The ELITE study is an ongoing prospective, global, post-market clinical follow up study designed to confirm the clinical performance and safety of a novel rechargeable sacral neuromodulation device in all indicated conditions: fecal incontinence, overactive bladder (OAB), and nonobstructive urinary retention. Since the initial approval of devices to deliver sacral neuromodulation, improvements have been made to both the procedure and the device technology, including the introduction of the tined lead to allow less invasive implant, and guidance on lead implant techniques to achieve optimal placement of the lead near a sacral nerve, typically S3 [1]. Recently, new leads were introduced that allow full body MRI usage in implanted subjects under certain conditions. The aim of this abstract is to describe device implant, device information, and change in quality of life for subjects enrolled in the OAB cohort through 6-month follow up visit.

Eligible subjects that met all inclusion and no exclusion criteria were enrolled in the OAB cohort after a successful basic or advanced therapy evaluation and implantation of a neurostimulator. Eligible subjects signed a study‐specific informed consent form before initiation into the study. The therapy evaluation success was recommended to be based on a 50% reduction in symptoms or return to normal voiding. Device programming data were collected at tined lead implant, at neurostimulator implant, and follow up visits occurring at 3- and 6-months post-implant. Subjects completed the OAB Quality of Life Questionnaire (OAB-q) at baseline and follow-up visits. Safety was evaluated as reportable adverse events. The study was approved by appropriate institutional review boards and ethics committees.

Sixty-eight subjects were enrolled in the OAB cohort. Enrolled subjects met all inclusion and no exclusion criteria. Mean age was 62±13 years and 90% of subjects were female (61/68). For those subjects with reported data, the majority of leads (88%, 58/66) were placed following established guidance [1] recommending that stimulation required to elicit a motor response (motor threshold) be 2 mA or below on all 4 electrodes (Table 1). The OAB-q Health Related Quality of Life (HRQL) demonstrated a significant improvement from baseline to 3-month follow-up with an average increase of 33±24 points (n=67, p<0.001). HRQL showed a consistent result at 6 months, with a change of 31±23 points (n=65). Eighty-two percent of subjects achieved the minimally important difference in HRQL score at 3- and 6- months with a change of 10 points or greater. At 3- and 6-month follow-up visits, the median amplitude was 1 mA, pulse width was 210 µs, and frequency 14 Hz (Table 2) for subjects with available data (n=66, 63 respectively). Five subjects (7.4%) had an MRI by the 6-month visit with a mean time from implant of 137 ± 38.1 days. MRI locations included head (1), lower abdomen (1), thoracic spine (1), and other (2). 
The incidence of device-, procedure-, or therapy- related adverse events was 7.3% (5/68). Out of these 5 related adverse events, there was 1 related serious adverse event (1.5%, implant site pain) at the time of database snapshot. There were no MRI related adverse events.

In the ELITE study, the majority of leads were implanted following established guidance for optimal lead placement near the sacral nerve. Optimal lead placement has been proposed to result in longer battery life for a non-rechargeable device [1] or extend the recharge interval for a rechargeable device by minimizing the amount of energy delivered. Consistent with this, the median amplitude at follow-up visits was relatively low at 1 mA. The quality-of-life improvement is consistent with previously reported results from both rechargeable and non-rechargeable devices [2,3]

These data confirm the clinical performance and safety for a novel rechargeable SNM device through 6-months post implant.

Liberman D, Ehlert MJ, Siegel SW. Sacral neuromodulation in urological practice. Urology. 2017; 99:14-22.
Siegel S, et al. Results of a prospective, randomized, multicenter study evaluating sacral neuromodulation with InterStim therapy compared to standard medical therapy at 6-months in subjects with mild symptoms of overactive bladder. Neurourol Urodyn. 2015 Mar;34(3):224-30.
McCrery R, et al. Treatment of Urinary Urgency Incontinence Using a Rechargeable SNM System: 6-Month Results of the ARTISAN-SNM Study. J Urol. 2020 Jan;203(1):185-192