eCoin Implantable Device to Control Urgent Urinary Incontinence

Late last year, the FDA granted a PMA to Valencia Technologies, a neuromodulation company, for its neurostimulator as a treatment for urgency urinary incontinence.¹ The tibial nerve, which supplies electrical signals to muscles in the lower leg via the brain, can also play a role in bladder control. The tibial nerve is connected to nerves that innervate the bladder,² an organ that for millions of women doesn’t work like it once did. Urinary incontinence, of all types, affects at least 60% of women in this country, as of 2018, according to government data. Reasons for the increase include an aging population and obesity.³

Tibial nerve stimulation is one incontinence treatment type, delivered with a needle electrode and a handheld stimulator. Patients visit their healthcare provider every week for 12 weeks, in a half-hour treatment.⁴ But a new treatment called the eCoin peripheral neurostimulator eliminates the weekly treatment requirements. Studies show the eCoin can continue to control urgent urinary incontinence for six months and beyond.⁵ The device is not approved for stress incontinence, nor is it approved as a first-line treatment. Patients must first have failed or not responded to behavioral, medicinal and digital therapies.⁶

For eCoin to work, a healthcare provider implants the nickel-sized unit under the skin above the ankle, and then uses a device to program it. The healthcare provider is provided a radio to monitor the programming, and a magnet to stop the programming if need be. Patients receive a separate device to stop the implanted unit if need be.⁷

For the first 18 weeks after the implant, 30-minute stimulation sessions occur every three days, then lengthen to every four.

In a pivotal study with 133 patients, the baseline urgency episodes were at least three every day. After 48 weeks, 68% of the patients (mostly women) achieved a 50% reduction in episodes. 16% of the patients reported a device-related event by one year, post-implant.⁸

References

1. FDA. Premarket approval. eCoin peripheral neurostimulator, March 1, 2022. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P200036
2. Cleveland Clinic. Tibial nerve. https://my.clevelandclinic.org/health/body/21962-tibial-nerve
3. Patel UJ, Godecker AL, Giles DL, Brown HW. Updated Prevalence of Urinary Incontinence in Women: 2015-2018 National Population-Based Survey Data. Female Pelvic Med Reconstr Surg. 2022 Apr 1;28(4):181-187. https://pubmed.ncbi.nlm.nih.gov/35030139/
4. Noridian. Posterior Tibial Nerve Stimulation Coverage https://med.noridianmedicare.com/web/jfb/policies/coverage-articles/posterior-tibial-nerve-stimulation-coverage
5. Kaaki B, English S, Gilling P, et al. Six-Month Outcomes of Reimplantation of a Coin-Sized Tibial Nerve Stimulator for the Treatment of Overactive Bladder Syndrome With Urgency Urinary Incontinence. Female Pelvic Med Reconstr Surg. 2022 May 1;28(5):287-292.
6. eCoin website. https://ecoin.us/eligibility/
7. eCoin® Peripheral Neurostimulator System Patient Manual. https://www.accessdata.fda.gov/cdrh_docs/pdf20/P200036C.pdf
8. 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 Aug;206(2):399-408. https://pubmed.ncbi.nlm.nih.gov/33797291/