Sacrospinous Hysteropexy Versus Vaginal Hysterectomy in Women with Uterine Prolapse: 10-year Follow-up of a Randomised Controlled Trial.

INTRODUCTION AND HYPOTHESIS: One-year results from the SAVE U trial showed that sacrospinous hysteropexy (SSH) was non-inferior to vaginal hysterectomy with uterosacral ligament suspension (VH) and 5-year follow-up favoured SSH for apical outcomes. Because long-term follow-up comparing these surgical procedures is lacking, it is unknown whether these outcomes remain stable over time. METHODS: This 10-year follow-up of the SAVE U randomised controlled trial compared SSH with VH with uterosacral ligament suspension in women with uterine prolapse with uterine descent stage ≥2. The primary outcome was surgical failure of the apical compartment, defined as recurrent prolapse stage ≥2 of the uterus or vaginal vault combined with bothersome bulge symptoms or repeat surgery for recurrent apical prolapse. Secondary outcomes included surgical failure in any compartment, overall anatomical failure, a composite outcome of success, functional outcomes, and quality of life. RESULTS: At 10 years, surgical failure of the apical compartment occurred in 3 out of 44 women (7%) after SSH and 7 out of 49 (14%) after VH with uterosacral ligament suspension (difference -6.6%, 95% CI -19.9% to 6.7%). Posterior compartment failure was less frequent after SSH (11.6% vs 52.2%; difference -37.1%, 95% CI -54.3% to -19.9%). Obstructive micturition scores were poorer after SSH despite median scores of zero in both groups owing to a skewed distribution (median 0 [IQR 0-33.3] vs 0 [0-0], p = 0.01). Other secondary outcomes did not differ significantly. CONCLUSION: No significant differences were found between SSH and VH with uterosacral ligament suspension in surgical failure at 10 years' follow-up. However, the reduced sample size may limit the ability to detect significant differences. Furthermore, posterior compartment outcomes favoured SSH, whereas obstructive voiding symptoms favoured VH.