A Randomized, Controlled Trial Comparing Fascia Lata and Synthetic Mesh for Sacral Colpopexy

Abstract

One hundred women with posthysterectomy vaginal vault prolapse who were scheduled for sacral colpopexy at the University of Louisville Health Sciences Center participated in this double-blind, randomized trial comparing the use of cadaveric fascia lata and polypropylene mesh. The Pelvic Organ Prolapse Quantification system (POP-Q) was used for patient evaluation preoperatively and at 3 months, 6 months, and 1 year postoperatively. Fascial lata was used in 46 patients and polypropylene mesh was used in 54. Eighty-nine women, 44 in the fascia group and 45 in the mesh group, completed the 1-year study period. The 2 groups were similar in social demographics, clinical characteristics, and operative data. Adverse events possibly related to the graft were experienced by 26% of women who received mesh and 15% of women who received fascia (P = .19). Other surgical procedures, in tension-free tape procedures, posterior repairs, and paravaginal repairs were performed frequently and at similar rates in the 2 groups. At the 1-year examination, the rate of objective anatomic failure, as defined by Weber et al, was greater in the women who received fascia (14 of 44; 32%) compared with those who received mesh (4 of 45; 9%) (P = .007). There were 15 instances of POP-Q point Aa (point along the distal anterior vaginal wall) and 3 of POP-Q point Ap (posterior vaginal wall) reaching at least the −1 position. There were no point C (vaginal cuff) failures. The results of the POP-Q evaluations changed over the year of observation. At the end of 12 months, significant differences in between the 2 groups were seen for the mean values of point Aa (P = .02), point C (P = .04), and prolapse stage (P = .03). No differences were seen in total vaginal length, genital hiatus, perineal body, or points Ap or Bp (points along the posterior vaginal wall). When risk factors for surgical failure of sacral colpopexy, other than graft material (age, body mass index, prior prolapse or continence surgery), were subjected to univariate analysis, no significant predictors of failure were seen.