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Randomized Controlled Trial
. 2014 Mar 12;311(10):1023-34.
doi: 10.1001/jama.2014.1719.

Comparison of 2 transvaginal surgical approaches and perioperative behavioral therapy for apical vaginal prolapse: the OPTIMAL randomized trial

Matthew D Barber  1 , Linda Brubaker  2 , Kathryn L Burgio  3 , Holly E Richter  4 , Ingrid Nygaard  5 , Alison C Weidner  6 , Shawn A Menefee  7 , Emily S Lukacz  8 , Peggy Norton  5 , Joseph Schaffer  9 , John N Nguyen  10 , Diane Borello-France  11 , Patricia S Goode  3 , Sharon Jakus-Waldman  10 , Cathie Spino  12 , Lauren Klein Warren  13 , Marie G Gantz  13 , Susan F Meikle  14 ; Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network
Collaborators, Affiliations
Randomized Controlled Trial

Comparison of 2 transvaginal surgical approaches and perioperative behavioral therapy for apical vaginal prolapse: the OPTIMAL randomized trial

Matthew D Barber et al. JAMA. .

Erratum in

  • Incorrect outcomes data.
    [No authors listed] [No authors listed] JAMA. 2015 Jun 9;313(22):2287. doi: 10.1001/jama.2015.4817. JAMA. 2015. PMID: 26057298 No abstract available.

Abstract

Importance: More than 300,000 surgeries are performed annually in the United States for pelvic organ prolapse. Sacrospinous ligament fixation (SSLF) and uterosacral ligament suspension (ULS) are commonly performed transvaginal surgeries to correct apical prolapse. Little is known about their comparative efficacy and safety, and it is unknown whether perioperative behavioral therapy with pelvic floor muscle training (BPMT) improves outcomes of prolapse surgery.

Objective: To compare outcomes between (1) SSLF and ULS and (2) perioperative BPMT and usual care in women undergoing surgery for vaginal prolapse and stress urinary incontinence.

Design, setting, and participants: Multicenter, 2 × 2 factorial, randomized trial of 374 women undergoing surgery to treat both apical vaginal prolapse and stress urinary incontinence was conducted between 2008 and 2013 at 9 US medical centers. Two-year follow-up rate was 84.5%.

Interventions: The surgical intervention was transvaginal surgery including midurethral sling with randomization to SSLF (n = 186) or ULS (n = 188); the behavioral intervention was randomization to receive perioperative BPMT (n = 186) or usual care (n = 188).

Main outcomes and measures: The primary outcome for the surgical intervention (surgical success) was defined as (1) no apical descent greater than one-third into vaginal canal or anterior or posterior vaginal wall beyond the hymen (anatomic success), (2) no bothersome vaginal bulge symptoms, and (3) no re-treatment for prolapse at 2 years. For the behavioral intervention, primary outcome at 6 months was urinary symptom scores (Urinary Distress Inventory; range 0-300, higher scores worse), and primary outcomes at 2 years were prolapse symptom scores (Pelvic Organ Prolapse Distress Inventory; range 0-300, higher scores worse) and anatomic success.

Results: At 2 years, surgical group was not significantly associated with surgical success rates (ULS, 59.2% [93/157] vs SSLF, 60.5% [92/152]; unadjusted difference, -1.3%; 95% CI, -12.2% to 9.6%; adjusted odds ratio [OR], 0.9; 95% CI, 0.6 to 1.5) or serious adverse event rates (ULS, 16.5% [31/188] vs SSLF, 16.7% [31/186]; unadjusted difference, -0.2%; 95% CI, -7.7% to 7.4%; adjusted OR, 0.9; 95% CI, 0.5 to 1.6). Perioperative BPMT was not associated with greater improvements in urinary scores at 6 months (adjusted treatment difference, -6.7; 95% CI, -19.7 to 6.2), prolapse scores at 24 months (adjusted treatment difference, -8.0; 95% CI, -22.1 to 6.1), or anatomic success at 24 months.

Conclusions and relevance: Two years after vaginal surgery for prolapse and stress urinary incontinence, neither ULS nor SSLF was significantly superior to the other for anatomic, functional, or adverse event outcomes. Perioperative BPMT did not improve urinary symptoms at 6 months or prolapse outcomes at 2 years.

Trial registration: clinicaltrials.gov Identifier: NCT00597935.

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Conflict of interest statement

Conflict of Interest Disclosures – The authors report the following potential conflicts of interest and financial disclosures consistent with the ICMJE Form for Disclosure of Potential Conflicts of Interest and JAMA policy:

Barber: Research Grant: Foundation for Female Health Awareness; Royalty: UptoDate, Elsevier

Burgio: Research Grant: Pfizer; Consultant: Pfizer, Astellas

Brubaker: Royalty: UptoDate

Lukacz: Research Grant: Renew Medical; Educational Grant: Ethicon/Johnson & Johnson; Consultant: Pfizer, Renew Medical, American Medical Systems; Payment for development of educational content: Sharp Chula Vista

Goode: Research Grant: Pfizer; Consultant: Astellas

Richter: Research Grant: Astellas, Univ. of CA/Pfizer, Pfizer; Consultant: Astellas Advisory Board, GlaxoSmithKline, Uromedica, IDEO, Xanodyne; Education Grant: Warner Chilcott

Schaffer: Research Support: Boston Scientific; Consultant: Ferring Pharmaceuticals; Advisory Board: Astellas, Cadence Pharmaceuticals; Speakers Bureau: Astellas, Cadence Pharmaceuticals; Royalty: McGraw-Hill.

The following authors report no such conflicts: Nygaard, Menefee, Norton, Weidner, Nguyen, Jakus-Waldman, Borello-France, Spino, Gantz, Warren, Wallace, Meikle

Figures

Figure 1
Figure 1
Optimal Trial Enrollment, Randomization and Assessment.
See this image and copyright information in PMC

Comment in

References

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