JAMA · 2014
OPTIMAL
Operations and Pelvic Muscle Training in the Management of Apical Support Loss

Factorial Comparison of Two Transvaginal Surgical Approaches and of Perioperative Behavioral Therapy for Women with Apical Vaginal Prolapse

Barber MD, Brubaker L, Burgio KL, Richter HE, Nygaard I, et al. · Pelvic Floor Disorders Network
DOI: 10.1001/jama.2014.1719 · NCT00597935
Design
2×2 RCT
Patients
374
Sites
9 US centers
Follow-up
2 years
Completion
84.5%
Randomization 1: Surgical Approach
Arm A · n = 188
ULS
Bilateral uterosacral ligament suspension (Shull technique)
Arm B · n = 186
SSLF
Unilateral sacrospinous ligament fixation (Michigan 4-wall technique)
Randomization 2: Perioperative BPMT (n=186) vs. usual care (n=188). All patients received concomitant retropubic TVT for SUI. BPMT did not improve urinary symptoms at 6 months or prolapse outcomes at 2 years (treatment difference UDI: −6.7 [95% CI −19.7, 6.2]; p=0.31).
Primary Outcome: Surgical Success at 2 Years
59.2%
ULS Success
93 / 157
60.5%
SSLF Success
92 / 152
OR 0.9
95% CI 0.6–1.5
p = 0.75
Key Outcome Components
Anatomic Failure
ULS
16.6%
SSLF
19.5%
p = 0.49
Bothersome Bulge Symptoms
ULS
19.2%
SSLF
20.8%
p = 0.70
Serious Adverse Events
ULS
16.5%
SSLF
16.7%
p = 0.83
Differential Complications
Higher with ULS
Ureteral obstruction: 3.2% vs 0%
Granulation tissue: 19.1% vs 14.0% (p=0.18)
Bladder injury: 11.7% vs 9.7% (p=0.60)
Higher with SSLF
Neurologic pain requiring Tx: 12.4% vs 6.9% (p=0.049)
Suture exposure: 17.2% vs 15.4% (p=0.60)
Clinical Bottom Line

ULS and SSLF are equivalent transvaginal apical suspension options at 2 years, with ~60% composite surgical success. Surgeons may choose based on anatomy and expertise. Composite success rates were lower than commonly reported 70–90% due to rigorous blinded assessment. Perioperative BPMT did not improve outcomes.