07 A novel, meshless method of vaginal colpopexy by sacrospinous ligament fixation in the context of comprehensive repair of pelvic organ prolapse

Abstract

Assess the safety and durability of EnPlace™ (formerly, NeuGuide™) as a minimally invasive treatment of uterine prolapse when used along with other surgical procedures for stress incontinence, cystocele, or rectocele. The study is a prospective, observational, single arm, international, multi-center study with 12-month follow-up in which 33 women > 35 years of age with pelvic organ prolapse (POP), defined as POP-Q C-point greater than -1 cm, were enrolled from 11 sites. Under anesthesia, EnPlace™ anchors were inserted bilaterally, transvaginally at the apex and deployed through the sacrospinous ligament. Two (pre-attached) sutures extend from each anchor and were tunneled behind the vagina and exited through a 1.5 cm 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. Along with EnPlace, other vaginal, non-mesh surgeries were permitted, as needed, to provide comprehensive repair of POP. Of the 33 women enrolled in this study, 6-month follow-up data are available for 23 patients. The women were post-menopausal (average age = 67.6 ± 10.1 years), and all complained of vaginal bulging. The nature of any additional surgery was reported in 17 patients: 4 patients had only the EnPlace sutures placed, and 2 patients had EnPlace and a mid-urethral sling, and 11 patients had one or more of the following: mid-urethral sling, anterior colporrhaphy, posterior colporrhaphy, perineorrhaphy and/or partial cervical amputation. The average time of the EnPlace procedure was 24 minutes, and blood loss attributed to the EnPlace procedure was minimal (< 5 ml on average). Anterior and posterior average pre-op Ba, Bp and C POP-Q scores were +0.5 cm, -0.6 cm, and +1.4 cm, respectively. At 6-month follow-up post-op, avg Bp- and C-point POP-Q scores were significantly more negative than baseline (P<0.02 for both comparisons). The average Bp-point was -2.4 cm and the C-point was -5.1 cm. Prolapse symptoms and C-point > -1 cm recurred in 4 of 23 patients at 6 months. There were 1 device related serious adverse event (SAE; rectal constriction), no procedure-related SAEs, and 1 unrelated SAE, and 1 device-related, 2 procedure-related and 3 unrelated AEs. Results obtained previously demonstrated that the EnPlace™ System was safe and effective when used as a standalone procedure without concomitant repairs, and now, these results demonstrate that the EnPlace™ System is also an effective, minimally invasive procedure for treatment of uterine prolapse that can be used with other common POP repair procedures. Further follow-up is necessary to establish long term durability of the EnPlace procedure for POP when used with other common surgical POP procedures.