Randomized trial of fascia lata and polypropylene mesh for abdominal sacrocolpopexy: 5-year follow-up

Abstract

The purpose of this study is to evaluate the 5-year surgical outcomes of abdominal sacrocolpopexy among subjects randomized to receive polypropylene mesh or cadaveric fascia lata. All 100 subjects from the original randomized clinical trial were eligible. Primary outcome was objective anatomic failure: any pelvic organ prolapse quantification (POP-Q) point ≥ - 1. Secondary outcome was clinical failure-presence of bulge or prolapse symptoms and either a POP-Q point C ≥ ½ TVL or any POP-Q point >0-and interim surgical re-treatment. Wilcoxon tests and Fisher's exact test were performed. Fifty-eight subjects returned for 5-year follow-up-29 mesh and 29 fascia. Objective anatomic success rates were: mesh, 93% (27/29) and fascia, 62% (18/29) (p = 0.02). Clinical success rates were: mesh, 97% (28/29) and fascia, 90% (26/29) (p = 0.61). Polypropylene mesh was superior to cadaveric fascia lata using objective anatomic outcomes. Success rates of mesh and fascia were comparable using a clinical definition that combined symptoms with anatomic measures.