Preliminary Outcomes of an Innovative Approach to Transvaginal Graft Augmentation for Pelvic Organ Prolapse in the “Post-Mesh Era”

Abstract

Study Objective The objective of this study is to report the early outcomes of a novel transvaginal reconstructive repair of pelvic organ prolapse (POP) augmented with a “Y-shaped” biologic graft (Axis Dermis). Design Retrospective Cohort Study Setting Urogynecology academic private practice in central Pennsylvania Patients or Participants 36 women who underwent transvaginal pelvic reconstructive surgery with augmentation using Axisтм Dermis graft combined with SSL fixation using polypropylene suture for symptomatic Stage 2 prolapse or higher between April 2019 and October 2019 Interventions All patients underwent transvaginal pelvic reconstructive surgery employing a “Y-shaped” Axisтм Dermis graft reinforced with bilateral permanent (polypropylene) suture suspension to the sacrospinous ligament (SSL). Measurements and Main Results Primary outcome was success of surgery, defined by both subjective and objective results up to 6 months post-operatively. Subjectively, as the resolution of bothersome pelvic prolapse related symptoms as indicated by either negative answers to post-op Pelvic Organ Prolapse Distress Inventory 6 or on follow-up telephone interview. Objectively, as a POP-Q Stage ≤ 1. Secondary outcomes were complications, retreatment, and reoperation. The average patient age and BMI was 69.8 years and 27.9 kg/m2, respectively. The average parity was 2.5. The proportion of women with the pre-op diagnosis of uterovaginal prolapse versus post-hysterectomy vaginal vault prolapse was 72.3% and 27.7%, respectively. The subjective and objective cure rate at 6 months was 97.3% and 94.5%, respectively. There were no major complications. There was one retreatment (with a pessary) at 6 weeks postoperatively. One patient was taken for reoperation for ureteral stent placement after post-op transient ureteral dysfunction. Conclusion In this small cohort, a unique technique for transvaginal pelvic reconstruction using biologic graft augmentation combined with permanent suture (polypropylene) SSL suspension has good short-term cure rates for pelvic organ prolapse, without safety concerns. A larger, longitudinal study is planned to investigate long-term success, cost, and efficacy.