Device evaluation: eCoin #x2013; implantable tibial nerve stimulator for overactive bladder

ABSTRACT

Introduction

Peripheral nerve stimulation has been demonstrated as a viable alternative to sacral nerve stimulation in managing refractory overactive bladder (OAB). New technologies allow the internalization of tibial nerve stimulators through various apparatuses. One such device, the eCoin, is a small, coin-shaped device that can be implanted adjacent to the tibial nerve that provides pre-programmed stimulation.

Areas Covered

We will review the literature on eCoin implantation, from proof of concept to mid-term data, with the longest period of follow-up being 12 months. All studies on this technology will be reviewed, along with an analysis of the current state of play in implantable neuromodulators for overactive bladder. Efficacy, durability, adverse events, and viability of eCoin as a long-term management option will be considered.

Expert Opinion

The eCoin device demonstrates promising early data for efficacy in managing overactive bladder symptoms. Complication rates remain low and are mostly related to wound healing following the initial placement of the device. Research into the continued improvement and modification of the device appears optimistic, but longer-term data still need to be obtained. Indeed, implantable PTNS have a role in the future management of overactive bladder, and devices such as eCoin will still need to prove a long-term benefit to be a mainstay of management.

KEYWORDS:

• Implantable devices
• neuromodulation
• overactive bladder
• urology
• posterior tibial nerve stimulation

Article highlights

• Posterior tibial nerve stimulators (PTNS) are a less invasive option to manage patients with refractory overactive bladder when compared to sacral nerve stimulators (SNS);

• PTNS are, in general, more cost-effective than SNS and do not require operation theater time;

• E-coin is an FDA-approved device. Post-FDS studies are currently ongoing, and although data is limited to a 12-month follow-up study, results are promising;

• In the 3 months study, 70% of patients reached the primary end-point (reduction in daily number of urgency urinary incontinence episodes). This was consistent through 12 months when 65% of participants were responders.

Declaration of interests

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

One reviewer was involved with most of the BlueWind studies. A separate reviewer received research funding from Blue Wind, INC. The remaining reviewers have no other relevant financial relationships or otherwise to disclose.

Additional information

Funding

This paper was not funded.