Sacrospinous Hysteropexy With Mesh vs Vaginal Hysterectomy for Treatment of Uterovaginal Prolapse: 10-Year Results of a Randomized Clinical Trial.

IMPORTANCE

Vaginal hysterectomy with suture apical suspension (hysterectomy) is commonly performed for uterovaginal prolapse, and a vaginal sacrospinous hysteropexy with graft (hysteropexy) is a uterine-sparing alternative. Ten-year outcomes for prolapse surgeries are rarely reported.

OBJECTIVE

To compare the efficacy and adverse events of these 2 procedures over 10 years.

DESIGN, SETTING, AND

PARTICIPANTS

At 9 clinical sites in the US Pelvic Floor Disorders Network, postmenopausal women with symptomatic uterovaginal prolapse were enrolled in a multisite superiority randomized clinical trial between April 2013 and February 2015. Study data were analyzed from February 2018 to November 2025.

INTERVENTIONS: Women were originally randomized to vaginal mesh hysteropexy or to vaginal hysterectomy with uterosacral ligament suspension. Participants had 5 years of masked follow-up at 6-month intervals followed by an extended unmasked annual follow-up from 6 to 10 years.

MAIN OUTCOMES AND MEASURES: The primary treatment failure composite outcome (retreatment of prolapse, prolapse beyond the hymen, or prolapse symptoms) was evaluated with time-to-failure models. Secondary outcomes included individual anatomic Pelvic Organ Prolapse Quantification measures, bothersome symptoms measured by validated questionnaires, complications and adverse events.

RESULTS

A total of 183 participants (mean [SD] age, 66 [7] years) were randomized, and 175 were included in the intention-to-treat analysis after ineligibility exclusions (88 hysteropexy group and 87 hysterectomy group), 112 of whom (64%; 55 hysteropexy group and 57 hysterectomy group) participated in the 6- to 10-year follow-up extension. There were fewer failures for hysteropexy (35 of 88 [40%]) compared with hysterectomy (46 of 87 [53%]) through 10 years. Time-to-failure analysis showed lower failure risk in hysteropexy (adjusted hazard ratio, 0.64; 95% CI, 0.41-1.00; P = .05). Both groups had sustained improvements in patient reported outcomes with no group differences demonstrated in patient-reported prolapse, urinary, or bowel symptoms, sexual function, dyspareunia, or clinically important complications.

CONCLUSIONS AND RELEVANCE: Results show that vaginal mesh hysteropexy continued to have a lower composite failure rate through 10 years than vaginal hysterectomy with uterosacral ligament suspension, although an expected increase in durability over the native tissue procedure in years 6 to 10 was not observed. Both procedures are reasonable options for patients. If available, hysteropexy with mesh augmentation for patients who desire uterine preservation is a low risk and effective option.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01802281.