title: Absorbable mesh augmentation compared with no mesh for anterior prolapse: a randomized controlled trial.
abstract: OBJECTIVE
  To compare anatomical and patient-reported outcomes at 12 months postoperatively for women who had anterior compartment pelvic organ prolapse (POP) surgery using a repair augmented with porcine small intestine submucosa mesh (Mesh Group) compared with those who had a native tissue repair (No Mesh Group).
  
  
  METHODS
  This was a randomized controlled trial with 12 months follow-up. The surgical procedure was identical in both groups except for the placement of intervening mesh. The primary outcome was anatomical "cure" (Ba of -1 or less on Pelvic Organ Prolapse Quantification [POP-Q]). Secondary outcomes included POP-Q stage, patient-reported outcomes, and patient satisfaction. The study was powered to detect a 40% difference at 80% power (α=0.05).
  
  
  RESULTS
  Fifty-seven women were randomized (28 to Mesh Group, 29 to No Mesh Group). Forty-five (79%) underwent concomitant surgery. At the 12-month follow-up, 56% (15/27) in the Mesh Group and 61% (17/28) in the No Mesh Group were considered cured (relative risk 0.90, 95% confidence interval 0.52-1.54). There were no significant differences between groups in recurrent or persistent prolapse (7% in each group) nor in patient-reported outcomes at 12 months. Pelvic girdle pain occurred in 4 of 27 in the Mesh Group and 3 of 28 in the No Mesh Group.
  
  
  CONCLUSIONS
  No significant differences were observed in anatomical or patient-reported outcomes outcome parameters at 12 months after correction of symptomatic anterior POP by mesh or no mesh repair. In our study, porcine small intestine submucosa mesh did not confer additional benefit over a native tissue repair.
  
  
  BACKGROUND
  ClinicalTrials.gov, www.clinicaltrials.gov, NCT0095544. LEVEL OF EVEDIENCE: I.
authors.affiliation: Departments of Obstetrics and Gynecology, University of Calgary, Calgary, and University of Edmonton, Edmonton, Alberta, and University of Sherbrooke, Sherbrooke, Quebec, Canada.
authors.forename: Magali
authors.initials: M
authors.lastname: Robert
authors.forename: Isabelle
authors.initials: I
authors.lastname: Girard
authors.forename: Erin
authors.initials: E
authors.lastname: Brennand
authors.forename: Selphee
authors.initials: S
authors.lastname: Tang
authors.forename: Colin
authors.initials: C
authors.lastname: Birch
authors.forename: Magnus
authors.initials: M
authors.lastname: Murphy
authors.forename: Sue
authors.initials: S
authors.lastname: Ross
mesh_terms: D000328:Adult; D000368:Aged; D000818:Animals; D005260:Female; D013509:Gynecologic Surgical Procedures / Q000009:adverse effects / Q000379:methods*; D006801:Humans; D007421:Intestine, Small; D008875:Middle Aged; D017060:Patient Satisfaction; D056887:Pelvic Organ Prolapse / Q000601:surgery*; D017699:Pelvic Pain; D011183:Postoperative Complications; D013526:Surgical Mesh; D013552:Swine; D016896:Treatment Outcome