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.

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.

Trial registration: ClinicalTrials.gov NCT00627549 NCT00774215.

Keywords: Anterior repair; collagen coated; mesh; pelvic organ prolapse; randomised controlled trial.