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

2013; Wiley; Volume: 121; Issue: 1 Linguagem: Inglês

10.1111/1471-0528.12454

1471-0528

Martin Rudnicki, E. Laurikainen, R Pogosean, I Kinne, Ulf Jakobsson, Pia Teleman,

Pelvic and Acetabular Injuries

Objective To investigate the anatomical cure rate and complications related to collagen‐coated mesh for cystocele, compared with a conventional anterior colporrhaphy. Design A randomised controlled study. Setting Six departments of obstetrics and gynaecology in Norway, Sweden, Finland, and Denmark. Population 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. Main outcome measures 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.