title: Can preoperative urodynamic investigation be omitted in women with stress urinary incontinence? A non-inferiority randomized controlled trial.
abstract: OBJECTIVE
  To assess in women with stress urinary incontinence (SUI) the value of urodynamics prior to treatment.
  
  
  METHODS
  We performed a multicenter non-inferiority randomized controlled trial. Women with SUI were randomly allocated to management based on a workup with or without urodynamics. The primary outcome was clinical reduction of complaints as measured with the Urogenital Distress Inventory urinary incontinence subscale (UDI-UI) at 12 months after the onset of treatment. A mean difference in improvement of less than 8 was considered non-inferior. The study was analyzed according to intention-to-treat.
  
  
  RESULTS
  The trial was stopped prematurely because of slow recruitment. We randomly allocated 59 women to a strategy with (N = 31) or without (N = 28) urodynamics. The mean difference in improvement on the UDI-UI was 14 in favor of the group without urodynamics (48 SD ± 22 vs. 34 SD ± 22, 95% CI: -28 to -0.26), confirming non-inferiority. Addition of urodynamics did not result in a lower occurrence of de novo overactive bladder complaints compared to a workup without urodynamics (6/31 vs. 1/28; RR 5.4, 95% CI: 0.70-42). In the group allocated to urodynamics, initial surgical management was more often abandoned compared to the group not allocated to urodynamics (5/31 vs. 1/28; RR 4.5, 95% CI: 0.56-36).
  
  
  CONCLUSIONS
  In this relatively small study, the omission of urodynamics was not inferior to the use of urodynamics in the preoperative workup of women with SUI. Women with SUI undergoing urodynamics had the risk of a choice for more prudent treatment, which seemed to result in a delay until effective treatment.
authors.affiliation: Department of Obstetrics & Gynecology, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands. s.vanleijsen@obgyn.umcn.nl
authors.forename: S A L
authors.initials: SA
authors.lastname: van Leijsen
authors.forename: K B
authors.initials: KB
authors.lastname: Kluivers
authors.forename: B W J
authors.initials: BW
authors.lastname: Mol
authors.forename: S R
authors.initials: SR
authors.lastname: Broekhuis
authors.forename: A L
authors.initials: AL
authors.lastname: Milani
authors.forename: M Y
authors.initials: MY
authors.lastname: Bongers
authors.forename: C I M
authors.initials: CI
authors.lastname: Aalders
authors.forename: V
authors.initials: V
authors.lastname: Dietz
authors.forename: G G A
authors.initials: GG
authors.lastname: Malmberg
authors.forename: M E
authors.initials: ME
authors.lastname: Vierhout
authors.forename: J P F A
authors.initials: JP
authors.lastname: Heesakkers
mesh_terms: D000328:Adult; D000368:Aged; D003950:Diagnostic Techniques, Urological; D005260:Female; D006801:Humans; D008875:Middle Aged; D009426:Netherlands; D016017:Odds Ratio; D011237:Predictive Value of Tests; D011300:Preoperative Care; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D001743:Urinary Bladder / Q000503:physiopathology*; D014550:Urinary Incontinence, Stress / Q000175:diagnosis* / Q000503:physiopathology / Q000601:surgery*; D014563:Urodynamics; D013520:Urologic Surgical Procedures / Q000009:adverse effects