Tibial nerve stimulator is safe, effective, and durable, 12-month data indicate

A nickel-sized tibial nerve stimulator offers overactive bladder (OAB) patients with urgency urinary incontinence long-term outcomes comparable to other treatment options, including percutaneous tibial nerve stimulation.

Findings of a study published in Urology¹ imply OAB treatment with the investigational eCoin (Valencia Technologies Corp) device is safe and achieves a durable response, says the study’s lead author, urologist Peter Gilling, MD, of Tauranga Urology Research Ltd, Tauranga, New Zealand.

“The decrease in incontinence episodes and the durability of the treatment [with eCoin] are as good as any of the other available devices and techniques for refractory urge incontinence. Sixty-five percent of patients were considered responders, which is a very competitive result,” Gilling said.

By 12 months, 26% of those studied achieved complete continence.

And compared with other neuromodulation techniques, eCoin appears to obviate patient factors that often affect compliance, such as onerous treatment schedules, according to Gilling.

“eCoin is a fully implantable device with no leads, transducers, electrodes, or control unit necessary,” he said.

Like percutaneous tibial nerve stimulation, eCoin aims to relieve symptoms of overactive bladder syndrome with urgency urinary incontinence by stimulating the tibial nerve.

A urologist implants the battery-powered eCoin subcutaneously in the medial lower leg. The in-office procedure, done under local anesthesia, takes about 20 minutes.

A field clinical engineer programs the device according to the individual patient’s sensitivity when the implantation is fully healed, at about 4 weeks. Subsequent stimulation happens automatically without patient involvement.

Gilling and colleagues in New Zealand and the US studied 46 patients (45 of whom were women) with refractory overactive bladder syndrome with urgency urinary incontinence implanted with the eCoin. The investigators looked at bladder diary data and quality of life at 3, 6, and 12 months postactivation.

They found median daily urgency urinary incontinence episodes dropped from 4.2 at baseline to 1.7 at 3 months and that remained consistent to 12 months. Seven in 10 participants reported feeling better, much better, or very much better.

While 21.7% of participants achieved 100% reduction in urgency urinary incontinence at 3 months, 26.1% reported continence at 12 months, which suggests a continuous improvement with long-term exposure to therapy, according to the paper.

One participant had serious cellulitis due to the eCoin treatment ankle wrap. There were no other serious procedure-related adverse events in the study. Incision site infection and swelling, pain, and bruising were other related adverse events through 12 months.

“The number of [urgency urinary incontinence] episodes per day experienced by the participants decreased by a median of 68% from baseline to 12 months, further demonstrating durability of the therapy,” the authors wrote. “However, after the stimulation schedule switch at 3 months from a treatment dose of every 2 days to a maintenance dose of every 15 days, some participants experienced a regression in objective symptoms and patient reported outcomes. The original schedule was reset once for some patients who returned during a second 3-month period to their previous response level.”

Investigators allowed participants to use overactive bladder medications after 3 months. Six of the 46 participants opted to add medications to their therapy. Two of the 6 responded to the overactive bladder medications with a 50% or greater reduction in urgency urinary incontinence.

Study limitations were that the research lacked blinding and comparison.

“[eCoin] is an option for patients refractory to medication and lifestyle modifications and have clinical overactive bladder, primarily. Patients who found other forms of tibial nerve stimulation or Botox [Allergan] unacceptable can also be considered,” Gilling said. “There is no data yet on neurogenic patients, so this group should be avoided.”

Reference

1. Gilling P, Meffan P, Kaaki B, et al. 12-month durability of a fully-implanted, nickel-sized and shaped tibial nerve stimulator for the treatment of overactive bladder syndrome with urgency urinary incontinence: a single-arm, prospective study. Urology. Published online May 25, 2021. doi:10.1016/j.urology.2021.04.039