title: A prospective randomized trial comparing the 1-stage with the 2-stage implantation of a pulse generator in patients with pelvic floor dysfunction selected for sacral nerve stimulation.
abstract: OBJECTIVE
  The aim of this study was to evaluate in a prospective, randomized setting if the 2-stage implant, compared to a 1-stage implant, leads to a superior subjective or objective outcome of sacral nerve stimulation after implantation of the pulse generator in patients with lower urinary tract symptoms.
  
  
  METHODS
  We implanted a sacral (S3) foramen lead and a pulse generator (model 3023, Medtronic Inc, Minneapolis, MN, USA) in 42 patients. They were randomized in a 1-stage or a 2-stage implant if a more than 50% improvement in voided volume or reduction of residual urine was seen during the test stimulation phase as compared to baseline.
  
  
  RESULTS
  At 24 months follow-up, subjective (visual analogue scale) and objective (voided volume or residual urine) assessment were significantly better in the 2-stage group. Ten patients (24%) failed therapy, 7 in the 1-stage implant and 3 in the 2-stage group. Two patients were lost to follow-up. Logistic regression analysis revealed that failure was positively related to the 1-stage implant and negatively to the age of the patients. 76% of the treated patients had sustained clinical benefit with 23 revisions performed. The mean cost is respectively for the PNE (2006 Euro), for the 2-stage implant (10826 Euro) and for the 1 stage implant (8505 Euro).
  
  
  CONCLUSIONS
  With this study, we demonstrated that the 2-stage implantation technique of the sacral neuromodulation therapy performed as a longer test stimulation phase has a higher success rate.
authors.affiliation: Department of Urology, Ghent University Hospital, De Pintelaan 185, B9000 Ghent, Belgium. karel.everaert@UGent.be
authors.forename: K
authors.initials: K
authors.lastname: Everaert
authors.forename: W
authors.initials: W
authors.lastname: Kerckhaert
authors.forename: H
authors.initials: H
authors.lastname: Caluwaerts
authors.forename: M
authors.initials: M
authors.lastname: Audenaert
authors.forename: H
authors.initials: H
authors.lastname: Vereecke
authors.forename: G
authors.initials: G
authors.lastname: De Cuypere
authors.forename: A
authors.initials: A
authors.lastname: Boelaert
authors.forename: U
authors.initials: U
authors.lastname: Van den Hombergh
authors.forename: W
authors.initials: W
authors.lastname: Oosterlinck
mesh_terms: D000465:Algorithms; D003365:Costs and Cost Analysis; D004599:Electric Stimulation Therapy / Q000191:economics / Q000295:instrumentation / Q000379:methods*; D005500:Follow-Up Studies; D006801:Humans; D008160:Lumbosacral Plexus; D008875:Middle Aged; D017773:Pelvic Floor / Q000503:physiopathology; D010865:Pilot Projects; D011446:Prospective Studies; D014555:Urination Disorders / Q000209:etiology / Q000628:therapy*