title: Value of urodynamics before stress urinary incontinence surgery: a randomized controlled trial.
abstract: OBJECTIVE
  To estimate whether a strategy of immediate surgery was noninferior to a strategy based on discordant urodynamic findings followed by individually tailored therapy in women with stress urinary incontinence (SUI).
  
  
  METHODS
  A multicenter diagnostic cohort study with an embedded noninferiority randomized controlled trial was conducted in six academic and 24 nonacademic Dutch hospitals. Women with predominant SUI eligible for surgical treatment based on clinical assessment were included between January 2009 and November 2010. All patients underwent urodynamics. In patients in whom urodynamics were discordant with clinical assessment, participants were randomly allocated to receive either immediate surgery or individually tailored therapy based on urodynamics. The primary outcome was clinical improvement assessed by the Urogenital Distress Inventory 12 months after baseline. Analysis was by intention to treat; a difference in mean improvement of 5 points or less was considered noninferior.
  
  
  RESULTS
  Five hundred seventy-eight women with SUI were studied, of whom 268 (46%) had discordant findings. One hundred twenty-six patients gave informed consent for randomization and were allocated to receive immediate surgery (n=64) or individually tailored therapy (n=62). The mean improvement measured with the Urogenital Distress Inventory after 1 year was 44 points (±24) in the group receiving immediate surgery and 39 (±25) points in the group receiving individually tailored treatment. The difference in mean improvement was 5 points in favor of the group receiving immediate surgery (95% confidence interval -∞ to 5). There were no differences with respect to cure or complication rate.
  
  
  CONCLUSIONS
  In women with uncomplicated SUI, an immediate midurethral sling operation is not inferior to individually tailored treatment based on urodynamic findings.
  
  
  BACKGROUND
  ClinicalTrials.gov, www.clinicaltrials.gov, NCT00814749.
  
  
  METHODS
  I.
authors: Radboud University Nijmegen Medical Centre, Nijmegen; Academic Medical Centre, Amsterdam; Reinier de Graaf Groep, Delft; Isala Klinieken Zwolle, Zwolle; University Medical Centre Utrecht, Utrecht; VieCuri Hospital Venlo, Venlo; Rijnstate Hospital Arnhem, Arnhem; Catharina Hospital, Eindhoven; VU Medical Centre, Amsterdam; Onze Lieve Vrouwe Gasthuis, Amsterdam; Maxima Medical Centre, Veldhoven; and Gelre Hospital, Apeldoorn, The Netherlands.
authors: Sanne Adriana Lucia
authors: SAL
authors: van Leijsen
authors: Kirsten B
authors: KB
authors: Kluivers
authors: Ben Willem J
authors: BWJ
authors: Mol
authors: Joanna 't
authors: J'
authors: Hout
authors: Alfredo L
authors: AL
authors: Milani
authors: Jan-Paul W R
authors: JWR
authors: Roovers
authors: Jan den
authors: JD
authors: Boon
authors: C Huub van der
authors: CHV
authors: Vaart
authors: Paul H
authors: PH
authors: Langen
authors: Francis E
authors: FE
authors: Hartog
authors: Viviane
authors: V
authors: Dietz
authors: E Stella M
authors: ESM
authors: Tiersma
authors: Marina C
authors: MC
authors: Hovius
authors: Marlies Y
authors: MY
authors: Bongers
authors: Wilbert
authors: W
authors: Spaans
authors: John P F A
authors: JPFA
authors: Heesakkers
authors: Mark E
authors: ME
authors: Vierhout
mesh_terms: D003950:Diagnostic Techniques, Urological; D005260:Female; D006801:Humans; D008875:Middle Aged; D011300:Preoperative Care; D016037:Single-Blind Method; D014550:Urinary Incontinence, Stress / Q000503:physiopathology* / Q000601:surgery*; D014563:Urodynamics
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