A nickel-sized leadless titanium device, implanted in patients’ ankles, could provide years of relief from overactive bladder syndrome.
If approved by the FDA, a nickel-sized leadless titanium device, implanted in patients’ ankles, could provide years of relief from overactive bladder syndrome.
Urologist Scott MacDiarmid, MD, of Alliance Urology Specialists’ Bladder Control Center and the University of North Carolina, Chapel Hill, recently presented early data on the investigational eCoin (Valencia Technology Corporation) device at the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU) winter meeting, in Austin, TX.
Dr. MacDiarmid told Urology Times the battery-powered device stimulates the posterior tibial nerve for the treatment of overactive bladder. It’s 23 mm in diameter and 2.2 mm thick.
“It’s the only fully implantable tibial nerve stimulator. To my knowledge, the others are powered from the outside,” said Dr. MacDiarmid.
Today’s approved options for refractory overactive bladder include percutaneous tibial nerve stimulation (UrgentPC, NURO), botulinum toxin injection therapy (Botox), and sacral nerve stimulation (Interstim).
Without head-to-head studies to confirm comparison data, Dr. MacDiarmid says he thinks the eCoin offers benefits when compared to all three.
eCoin eliminates frequent follow-up visits to urologists’ offices and associated costs, which are necessary with percutaneous tibial nerve stimulation; avoids the invasiveness and associated costs of an operation necessary for sacral nerve stimulation; and is a longer term solution than botulinum toxin and avoids botulinum-related complications, including the potential for incomplete bladder emptying.
Dr. MacDiarmid anticipates eventual FDA approval for the device for overactive bladder, but third-party payers might limit coverage of eCoin treatment to refractory patients. Regardless, Dr. MacDiarmid said eCoin could also be a first-line therapy for patients who don’t want to take medications.
Data presented at the SUFU meeting did not include the entire 46-patient cohort in the pilot study. Rather, most of the information presented was on 22 patients, who were 12 weeks posttreatment. The rest of the data aren’t publically available, yet, according to Dr. MacDiarmid.
Patients in the study were a mean age of 63.4 years, and were not on any medications to treat incontinence at the time of the study. Results include voiding diary assessments and patients’ incontinence quality-of-life assessments.
Mean urinary urge incontinence episodes per day decreased by 4.27 episodes daily at 12 weeks, from a mean baseline of 5.46 daily. Eighty-six percent of the 22 patients improved 50% or more. Nearly a third, or 32%, demonstrated no incontinence episodes in a 3-day diary at 3 months.
Statistically significant improvements in quality of life, using the Incontinence Quality of Life instrument, were demonstrated after 3 months of therapy, and 18 of 22 subjects, or 82%, reported they were better, much better, or very much better.
Among the 22 patients, there were two serious adverse events. One was an unrelated pneumonia. One was an infected blister, secondary to the leg wrap used for wound care after the procedure.
“I was impressed with the improvement, especially in urgency incontinence in the 22 patients at 3 months. That was a significant drop in the number of leaks per day,” Dr. MacDiarmid said. “The results were very promising with regard to efficacy. The FDA pivotal trial will start soon. That will be a U.S. multicenter study.”
Urologists implant the eCoin device in the office, with patients fully awake but under local anesthetic. The procedure takes from 10 to 20 minutes. Urologists place the implant using well-defined bony and soft tissue landmarks on the ankle, making a small incision to create a pocket for the device. They insert the device, close the incisions, and administer proper wound care.
“The device is then activated after 1 month to let it heal,” he said. “I believe that, once this gets FDA approval, a proctorship-type learning, with a very short learning curve, will be all that’s needed to place the device safely in our patients.”
Ideal candidates are patients with no contraindications or health conditions that could affect healing in the lower extremities, and patients who have an intact nervous system.
The battery in today’s device lasts from 2 to 4 years. But the manufacturer is working on developing a longer lasting and possibly smaller version, according to Dr. MacDiarmid.
While in many patients, it clearly eliminates the need for daily incontinence medication, others might opt to combine the eCoin and medication to boost outcomes, he said.
“I was delighted on how well this works,” Dr. MacDiarmid said. “My personal patients, though a limited number, were delighted with it. And I think it’s going to make a really substantial impact in providing us a tool to help our patients with overactive bladder in the future because it truly does eliminate some of the current barriers.”
Dr. MacDiarmid is a consultant and adviser to Valencia Technology.
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