The prospective, multi-center, single-arm study of the safety and effectiveness of the eCoin peripheral neurostimulator showed clinically significant improvements. The eCoin Pivotal Trial study, intended to support the Food and Drug Administration (FDA) approval of the eCoin device, enrolled 133 subjects with urgency urinary incontinence. All available data was presented and the protocol did not include a trial of the therapy prior to eCoin implantation.
Data Highlights1
- Clinically significant improvements at 6 months in urgency urinary incontinence (UUI)
- 71% of patients reported a greater than or equal to 50% improvement in UUI
- 46% of patients reported a greater than or equal to 75% improvement in UUI
- 25% of patients reported a 100% improvement in UUI
- 70% median percent change from baseline in UUI as measured in episodes per day
- 34% mean improvement in quality of life and 34% reduction in symptom bother on the OABq
- Infection rate of 2.3% with no other significant adverse events
Scott A. MacDiarmid, MD, an investigator in the trial, commented, “We are extremely encouraged by this early data and I continue to believe in the paradigm-shifting potential of eCoin. Despite the extremely high prevalence of OAB symptoms, many of my patients find current therapies as suboptimal and intolerable. We are overdue for a novel therapy that is well-tolerated, reasonably priced, efficacious with minimal maintenance and most importantly appealing to patients, and I believe eCoin is that therapy.”
Jeff Greiner, Chief Executive Officer of Valencia, stated, “We were excited to have Dr. Rogers present interim efficacy data from our pivotal trial at SUFU 2020. We continue to believe that upon trial completion and regulatory review, the simplicity and effectiveness of eCoin will allow Valencia to significantly broaden the addressable OAB market beyond what has been captured by sacral neuromodulation and other suboptimal therapy alternatives.”
Valencia’s pivotal study is evaluating the use of its eCoin implantable tibial neurostimulator for the treatment of overactive bladder syndrome (OAB) in patients with urgency urinary incontinence. The study is a prospective, multicenter, single-arm trial to evaluate the safety and effectiveness of tibial nerve stimulation with eCoin in 133 participants. Implanted under local anesthetic in approximately 20 minutes, the eCoin provides automated therapy and eliminates compliance-related burdens to patients. The study is designed to evaluate changes from baseline in OAB symptoms as measured by voiding diaries and patient-reported outcomes through 48 weeks of eCoin therapy. Results from the trial will support Valencia’s pre-market approval application to the U.S. Food and Drug Administration upon completion.
Reference
1 Data representative of patient-reported outcomes of 119 intent-to-treat (ITT) patients
Other clinical trial news can be found here.
