title: Anterior colporrhaphy compared with collagen-coated transvaginal mesh for anterior vaginal wall prolapse: a randomised controlled trial.
abstract: OBJECTIVE
  To investigate the anatomical cure rate and complications related to collagen-coated mesh for cystocele, compared with a conventional anterior colporrhaphy.
  
  
  METHODS
  A randomised controlled study.
  
  
  METHODS
  Six departments of obstetrics and gynaecology in Norway, Sweden, Finland, and Denmark.
  
  
  METHODS
  Women aged 55 years or older, referred for surgery with a prolapse of the anterior vaginal wall of stage 2 or higher.
  
  
  METHODS
  Women scheduled for primary cystocoele surgery were randomised to either anterior colporrhaphy or a collagen-coated Prolene mesh. Power analysis indicated that 130 patients had to be randomised. All patients were evaluated using the Pelvic Organ Prolapse-Quantification (POP-Q) measurement. Quality of life, symptoms, and sexual function were evaluated using the Pelvic Floor Impact Questionnaire, the Pelvic Floor Distress Inventory, and the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire.
  
  
  METHODS
  The primary outcome was objective cure, defined as prolapse below POP-Q stage 2 at the 12-months follow-up. Secondary outcomes were quality of life, symptoms, and presence (or not) of complications.
  
  
  RESULTS
  In total, 161 women were randomised to either anterior colporrhaphy or mesh (participant ages 64.9 ± 6.4 years versus 64.7 ± 6.6 years, respectively; mean ± SD). The objective cure rate was 39.8% (95% CI 28.6-50.9%) in the anterior colporrhaphy group, compared with 88.1% (95% CI 80.7-95.6%) in the mesh group (P < 0.001). Vaginal mesh exposure occurred in ten women (13.3%) and dyspareunia occurred in two women (2.7%, not significant) in the mesh group at the 12-months follow-up. Questionnaires revealed no difference between the groups.
  
  
  CONCLUSIONS
  Our study demonstrates a significantly improved objective cure rate associated with a high exposure rate among women with mesh surgery as opposed to conventional surgery.
authors.affiliation: Department of Obstetrics and Gynaecology, Roskilde University Hospital, Roskilde, Denmark.
authors.forename: M
authors.initials: M
authors.lastname: Rudnicki
authors.forename: E
authors.initials: E
authors.lastname: Laurikainen
authors.forename: R
authors.initials: R
authors.lastname: Pogosean
authors.forename: I
authors.initials: I
authors.lastname: Kinne
authors.forename: U
authors.initials: U
authors.lastname: Jakobsson
authors.forename: P
authors.initials: P
authors.lastname: Teleman
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D003094:Collagen; D052858:Cystocele / Q000601:surgery*; D003718:Denmark; D005260:Female; D005387:Finland; D006801:Humans; D008875:Middle Aged; D009664:Norway; D011788:Quality of Life; D019529:Sexuality; D013526:Surgical Mesh; D011795:Surveys and Questionnaires; D013548:Sweden; D016896:Treatment Outcome; D014621:Vagina / Q000601:surgery*
chemical_list: D003094:Collagen
keywords: Anterior repair; collagen coated; mesh; pelvic organ prolapse; randomised controlled trial