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Implantable Tibial Nerve Stimulation (iTNM)

Implantable tibial nerve stimulation (iTNM) represents a significant evolution from percutaneous tibial nerve stimulation (PTNS), delivering the same neuromodulatory mechanism of action to the posterior tibial nerve via a permanently implanted device that enables at-home, patient-controlled therapy — eliminating the need for repeated in-office visits.[1] At least three FDA-authorized or FDA-cleared devices have been studied, with the two most advanced being the eCoin® (Valencia Technologies) and the Revi® (BlueWind Medical).

This page is the canonical implantable tibial-nerve stimulation target for the OAB database. It is intentionally separate from PTNS because the procedure, durability, maintenance burden, and device counseling differ substantially. Mechanism-of-action and efficacy fundamentals shared with PTNS are not duplicated here — see the PTNS page for the underlying neuromodulation rationale and the SUmiT pivotal sham-controlled foundation.

Rationale for Implantable Devices​

The primary limitations of PTNS — the burden of weekly in-office visits, short-lived effects requiring indefinite maintenance, and limited insurance coverage — have driven the development of implantable alternatives. Real-world data show that over 40% of PTNS maintenance patients discontinue therapy due to logistic reasons and physical strain rather than treatment failure.[2] Implantable devices address these barriers by providing continuous or scheduled at-home stimulation through a permanent implant, with the added potential for dynamic, patient-centered programming.[1]

FDA-Authorized Devices​

eCoin® (Valencia Technologies)​

The eCoin is a nickel-sized, coin-shaped, fully implanted, primary battery-powered device placed in the lower leg above the fascia over the tibial nerve. It delivers automated, pre-programmed, low-duty-cycle stimulation without requiring any external wearable for daily therapy.[3][4]

  • Implantation: Performed under local anesthesia in approximately 20 minutes; placed suprafascially over the tibial nerve in the lower leg and activated 4 weeks post-implantation.[5][6]
  • Power source: Internal primary (non-rechargeable) battery
  • Stimulation: Automatic, intermittent low-duty cycle; no patient interaction required for daily therapy delivery[4]
  • FDA status: FDA-approved for refractory urgency urinary incontinence[7]

Revi® (BlueWind Medical, formerly RENOVA™)​

The Revi is a leadless, miniature, battery-free implant placed subfascially near the tibial nerve. It is powered wirelessly by an external, battery-operated ankle wearable that the patient controls, allowing individually tailored stimulation parameters.[8][9]

  • Implantation: Subfascial placement near the tibial nerve; median operative time approximately 34 minutes in early studies[10]
  • Power source: Battery-free implant; powered externally by a wearable ankle device
  • Stimulation: Patient-controlled via the external wearable, enabling personalized therapy sessions at home[9][11]
  • FDA status: First FDA-cleared implantable neuromodulation device that can be used in traditionally non-refractory patients (does not require prior failure of conservative therapy)[8][9]

Protect PNS (Uro Medical Corp.) and Others​

A percutaneous implantable pulse generator (pIPG) with integrated quadripolar electrodes has been studied in a pilot trial. It is implanted in the office under local anesthesia using a retrograde approach and activated via an external wireless transmitter. Early data show feasibility and safety, though larger studies are needed.[12]

A newer implantable tibial nerve stimulator has completed a first-in-human feasibility study (n=10), showing 80% responder rates at 13 weeks with no serious adverse events.[13]

Clinical Evidence Summary​

DeviceStudyNFollow-up≥50% UUI reductionKey safety findings
eCoinFeasibility[1][6]4612 mo65%; 26% dry1 SAE (wound care, resolved)
eCoinPivotal[4]13248 wk68%16% device-related AEs; no serious / unanticipated AEs
eCoinPivotal extension[7]7296 wk78%; 22% dryNo serious or unanticipated AEs
ReviOASIS pivotal[9]1516 mo78%No device / procedure-related SAEs
ReviOASIS 2-year[9]9724 mo79%No device / procedure-related SAEs; 97% satisfaction
ReviOASIS 3-year[8]9036 mo79%No device / procedure-related SAEs; 95% satisfaction
Medtronic ITNMTITAN 2 pivotal[14]12612 mo61%20% ADEs; 1 serious ADE (resolved)

