vNOTES Pelvic Reconstruction and Presacral-uterosacral Ligament Compound Suspension for Treatment of Multicompartment Pelvic Organ Prolapse: A 3-year, 3-arm, Open-label, Randomized Controlled Trial.

OBJECTIVE

To compare the effectiveness and safety of transvaginal natural orifice transluminal endoscopic surgery (vNOTES) pelvic reconstruction (PRC), vNOTES presacral-uterosacral ligament suspension (PULS), and sacrospinous ligament fixation (SSLF) during 3-year follow-up.

DESIGN

A single-center, open-label, 3-arm, prospective randomized controlled trial.

SETTING

A single-center specialized hospital (Obstetrics & Gynecology Hospital, Fudan University).

PATIENTS: Women aged 50 to 80 years undergoing initial surgery for severe multicompartment pelvic organ prolapse (POP), with stage II or higher prolapse in 2 or more compartments and no desire for uterine preservation.

INTERVENTIONS: Participants were randomly assigned in a 1:1:1 ratio to undergo either vNOTES-PRC (n = 50), vNOTES-PULS with colporrhaphy (n = 50), or SSLF with colporrhaphy (n = 50) following a vaginal hysterectomy.

MEASUREMENTS AND MAIN

RESULTS

The primary outcome was composite surgical success, defined as absence of prolapse beyond the hymen, absence of bothersome bulge symptoms, and no retreatment (pessary or surgery) for POP in any compartment. Secondary outcomes included anatomic results, patient-reported outcomes, perioperative variables, and surgery-related complications. Among 150 enrolled patients, a total of 140 completed the 3-year follow-up. The composite surgical success rate was highest in the vNOTES-PRC group (95.7%), compared with 78.2% in the vNOTES-PULS group and 74.5% in the SSLF group. No significant difference was observed between vNOTES-PULS and SSLF. Perioperative outcomes and complication rates were similar across all groups.

CONCLUSIONS

vNOTES-PRC was superior to vNOTES-PULS and SSLF in the treatment of severe multicompartment POP based on composite surgical success at 3 years.