An application for the eCoin device has been submitted to the FDA for regulatory approval.
Subcutaneous nerve stimulation with a coin-sized implantable tibial device (eCoin; Valencia Technologies) showed a sustained reduction in urgency urinary incontinence (UUI) episodes in patients with overactive bladder (OAB), according to updated data from a pivotal trial presented during the 2020 International Continence Society online meeting.1
Compared to baseline, the average change in daily UUI episodes at 9 months’ (36 weeks’) follow-up was -2.73 (P <.001). The average daily number of UUI episodes was 1.64, compared with 4.28 at baseline. In 73% of patients, UUI episodes decreased by 50% or more. Almost half (49.18%) of patients experienced a UUI episode decrease of at least 75%, and nearly one-third (30.33%) were dry, no longer having any UUI episodes.
Similar efficacy was previously reported in 6-month follow-results. An application for the device has been submitted to the FDA for regulatory approval.
“After FDA approval, eCoin will provide an appealing choice delivered with minimal resources. This automatic therapy will potentially better penetrate the undertreated OAB population, which is not well-managed with burdensome and/or undesirable options often compromised by poor adherence,” said lead study author Alexandra Rogers, MD, Sansum Clinic, Santa Barbara, CA.
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.
“Although placement is more specific compared with sacral neuromodulation implantable pulse generator surgery, the procedure has a short learning curve and should allow for an efficient workflow,” said Rogers, adding, “the therapy is automatic with no patient involvement, with a 3-year battery average with the current generation device.”
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. Patients were followed for at least 12 months.
At baseline, the average patient age was 64 years and the average BMI was 30.4. Overall, 84% of patients were white and 99% were female. The mean OABq symptom bother score was 65.7, and the mean OABq quality of life score was 45.7.
Patients were treated at 15 sites in the United States. The efficacy-evaluable population included 122 patients. The average implantation time was 21 minutes. The primary efficacy end point was the rate of patients having a ≥50% improvement in UUI episodes.
Outcomes on the PGI-I scale showed that over three-fourths (77%) of patients reported feeling at least “better” and over one-third (36.89%) reported feeling “very much better.” Investigators reported a significant -36.2% (P <.001) improvement in OABq symptom bother scores, as well as a significant 35.7% improvement (P <.001) in quality of life scores.
Safety data showed that 12.8% of patients experienced moderate wound healing issues, most of which resolved within 4 weeks and had no impact on the outcome of the therapy. The infection rate resulting in explant was 2.3%. “One related serious adverse event occurred with incision site infection prior to activation, which was managed with explant at a hospital with no long-term sequela,” said Rogers.
The study was sponsored by Valencia Technologies and Rogers included the company among her disclosures.
Rogers A, McCrery R, MacDiarmid S, et al. Pivotal study of subcutaneous tibial nerve stimulation with coin-sized implantable tibial neurostimulator (eCoin device) for urgency urinary incontinence. Presented during: 2020 International Continence Society online meeting. November 19-22, 2020. Abstract 3.