Minimally Invasive Sacrohysteropexy Versus Vaginal Hysterectomy With Uterosacral Ligament Suspension for Pelvic Organ Prolapse: A Prospective Randomized Non-Inferiority Trial

Abstract

Study ObjectiveTo investigate whether minimally invasive Sacrohysteropexy (SH) is non-inferior to Vaginal hysterectomy (VH) with uterosacral ligament suspension (USLS) in women with symptomatic uterovaginal prolapse. DesignProspective, randomized, non-inferiority study SettingTertiary university-based hospital. PatientsA total of 146 patients with uterovaginal prolapse between July 2016 and August 2019. InterventionsPatients were randomly assigned in a 1:1 ratio to either laparoscopic or robotic SH surgery or VH with USLS surgery. Measurements and Main ResultsThe primary outcome was prolapse recurrence at 1 year after surgery, defined as prolapse ≥ stage 2 evaluated using the pelvic organ prolapse quantification system, bothersome vaginal bulge symptoms, or retreatment for prolapse. The secondary outcomes included operation time, estimated blood loss, hospital stay, operation-related complications, pain intensity, quality of life, and activities of daily living. Of 146 women who underwent randomization, 73 in the SH group and 73 in the VH with USLS group were analyzed. SH was non-inferior for recurrence compared with VH with USLS (16.4% vs.15.8%, 95% confidence interval: -13.0%, 14.2%). Operating duration and transvaginal length were significantly longer in the SH group, while there were no significant differences in the estimated blood loss, length of hospital stay, or postoperative complication rates. Although perioperative pain intensity was greater from 1 week to 1 month in the SH group, the quality of life and activities of daily living did not differ between the groups throughout postoperative year 1. ConclusionLaparoscopic or robotic SH was non-inferior to VH with USLS for the recurrence of pelvic organ prolapse at the 1-year follow-up.