title: Retropubic versus transobturator midurethral slings for stress incontinence.
abstract: BACKGROUND
  Midurethral slings are increasingly used for the treatment of stress incontinence, but there are limited data comparing types of slings and associated complications.
  
  
  METHODS
  We performed a multicenter, randomized equivalence trial comparing outcomes with retropubic and transobturator midurethral slings in women with stress incontinence. The primary outcome was treatment success at 12 months according to both objective criteria (a negative stress test, a negative pad test, and no retreatment) and subjective criteria (self-reported absence of symptoms, no leakage episodes recorded, and no retreatment). The predetermined equivalence margin was +/-12 percentage points.
  
  
  RESULTS
  A total of 597 women were randomly assigned to a study group; 565 (94.6%) completed the 12-month assessment. The rates of objectively assessed treatment success were 80.8% in the retropubic-sling group and 77.7% in the transobturator-sling group (3.0 percentage-point difference; 95% confidence interval [CI], -3.6 to 9.6). The rates of subjectively assessed success were 62.2% and 55.8%, respectively (6.4 percentage-point difference; 95% CI, -1.6 to 14.3). The rates of voiding dysfunction requiring surgery were 2.7% in those who received retropubic slings and 0% in those who received transobturator slings (P=0.004), and the respective rates of neurologic symptoms were 4.0% and 9.4% (P=0.01). There were no significant differences between groups in postoperative urge incontinence, satisfaction with the results of the procedure, or quality of life.
  
  
  CONCLUSIONS
  The 12-month rates of objectively assessed success of treatment for stress incontinence with the retropubic and transobturator approaches met the prespecified criteria for equivalence; the rates of subjectively assessed success were similar between groups but did not meet the criteria for equivalence. Differences in the complications associated with the two procedures should be discussed with patients who are considering surgical treatment for incontinence. (ClinicalTrials.gov number, NCT00325039.)
authors.affiliation: Department of Obstetrics and Gynecology, University of Alabama at Birmingham, 1700 6th Ave. South, Suite 10382, Birmingham, AL 35233, USA. hrichter@uabmc.edu
authors.forename: Holly E
authors.initials: HE
authors.lastname: Richter
authors.forename: Michael E
authors.initials: ME
authors.lastname: Albo
authors.forename: Halina M
authors.initials: HM
authors.lastname: Zyczynski
authors.forename: Kimberly
authors.initials: K
authors.lastname: Kenton
authors.forename: Peggy A
authors.initials: PA
authors.lastname: Norton
authors.forename: Larry T
authors.initials: LT
authors.lastname: Sirls
authors.forename: Stephen R
authors.initials: SR
authors.lastname: Kraus
authors.forename: Toby C
authors.initials: TC
authors.lastname: Chai
authors.forename: Gary E
authors.initials: GE
authors.lastname: Lemack
authors.forename: Kimberly J
authors.initials: KJ
authors.lastname: Dandreo
authors.forename: R Edward
authors.initials: RE
authors.lastname: Varner
authors.forename: Shawn
authors.initials: S
authors.lastname: Menefee
authors.forename: Chiara
authors.initials: C
authors.lastname: Ghetti
authors.forename: Linda
authors.initials: L
authors.lastname: Brubaker
authors.forename: Ingrid
authors.initials: I
authors.lastname: Nygaard
authors.forename: Salil
authors.initials: S
authors.lastname: Khandwala
authors.forename: Thomas A
authors.initials: TA
authors.lastname: Rozanski
authors.forename: Harry
authors.initials: H
authors.lastname: Johnson
authors.forename: Joseph
authors.initials: J
authors.lastname: Schaffer
authors.forename: Anne M
authors.initials: AM
authors.lastname: Stoddard
authors.forename: Robert L
authors.initials: RL
authors.lastname: Holley
authors.forename: Charles W
authors.initials: CW
authors.lastname: Nager
authors.forename: Pamela
authors.initials: P
authors.lastname: Moalli
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Mueller
authors.forename: Amy M
authors.initials: AM
authors.lastname: Arisco
authors.forename: Marlene
authors.initials: M
authors.lastname: Corton
authors.forename: Sharon
authors.initials: S
authors.lastname: Tennstedt
authors.forename: T Debuene
authors.initials: TD
authors.lastname: Chang
authors.forename: E Ann
authors.initials: EA
authors.lastname: Gormley
authors.forename: Heather J
authors.initials: HJ
authors.lastname: Litman
mesh_terms: D057186:Comparative Effectiveness Research; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D057194:Intention to Treat Analysis; D007431:Intraoperative Complications / Q000453:epidemiology; D008875:Middle Aged; D017060:Patient Satisfaction; D011183:Postoperative Complications / Q000453:epidemiology; D053825:Suburethral Slings; D016896:Treatment Outcome; D014550:Urinary Incontinence, Stress / Q000601:surgery*; D014555:Urination Disorders / Q000209:etiology; D014563:Urodynamics; D013520:Urologic Surgical Procedures / Q000295:instrumentation / Q000379:methods*