OAB device produces durable efficacy at 12 months

An implantable neuromodulation device appears to be safe and produce durable efficacy through 12 months and may be a promising new treatment option for patients with refractory overactive bladder (OAB) syndrome with urgency urinary incontinence (UUI).

Known as the electroceutical Coin (eCoin), the device was tested in a prospective, single-arm, open-label study with 46 participants who had refractory UUI. The study was conducted at multiple sites in the United States and New Zealand, and the latest feasibility data were presented at the AUA annual meeting in Chicago.

Researchers found that 30 of the 46 participants (65%) experienced more than a 50% improvement in UUI. Among these 30 patients, eight experienced a 75% improvement and 12 patients experienced 100% improvement. Overall, patients experienced a mean increase of 86% improvement in their incontinence quality of life (I-QOL) scores.

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“I believe that eCoin therapy will be first tried by most patients and urologists when medications fail, and it will be a very important treatment modality for our refractory OAB population,” said study investigator Scott A. MacDiarmid, MD, a urologist with Alliance Urology Specialists, Greensboro, NC.

The eCoin, which is being developed by Valencia Technologies Corp., is an investigational battery-powered device. It is just slightly larger than a nickel in diameter (23.3 mm) and thickness (2.4 mm). Dr. MacDiarmid and colleagues evaluated its safety and durability over a 12-month period in adults with UUI who had already failed or were intolerant of OAB medications.

The device works by electrically stimulating the tibial nerve, and it can be implanted during an office-based procedure under local anesthesia.

The eCoin has a significant advantage because it does not require external stimulation, Dr. MacDiarmid noted. A majority of OAB patients currently do not reach their treatment goal with medication, either due to a lack of efficacy, side effects, or costs. Dr. MacDiarmid said the penetrance of three third-line therapies is less than 5%, due to a variety of patient and physician barriers.

“eCoin is an effective, safe, and easy-to-perform office-based procedure that addresses such barriers and I’m hopeful will bring us one step closer to bring neuromodulation for the masses,” he told Urology Times.

In the current investigation, the mean age of the patients was 63.4 years and 45 of the 46 participants were female. The investigators found that episodes of UUI were reduced by a median 68% (4.2 versus 1.7 episodes/day at 12 months). The device was implanted in the lower leg over the tibial nerve and activated after 4 weeks. Patients kept bladder diaries and the investigators used validated quality-of-life instruments. Patients were assessed at 3, 6, and 12 months post-activation.

This approach is attractive because it eliminates the need for frequent visits and the required office infrastructure associated with percutaneous tibial nerve stimulation (PTNS), Dr. MacDiarmid said.

“It eliminates the safety concerns, the retreatment rate, and the fear of urinary retention requiring self-catheterization associated with onabotulinumtoxinA (Botox) injection therapy. It eliminates the surgery, the cost, and the perceived invasiveness of sacral nerve stimulation,” said Dr. MacDiarmid, who presented the study findings at the AUA annual meeting in Chicago.

Only one serious adverse event turned up in the trial, and it was resolved with intravenous antibiotics. A patient developed an infected blister from an ankle wrap that resolved.

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“eCoin therapy has the potential to become the preferred third-line therapy chosen by patients and recommended by urologists. It will have a major positive impact in treating patients with refractory OAB,” said Dr. MacDiarmid. “I would expect the device to be approved and able to help patients by 2021.”

Ajay Singla, MD, a urologist with the faculty of medicine at Harvard Medical School, Boston, said this approach appears to be an improvement over the traditional PTNS device.

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“PTNS over the years has been used for peripheral nerve stimulation in the office setting. The disadvantage has been performing weekly sessions for a total of 12 weeks. This has caused non-compliance and inconvenience to the patients. This new battery-operated device avoids the need for weekly visits for external stimulation,” said Dr. Singla, who was not involved with the research.

He noted in the current study the efficacy still remains low with approximately 65% experiencing more than a 50% improvement. Dr. Singla said this is in line with prior PTNS studies.

“This study shows that it is useful to have an implantable device rather than frequent external stimulations, which results in better patient compliance, but overall efficacy in the short term has not shown any improvement over traditional PTNS,” he said.

Valencia Technologies Corp. provided funding for the study.