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We are providing in person Bulkamid training in Santa Barbara at Sansum Clinic with Alexandra Rogers MD. Please contact [email protected] to arrange a session.
This video was created by Axonics to demonstrate SNM implant best practices and highlight the distinct features of the Axonics system for the treatment of OAB, FI and Urinary Retention. For more provider resources or assitance please contact Axonics.
“PLACEMENT OF A COIN-SIZED IMPLANTABLE TIBIAL NEUROSTIMULATOR (eCoin Device) FOR URGENCY URINARY INCONTINENCE” accepted for publication in Urology Video Journal 2021.
Overactive bladder (OAB) remains a highly prevalent, costly, debilitating and refractory condition despite efficacious third line therapies that often penetrate poorly, suffer from inconsistent delivery and frequently burdensome for patients which contribute to compromised compliance.1,2 A leadless tibial nerve stimulator (LTNS) might provide an efficacious, reproducible, convenient and appealing treatment option requiring minimal maintenance.3 The coin-sized neurostimulator (eCoin®) is subcutaneously implanted using only local anaesthetic and delivers a forgiving dome-like stimulation from the cathode center to the anode rim (Figure 1). The procedure can be performed in the office setting utilizing minimal resources with no imaging nor interrogation of the device required (Figure 2). Roughly 4-weeks after the implantation procedure, the eCoin is activated and automatically delivers intermittent low-duty 30-minute tibial stimulation sessions every few days with no patient involvement.
To demonstrate the technique for eCoin placement for the treatment of OAB with Urinary Urge Incontinence (UUI).
Video obtained during an eCoin implant using eCoin procedure sterile kit, local anaesthetic, eCoin implant template, eCoin blunt dissection tool and eCoin device.
A total of 133 patients across 15 sites were implanted with the eCoin device in a clinical trial. The mean implant time from incision to closure was 19.8 (SD 14.3) minutes. Only 12.8% of patients reported mild to moderate wound healing issues with 2.3% explanted due to infection. 1 serious adverse event occurred with an incision site infection managed with removal at a hospital with no long-term sequela. At 36-weeks 73% (95% CI, 64.16, 80.59) of patients reported a reduction of their UUI episodes by at least 50% and 30% (95% CI, 22.33, 39.30) were dry with no screening test performed prior to implant. The mean change in UUI episodes collected from a 3-day diary compared to baseline was -2.73 (-3.24, -2.22) (p<0.001).
We demonstrate a brief procedure to implant a subcutaneous LTNS performed with minimal resources using just local anaesthetic offering a benign safety profile. Unlike current neurostimulators surgically implanted with a pulse generator and separate lead wire this novel LTNS eliminates many inherent barriers with neuromodulation given its distinct form factor that is well tolerated by patients, highly reproducible by even a novice provider and minimizes compliance issues.4,5 This automatic therapy with an average battery life of 3-years will potentially better penetrate the undertreated OAB population not well managed with current burdensome or undesirable options often compromised by poor adherence, immodesty or invasiveness.
Figure 1. eCoin Overview. (A) The eCoin is implanted subcutaneously in a 20-minute office or outpatient procedure under local anesthetic. (B) The eCoin has a forgiving dome-like field. Medical Illustration by Justin A. Klein, CMI.
Figure 2. eCoin implant procedure. (A) Procedure to mark incision and implant location. (B) Creation of pocket using custom tool. (C) Insertion of eCoin. (D) Complete subcutaneous implantation. Medical Illustration by Justin A. Klein, CMI
“Pivotal Study of Leadless Tibial Nerve Stimulation with eCoin® for Urgency Urinary Incontinence” accepted for publication in Journal of Urology 2021.
Purpose: A novel leadless tibial nerve stimulator (LTNS) provides a primary battery-powered, coin-sized, minimally invasive option to deliver automatic low-duty cycle stimulation for overactive bladder syndrome (OAB) therapy. A pivotal trial was conducted to evaluate the safety and efficacy of this device, called eCoin® (Valencia Technologies Corporation, Valencia, CA, USA) for treating refractory urgency urinary incontinence (UUI).
Materials and Methods: This was a prospective, open-label, single-arm trial carried out at 15 US medical centers involving 137 subjects with refractory UUI. After implantation in the lower leg above the fascia over the tibial nerve, eCoin delivered automated stimulation sessions for the duration of the study. The primary efficacy measure was the proportion of subjects who achieved a 50% or greater reduction from baseline in UUI episodes after 48 weeks of therapy. The primary safety measure was device-related adverse events at the same time point.
Results: Of 137 subjects enrolled, 133 were implanted with eCoin, and 132 were included in the intention-to-treat (ITT) population. Of those 132 subjects, 98% were female, mean (SD) age was 63.9 (10.9), and mean (SD) baseline daily UUI episodes was 4.3 (3.1). The primary efficacy analysis showed 68% (95% CI: 60%, 76%) of subjects experienced at least a 50% reduction in UUI episodes at 48-weeks post-activation. Sixteen percent (16%) of implanted subjects experienced device-related events through 52 weeks post-implantation.
Conclusions: eCoin demonstrated clinical benefit for treating OAB with automatic delivery of an intermittent low-duty cycle and implanted with a minimally-invasive, brief procedure.