A subcutaneously implanted tibial nerve stimulation device, eCoin, showed safety and efficacy for treating urgency urinary incontinence (UUI), according to results of a pilot study presented at ICS 2020, a virtual meeting sponsored by the International Continence Society.
In the trial (NCT03556891), 133 patients with overactive bladder (OAB) and predominant UUI who had inadequate response or intolerance to second- or third-line therapies (excluding sacral neuromodulation) underwent an approximately 20-minute procedure. Urologists and urogynecologists from 15 sites implanted eCoin, a flat, nickel-sized, and leadless neurostimulator, above patients’ tibial nerve near the ankle using only local anesthesia.. No imaging or interrogation of the device was required. For wound healing, patients covered the incision for several days, wore a shower bag for 2 weeks, wore flat footwear 4 weeks, and avoided vigorous ankle movement (such as running or cycling) for 8 weeks to mitigate device migration prior to encapsulation. Some patients had “inconsequential” device migrations prior to encapsulation, typically cephalad micro movements along the tibial nerve. The device was activated after an approximate 4-week healing period.
The device delivered automatic 30-minute tibial nerve stimulation twice weekly without patients needing to use a remote or recharge it. A field of stimulation radiates from the center cathode to the anode outer rim, investigators explained. Cell battery life is 3 years.
Patients who had a mean 4.28 UUI episodes daily at baseline had 2.73 fewer episodes at 36 weeks — a 59% mean and 73% median decline in daily UUI, Alexandra Rogers, MD, of Sansum Clinic in Santa Barbara, California, reported. Patient-reported outcomes aligned with voiding diary data. At 36 weeks, 73% of patients reported feeling at least 50% better, 48% at least 75% better, and 30% felt completely dry, according to results from the Patient Global Impression of Improvement in Incontinence (PGI-I) survey. However, 19% of patients felt about the same and 4% felt worse.
Findings from the OAB questionnaire (OABq) showed that patients experienced a 36.0% decline in symptom bother (from a mean score of 65.7) and a 35.7% improvement in quality of life (from a mean score of 45.7).
With respect to adverse events, clinicians performed 3 explants for infection (1 serious requiring a hospital visit with uneventful recovery), 1 explant for contact dermatitis, and 3 explants for MRI purposes. According to Dr Rogers, the infection rate of 2.3% was within the range seen with other implanted neuromodulation procedures.
“After FDA approval, eCoin will provide an appealing choice delivered with minimal resources,” Dr Rogers said. “This automatic therapy for years will potentially better penetrate the undertreated OAB population not well-managed with current, burdensome and/or undesirable options often compromised by poor adherence.”
Study exclusions included patients with lower leg conditions posing a higher risk of poor wound healing, neurogenic bladder, bladder pain syndrome, stress urinary incontinence (SUI) comprising more than a third of daily episodes, or urinary retention (post-void residual volume of more than 150 cc).
Disclosure: This clinical trial was supported by Valencia Technologies. Please see the original reference for a full list of authors’ disclosures.
Rogers A, McCrery R, MacDiarmid S, et al. Pivotal study of subcutaneous tibial nerve stimulation with coin-sized implantable tibial neurostimulator (eCoin device) for urgency urinary incontinence. Presented at: ICS 2020 Online, November 19-22, 2020. Abstract 3.