The FDA has approved the eCoin leadless tibial neurostimulator for the treatment of urinary urge incontinence (UUI), a condition experienced by more than 60% of patients with overactive bladder.1
The approval was based on results from a pivotal, open-label, single-arm trial that were previously published in the Journal of Urology.2 The eCoin device met the primary end point of the study by achieving a ≥50% improvement in urgency urinary incontinence (UUI) in 68% of patients after 48 weeks of treatment.
"Beyond delivering impressive results achieved without the need for prior screening, the eCoin procedure is easily understood by patients, reproducible amongst physicians, and accomplished in a safe and effective manner," Rebecca McCrery, MD, an investigator in the eCoin pivotal trial and urologist at Nebraska Medicine, stated in a news release.
"Under 5% of OAB patients select burdensome third line interventions due to invasiveness or potential side effects of available therapies and limitations in access, resulting in a staggering unmet clinical need. The effortless relief provided by the automatic nature of eCoin neuromodulation therapy will potentially better treat the vast population—often desperate for relief—who are not well managed by the current options available to them," added McCrery.
The eCoin device is a tibial neurostimulator that is the shape and size of a nickel. It is implanted in the lower leg under local anesthetic in an office or outpatient procedure by a urologist or urogynecologist. The procedure takes about 20 minutes.
Overall, the open-label, single-group assignment pivotal trial of eCoin (NCT03556891) included 133 patients with OAB with UUI. eCoin was a third- or fourth-line OAB therapy for these patients, who went through a washout period for any OAB medications. OAB drugs were not allowed during the trial. There was no screening prior to device implantation.
There were 132 patients included in the intent-to-treat population. Baseline characteristics from these patients showed that the mean age was 63.9 years, 98% of patients were female, 84% were white, and the mean number of daily UUI episodes was 4.3. Based on patient reporting, the mean history of OAB was 11 years.
Device implantation was performed under local anesthesia and the mean time from initial incision to the final suture was 19.8 minutes. The primary efficacy end point was the rate of patients having a ≥50% improvement in UUI episodes as measured by a 3-day voiding diary at 48 weeks following activation of eCoin.
At 28 and 52 weeks, the rate of device-related adverse events (AEs) was 15%. AEs related to device or procedure were generally considered to be mild to moderate. At 52 weeks post-implantation, 19% of patients had AEs related to either the procedure or device. The specific incidence of device-related events at 52 weeks of treatment was 16%. There was 1 serious AE, consisting of an infection related to the study procedure. According to the investigators, this resulted in an explant, which investigators were able to resolve without sequelae.
Patents feedback also showed that one year after the procedure, 81% of patients indicated they felt "better" to "very much better." Additionally, 89% of patients reported they would recommend eCoin treatment to their family or friends.
"eCoin is neuromodulation for the masses," Scott MacDiarmid, MD, a urologist with Alliance Urology Specialists in Greensboro, NC, and an investigator in the feasibility and pivotal trials of eCoin, stated in the news release. "Being the first leadless neurostimulator for bladder control is groundbreaking and paves the way for further applications."
1. Valencia Technologies Announces FDA Approval of eCoin® Therapy to Treat Urinary Urge Incontinence. Published online March 2, 2022. Accessed March 2, 2022. https://bit.ly/35LnYug
2. Rogers A, Bragg S, Ferrante K, et al. 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