title: One-year objective and functional outcomes of a randomized clinical trial of vaginal mesh for prolapse.
abstract: OBJECTIVE
  The purpose of this study was to show 12-month outcomes of a randomized trial that compared vaginal prolapse repair with and without mesh.
  
  
  METHODS
  Women with stage ≥2 prolapse were assigned randomly to vaginal repair with or without mesh. The primary outcome was prolapse stage ≤1 at 12 months. Secondary outcomes included quality of life and complications.
  
  
  RESULTS
  All 65 evaluable participants were followed for 12 months after trial stoppage for mesh exposures. Thirty-two women had mesh repair; 33 women had traditional repair. At 12 months, both groups had improvement of pelvic organ prolapse-quantification test points to similar recurrence rates. The quality of life improved and did not differ between groups: 96.2% mesh vs 90.9% no-mesh subjects reported a cure of bulge symptoms; 15.6% had mesh exposures, and reoperation rates were higher with mesh.
  
  
  CONCLUSIONS
  Objective and subjective improvement is seen after vaginal prolapse repair with or without mesh. However, mesh resulted in a higher reoperation rate and did not improve 1-year cure.
authors.affiliation: Section of Female Pelvic Medicine and Reconstructive Surgery, Department of Women and Infants' Services, Washington Hospital Center/Georgetown University School of Medicine, Washington, DC, USA. asokol72@gmail.com
authors.forename: Andrew I
authors.initials: AI
authors.lastname: Sokol
authors.forename: Cheryl B
authors.initials: CB
authors.lastname: Iglesia
authors.forename: Bela I
authors.initials: BI
authors.lastname: Kudish
authors.forename: Robert E
authors.initials: RE
authors.lastname: Gutman
authors.forename: David
authors.initials: D
authors.lastname: Shveiky
authors.forename: Richard
authors.initials: R
authors.lastname: Bercik
authors.forename: Eric R
authors.initials: ER
authors.lastname: Sokol
mesh_terms: D000368:Aged; D004311:Double-Blind Method; D005260:Female; D013509:Gynecologic Surgical Procedures / Q000009:adverse effects / Q000379:methods / Q000706:statistics & numerical data*; D006801:Humans; D008875:Middle Aged; D017060:Patient Satisfaction / Q000706:statistics & numerical data; D019736:Prostheses and Implants / Q000009:adverse effects / Q000706:statistics & numerical data*; D011788:Quality of Life / Q000523:psychology; D012086:Reoperation / Q000706:statistics & numerical data; D013526:Surgical Mesh / Q000009:adverse effects / Q000706:statistics & numerical data*; D016896:Treatment Outcome; D014596:Uterine Prolapse / Q000601:surgery*