodulation for the refractory overactive bladder: results of a multicenter study". primary. The Journal of Urology. 165 (4): 1193–8. doi:10.1016/s0022-5347(05)66469-5. PMID   11257669.
  13. ↑ Dr. Marshall Stoller's Guest Lecture On IC Network[ verification needed ]
  14. ↑ Shafik A, Ahmed I, El-Sibai O, Mostafa RM (2003). "Percutaneous peripheral neuromodulation in the treatment of fecal incontinence". primary. European Surgical Research. 35 (2): 103–7. doi:10.1159/000069399. PMID   12679620. S2CID   21082372.
  15. ↑ "Medtronic Unveils NURO System in US for Overactive Bladder". Zacks Investment Research.
  16. ↑ CPT copyright 2009 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.[ citation needed ]
  17. ↑ "Uroplasty, Inc. Announces CPT(R) Category I Code and Associated Reimbursement Value for Posterior Tibial Nerve Stimulation" (Press release). Uroplasty. 3 November 2010. Retrieved 29 August 2018.
  18. ↑ "Percutaneous Posterior Tibial Nerve stimulation for overactive bladder symptoms". U.K. National Institute for Clinical Excellence. 27 October 2010.
  19. ↑ Gaziev G, Topazio L, Iacovelli V, Asimakopoulos A, Di Santo A, De Nunzio C, Finazzi-Agrò E (November 2013). "Percutaneous Tibial Nerve Stimulation (PTNS) efficacy in the treatment of lower urinary tract dysfunctions: a systematic review". review. BMC Urology. 13: 61. doi: 10.1186/1471-2490-13-61 . PMC   4222591 . PMID   24274173.
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