PMID- 27491027
OWN - NLM
STAT- MEDLINE
DCOM- 20170607
LR  - 20170607
IS  - 1520-6777 (Electronic)
IS  - 0733-2467 (Linking)
VI  - 36
IP  - 4
DP  - 2017 Apr
TI  - Detailed analysis of adverse events and surgical interventions in a large 
      prospective trial of sacral neuromodulation therapy for overactive bladder 
      patients.
PG  - 1136-1139
LID - 10.1002/nau.23076 [doi]
AB  - INTRODUCTION: The InSite trial is a prospective, multicenter study of sacral 
      neuromodulation (SNM) therapy with the InterStim(R) 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. (c) 2016 Wiley Periodicals, Inc.
CI  - (c) 2016 Wiley Periodicals, Inc.
FAU - Noblett, Karen
AU  - Noblett K
AD  - University of California, Riverside, California.
FAU - Benson, Kevin
AU  - Benson K
AD  - Sanford Health, Sioux Falls, South Dakota.
FAU - Kreder, Karl
AU  - Kreder K
AD  - University of Iowa, Iowa City, Iowa.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20160804
PL  - United States
TA  - Neurourol Urodyn
JT  - Neurourology and urodynamics
JID - 8303326
SB  - IM
CIN - J Urol. 2018 Apr;199(4):898. PMID: 29642366
MH  - *Electric Stimulation Therapy/adverse effects
MH  - Female
MH  - Humans
MH  - Lumbosacral Plexus
MH  - Male
MH  - Postoperative Complications/therapy
MH  - Prospective Studies
MH  - Prosthesis Failure
MH  - Reoperation
MH  - Sacrum
MH  - Urinary Bladder, Overactive/*therapy
OTO - NOTNLM
OT  - adverse event
OT  - overactive bladder
OT  - sacral neuromodulation
OT  - surgical intervention
EDAT- 2016/08/05 06:00
MHDA- 2017/06/08 06:00
CRDT- 2016/08/05 06:00
PHST- 2016/03/30 00:00 [received]
PHST- 2016/07/06 00:00 [accepted]
PHST- 2016/08/05 06:00 [pubmed]
PHST- 2017/06/08 06:00 [medline]
PHST- 2016/08/05 06:00 [entrez]
AID - 10.1002/nau.23076 [doi]
PST - ppublish
SO  - Neurourol Urodyn. 2017 Apr;36(4):1136-1139. doi: 10.1002/nau.23076. Epub 2016 Aug 
      4.