Abstract / Summary
Background: Apical pelvic organ prolapse remains a considerable surgical challenge given its comparatively high recurrence rates. The EnPlace® device provides a mesh-free, minimally invasive option for sacrospinous ligament fixation (SSLF). This study evaluates the long-term safety and durability of SSLF performed with the EnPlace® device. Methods: We conducted a retrospective cohort study at Assuta Medical Center between October 2020 and October 2021, enrolling 91 patients with stage III–IV apical POP who underwent SSLF with the EnPlace® device. Data were extracted from a real-time institutional database. Patients were assessed at 1 day, 1 month, and 6 months postoperatively, and patient-reported satisfaction was subsequently obtained by telephone interview at 3–4 years. Results: The cohort comprised 91 women (mean age 63.9 ± 11.85 years); prolapse was uterine in 80 (87.9%) and involved the vaginal vault in 11 (12.1%), with mean preoperative point C measurements of 2.11 ± 3.04 and 1.55 ± 3.01, respectively. Concomitant colporrhaphy was performed in all patients, and 19 (20.9%) also underwent a mid-urethral sling. Surgery lasted a mean of 23.46 ± 5.09 min, with mean blood loss of 23.7 ± 6.06 mL, and no intraoperative or early postoperative complications were recorded. By 6 months, POP-Q values had improved to a mean point C of −4.84 ± 1.05 cm, point Ba of −2.25 ± 0.69 cm, and point Bp of −2.63 ± 0.69 cm. Surgical failure occurred in two patients (2.5%) with uterine prolapse, both of whom were successfully managed with repeat SSLF using EnPlace®, and recurrent stage II cystocele was identified in five patients (5.2%), all treated with a pessary. At 3–4 years, patient-reported satisfaction was available for 75 of 91 patients (82.4%) and averaged 91.93% ± 17.06; no repeat objective (POP-Q) assessment was performed at this later time point. Conclusions: These findings indicate that the EnPlace® device offers a favorable safety and efficacy profile for apical POP repair, characterized by low recurrence and high patient satisfaction, representing a promising alternative to conventional techniques. Given its minimally invasive nature and compatibility with regional anesthesia, this approach may be of particular interest for older or higher-risk surgical candidates; further prospective research incorporating formal frailty and surgical-risk assessment is warranted to confirm this potential benefit.