Anterior colporrhaphy compared with collagen-coated transvaginal mesh for anterior vaginal wall prolapse: a randomised controlled trial

ObjectiveTo investigate the anatomical cure rate and complications related to collagen-coated mesh for cystocele, compared with a conventional anterior colporrhaphy. DesignA randomised controlled study. SettingSix departments of obstetrics and gynaecology in Norway, Sweden, Finland, and Denmark. PopulationWomen aged 55years or older, referred for surgery with a prolapse of the anterior vaginal wall of stage2 or higher. MethodsWomen 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. Main outcome measuresThe primary outcome was objective cure, defined as prolapse below POP-Q stage2 at the 12-months follow-up. Secondary outcomes were quality of life, symptoms, and presence (or not) of complications. ResultsIn total, 161 women were randomised to either anterior colporrhaphy or mesh (participant ages 64.96.4years versus 64.7 +/- 6.6years, 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