Elevate and Uterine Preservation: Two-Year Results.

OBJECTIVE: To evaluate efficacy of the Elevate Anterior and Apical (EAA) in the repair of pelvic organ prolapse (POP) when performed after previous hysterectomy and with or without uterine preservation during POP surgery. MATERIALS AND METHODS: One hundred forty-two women with anterior vaginal prolapse and/or apical descent ≥ stage II were enrolled. The primary outcome was treatment failure defined as > stage II POP-Q during follow-up using the Last observed Failure Carried Forward method. Three sub-groups were analysed: baseline previous hysterectomy (N = 61); concomitant hysterectomy (N = 29), and preserved uterus/no hysterectomy (N = 51). Demographics, primary and secondary outcomes, and extrusion were compared between the groups. A P value less than 0.05 was considered statistically significant. RESULTS: Anatomic success shows significant and durable improvement at 24 months. The success for the apical compartment ranged between 93.8% and 100%. Success was slightly lower for the anterior compartment (70.8-89.1%). No statistically significant difference between the 3 subgroups. Age was the only patient characteristic to be found different between the 3 subgroups. In addition, there was no difference in overall intraoperative complications (P = 0.263). Mesh extrusion was found in all groups: 3 of 61 (4.9%) had previous hysterectomy; 4 of 29 (13.8%) had concomitant hysterectomy; and 1 of 51 (2.0%) had uterus preserved (P = 0.094). There appears to be a trend toward higher extrusion when a hysterectomy was performed with the EAA. CONCLUSIONS: Anatomic success and complications for the EAA do not appear to be significantly impacted when the uterus is removed before or during surgery or preserved. There may be a trend toward increased mesh extrusion when a hysterectomy is performed. However, larger cohort studies are needed to determine if concomitant hysterectomy impact extrusion.

Single-incision apical and posterior mesh repair: 1-year prospective outcomes.

INTRODUCTION AND HYPOTHESIS: The objective of this study was to assess the safety and efficacy of the Elevate Apical and Posterior single-incision mesh system (SIMS) with IntePro Lite for pelvic organ prolapse repair. METHODS: This prospective multicenter study included 139 women with ≥ stage II posterior vaginal prolapse and/or apical descent who underwent placement of type I polypropylene mesh through a single transvaginal incision with no external needle passes. Primary endpoint was the percent of patients with posterior and/or apical stage ≤ I ("cure") at follow-up. Secondary endpoints included, but were not limited to, rate of mesh extrusion and disease-specific quality of life outcomes. RESULTS: At 12 months, objective posterior wall and apical cure rates were 92.5 and 89.2 %, respectively, with an extrusion rate of 6.5 %. CONCLUSIONS: The SIMS appears to be effective and safe in treating patients with posterior vaginal and/or apical prolapse. The risks and benefits of transvaginal synthetic mesh insertion should be considered.

Anterior repair with or without collagen matrix reinforcement: a randomized controlled trial.

OBJECTIVE: To compare outcomes of anterior colporrhaphy alone to that reinforced with bovine pericardium graft. METHODS: Women with anterior vaginal wall prolapse were enrolled in a randomized fashion in this grafted compared with nongrafted repair study. Outcome measures included pelvic organ prolapse quantification data, quality-of-life assessment, healing abnormalities, and complications. RESULTS: Ninety-four patients were enrolled. Seventy-two (77%) provided 1-year data, and 59 (63%) supplied 2-year data. Demographics and stage of prolapse were similar between groups at baseline. Postoperative complications consisted basically of low urinary tract infection and were low in both groups (10 in bovine pericardium graft and 16 in anterior colporrhaphy alone). One year after surgery, successful anterior vaginal wall support was obtained in 85.7% of the bovine pericardium graft group and 78.4% of anterior colporrhaphy-alone group (P=.544). For the cohort that comprised 2-year analyses, the success rate was 76.5% for the bovine pericardium graft group and 63% for anterior colporrhaphy-alone group (P=.509). Postoperative Urogenital Distress Inventory-6 and Pelvic Organ Prolapse-Urinary Incontinence Sexual Function Questionnaire-12 scores were uniformly improved over baseline in both groups. CONCLUSION: The use of bovine pericardium graft for anterior vaginal prolapse does not have higher complication rates or healing difficulties. At 1- and 2-year follow-up, anterior colporrhaphy with bovine pericardium reinforcement did not show a statistically significant improvement over colporrhaphy alone. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00860912 LEVEL OF EVIDENCE: I.