Key Pivotal Trials​

OASIS Study (Revi)​

The pivotal OASIS trial enrolled 151 women with UUI. The primary endpoint — ≥50% reduction in UUI episodes at 6 months — was met by 78% of participants. This response was durable through 3 years (79% at 36 months). Quality-of-life improvements were clinically significant across all OAB-q domains. Notably, 95% reported therapeutic satisfaction and 82% reported feeling "much better" or "very much better" at 3 years. No device- or procedure-related serious adverse events occurred through 36 months.[8][9][11]

eCoin Pivotal Trial​

The pivotal trial enrolled 137 subjects (132 ITT) with refractory UUI. At 48 weeks, 68% achieved ≥50% reduction in UUI episodes. At the 2-year extension, this improved to 78%, with 22% achieving complete dryness. Approximately 91% did not require additional OAB medications. No serious or unanticipated adverse events were reported in the extension phase.[4][7]

TITAN 2 (Medtronic ITNM)​

This pivotal IDE study enrolled 126 subjects implanted with the Medtronic leadless, rechargeable ITNM system. At 6 months, 59% achieved ≥50% improvement in UUI episodes/day (primary endpoint met, p < 0.001 vs performance goal). Twenty percent experienced adverse device effects through 12 months; one serious ADE resolved without sequelae.[14]

Comparison with Sacral Neuromodulation (SNM)​

A systematic review and meta-analysis comparing iTNM and SNM (20 studies, 1,766 patients) found similar UUI responder rates (iTNM 71.3% vs. SNM 71.8%) and similar OAB responder rates (iTNM 79.4% vs. SNM 73.9%), with comparable rates of device-related adverse events. Notably, iTNM achieved this comparable efficacy without requiring a trial stimulation phase, which is standard for SNM.[15]

Safety Profile​

Across all studied devices, the safety profile has been favorable:

  • eCoin: Most adverse events relate to wound healing at the implant site. In the pivotal trial, 16% experienced device-related events through 52 weeks, mostly minor. No serious or unanticipated AEs in the 2-year extension.[3][4][7]
  • Revi: No device- or procedure-related serious adverse events through 3 years of follow-up in the OASIS study. Early studies reported implant site pain (14%), suspected infection (22%), and procedural wound complications (8%).[8][16]
  • Medtronic ITNM: 20% adverse device effects through 12 months; one serious ADE that resolved.[14]

Advantages Over PTNS​

  • Eliminates in-office visit burden — at-home therapy delivery[1]
  • Improved compliance — removes the primary reason for PTNS discontinuation[2]
  • Durable long-term efficacy — sustained response rates through 2–3 years without the "wearing off" effect seen between PTNS sessions[7][8]
  • Patient-controlled therapy (Revi) — allows individualized stimulation parameters[9]
  • No trial phase required — unlike SNM, iTNM devices do not require a trial stimulation period before permanent implantation[15]

Guideline Positioning​

The AUA/SUFU 2024 guidelines include implantable tibial nerve stimulation among the minimally invasive therapies recommended for OAB, noting that these devices have been associated with high success rates, durable efficacy, and excellent patient satisfaction. The guidelines also allow offering minimally invasive therapies without requiring prior trials of behavioral or pharmacologic management.[17]

Limitations and Considerations​

  • All pivotal trials to date are single-arm, open-label studies without sham controls, though the underlying mechanism is supported by sham-controlled PTNS trials[1]
  • No head-to-head randomized trials comparing iTNM devices to each other, to SNM, or to onabotulinumtoxinA[15]
  • Long-term data beyond 3 years remain limited
  • The eCoin uses a non-rechargeable primary battery, raising questions about device longevity and potential need for replacement
  • MRI compatibility varies by device and should be confirmed before implantation
  • Cost-effectiveness data are still emerging

See Also​

References​

1. Lee UJ, MacDiarmid S, Matthews CA, Gillespie E, Peters KM. "Tibial Nerve Stimulation for Urge Urinary Incontinence and Overactive Bladder: Narrative Review of Randomized Controlled Trials and Applicability to Implantable Devices." Adv Ther. 2024;41(7):2635-2654. doi:10.1007/s12325-024-02864-3

2. Te Dorsthorst MJ, Heesakkers JPFA, van Balken MR. "Long-Term Real-Life Adherence of Percutaneous Tibial Nerve Stimulation in Over 400 Patients." Neurourol Urodyn. 2020;39(2):702-706. doi:10.1002/nau.24254

