title: Anterior colporrhaphy versus transvaginal mesh for pelvic-organ prolapse.
abstract: BACKGROUND
  The use of standardized mesh kits for repair of pelvic-organ prolapse has spread rapidly in recent years, but it is unclear whether this approach results in better outcomes than traditional colporrhaphy.
  
  
  METHODS
  In this multicenter, parallel-group, randomized, controlled trial, we compared the use of a trocar-guided, transvaginal polypropylene-mesh repair kit with traditional colporrhaphy in women with prolapse of the anterior vaginal wall (cystocele). The primary outcome was a composite of the objective anatomical designation of stage 0 (no prolapse) or 1 (position of the anterior vaginal wall more than 1 cm above the hymen), according to the Pelvic Organ Prolapse Quantification system, and the subjective absence of symptoms of vaginal bulging 12 months after the surgery.
  
  
  RESULTS
  Of 389 women who were randomly assigned to a study treatment, 200 underwent prolapse repair with the transvaginal mesh kit and 189 underwent traditional colporrhaphy. At 1 year, the primary outcome was significantly more common in the women treated with transvaginal mesh repair (60.8%) than in those who underwent colporrhaphy (34.5%) (absolute difference, 26.3 percentage points; 95% confidence interval, 15.6 to 37.0). The surgery lasted longer and the rates of intraoperative hemorrhage were higher in the mesh-repair group than in the colporrhaphy group (P<0.001 for both comparisons). Rates of bladder perforation were 3.5% in the mesh-repair group and 0.5% in the colporrhaphy group (P=0.07), and the respective rates of new stress urinary incontinence after surgery were 12.3% and 6.3% (P=0.05). Surgical reintervention to correct mesh exposure during follow-up occurred in 3.2% of 186 patients in the mesh-repair group.
  
  
  CONCLUSIONS
  As compared with anterior colporrhaphy, use of a standardized, trocar-guided mesh kit for cystocele repair resulted in higher short-term rates of successful treatment but also in higher rates of surgical complications and postoperative adverse events. (Funded by the Karolinska Institutet and Ethicon; ClinicalTrials.gov number, NCT00566917.).
authors.affiliation: Division of Obstetrics and Gynecology, Department of Clinical Science, Danderyd Hospital, Stockholm, Sweden. daniel.altman@ds.se
authors.forename: Daniel
authors.initials: D
authors.lastname: Altman
authors.forename: Tapio
authors.initials: T
authors.lastname: Väyrynen
authors.forename: Marie Ellström
authors.initials: ME
authors.lastname: Engh
authors.forename: Susanne
authors.initials: S
authors.lastname: Axelsen
authors.forename: Christian
authors.initials: C
authors.lastname: Falconer
mesh_terms: D000368:Aged; D005260:Female; D013509:Gynecologic Surgical Procedures / Q000379:methods*; D006801:Humans; D016015:Logistic Models; D008875:Middle Aged; D056887:Pelvic Organ Prolapse / Q000601:surgery*; D011183:Postoperative Complications; D013526:Surgical Mesh; D016896:Treatment Outcome; D001743:Urinary Bladder / Q000293:injuries; D014621:Vagina / Q000601:surgery*