Skip to main content

Advertisement

SpringerLink
Log in

Update on Implantable PTNS Devices

  • Female Urology (L Cox, Section Editor)
  • Published:
Current Urology Reports Aims and scope Submit manuscript

Abstract

Purpose of Review

There is growing evidence supporting the use of percutaneous tibial nerve stimulation to manage lower urinary tract symptoms (LUTS) such as urgency, frequency and urge incontinence, in a non-pharmacologic, minimally invasive approach. Given this, there is now an impetus to move this technology forward from an interval (i.e., weekly and/or monthly) toward a continuous dosing, using implantable devices. This review article focuses on the newest implantable devices and the most current data demonstrating safety and efficacy in the management of refractory overactive bladder.

Recent Findings

There are new studies showing that continuous (or even semi-continuous) stimulation of the tibial nerve can be of similar efficacy as other chronic neural implant devices, such as sacral neuromodulation. This includes the Blue Wind Renova, StimGuard, eCoin, and Bioness Stimrouter.

Summary

While the data on these devices are still short-term, implantable tibial nerve stimulation holds promise in the field of managing LUTS and pelvic floor disorders. Durability and minimizing migration remain challenging.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2

Similar content being viewed by others

References

Papers of particular interest, published recently, have been highlighted as: • Of importance

  1. Gormley EA, Lightner DJ, Faraday M, Vasavada SP, American Urological Association, Society of Urodynamics, Female Pelvic Medicine. Diagnosis and treatment of overactive bladder (non-neurogenic) in adults: AUA/SUFU guideline amendment. J Urol. 2015;193(5):1572–80.

    Article  Google Scholar 

  2. Mcguire EJ, Shi-chun Z, Horwinski ER, Lytton B. Treatment of motor and sensory detrusor instability by electrical stimulation. J Urol. 1983;129(1):78–9.

    Article  CAS  Google Scholar 

  3. Wolff G. F., R.M. Krlan., Posterior Tibial Nerve Stimulation, in Adult and Pediatric Neuromodulation, A.S. Gilleran J., Editor. 2018, Springer.

  4. Peters KM, Carrico DJ, Perez-Marrero RA, Khan AU, Wooldridge LS, Davis GL, et al. Randomized trial of percutaneous tibial nerve stimulation versus sham efficacy in the treatment of overactive bladder syndrome: results from the SUmiT trial. J Urol. 2010;183(4):1438–43.

    Article  Google Scholar 

  5. Peters KM, MacDiarmid SA, Wooldridge LS, Leong FC, Shobeiri SA, Rovner ES, et al. Randomized trial of percutaneous tibial nerve stimulation versus extended-release tolterodine: results from the overactive bladder innovative therapy trial. J Urol. 2009;182(3):1055–61.

    Article  CAS  Google Scholar 

  6. van der Pal F, van Balken M, Heesakkers JP, Debruyne FM, Bemelmans BL. Percutaneous tibial nerve stimulation in the treatment of refractory overactive bladder syndrome: is maintenance treatment necessary? BJU Int. 2006;97(3):547–50.

    Article  Google Scholar 

  7. Peters KM, Carrico DJ, Wooldridge LS, Miller CJ, MacDiarmid SA. Percutaneous tibial nerve stimulation for the long-term treatment of overactive bladder: 3-year results of the STEP study. J Urol. 2013;189(6):2194–201.

    Article  Google Scholar 

  8. Thomas GP, Dudding TC, Bradshaw E, Nicholls RJ, Vaizey CJ. A pilot study to compare daily with twice weekly transcutaneous posterior tibial nerve stimulation for faecal incontinence. Color Dis. 2013;15(12):1504–9.

    Article  CAS  Google Scholar 

  9. Heesakkers J, et al. A novel leadless, miniature implantable Tibial Nerve Neuromodulation System for the management of overactive bladder complaints. Neurourol Urodyn. 2018;37(3):1060–7 This publication shows 6-month data from 36 BlueWind RENOVA patients demonstrating safety of the technology as well as improvement in subjecive and objective OAB parameters.