3. Bressington MJ, Scholtz D, Hooshiary A, et al. "Device Evaluation: eCoin — Implantable Tibial Nerve Stimulator for Overactive Bladder." Expert Rev Med Devices. 2023;20(11):899-904. doi:10.1080/17434440.2023.2254678

4. Rogers A, Bragg S, Ferrante K, Thenuwara C, Peterson DKL. "Pivotal Study of Leadless Tibial Nerve Stimulation With eCoin® for Urgency Urinary Incontinence: An Open-Label, Single Arm Trial." J Urol. 2021;206(2):399-408. doi:10.1097/JU.0000000000001733

5. Gilling P, Meffan P, Kaaki B, et al. "Twelve-Month Durability of a Fully-Implanted, Nickel-Sized and Shaped Tibial Nerve Stimulator for the Treatment of Overactive Bladder Syndrome With Urgency Urinary Incontinence: A Single-Arm, Prospective Study." Urology. 2021;157:71-78. doi:10.1016/j.urology.2021.04.039

6. MacDiarmid S, Staskin DR, Lucente V, 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." J Urol. 2019;201(5):967-972. doi:10.1016/j.juro.2018.10.017

7. Lucente V, Giusto L, MacDiarmid S. "Two-Year Pivotal Study Analysis of the Safety and Efficacy of Implantable Tibial Nerve Stimulation With eCoin® for Urgency Urinary Incontinence." Urology. 2024;194:17-23. doi:10.1016/j.urology.2024.07.046

8. Amundsen CL, Sutherland SE, Heesakkers JPFA, et al. "Three-Year Efficacy and Safety of Revi® Implantable Tibial Neuromodulation From the Pivotal OASIS Study." J Urol. 2026. doi:10.1097/JU.0000000000005062

9. Heesakkers JPFA, Toozs-Hobson P, Sutherland SE, et al. "Two-Year Efficacy and Safety Outcomes of the Pivotal OASIS Study Using the Revi System for Treatment of Urgency Urinary Incontinence." J Urol. 2025;213(3):323-332. doi:10.1097/JU.0000000000004328

10. van Breda HMK, Martens FMJ, Tromp J, Heesakkers JPFA. "A New Implanted Posterior Tibial Nerve Stimulator for the Treatment of Overactive Bladder Syndrome: 3-Month Results of a Novel Therapy at a Single Center." J Urol. 2017;198(1):205-210. doi:10.1016/j.juro.2017.01.078

11. Sutherland SE, Heesakkers JPFA, Ferrante KL, Dmochowski RR. "Impact of Revi® Implantable Tibial Neuromodulation on Quality of Life in Patients With Urgency Urinary Incontinence." Int Urogynecol J. 2026. doi:10.1007/s00192-026-06538-2

12. Sirls LT, Schonhoff A, Waldvogel A, Peters KM. "Development of an Implant Technique and Early Experience Using a Novel Implantable Pulse Generator With a Quadripolar Electrode Array at the Tibial Nerve for Refractory Overactive Bladder." Neurourol Urodyn. 2023;42(2):427-435. doi:10.1002/nau.25117

13. Sethi PS, Peters KM. "A First-in-Human Feasibility Study of a New Implantable Tibial Nerve Stimulator for Overactive Bladder Syndrome." Neuromodulation. 2025;28(5):832-839. doi:10.1016/j.neurom.2025.01.013

14. Lee U, Xavier K, Carey J, et al. "Implantable Tibial Neuromodulation Therapy Improves Symptoms of Urge Urinary Incontinence From the TITAN 2 Pivotal Study." J Urol. 2026. doi:10.1097/JU.0000000000004958

15. Amundsen CL, Sutherland SE, Kielb SJ, Dmochowski RR. "Sacral and Implantable Tibial Neuromodulation for the Management of Overactive Bladder: A Systematic Review and Meta-Analysis." Adv Ther. 2025;42(1):10-35. doi:10.1007/s12325-024-03019-0

16. Heesakkers JPFA, Digesu GA, van Breda J, Van Kerrebroeck P, Elneil S. "A Novel Leadless, Miniature Implantable Tibial Nerve Neuromodulation System for the Management of Overactive Bladder Complaints." Neurourol Urodyn. 2018;37(3):1060-1067. doi:10.1002/nau.23401

17. Cameron AP, Chung DE, Dielubanza EJ, et al. "The AUA/SUFU Guideline on the Diagnosis and Treatment of Idiopathic Overactive Bladder." J Urol. 2024;212(1):11-20. doi:10.1097/JU.0000000000003985