Cited by 431Pelvic floor disorders treatmentsUterine Myomas and TreatmentsSexual function and dysfunction studies

Comparison of 2 Transvaginal Surgical Approaches and Perioperative Behavioral Therapy for Apical Vaginal Prolapse: The OPTIMAL Randomized Trial

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Barber, Matthew D., Brubaker, Linda, Burgio, Kathryn L., Richter, Holly E., Nygaard, Ingrid, Weidner, Alison C., Menefee, Shawn A., Lukacz, Emily S. +10 more·2014·JAMA

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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Crossref · 10.1001/jama.2014.1719

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  • A lack of individualized progression and of reporting adherence may explain the limited benefit of pelvic floor muscle training on postoperative pelvic floor muscle function in those studies.

    “The lack of individualized progression and reporting of adherence might be a reason for the limited benefit of PFMT on the postoperative PFM function found in those studies.14,38,39”

    From Postoperative Physiotherapy in Women Undergoing Pelvic Floor Reconstructive Surgery: A Randomized Controlled Clinical Trial (2022) · cites this paper as [39]

    The Results (Behavioral Intervention Outcomes; page not specified) found no difference in pelvic floor muscle strength between groups, but the proposed explanation is contrary to this trial’s Methods. The Methods (Study Interventions; page not specified) state that exercises were individually progressed and adherence was assessed; the Results report adherence at 6 and 24 months. (LLM, conf=0.88)

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  • This trial's finding of improved strength but not EMG differs from Frawley, Barber, and Duarte, who found no improvement in pelvic floor muscle strength or EMG.

    “This differs from the findings of Frawley and colleagues, Barber and colleagues, and Duarte and colleagues, 14,39,40 who did not find improvement in PFM strength or EMG measures.”

    From Postoperative Physiotherapy in Women Undergoing Pelvic Floor Reconstructive Surgery: A Randomized Controlled Clinical Trial (2022) · cites this paper as [39]

    The Results (Behavioral Intervention Outcomes; page not provided) report no between-group difference in change in pelvic floor muscle strength at 6 or 24 months. The Methods (Outcomes; page not provided) identify strength as a Brink-scale measure, but the paper does not report EMG measures, so it cannot support that part of the attributed finding. (LLM, conf=0.86)

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  • The trial's quality-of-life and symptom results were similar to those of most earlier studies.

    “The findings of this study regarding the effect on QOL and symptoms are similar to those of most previous studies.13,14,38 -40”

    From Postoperative Physiotherapy in Women Undergoing Pelvic Floor Reconstructive Surgery: A Randomized Controlled Clinical Trial (2022) · cites this paper as [39]

    The Results (Behavioral Intervention Outcomes; page unavailable) report changes in urinary and prolapse symptoms, so this trial provides an earlier symptom finding for comparison. The paper does not report its own quality-of-life result or establish that its findings were similar to those of most previous studies; its Discussion also notes a prior trial with contrasting results. (LLM, conf=0.77)

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  • McClurg and colleagues and Barber and colleagues, like the current trial, used individualized pelvic floor muscle exercises rather than a standard protocol.

    “Like Barber and colleagues 39 and the current study, they included individualized PFM exercises instead of a standard protocol.”

    From Postoperative Physiotherapy in Women Undergoing Pelvic Floor Reconstructive Surgery: A Randomized Controlled Clinical Trial (2022) · cites this paper as [39]

    The Methods (Study Interventions; page unavailable) describe individualized progressive pelvic floor muscle exercises. But the Discussion (page unavailable) says the individualized intervention used a standard protocol, contrary to the claim that it was used instead of one. (LLM, conf=0.89)

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  • A single trial reported no difference in rate of transfusion between uterosacral and sacrospinous colpopexy (RR 1.67, 95% CI 0.50 to 5.60; n = 30).

    “A single trial (Barber 2014) reported no difference in rate of transfusion between the uterosacral and sacrospinous colpopexy (RR 1.67 95% CI 0.50 to 5.60; n=30; Analysis 6.14).”

    From Surgery for women with apical vaginal prolapse (2023) · cites this paper as Barber 2014

    The Results (Surgical Intervention Outcomes; page unavailable) report no significant difference between uterosacral and sacrospinous groups in estimated blood loss or overall serious adverse events. Our copy does not report a transfusion-rate comparison or the stated RR and confidence interval; the Results (Study Populations and Treatment Assignments; page unavailable) give 374 participants in the surgical comparison, not n=30. (LLM, conf=0.82)

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Authors
Barber, M. D., Brubaker, L., Burgio, K. L., Richter, H. E., Nygaard, I., Weidner, A. C., Menefee, S. A., Lukacz, E. S., Norton, P., Schaffer, J., Nguyen, J. N., Borello-France, D., Goode, P. S., Jakus-Waldman, S., Spino, C., Warren, L. K., Gantz, M. G., & Meikle, S. F.
Affiliations
  • Cleveland Clinic (US)
  • Loyola University Chicago (US)
  • University of Alabama at Birmingham (US)
  • University of Utah (US)
  • Duke University (US)
  • Kaiser Permanente (US)
  • UC San Diego Health System (US)
  • The University of Texas Southwestern Medical Center (US)
  • Department of Physical Therapy, Duquesne University, Pittsburgh, Pennsylvania
  • University of Michigan (US)
  • RTI International (US)
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (US)
Venue
JAMA
Published
2014-03-12
Volume
311
Issue
10
Pages
1023
ISSN
  • 0002-9955 (ISSN-L)
  • 0098-7484
OpenAlex
W2151316027
Cited by
428
References
53
Citations by year
2026: 21 · 2025: 34 · 2024: 31 · 2023: 35 · 2022: 31 · 2021: 40 · 2020: 51 · 2019: 37 · 2018: 41 · 2017: 37 · 2016: 38 · 2015: 16 · 2014: 13 · 2012: 1
FWCI
28.81
Type
journal article
Language
en
Open access
Locations
  • JAMA (publishedVersion)
  • PubMed (publishedVersion)
  • PubMed Central (acceptedVersion)
  • eScholarship (California Digital Library) (submittedVersion)
Funders
  • Pfizer
  • GlaxoSmithKline
  • Boston Scientific Corporation
  • Astellas Pharma
  • National Institutes of Health
  • National Institute of Child Health and Human Development
  • Office of Research on Women's Health
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (U10HD041261, U10HD054136, UG1HD041261, HD054214, U10HD054214, U01HD041249, U10HD054215, UG1HD054215, HD054241, U10HD069006, U01HD069031, HD041267, U10HD041267, U10HD054241, HD069031, HD041261, U10HD041250, UG1HD054214, UG1HD054241, UG1HD041267)
Topics
  • Health Sciences › Medicine › Rheumatology › Pelvic floor disorders treatments
  • Health Sciences › Medicine › Obstetrics and Gynecology › Uterine Myomas and Treatments
  • Health Sciences › Medicine › Psychiatry and Mental health › Sexual function and dysfunction studies
Keywords
apical vaginal prolapse, sacrospinous ligament fixation, uterosacral ligament suspension, pelvic floor muscle training, stress urinary incontinence, midurethral sling, surgical success, pelvic organ prolapse, women's health, surgical outcomes comparison, retreatment
MeSH terms
Adult, Aged, Aged, 80 and over, Behavior Therapy, Exercise Therapy, Female, Humans, Middle Aged, Gynecologic Surgical Procedures, Urinary Incontinence, Stress, Urination, Uterine Prolapse, Treatment Outcome, Pelvic Floor, Suburethral Slings

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