SINGLE-INCISION MESH REPAIR VERSUSNATIVE TISSUE REPAIR FOR ADVANCED PELVIC ORGAN PROLAPSE
A. PADOA1, A. TSVIBAN2, N. SMORGICK 1;
1Assaf HarofeMedical Center, Assaf Harofeh Med. Ctr., Zrifin, Israel, 2Assadharofeh Med. center, Rehovot, Israel.
Introduction: Since the FDAalert on vaginal meshes in 2011, many surgeons abandoned the use ofvaginal implants in pelvic organ prolapse (POP) repair. Our policyhas been to limit the use of vaginal meshes to recurrent POP and tostage 4 anterior and apical vaginal prolapse. We offer native tissuerepair to all other candidates for vaginal POP surgery.
Objective:This longitudinal cohort study compares the outcome of vaginalsurgery for apical and anterior compartment prolapse >stage 3 using one of two techniques: 1. Sacrospinous fixation (SSF)and colporrhaphy (group 1) 2. Single-incision mesh repair usinganterior Elevate and posterior Elevate when required (group 2). Theprimary outcome is anatomical success at the latest follow-up visit.As secondary outcomes, quality of life (QoL) measures and the rate oflong-term complications of the two surgical approaches wereassessed.
Methods: Between February 2013 and February 2016,patients who underwent vaginal POP surgery for stage > 3anterior and apical prolapse were recruited. All patients underwentpre-operative evaluation using a structured symptom questionnaire andPOP-Q examination. Patients who could read and understand the locallanguage filled the PFDI-20 and PISQ-12 questionnaires. All surgicalprocedures were carried out by a single experienced surgeon. Rightsacrospinous fixation was performed using either the Capio or theDigitex device with vicryl or PDS sutures. The Elevate procedure wascarried out according to manufacturer instructions and after formaltraining. Vaginal packing and a foley catheter were left for 24hours, patients were discharged on POD-2 in the absence ofcomplications. Patients returned for routine post-operative follow upevaluations at 3 weeks, 8 weeks, 6 months and then annually.
Results:In the study period, 86 patients were recruited. Patients whoreturned for follow-up at least 6 months after surgery were includedin data analysis: 51 patients in the SSF group and 24 patients in theElevate™ group. No difference between groups was found indemographic characteristics. Pre-operative POP-Q stage was moreadvanced in group 2 at the anterior and posterior compartment (meanBa=+2.2 cm in group 1 and +4.7 in group 2 (p< 0.05), mean Bp=-0.5in group 1 and +1.4 in group 2 (p=0.03)). No statistical differencewas found at the vaginal apex (mean C=+1.9 in group 1 and +4.5 ingroup 2, p=0.08). A concomitant vaginal hysterectomy vas carried outin 86% of patients in group 1 and in 71% in group 2 (p=0.12).Fifty-three percent of patients in group 1 and 62% in group 2 had aTVT procedure. One-third of patients in group 2 had both anterior andposterior Elevate. A posterior colporrhaphy was carried out in 21.6%of patients in group 1 and 50% in group 2 (p=0.01). Median follow-upwas similar in both groups: 13 months (range 6-40 months) and 12.5months (range 6-39 months), respectively (p=0.82). At the lastfollow-up visit, 4 patients in group 1 and none in group 2 complainedof bulge symptoms (p=0.2). Post-operative POP-Q measurements weresimilar between groups for all compartments: mean Ba=-1.7 in group 1and -1.9 in group 2 (p=0.57), mean Bp=-1.9 in group 1 and -2.3 ingroup 2 (p=0.09), mean C=-8 in group 1 and -8.6 in group 2 (p=0.2).Anatomical success, defined as POP less than stage 2, was 82% ingroup 1 and 91.7% in group 2 (p=0.48). Subjective outcome wasassessed using validated questionnaires in the local language. With alarge population of immigrants, only 41% of patients in group 1 and46% in group 2 could complete the PFDI-20 questionnaire. Percentageswere even lower for the PISQ-12 as only 58% of group 1 patients and37% of group 2 patients were sexually active. In both groups, weobserved a significant postoperative improvement in the prolapse(POPDI-6) and urinary symptom domains (UDI-6) and no deterioration incolorectal symptoms (CRADI-8) or in sexual function (PISQ-12).Post-operative QoL questionnaires scores were similar between groupsin all domains. As for complications, there were 3 cases of mesherosion in group 2 (12.5%). Vaginal pain was reported by fourpatients in group 1 and by none in group 2. The incidence of de-novodyspareunia after surgery was 9.8% in group 1 and 4.2% in group 2(p=0.6). De-novo SUI was reported by 2% of patients in group 1 and by12.5% in group 2, with no statistical significance(p=0.94).
Conclusions: Native tissue surgery and vaginalmesh are equally safe and effective for surgical repair of advancedapical and anterior compartment prolapse. We believe accurateselection of patients and appropriate informed consent still justifythe use of vaginal meshes in the treatment of advancedPOP.
References: Cochrane Database Syst Rev. 2016 feb 9