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Comparison of 2 Transvaginal Surgical Approaches and Perioperative Behavioral Therapy for Apical Vaginal Prolapse: The OPTIMAL Randomized Trial
Open accessAbstract
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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“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]
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Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“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]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“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]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“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]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“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
Experimental — accuracy not yet measured
The source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“Three trials were included: Barber 2014 and Martins 2020 compared uterosacral and sacrospinous colpopexy, and Natale 2010 compared uterosacral colpopexy and levator myorrhaphy with no differences identified between the groups in anatomical, functional and perioperative outcomes.”
From Surgery for women with apical vaginal prolapse (2023) · cites this paper as Barber 2014
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“However, there was no effect of PFMT in this study on either PFM strength or POP.”
From International urogynecology consultation chapter 3 committee 2; conservative treatment of patient with pelvic organ prolapse: Pelvic floor muscle training (2022) · cites this paper as [62]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“Furthermore, if there was no short-term effect of a PFMT program [49, 50, 62, 67, 71, 75], then long-term effects are unlikely.”
From International urogynecology consultation chapter 3 committee 2; conservative treatment of patient with pelvic organ prolapse: Pelvic floor muscle training (2022) · cites this paper as [62]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“However, high-quality randomised controlled trial (RCT) data suggest that this approach might be associated with a high surgical failure rate of up to 35% at 2 years [5].”
From Laparoscopic sacrohysteropexy versus vaginal hysterectomy and apical suspension: 7-year follow-up of a randomized controlled trial (2022) · cites this paper as [5]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“Two trials exclusively assessed women undergoing primary prolapse repairs only (Barber 2014; Duarte 2020), with no other trials excluding previous prolapse surgeries.”
From Perioperative interventions in pelvic organ prolapse surgery (2025) · cites this paper as Barber 2014
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“Based on data from a single trial (Barber 2014), there may be no clinically relevant difference in POPQ assessment for Point C with or without pelvic floor training (OR 0.62, 95% CI 0.25 to 1.74; 1 study, 307 women; low‐certainty evidence; Analysis 1.4).”
From Perioperative interventions in pelvic organ prolapse surgery (2025) · cites this paper as Barber 2014
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“Based on data from a single trial (Barber 2014), there may be no clinically relevant difference in repeat surgery for prolapse with or without pelvic floor training (OR 0.86, 95% CI 0.23 to 3.26; P = 0.82; 1 study, 316 women; low‐certainty evidence; Analysis 1.2).”
From Perioperative interventions in pelvic organ prolapse surgery (2025) · cites this paper as Barber 2014
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“Based on data from a single trial (Barber 2014), there may be no clinically relevant difference in POPQ assessment for Point Ba with or without pelvic floor training (OR 0.92, 95% CI 0.49 to 1.74; 1 study, 308 women; low‐certainty evidence; Analysis 1.4).”
From Perioperative interventions in pelvic organ prolapse surgery (2025) · cites this paper as Barber 2014
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“Based on data from a single trial (Barber 2014), there may be no clinically relevant difference in POPQ assessment for Point Bp with or without pelvic floor training (OR 0.66, 95% CI 0.25 to 1.76; 1 study, 308 women; low‐certainty evidence; Analysis 1.4).”
From Perioperative interventions in pelvic organ prolapse surgery (2025) · cites this paper as Barber 2014
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“Based on data from a single trial (Barber 2014), there may be no clinically relevant difference in recurrent prolapse on examination with or without pelvic floor training (OR 1.24, 95% CI 0.67 to 2.29; P = 0.49; 1 study, 307 women; low‐certainty evidence; Analysis 1.3).”
From Perioperative interventions in pelvic organ prolapse surgery (2025) · cites this paper as Barber 2014
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“Based on data from a single trial (Barber 2014), there was no clinically relevant difference in patient awareness of prolapse with or without pelvic floor training (OR 1.07, 95% CI 0.61 to 1.87; 1 study, 305 women; low‐certainty evidence; Analysis 1.1).”
From Perioperative interventions in pelvic organ prolapse surgery (2025) · cites this paper as Barber 2014
Experimental — accuracy not yet measuredThe cited source says what the claim attributes to it.
In the citing paper
“This contradicts the results of studies with a high number of postoperative follow-up sessions, 39,40 which have demonstrated a limited benefit of PFMT on strength measures.”
From Postoperative Physiotherapy in Women Undergoing Pelvic Floor Reconstructive Surgery: A Randomized Controlled Clinical Trial (2022) · cites this paper as [39]
The cited source says what the claim attributes to it.
In the citing paper
“These have been shown to be essentially equivalent in efficacy.9”
From Characteristics Associated With Surgical Failure After Native Tissue Apical Prolapse Repair (2024) · cites this paper as [9]
The cited source says what the claim attributes to it.
In the citing paper
“Furthermore, there was no effect of the original training program in this study [62], and a long-term effect may therefore not be expected.”
From International urogynecology consultation chapter 3 committee 2; conservative treatment of patient with pelvic organ prolapse: Pelvic floor muscle training (2022) · cites this paper as [62]
The cited source says what the claim attributes to it.
In the citing paper
“Two trials reported on objective failure at any site (Barber 2014; Mueller 2017).”
From Perioperative interventions in pelvic organ prolapse surgery (2025) · cites this paper as Barber 2014
The cited source says what the claim attributes to it.
In the citing paper
“Eleven full publications or meeting abstracts which were published from 2005 until 2021 [62–72] were included.”
From International urogynecology consultation chapter 3 committee 2; conservative treatment of patient with pelvic organ prolapse: Pelvic floor muscle training (2022) · cites this paper as [62]
The cited source says what the claim attributes to it.
