title: Detailed analysis of adverse events and surgical interventions in a large prospective trial of sacral neuromodulation therapy for overactive bladder patients.
abstract: BACKGROUND
  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.
authors.affiliation: University of California, Riverside, California.
authors.forename: Karen
authors.initials: K
authors.lastname: Noblett
authors.affiliation: Sanford Health, Sioux Falls, South Dakota.
authors.forename: Kevin
authors.initials: K
authors.lastname: Benson
authors.affiliation: University of Iowa, Iowa City, Iowa.
authors.forename: Karl
authors.initials: K
authors.lastname: Kreder
mesh_terms: D004599:Electric Stimulation Therapy / Q000009:adverse effects; D005260:Female; D006801:Humans; D008160:Lumbosacral Plexus; D008297:Male; D011183:Postoperative Complications / Q000628:therapy; D011446:Prospective Studies; D011475:Prosthesis Failure; D012086:Reoperation; D012447:Sacrum; D053201:Urinary Bladder, Overactive / Q000628:therapy*
keywords: adverse event; overactive bladder; sacral neuromodulation; surgical intervention