Surgical Arms
Arm A · n = 88
Mesh Hysteropexy
Sacrospinous hysteropexy with Uphold LITE mesh
Arm B · n = 87
Hysterectomy + USLS
Vaginal hysterectomy with uterosacral ligament suspension
Primary Outcome: Composite Failure at 5 Years
37%
Hysteropexy Failure
29/79
54%
Hysterectomy Failure
42/78
aHR 0.58
Favors Hysteropexy
95% CI 0.36–0.94; P = .03
−18%
Risk Difference
95% CI −33% to −3%
Composite Failure Trajectory
| 1 yr | 2 yr | 3 yr | 4 yr | 5 yr |
| Hysteropexy |
15% | 24% | 31% | 34% | 37% |
| Hysterectomy |
25% | 34% | 41% | 49% | 54% |
Failure patterns: Persistent success: 66.7% hysteropexy vs 51.2% hysterectomy. Intermittent failure/success: 17.2% vs 26.7%. Persistent failure: 16.1% vs 22.1%. >60% of intermittent participants were terminal successes.
Key Comparisons at 5 Years
PGI-I "Much / Very Much Better"
Total Vaginal Length at 5 yr (cm)
Safety
Mesh exposure: 8% (7/91) — stable from 3-year follow-up, all managed conservatively.
Granulation tissue: 1% vs 12% (P = .003).
Suture exposure: 3% vs 21% (P < .001).
Masking: 70% remained masked at 5 years.
Context: This is the only multicenter RCT demonstrating superiority of vaginal mesh hysteropexy over native tissue hysterectomy through 5 years. Superiority was not evident until after 36 months — the FDA's own benchmark for mesh evaluation. Uphold LITE mesh was removed from the US market by the FDA in April 2019.
Clinical Bottom Line
At 5 years, sacrospinous hysteropexy with mesh was significantly superior to hysterectomy + USLS (37% vs 54% composite failure; aHR 0.58, P = .03). Mesh exposure was 8% and stable, managed conservatively. These results suggest the FDA's removal of this mesh from the market should be reconsidered.