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eCoin® — Implantable Tibial Nerve Stimulator

The eCoin (Valencia Technologies; eCoin Implantable Tibial Nerve Stimulator, ITNS) is the first FDA-approved, fully implantable, leadless, coin-sized neuromodulation device for refractory urgency urinary incontinence (UUI) associated with overactive bladder.[1]

Design​

  • Nickel-sized, nickel-shaped, fully implantable; no external leads, wires, or patient-operated components.[1]
  • Implanted subcutaneously above the fascia in the lower leg, directly over the posterior tibial nerve.[1]
  • Contains a primary (non-rechargeable) battery delivering pre-programmed, automated, low-duty-cycle stimulation; no patient interaction or in-clinic sessions required for therapy delivery.[2]
  • Implantation is a ~20-minute outpatient procedure under local anesthesia.[2]
  • Device is activated approximately 4 weeks post-implantation to allow wound healing.[3]

Mechanism of Action​

The eCoin delivers peripheral tibial nerve stimulation (PTNS). Tibial afferents share sacral spinal segments (S2–S4) with bladder and pelvic-floor innervation; chronic afferent modulation reduces detrusor overactivity and urgency.[4] The advantage over conventional percutaneous PTNS — which requires weekly 30-minute office sessions for 8–12 weeks plus ongoing maintenance — is continuous, automated therapy without recurring clinic visits.[5]

Clinical Evidence​

Evidence spans feasibility through pivotal-trial 2-year data, all open-label single-arm.

Feasibility trial (n = 46): At 3 months, 69.6% achieved ≥50% reduction in UUI episodes (median 71% relative reduction, 4.2 → 1.7 episodes/day, p = 0.001); >20% achieved complete dryness; mean I-QOL improvement 25.9 points.[3] At 12 months, 65% remained responders and 26% were completely dry.[2]

Pivotal trial (n = 137; 132 ITT): At 48 weeks, 68% (95% CI 60–76%) achieved ≥50% UUI reduction; device-related adverse-event rate was 16% through 52 weeks.[1]

Two-year pivotal extension (n = 72 completers): Efficacy improved over time — 78% (95% CI 67–87%) ≥50% reduction, 48% ≥75% reduction, 22% complete dryness at 96 weeks. ~91.3% did not require additional OAB medications. No serious or unanticipated adverse events occurred during the extension phase.[6]

Timepointn≥50% UUI ReductionComplete DrynessReference
3 mo (feasibility)4669.6%>20%[3]
12 mo (feasibility)4665%26%[2]
48 wk (pivotal)13268%—[1]
96 wk (pivotal extension)7278%22%[6]

Safety​

  • Most adverse events relate to wound healing at the implantation site.[5]
  • 16% device-related AE rate through 52 weeks in the pivotal trial; no unanticipated serious AEs in the 2-year extension.[1][6]
  • No increase in post-void residual — an advantage over antimuscarinic OAB pharmacotherapy.[4]

Regulatory Status​

The eCoin holds FDA approval for urgency urinary incontinence, establishing implantable peripheral tibial neuromodulation as a distinct category from percutaneous PTNS (repeat office sessions) and sacral neuromodulation (more invasive sacral implant).[5][6]

Indications and Positioning​

Indicated for refractory UUI — patients who have failed or are intolerant of behavioral modification and pharmacotherapy. Fills the gap between office-based PTNS and sacral neuromodulation.[5] Pivotal and feasibility populations were ~98% female, mean age ~63 years.[1][3]

Limitations​

  • All published trials are open-label single-arm — no sham or active comparator.[1][5]
  • Primary battery has finite life; durability beyond 2 years remains poorly characterized.[5]
  • Stimulation parameters are fixed by the manufacturer; no patient-titratable control.
  • Metal-containing implant has implications for future MRI compatibility.[4]

Comparison to Other Tibial Neuromodulation​

The Medtronic implantable tibial neuromodulation system (TITAN 2 pivotal study) is a rechargeable, leadless alternative: 59% responder rate at 6 months and 61% at 12 months in 126 subjects.[7] No head-to-head data exist.

See also: Revi System, Altaviva, PTNS Systems, Medtronic InterStim.

References​

1. 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. The Journal of Urology. 2021;206(2):399-408. doi:10.1097/JU.0000000000001733

2. 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

3. 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. The Journal of Urology. 2019;201(5):967-972. doi:10.1016/j.juro.2018.10.017

4. Panicker JN, Fowler CJ, Kessler TM. Lower Urinary Tract Dysfunction in the Neurological Patient: Clinical Assessment and Management. The Lancet Neurology. 2015;14(7):720-732. doi:10.1016/S1474-4422(15)00070-8

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

6. 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

7. Lee U, Xavier K, Carey J, et al. Implantable Tibial Neuromodulation Therapy Improves Symptoms of Urge Urinary Incontinence From the TITAN 2 Pivotal Study. The Journal of Urology. 2026;215(6):702-712. doi:10.1097/JU.0000000000004958