Detailed analysis of adverse events and surgical interventions in a large prospective trial of sacral neuromodulation therapy for overactive bladder patients.

INTRODUCTION: The InSite trial is a prospective, multicenter study of sacral neuromodulation (SNM) therapy with the InterStim® System in subjects with overactive bladder (OAB). One of the primary aims of the study is to report on long-term safety of the tined lead. This analysis provides detailed descriptions of device-related adverse events (AEs) and surgical interventions to 12 months. METHODS: Analysis included those subjects who completed test stimulation with a tined lead, received a full implant, and reported device-related AEs out to 12 months. A Clinical Events Committee (CEC) adjudicated AEs to 12 months. RESULTS: Device-related AEs occurred in 30% (82/272) of subjects, with only one considered serious. Fifty-six percent of the device-related AEs occurred between implant and 3 months. The most frequent device-related AEs were undesirable change in stimulation (12%, 32/272); implant site pain (7%, 20/272); and implant site infection (3%, 9/272). Of the 26 events of implant site pain, 13 required surgical intervention, with only two resulting in explant. Ten subjects experienced 13 events of a surgical site infection (including an additional cellulitis), five of which resolved with antibiotics and eight required explantation. The overall surgical intervention rate was 13% with the most common reasons being pain at the surgical site (4%), lack/loss of efficacy (4%), and infection (3%). CONCLUSIONS: Although a 30% AE rate was reported, most AEs were minor and were resolved without surgical intervention. Surgical intervention was required in 13% of subjects, with the majority being revision or replacement. Neurourol. Urodynam. 36:1136-1139, 2017. © 2016 Wiley Periodicals, Inc.