JAMA · 2018
E-OPTIMAL
Extended OPTIMAL — 5-Year Follow-up of the OPTIMAL Randomized Trial

Effect of Uterosacral Ligament Suspension vs Sacrospinous Ligament Fixation With or Without Perioperative Behavioral Therapy on Surgical Outcomes at 5 Years

Jelovsek JE, Barber MD, Brubaker L, Norton P, Gantz M, Richter HE, et al. · Pelvic Floor Disorders Network
DOI: 10.1001/jama.2018.2827 · NCT01166373
Design
2×2 RCT
Patients
285
Sites
9 US centers
Follow-up
5 years
Completion
86%
Surgical Arms
Arm A · n = 188
ULS
Bilateral uterosacral ligament suspension
Arm B · n = 186
SSLF
Unilateral sacrospinous ligament fixation
Primary Outcome: Surgical Failure at 5 Years
61.5%
ULS Failure
Adjusted probability
70.3%
SSLF Failure
Adjusted probability
−8.8%
Adj. Difference
95% CI −24.2 to 6.6; p=0.25
Failure Trajectory Over Time
6 mo1 yr2 yr3 yr4 yr5 yr
ULS Failure 23.7%34.0%45.7%52.7%57.7%61.5%
SSLF Failure 24.8%37.6%52.0%60.4%66.1%70.3%
Failure is dynamic: 34.5% of anatomic failures and 30% of patients with bothersome bulge symptoms subsequently met criteria for success at a later visit. Median time to failure: ULS 2.6 years vs SSLF 1.8 years.
Quality of Life Improvement at 5 Years (vs. Baseline)
−67.6
ULS POPDI
scale 0–300
−74.2
SSLF POPDI
scale 0–300
−75.8
ULS UDI
scale 0–300
−80.3
SSLF UDI
scale 0–300
Retreatment by 5 Years
ULS
11.9%
SSLF
8.1%
ARD 3.9% (CI −3.8, 11.5)
BPMT vs Usual Care at 5 years: No significant differences. Anatomic failure 45.6% vs 47.2% (ARD −1.6% [95% CI −21.2, 17.9]). POPDI improvement −59.4 vs −61.8. PGI-I "much/very much better": 54–59%.
Clinical Bottom Line

At 5 years, ULS and SSLF remain equivalent, but composite failure rates are high (61–70%) despite sustained quality-of-life improvements and low retreatment rates (<12%). One-third of "failures" later meet success criteria, suggesting prolapse status fluctuates rather than progressing unidirectionally—important context for patient counseling.