    Article  Google Scholar 

  10. Digesu A E.S., Heesakkers J P F A, Van Kerrebroeck P, A prospective, multicenter, international clinical trial to assess the efficacy and safety of a novel wireless implantable tibial nerve stimulator for the treatment of patients with refractory overactive bladder (OAB): 3-years results, in International Continence Society. 2018 Philadelphia.

  11. BlueWind Medical. [Website. ] January 7th 2020 [cited 2020 January 10]; Available from: http://www.bluewindmedical.com/products.

  12. BlueWind medical receives FDA approval for pivotal trial design of RENOVA iStim™ implantable tibial nerve neuromodulator for overactive bladder. 2018, BlueWind Medical HERZLIYA, Israel p 2.

  13. Sirls L P.K., Retrograde percutaneous technique of lead placement for chronic tibial nerve stimulation, an office based procedure, in International Continence Society 2019. 2019: Goethenburg.This conference abstract demonstrates the safety of retrograde placement of the StimGuard device.

  14. CAN-stim compared to SNS in treatment of urinary urgency incontinence with wireless neuromodulation technology (PROTECT). Available from: https://clinicaltrials.gov/ct2/show/NCT02577302.

  15. MacDiarmid S, et al. Feasibility of a fully implanted, nickel sized and shaped tibial nerve stimulator for the treatment of overactive bladder syndrome with urgency urinary incontinence. Journal of Urology. 2019;201(5):967–72 This publication shows 3 and 6-month data from 46 eCoin-implanted patients demonstrating safety of the technology as well as improvement in subjecive and objective OAB parameters.

    Article  Google Scholar 

  16. Choi, J., AUA 2018: Safety & efficacy of the eCOIN™ implantable tibial nerve stimulation device for overactive bladder syndrome, in AUA 2018 conference highlights, lower urinary tract conditions - nocturia 2018, Uro Today.

  17. Deer T, Pope J, Benyamin R, Vallejo R, Friedman A, Caraway D, et al. Prospective, multicenter, randomized, double-blinded, partial crossover study to assess the safety and efficacy of the novel neuromodulation system in the treatment of patients with chronic pain of peripheral nerve origin. Neuromodulation: Technology at the Neural Interface. 2016;19(1):91–100.

    Article  Google Scholar 

  18. Marcio Augusto Averbeck, J.M. Guzman Negron, Howard Goldman, Neuromodulation for lower urinary tract dysfunction – an ICS* update. 2018, Urology News.

  19. • Giusto L, Zahner P, Goldman H. V12–04 Placement of an implantable tibial nerve stimulator under local anesthesia: step by step instructions. Journal of Urology. 2019;201(Supplement 4):e1205–5 This conference abstract demonstrates the safety of the procedure used for Bioness StimRouter implantation.

  20. Overactive bladder treatment using stimrouter neuromodulation system: a prospective randomized trial. Clinical Trials December [cited 2020 January 11]; Available from: https://clinicaltrials.gov/ct2/show/NCT02873312?term=stimrouter.

Download references

Author information

Authors and Affiliations

  1. Department of Urology, William Beaumont Hospital, Royal Oak, MI, 48073, USA

    Annah Vollstedt & Jason Gilleran

Authors
  1. Annah Vollstedt
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Jason Gilleran
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Jason Gilleran.

Ethics declarations

Human and Animal Rights and Informed Consent

This article does not contain any studies with human or animal subjects performed by any of the authors.

Additional information

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

This article is part of the Topical Collection on Female Urology

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Vollstedt, A., Gilleran, J. Update on Implantable PTNS Devices. Curr Urol Rep 21, 28 (2020). https://doi.org/10.1007/s11934-020-00980-5

Download citation

  • Published:

  • DOI: https://doi.org/10.1007/s11934-020-00980-5

Keywords

Search

Navigation