PLACEMENT OF A COIN-SIZED IMPLANTABLE TIBIAL NEUROSTIMULATOR (eCoin Device) FOR URGENCY URINARY INCONTINENCE

Rogers A1, Sen S2

Research Type

Clinical

Abstract Category

Overactive Bladder

Abstract 614
Video 3: Creative Ideas
Scientific Podium Video Session 40
On-Demand
Overactive Bladder Urgency Urinary Incontinence Neuromodulation Voiding Dysfunction New Devices
1. Sansum Clinic, 2. Stanford University Medical School
Presenter
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Abstract

Introduction
The treatment of overactive bladder (OAB) with urgency urinary incontinence (UUI) symptoms follows an algorithmic pathway. Patients who fail first- and second-line treatments may be offered percutaneous tibial nerve stimulation (PTNS), onabotulinumtoxinA injections (BOTOX) or sacral neuromodulation as a third-line treatment. An implantable tibial nerve stimulator may present a more convenient and effective treatment than these options. The coin-sized neurostimulator is subcutaneously implanted in a single visit using only local anesthesia. We present an instructional video demonstrating the brief placement of the eCoin device for the treatment of OAB with UUI.
Design
The eCoin placement technique is demonstrated on a patient in an ambulatory surgery center procedure room setting. A custom marking template (Figure 1A) is provided to indicate the location of the incision and final eCoin placement. Once the markings are made, the patient is prepped for the procedure with local anesthesia. The lower leg is then sterilized and draped. The custom marking tool is used again to remark the incision site and eCoin placement location. Once the incision is made, a custom sizing blunt dissection tool (Figure 1B) is used to create a pocket for device placement. The eCoin is then easily inserted into the pocket (Figure 2A), located above the tibial nerve. A layered closure technique is completed (Figure 2B). The patient is then fitted with an ankle support to provide gentle compression for 4 weeks. During this period, the patient is instructed to comply with provided aftercare instructions and materials in order to prevent infection or eCoin device migration. After the 4-week healing duration, the eCoin device is activated.
Results
A total of 133 patients across 15 study sites were implanted with the eCoin device in a clinical trial. The mean implant time from incision to closure was 20.77 minutes (SD 9.08). The median implant time was 18 minutes. All of the patients were evaluated for wound healing approximately 2 weeks post implant. There was 1 related severe adverse event, an infection resulting in uncomplicated explant at a hospital setting. At the time of this writing, patients in the study have had the device implanted for an average of 56.9 weeks. The treatment is effective and sustainable as described in other abstract submissions.
Conclusion
We demonstrate the use of a safe method of subcutaneous tibial nerve stimulation implant placement that is done in the office under local anesthesia. The procedure time is relatively brief resulting in minimal adverse events in a large cohort.
Figure 1
Figure 2
Disclosures
Funding Valencia Technologies Corporation Clinical Trial Yes Registration Number NCT03556891 RCT No Subjects Human Ethics Committee Western Institutional Review Board Helsinki Yes Informed Consent Yes
11/12/2024 16:30:03