A 3-year follow-up after anterior colporrhaphy compared with collagen-coated transvaginal mesh for anterior vaginal wall prolapse: a randomised controlled trial

Abstract

Objective: To compare the 1-year (previously published) and 3-year objective and subjective cure rates, and complications, related to the use of a collagen-coated transvaginal mesh for anterior vaginal wall prolapse against a conventional anterior repair.

Design: Randomised controlled study.

Setting: Six departments of obstetrics and gynaecology in Norway, Sweden, Finland, and Denmark.

Population: A total of 138 women, of 55 years of age or older, admitted for stage ≥2 anterior vaginal wall prolapse.

Methods: The women scheduled for primary anterior vaginal wall prolapse surgery were randomised between conventional anterior colporrhaphy and surgery with a collagen-coated prolene mesh. All patients were evaluated using the Pelvic Organ Prolapse Quantification (POP-Q) assessment before and after surgery. Symptoms related to pelvic organ prolapse were evaluated using the Pelvic Floor Impact Questionnaire (PFIQ-7) and the Pelvic Floor Distress Inventory (PFDI-20).

Main outcome measures: Objective cure, defined as POP-Q stage <2 prolapse at the 1- and 3-year follow-ups. Furthermore, mesh exposure and dyspareunia were also recorded.

Results: In total, 138 patients (70 from the mesh group versus 68 from the conventional anterior colporrhaphy group) out of 160 (86.3%) participated in the 3-year follow-up. POP-Q revealed an objective anatomic cure for 88.1 and 91.4%, respectively, in the mesh group at the 1- and 3-year follow-ups, compared with 39.9 and 41.2% in the colporrhaphy group. No difference between the groups was observed regarding PFIQ-7, PFDI-20, and Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) scores. The number of mesh exposures did not change during the study period and all exposures were minor.

Conclusion: Our study demonstrates that although the objective outcome was superior in the mesh group, the use of mesh had no impact on the subjective outcome.

Tweetable abstract: POP-Q deteriorates after anterior prolapse surgery but remains stable in women with mesh implantation.

Trial registration: ClinicalTrials.gov NCT00627549.

Keywords: Anterior colporrhaphy; erosion; pelvic organ prolapse; synthetic mesh.