Randomized Arms
Arm A · n = 88
Mesh Hysteropexy
Uphold LITE transvaginal mesh (Boston Scientific)
Arm B · n = 87
Hysterectomy + USLS
Vaginal hysterectomy with uterosacral ligament suspension
Primary Outcome: Composite Failure at 36 Months
24%
Hysteropexy Failure
95% CI 14%–33%
36%
Hysterectomy Failure
95% CI 24%–47%
aHR 0.61
95% CI 0.37–1.02
P = .06 — Not significant
Key Comparisons
PGI-I “Much / Very Much Better”
Differential Adverse Events
Higher with Hysteropexy
Mesh exposure: 8% vs 0%
Dyspareunia: 10% vs 2% (P = .03)
Higher with Hysterectomy
Ureteral kinking: 7% vs 0% (P = .01)
Granulation tissue: 11% vs 1% (P = .005)
Suture exposure: 21% vs 3% (P < .001)
Note: Primary endpoint did not reach statistical significance (P = .06). Point estimate consistently favored hysteropexy, but the confidence interval was wide. The Uphold LITE mesh was removed from the US market by FDA order in April 2019. The 5-year follow-up (E-SUPeR, Nager 2021) did reach statistical significance.
Clinical Bottom Line
Vaginal mesh hysteropexy with Uphold LITE showed a trend toward lower composite failure than hysterectomy + USLS at 3 years (24% vs 36%), with shorter OR time, but did not reach statistical significance. Mesh exposure rate was 8% (none requiring reoperation). The FDA removed this device from market in 2019.