Genital prolapse: Randomized, multicenter trial of surgical assessment for fascial repair versus synthetic polypropylene mesh repair

Objective: The aim of the study was to compare fascial and synthetic polypropylene mesh repair to treat severe genital prolapse Background: Despite of it presents better rates of cure; the use of synthetic material brought us new complications. The relevance of this study is the efficacy and security criterious evaluation of the use of synthetic meshes when compared to the fascial repair Methods: multicenter and randomized study that included 172 women with genital prolapse S3 or S4 by POP‐Q. The women were randomized by a software to surgical treatment using fascial repair (Group F‐ 82) or synthetic mesh, Prolift (Group M‐ 90). Twelve cases were excluded due to the follow‐up loss. The fascial repair surgery was performed according to site‐specific defects. We performed sacrospinal ligament fixation with non‐absorbable sutures for correcting the apical defects. The Prolift was conducted according to the technique recommended by the manufacturer. Hysterectomy was performed in cases of uterine prolapse, and the passage of the anterior mesh was through the same incision, without performing "T" incision. The primary outcomes were considered the evaluation of POP‐Q and the questionnaire of quality of life (P‐QoL validated for idiom). The secondary outcomes were considered the complication during and after surgeries. The anatomic cure was considered S <2. This study is ongoing and we presented the 6 months results. Data were allocated in programm with double entry into two identical databases. It was used association statistical tests and comparison according to the nature of the variables. Alpha risk <5 %. The amostral data were calculated considering failure between techniques 15 % Results: Both groups were homogeneous regarding age (mean F=65,1;M=66,3), obstetric history, hemoglobin level, hematocrit, quality of live (total score mean F=50,8; M=48,3‐p0 0,450), stage and type of prolapse‐Anterior (mean F=2,6; M=2,8‐p=0,114) Apical (mean F=1,9; M=2,1‐p=0,478) and Posterior (mean F=1,8; M=2,0‐p=0,323). No significant differences were observed between the two groups at the time of surgery (mean: F=110.7 min andM=106.0‐p=0,447). The anatomic cure rate was 32.9%in group F and 53.3%inM(p0 0.007). Comparing the groups regarding the POP‐Q points after 6 months we obtained a significant difference in point Ba (mean F=‐0,3 and M=‐1,2‐p=0,003). For other points the result was: C (mean F=‐4,2 andM=‐5,3‐p=0,225); Bp (mean F=‐2,0 and M=‐2,4‐p=0,115) and TVL (F=7,2 andM=6,9‐ p=0,118). There was recurrence of apical prolapse beyond E2 in 8 cases in F and 4 in M. Comparing pre‐and post‐operative POP‐Q points: C was from 0.8 to ‐4.2 in F and from 1.0 to ‐5.3 inM; Ba was from3.3 to 0.3 in the F and from3.6 to ‐1.2 in M; Bp was from 1.3 to ‐2.0 in F and 2.0 to ‐2.4 inM; TVL was form 8.5 to 7.2 in F and the M from 8.4 to 6.9 (all these changes with p<0.001). Intraoperative complications included bleeding with blood transfusion (F=2 and M=1‐p=0.606), bowel perforation (M=1‐p01,000), and bladder injury (F=1 and M 03‐p=0,622). Post‐operative complication was exposure (M=16). Other complications did not present relevant differences andwere described as: dysuria (F=0 andM=3‐p0 0,247), bleeding (F=1 and M=2‐p01,000), pain (F=5 and M=12‐p=0,112), dyspareunia (F=2 and M=6‐p=0,282), miccional dysfunction (F=1 and M=3‐p=0,622), difficult defecation (F=4 and M=4‐p01,000) and infection (F=1 and M=4‐p=0,370). Regarding to quality of life the total score between the groups was F=13,8 and M=13,5‐p=0,478) Conclusions: This study is ongoing and showed that the anatomical success in the mesh group was better than fascial group only regarding anterior prolapse for 6 months post‐operative period. The patients presented similar and significant improvement on quality of life in both groups and the main complication was exposure that occurred in a significant part of group M.