12-Month Follow-up of a Novel, Meshless Method of Vaginal Colpopexy By Sacrospinous Ligament Fixation to Treat Pelvic Organ Prolapse

Abstract

Study Objective To assess safety and durability of EnPlace (formerly, NeuGuide) for vaginal colpopexy to treat uterine prolapse. Design Prospective, observational, single arm, multi-center study with 12-month follow-up. Setting Academic centers and community hospitals. Patients or Participants Sixty-seven women > 35 years of age with symptomatic pelvic organ prolapse (POP) were enrolled from 13 (global) sites. Interventions EnPlace anchors were inserted bilaterally, transvaginally at the apex and deployed through the sacrospinous ligament under anesthesia. Two (pre-attached) sutures extend from the anchors and were tunneled behind the vagina and exited through a para-cervical incision. The bilateral suture tails were passed through cervical stroma and tied to reduce the cervix to a normal position and suspend the uterus. Measurements and Main Results All the women were post-menopausal (average age=69.4 ± 8.6 years), and all complained of vaginal bulging. Fifty patients completed 6-month follow-up, and 22 completed 12-month follow-up. Anterior and posterior average pre-op Ba, Bp and C POP-Q scores were +0.09 cm, -1.0 cm and +0.98 cm, respectively. At 6- and 12-month post-op, avg Bp and C point POP-Q scores were significantly more negative than baseline (p Conclusion The EnPlace System is feasible and safe as a minimally invasive procedure for the treatment of uterine prolapse. The preliminary results of this cohort of patients demonstrate that the procedure is effective for the treatment of uterine prolapse. There was no significant change in the C point between 6 and 12 months, suggesting that the EnPlace repair is durable, though further follow-up is necessary to establish long term durability.