OPTIMAL TRIAL.

Factorial comparison of two transvaginal surgical approaches and of perioperative behavioral therapy for women with apical vaginal prolapse: The OPTIMAL Randomized Trial

Barber et al. JAMA 2014. PubMed

In women undergoing transvaginal apical prolapse repair with a concomitant mid-urethral sling, uterosacral ligament suspension (ULS) and sacrospinous ligament fixation (SSLF) had similar 2-year composite success and serious adverse event rates. A structured perioperative behavioral and pelvic floor muscle training (BPMT) program did not improve urinary symptoms at 6 months or prolapse outcomes at 2 years.

QUESTION

Among women undergoing vaginal surgery for apical prolapse and stress urinary incontinence, is ULS superior to SSLF, and does perioperative BPMT improve postoperative urinary and prolapse outcomes?

DESIGN

• Population: 374 women (age range 29-80) undergoing vaginal surgery for Stage 2-4 prolapse with bothersome bulge symptoms, apical descent at least halfway into the vagina, and stress urinary incontinence symptoms with objective demonstration within 12 months; 9 U.S. medical centers (2008-2013); 2-year follow-up rate 84.5%.


• Intervention: Transvaginal prolapse surgery plus retropubic mid-urethral sling (TVT in 99%); randomized apical suspension to ULS (bilateral) or SSLF (unilateral, Michigan 4-wall modification). Perioperative BPMT program: 1 pre-op visit (2-4 weeks prior) plus 4 post-op visits (2, 4-6, 8, and 12 weeks) with pelvic floor muscle training and behavioral strategies for urinary and colorectal symptoms.


• Comparison: ULS vs SSLF; and BPMT vs usual perioperative care (routine teaching and standardized postop instructions).

OUTCOMES

• Primary outcome: Surgical success at 2 years (composite: anatomic success + no bothersome bulge symptoms + no retreatment for prolapse).
  • ULS 59.2% (93/157) vs SSLF 60.5% (92/152): OR 0.9 (95% CI 0.6-1.5), p=0.75.
  • Serious adverse events: ULS 16.5% (31/188) vs SSLF 16.7% (31/186), OR 0.9 (95% CI 0.5-1.6), p=0.83.


• Secondary outcomes:
  • BPMT urinary symptoms at 6 months (UDI change from baseline): BPMT -94.6 vs usual care -87.9; treatment difference -6.7 (95% CI -19.7 to 6.2), p=0.31.
  • BPMT prolapse symptoms at 24 months (POPDI change from baseline): BPMT -73.3 vs usual care -65.2; treatment difference -8.0 (95% CI -22.1 to 6.1), p=0.26.
  • Anatomic outcomes at 24 months: Anterior prolapse beyond hymen: ULS 15.5% (24/155) vs SSLF 13.7% (21/153), OR 1.2 (95% CI 0.6-2.2), p=0.65; Posterior prolapse beyond hymen: ULS 4.5% (7/155) vs SSLF 7.2% (11/153), OR 0.6 (95% CI 0.3-1.3), p=0.21.
  • Retreatment for prolapse at 24 months (surgery or pessary): ULS 5.0% (8/161) vs SSLF 5.2% (8/155), OR 0.9 (95% CI 0.3-2.6), p=0.81.
  • Neurologic pain requiring treatment (perioperative): ULS 6.9% (13/188) vs SSLF 12.4% (23/186), OR 0.5 (95% CI 0.2-1.0), p=0.049; persisted to 4-6 weeks in ULS 0.5% (1/188) vs SSLF 4.3% (8/186).
  • Ureteral obstruction and injury: Intraoperative ureteral obstruction: ULS 3.2% (6/188) vs SSLF 0%; delayed ureteral injury: ULS 0.5% (1/188) vs SSLF 0%.
  • Important null findings: BPMT did not reduce retreatment for incontinence: OR 1.4 (95% CI 0.8-2.3). No difference in vaginal granulation tissue: ULS 19.1% vs SSLF 14.0%, OR 1.5 (95% CI 0.8-2.6), p=0.18.

QUIZ

1. A 58-year-old with Stage 3 apical prolapse and stress urinary incontinence is planning transvaginal repair with a mid-urethral sling. Which statement best reflects 2-year outcomes when comparing ULS vs SSLF in the OPTIMAL trial?

A. ULS had significantly higher composite surgical success than SSLF
B. SSLF had significantly fewer serious adverse events than ULS
C. Composite surgical success was similar between ULS and SSLF at 2 years
D. ULS had a significantly higher retreatment rate than SSLF

Answer: C. Composite surgical success at 2 years was similar (ULS 59.2% vs SSLF 60.5%; OR 0.9, 95% CI 0.6-1.5; p=0.75), and serious adverse event rates were also similar.

2. A patient asks whether she should do perioperative supervised pelvic floor muscle training (BPMT) to improve outcomes after her planned prolapse and sling surgery. Based on OPTIMAL, what is the best counseling?

A. BPMT significantly improves urinary symptoms at 6 months and should be routine
B. BPMT significantly improves prolapse symptoms at 24 months and should be routine
C. BPMT did not improve urinary symptoms at 6 months or prolapse outcomes at 2 years compared with usual care
D. BPMT reduced serious adverse events compared with usual care

Answer: C. BPMT was not associated with greater improvement in UDI at 6 months (difference -6.7; p=0.31) or POPDI at 24 months (difference -8.0; p=0.26), and anatomic outcomes were not improved.