title: Protocol for a randomized, placebo-controlled, double-blind clinical trial investigating sacral neuromodulation for neurogenic lower urinary tract dysfunction.
abstract: BACKGROUND
  Sacral neuromodulation has become a well-established and widely accepted treatment for refractory non-neurogenic lower urinary tract dysfunction, but its value in patients with a neurological cause is unclear. Although there is evidence indicating that sacral neuromodulation may be effective and safe for treating neurogenic lower urinary tract dysfunction, the number of investigated patients is low and there is a lack of randomized controlled trials.
  
  
  METHODS
  This study is a prospective, randomized, placebo-controlled, double-blind multicenter trial including 4 sacral neuromodulation referral centers in Switzerland. Patients with refractory neurogenic lower urinary tract dysfunction are enrolled. After minimally invasive bilateral tined lead placement into the sacral foramina S3 and/or S4, patients undergo prolonged sacral neuromodulation testing for 3-6 weeks. In case of successful (defined as improvement of at least 50% in key bladder diary variables (i.e. number of voids and/or number of leakages, post void residual) compared to baseline values) prolonged sacral neuromodulation testing, the neuromodulator is implanted in the upper buttock. After a 2 months post-implantation phase when the neuromodulator is turned ON to optimize the effectiveness of neuromodulation using sub-sensory threshold stimulation, the patients are randomized in a 1:1 allocation in sacral neuromodulation ON or OFF. At the end of the 2 months double-blind sacral neuromodulation phase, the patients have a neuro-urological re-evaluation, unblinding takes place, and the neuromodulator is turned ON in all patients. The primary outcome measure is success of sacral neuromodulation, secondary outcome measures are adverse events, urodynamic parameters, questionnaires, and costs of sacral neuromodulation.
  
  
  CONCLUSIONS
  It is of utmost importance to know whether the minimally invasive and completely reversible sacral neuromodulation would be a valuable treatment option for patients with refractory neurogenic lower urinary tract dysfunction. If this type of treatment is effective in the neurological population, it would revolutionize the management of neurogenic lower urinary tract dysfunction.
  
  
  BACKGROUND
  
  
  
  BACKGROUND
  http://www.clinicaltrials.gov; Identifier: NCT02165774.
authors.forename: Stephanie C
authors.initials: SC
authors.lastname: Knüpfer
authors.forename: Martina D
authors.initials: MD
authors.lastname: Liechti
authors.forename: Livio
authors.initials: L
authors.lastname: Mordasini
authors.forename: Dominik
authors.initials: D
authors.lastname: Abt
authors.forename: Daniel S
authors.initials: DS
authors.lastname: Engeler
authors.forename: Jens
authors.initials: J
authors.lastname: Wöllner
authors.forename: Jürgen
authors.initials: J
authors.lastname: Pannek
authors.forename: Bernhard
authors.initials: B
authors.lastname: Kiss
authors.forename: Fiona C
authors.initials: FC
authors.lastname: Burkhard
authors.forename: Marc P
authors.initials: MP
authors.lastname: Schneider
authors.forename: Elena
authors.initials: E
authors.lastname: Miramontes
authors.forename: Alfons G
authors.initials: AG
authors.lastname: Kessels
authors.forename: Lucas M
authors.initials: LM
authors.lastname: Bachmann
authors.affiliation: Neuro-Urology, Spinal Cord Injury Center & Research, University of Zürich, Balgrist University Hospital, Forchstrasse 340, 8008 Zürich, Switzerland. tkessler@gmx.ch.
authors.forename: Thomas M
authors.initials: TM
authors.lastname: Kessler
mesh_terms: D000704:Analysis of Variance; D004311:Double-Blind Method; D004599:Electric Stimulation Therapy / Q000009:adverse effects / Q000379:methods; D004567:Electrodes, Implanted; D006801:Humans; D018579:Patient Selection; D011446:Prospective Studies; D012107:Research Design; D012445:Sacrococcygeal Region; D016896:Treatment Outcome; D001750:Urinary Bladder, Neurogenic / Q000628:therapy*