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Focus on FPMRS

UI Urology offers eCoin® implant, joins RECIPE post-FDA-approval trial

Pivot study showed 70% of patients had at least a 50% reduction in their UUI episodes, and 89% reported they would recommend the device to friends and family.

By Annah J. Vollstedt, MD

Overactive bladder (OAB) and urgency urinary incontinence (UUI) affect up to one-third of adults in the U.S. These symptoms have a tremendous negative impact on the quality of life of our patients. UUI, specifically, can cause significant anxiety. While behavioral modifications, physical therapy, and medications may be relatively effective, many patients still have poor control of their symptoms. Our FPMRS providers are participating in the multi-institutional RECIPE (A Real World Study of eCoin for Urgency Urinary Incontinence: Post Approval Evaluation) trial. This post-FDA approval study is designed to assess the five-year safety and effectiveness of eCoin for the treatment of UUI.

eCoin® is a small, leadless, disc-shaped implantable device about the size of a nickel.

Percutaneous tibial nerve stimulation (PTNS) is an excellent option for refractory UUI in terms of minimal side effects and risks. Based on traditional Chinese acupuncture, electrical stimulation of the tibial nerve decreases bladder overactivity. Though the mechanism of action is not completely understood, it is hypothesized that the stimulation of the tibial nerve, which is a sensory-motor nerve arising from L4-S3 spinal roots, modulates the lower urinary tract by these shared spinal tracts. 

Unfortunately, the need for frequent office visits may limit the clinical utility of PTNS. The use of a small, fully implantable device has several advantages: automated compliance, lower cost over device life compared with long-term visit costs, and improved efficacy through accurate device placement and ability for more frequent stimulation. 

eCoin is a small, leadless, disc-shaped implantable device about the size of a nickel. The prior pivot study of eCoin showed that 70% of patients showed at least a 50% reduction in their UUI episodes, and 89% reported they would recommend the device to friends and family. 

Key inclusion criteria for the RECIPE trial include adults with daily UUI that is refractory to pharmaceuticals or another third-line therapy, including sacral neuromodulation, PTNS, or bladder onabotulinum toxin. If patients do not meet the study criteria, we also offer implantation of the device in the office setting on a commercial basis. 

If you have patients in your practice with bothersome UUI refractory to behavioral modifications, OAB medications, or other third-line therapies, please consider referral to the University of Iowa Health Care Department of Urology for consultation to see if eCoin or other treatment options may be beneficial.