In the citing paper
“only Barber et al. (2014) [62] reported long-term adherence to PFMT”
From International urogynecology consultation chapter 3 committee 2; conservative treatment of patient with pelvic organ prolapse: Pelvic floor muscle training (2022) · cites this paper as [62]
The cited source says what the claim attributes to it.
In the citing paper
“They found that 93.4% reported to adhere to PFMT 6 months after the intervention and 81.4% at 2 years.”
From International urogynecology consultation chapter 3 committee 2; conservative treatment of patient with pelvic organ prolapse: Pelvic floor muscle training (2022) · cites this paper as [62]
The cited source says what the claim attributes to it.
In the citing paper
“given comparable outcomes), 69”
From Hysterectomy versus uterine preservation for pelvic organ prolapse surgery: a prospective cohort study (2025) · cites this paper as [69]
The cited source says what the claim attributes to it.
In the citing paper
“At two years, BPMT did not significantly improve urinary or prolapse symptom scores (UDI, POPDI) or anatomical outcomes.”
From Pelvic Floor Muscle Training Following Surgery for Pelvic Organ Prolapse: Recommendation from Scientific Literature (2026) · cites this paper as [33]
The cited source says what the claim attributes to it.
In the citing paper
“Concomitant stress incontinence was an inclusion criterion in Barber 2014, and an exclusion criterion in Bray 2017.”
From Perioperative interventions in pelvic organ prolapse surgery (2025) · cites this paper as Barber 2014
The cited source says what the claim attributes to it.
In the citing paper
“The length of follow‐up varied, from a few days of postoperative follow‐up in Chan 2014 and Henn 2016, to 24 months in Barber 2014.”
From Perioperative interventions in pelvic organ prolapse surgery (2025) · cites this paper as Barber 2014
The cited source says what the claim attributes to it.
In the citing paper
“POP surgery with or without pelvic floor muscle training (PFMT): seven trials with a total of 1032 women (Barber 2014; Brandt 2019; Duarte 2020; Mathew 2021; McClurg 2014; Nyhus 2020; Pauls 2013).”
From Perioperative interventions in pelvic organ prolapse surgery (2025) · cites this paper as Barber 2014
The cited source says what the claim attributes to it.
In the citing paper
“Seven trials reported on PROMs (Antosh 2013; Arunachalam 2019; Barber 2014; Duarte 2020; Mueller 2017; Pauls 2013; Russo 2020).”
From Perioperative interventions in pelvic organ prolapse surgery (2025) · cites this paper as Barber 2014
The cited source says what the claim attributes to it.
In the citing paper
“One trial reported on repeat surgery for recurrent prolapse (Barber 2014).”
From Perioperative interventions in pelvic organ prolapse surgery (2025) · cites this paper as Barber 2014
The cited source says what the claim attributes to it.
In the citing paper
“Three trials reported on awareness of prolapse (Ballard 2014; Barber 2014; Mueller 2017).”
From Perioperative interventions in pelvic organ prolapse surgery (2025) · cites this paper as Barber 2014
The cited source says what the claim attributes to it.
In the citing paper
“Two trials reported on POPQ assessments (Barber 2014; Mueller 2017).”
From Perioperative interventions in pelvic organ prolapse surgery (2025) · cites this paper as Barber 2014
The cited source says what the claim attributes to it.
In the citing paper
“the OPTIMAL trial was also unable to demonstrate a clear superiority of one apical suspension technique over the other in terms of either success rates or complication rates [32”
From The uterus debate in vaginal native tissue repair for pelvic organ prolapse: Hysteropexy versus hysterectomy – A systematic review and meta-analysis (2025) · cites this paper as [32]
The check wasn’t confident either way, so it gives no verdict — never disputed.
In the citing paper
“This mismatch, and that between expectations and goals, may be influenced by inadequate counselling, poor ‘customer’ care, consideration of the impact of prolapse on body image, sexual function, and perhaps other indirect effects; those on a woman's anxiety, depression, and cognitive state [25, 26, 27, 28, 29].”
From How Can We Improve the Assessment and Indifferent Outcomes From Pelvic Organ Prolapse Management From Conservative and Surgical Therapies? ICI‐RS 2025 (2026) · cites this paper as [26]
Experimental — accuracy not yet measuredIn the citing paper
“The incidence of serious adverse events from other trials range from 11.6-16.7% [20, 21].”
From Outpatient visits versus telephone interviews for postoperative care: a randomized controlled trial (2019) · cites this paper as [21]
In the citing paper
“Moreover, the failure rate of unilateral sacrospinous fixation is high (40–70%) [ 29 , 30 ].”
From Recurrent pelvic organ prolapse after hysterectomy; a 10-year national follow-up study (2024) · cites this paper as [29]
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Self-citationSurgery for pelvic organ prolapse
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Self-citationThe impact of midurethral sling surgery on the development of urinary tract infections
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Robotic Sacrocolpopexy—Is It the Treatment of Choice for Advanced Apical Pelvic Organ Prolapse?
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Self-citationSurgical Outcomes After Apical Repair for Vault Compared With Uterovaginal Prolapse
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Self-citationSacrospinous fixation versus uterosacral ligament suspension in managing apical prolapse
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Metadata
- 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)
- ORCID
- Venue
- JAMA
- Publisher
- American Medical Association (AMA)
- Published
- 2014-03-12
- Volume
- 311
- Issue
- 10
- Pages
- 1023
- ISSN
- 0002-9955 (ISSN-L)
- 0098-7484
- PMC
- PMC4083455
- OpenAlex
- W2151316027
- Semantic Scholar
- c7221d0dc04ee3d48408809eb8d70e3f407683d0
- 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
- FWCI
- 28.81
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- 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 › Urology › 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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