title: A randomized trial of urodynamic testing before stress-incontinence surgery.
abstract: BACKGROUND
  Urodynamic studies are commonly performed in women before surgery for stress urinary incontinence, but there is no good evidence that they improve outcomes.
  
  
  METHODS
  We performed a multicenter, randomized, noninferiority trial involving women with uncomplicated, demonstrable stress urinary incontinence to compare outcomes after preoperative office evaluation and urodynamic tests or evaluation only. The primary outcome was treatment success at 12 months, defined as a reduction in the score on the Urogenital Distress Inventory of 70% or more and a response of "much better" or "very much better" on the Patient Global Impression of Improvement. The predetermined noninferiority margin was 11 percentage points.
  
  
  RESULTS
  A total of 630 women were randomly assigned to undergo office evaluation with urodynamic tests or evaluation only (315 per group); the proportion in whom treatment was successful was 76.9% in the urodynamic-testing group versus 77.2% in the evaluation-only group (difference, -0.3 percentage points; 95% confidence interval, -7.5 to 6.9), which was consistent with noninferiority. There were no significant between-group differences in secondary measures of incontinence severity, quality of life, patient satisfaction, rates of positive provocative stress tests, voiding dysfunction, or adverse events. Women who underwent urodynamic tests were significantly less likely to receive a diagnosis of overactive bladder and more likely to receive a diagnosis of voiding-phase dysfunction, but these changes did not lead to significant between-group differences in treatment selection or outcomes.
  
  
  CONCLUSIONS
  For women with uncomplicated, demonstrable stress urinary incontinence, preoperative office evaluation alone was not inferior to evaluation with urodynamic testing for outcomes at 1 year. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and the Eunice Kennedy Shriver National Institute of Child Health and Human Development; ClinicalTrials.gov number, NCT00803959.).
authors.affiliation: University of California at San Diego, La Jolla, CA 92037-1300, USA. cnager@ucsd.edu
authors.forename: Charles W
authors.initials: CW
authors.lastname: Nager
authors.forename: Linda
authors.initials: L
authors.lastname: Brubaker
authors.forename: Heather J
authors.initials: HJ
authors.lastname: Litman
authors.forename: Halina M
authors.initials: HM
authors.lastname: Zyczynski
authors.forename: R Edward
authors.initials: RE
authors.lastname: Varner
authors.forename: Cindy
authors.initials: C
authors.lastname: Amundsen
authors.forename: Larry T
authors.initials: LT
authors.lastname: Sirls
authors.forename: Peggy A
authors.initials: PA
authors.lastname: Norton
authors.forename: Amy M
authors.initials: AM
authors.lastname: Arisco
authors.forename: Toby C
authors.initials: TC
authors.lastname: Chai
authors.forename: Philippe
authors.initials: P
authors.lastname: Zimmern
authors.forename: Matthew D
authors.initials: MD
authors.lastname: Barber
authors.forename: Kimberly J
authors.initials: KJ
authors.lastname: Dandreo
authors.forename: Shawn A
authors.initials: SA
authors.lastname: Menefee
authors.forename: Kimberly
authors.initials: K
authors.lastname: Kenton
authors.forename: Jerry
authors.initials: J
authors.lastname: Lowder
authors.forename: Holly E
authors.initials: HE
authors.lastname: Richter
authors.forename: Salil
authors.initials: S
authors.lastname: Khandwala
authors.forename: Ingrid
authors.initials: I
authors.lastname: Nygaard
authors.forename: Stephen R
authors.initials: SR
authors.lastname: Kraus
authors.forename: Harry W
authors.initials: HW
authors.lastname: Johnson
authors.forename: Gary E
authors.initials: GE
authors.lastname: Lemack
authors.forename: Marina
authors.initials: M
authors.lastname: Mihova
authors.forename: Michael E
authors.initials: ME
authors.lastname: Albo
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Mueller
authors.forename: Gary
authors.initials: G
authors.lastname: Sutkin
authors.forename: Tracey S
authors.initials: TS
authors.lastname: Wilson
authors.forename: Yvonne
authors.initials: Y
authors.lastname: Hsu
authors.forename: Thomas A
authors.initials: TA
authors.lastname: Rozanski
authors.forename: Leslie M
authors.initials: LM
authors.lastname: Rickey
authors.forename: David
authors.initials: D
authors.lastname: Rahn
authors.forename: Sharon
authors.initials: S
authors.lastname: Tennstedt
authors.forename: John W
authors.initials: JW
authors.lastname: Kusek
authors.forename: E Ann
authors.initials: EA
authors.lastname: Gormley
mesh_terms: D005260:Female; D006801:Humans; D057194:Intention to Treat Analysis; D008875:Middle Aged; D009819:Office Visits; D012720:Severity of Illness Index; D016896:Treatment Outcome; D014550:Urinary Incontinence, Stress / Q000145:classification / Q000175:diagnosis* / Q000503:physiopathology / Q000601:surgery; D014563:Urodynamics; D013520:Urologic Surgical Procedures