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Tibial Nerve Stimulation for Urge Urinary Incontinence and Overactive Bladder: Narrative Review of Randomized Controlled Trials and Applicability to Implantable Devices

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Abstract

The tibial nerve is an established target for neuromodulation in the management of overactive bladder (OAB) and its associated symptoms, including urge urinary incontinence (UUI). Technologies are currently available to deliver tibial nerve stimulation (TNS) through percutaneous devices or through implantable devices. The benefits and safety of percutaneous TNS have led to it as a guideline-recommended therapy. However, patient compliance is limited by the burden of weekly office visits and the need for maintenance treatments. Further, insurance often only covers a limited number of lifetime visits for percutaneous TNS. These factors and others have led to the development, study, and utilization of implantable TNS devices. Implantable TNS devices deliver the same therapeutic mechanism of action for nerve stimulation with a permanent implanted device that provides at-home stimulation rather than in-office therapy delivery. Additionally, there is an added potential for dynamic and patient-centered stimulation. There is a large body of high-quality evidence published for TNS, including numerous randomized controlled trials published on percutaneous TNS which have consistently demonstrated superior efficacy to sham and similar efficacy to that of anticholinergic medications. Percutaneous TNS also performs better than conservative therapy including pelvic floor muscle training. The percutaneous and implantable approaches deliver nerve stimulation to the same target nerve, using the same mechanism of action. Therefore, data from randomized trials of percutaneous TNS are informative for implantable TNS devices. At the time of this article’s publication, at least two implantable TNS devices have received marketing authorization from the Food and Drug Administration (FDA). The objective of this review is to discuss the mechanism of action for TNS and summarize the published literature from clinical trials of percutaneous TNS as a foundation of high-quality evidence for implantable devices targeting the tibial nerve.

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Medical Writing, Editorial, and Other Assistance.

The authors thank Ann Decker and Nicole Barber (Valencia Technologies) and Holly Norman (Coloplast) for their writing and editing contributions.

Funding

The Rapid Service Fee was funded by Medtronic, Valencia, and Coloplast. No other funding was received for this work.

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Authors and Affiliations

  1. Virginia Mason Medical Center, 1100 Ninth Ave C7-URO, Seattle, WA, 98101, USA

    Una J. Lee

  2. Alliance Urology Specialists, Greensboro, NC, USA

    Scott MacDiarmid

  3. Wake Forest Baptist Medical Center, Winston-Salem, NC, USA

    Catherine A. Matthews

  4. Medtronic, Minneapolis, MN, USA

    Emily Gillespie

  5. Corewell Health William Beaumont University Hospital, Royal Oak, MI, USA

    Kenneth M. Peters

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Contributions

All authors (Una Lee, Scott MacDiarmid, Catherine Matthews, Emily Gillespie, Kenneth Peters) contributed to the article conception and design. The first draft of the manuscript was written by Emily Gillespie and all authors critically revised the work. All authors read and approved the final manuscript.

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Correspondence to Una J. Lee.

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Conflict of Interest

Una Lee is a Consultant for Medtronic, Axonics, and Laborie; Primary Investigator Patient-Centered Outcomes Research Institute; and Site Investigator for Cook Myosite. Scott MacDiarmid is an Advisor and Consultant for Valencia Technologies. Catherine Matthews has grant support from Boston Scientific and Coloplast, is a consultant for Boston Scientific and Coloplast, serves as an Expert Witness for Johnson & Johnson, and is a Co-Editor for the International Urogynecology Journal. Emily Gillespie is an employee and stock owner, Medtronic. Kenneth Peters is a Consultant for Coloplast and Uromedical and Equity Owner of Uromedical.

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This article is based on previously conducted studies and does not contain any new studies with human participants or animals performed by any of the authors.

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Lee, U.J., MacDiarmid, S., Matthews, C.A. et al. Tibial Nerve Stimulation for Urge Urinary Incontinence and Overactive Bladder: Narrative Review of Randomized Controlled Trials and Applicability to Implantable Devices. Adv Ther (2024). https://doi.org/10.1007/s12325-024-02864-3

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