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.