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Cited by 256Pelvic floor disorders treatmentsUterine Myomas and TreatmentsSexual function and dysfunction studies

Effect of Uterosacral Ligament Suspension vs Sacrospinous Ligament Fixation With or Without Perioperative Behavioral Therapy for Pelvic Organ Vaginal Prolapse on Surgical Outcomes and Prolapse Symptoms at 5 Years in the OPTIMAL Randomized Clinical Trial

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Jelovsek, J. Eric, Barber, Matthew D., Brubaker, Linda, Norton, Peggy, Gantz, Marie, Richter, Holly E., Weidner, Alison, Menefee, Shawn +4 more·2018·JAMA
DOI 10.1001/jama.2018.2827PMC PMC5933329
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Abstract

Importance: Uterosacral ligament suspension (ULS) and sacrospinous ligament fixation (SSLF) are commonly performed pelvic organ prolapse procedures despite a lack of long-term efficacy data. Objective: To compare outcomes in women randomized to (1) ULS or SSLF and (2) usual care or perioperative behavioral therapy and pelvic floor muscle training (BPMT) for vaginal apical prolapse. Design, Setting, and Participants: This 2 × 2 factorial randomized clinical trial was conducted at 9 US medical centers. Eligible participants who completed the Operations and Pelvic Muscle Training in the Management of Apical Support Loss Trial enrolled between January 2008 and March 2011 and were followed up 5 years after their index surgery from April 2011 through June 2016. Interventions: Two randomizations: (1) BPMT (n = 186) or usual care (n = 188) and (2) surgical intervention (ULS: n = 188 or SSLF: n = 186). Main Outcomes and Measures: The primary surgical outcome was time to surgical failure. Surgical failure was defined as (1) apical descent greater than one-third of total vaginal length or anterior or posterior vaginal wall beyond the hymen or retreatment for prolapse (anatomic failure), or (2) bothersome bulge symptoms. The primary behavioral outcomes were time to anatomic failure and Pelvic Organ Prolapse Distress Inventory scores (range, 0-300). Results: The original study randomized 374 patients, of whom 309 were eligible for this extended trial. For this study, 285 enrolled (mean age, 57.2 years), of whom 244 (86%) completed the extended trial. By year 5, the estimated surgical failure rate was 61.5% in the ULS group and 70.3% in the SSLF group (adjusted difference, -8.8% [95% CI, -24.2 to 6.6]). The estimated anatomic failure rate was 45.6% in the BPMT group and 47.2% in the usual care group (adjusted difference, -1.6% [95% CI, -21.2 to 17.9]). Improvements in Pelvic Organ Prolapse Distress Inventory scores were -59.4 in the BPMT group and -61.8 in the usual care group (adjusted mean difference, 2.4 [95% CI, -13.7 to 18.4]). Conclusions and Relevance: Among women who had undergone vaginal surgery for apical pelvic organ vaginal prolapse, there was no significant difference between ULS and SSLF in rates of surgical failure and no significant difference between perioperative behavioral muscle training and usual care on rates of anatomic success and symptom scores at 5 years. Compared with outcomes at 2 years, rates of surgical failure increased during the follow-up period, although prolapse symptom scores remained improved. Trial Registration: clinicaltrials.gov Identifier: NCT01166373.

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  • The recurrence rate in this study is lower than rates of 42%, 35%, and 27% reported in other studies with longer follow-up.

    “However, it is lower than that found in other studies [16,17,19] where rates of 42%, 35%, and 27% were reported.”

    From Recurrence Rate and Risk Factors for Apical Prolapse After Sacrospinous Ligament Fixation: A Prospective Cohort Study (2026) · cites this paper as [19]

    The Primary Outcome of Surgical Intervention (page unavailable) reports five-year surgical failure rates of 61.5% and 70.3%, not a 27% recurrence rate. Its 27% figure is the proportion of POP-Q failures involving the apex only; it does not describe the overall recurrence rate attributed to this study. (LLM, conf=0.84)

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  • Recurrence rates after sacrospinous fixation vary widely (17-42%), influenced by patient and surgical factors such as younger age <60 years, high BMI, advanced preoperative POP-Q stage, and smoking.

    “Despite its effectiveness, recurrence rates after sacrospinous fixation vary widely (17-42%), influenced by patient and surgical factors, such as younger age <60 years, high body mass index (BMI), advanced preoperative POP-Q stage, and smoking [18-20].”

    From Recurrence Rate and Risk Factors for Apical Prolapse After Sacrospinous Ligament Fixation: A Prospective Cohort Study (2026) · cites this paper as [19]

    The Primary Outcome of Surgical Intervention reports failure after sacrospinous ligament fixation, but its five-year estimates are 70.3% for surgical failure and 61.8% for anatomic failure, not a recurrence range of 17–42%. The paper lists BMI, smoking, and POP-Q stage as baseline characteristics (Limitations table), but the passages do not establish them—or age under 60—as factors influencing recurrence. Page numbers were not available in our copy. (LLM, conf=0.88)

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  • The longest follow-up period was 5 years after surgery, but there were no incentives for continuous PFMT during the follow-up period after the last training session 12 weeks post-surgery, and there was no report on adherence to maintenance training.

    “The longest follow-up period was 5 years after surgery, but there were no incentives for continuous PFMT during the follow-up period after the last training session 12 weeks post-surgery, and there was no report on adherence to maintenance training [67].”

    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 [67]

    The Study Interventions section says therapist visits ended 12 weeks after surgery and that patients received a daily maintenance exercise program at the final session. The paper reports outcomes through 5 years, but the passages do not establish that there were no incentives to continue training or document adherence to the maintenance program. Page numbers were not available in our copy. (LLM, conf=0.84)

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  • If there was no short-term effect of a PFMT program, long-term effects are unlikely.

    “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 [67]

    The introduction (section P; page unavailable) reports no observed benefit from perioperative behavioral therapy and pelvic floor muscle training at 6 months or 2 years. The Primary Outcome of the Behavioral Intervention and Discussion (pages unavailable) report no significant difference from usual care at 5 years. This supports the pattern in this surgical trial, but not a general prediction that any PFMT program without a short-term effect is unlikely to have a long-term effect. (LLM, conf=0.84)

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  • The risk of subsequent reoperation for posthysterectomy vault prolapse is between 4.6% and 18%.

    “The risk of subsequent reoperation for posthysterectomy vault prolapse is between 4.6% and 18% [6, 7].”

    From Laparoscopic sacrohysteropexy versus vaginal hysterectomy and apical suspension: 7-year follow-up of a randomized controlled trial (2022) · cites this paper as [6]

    The Primary Outcome of Surgical Intervention section reports repeat surgery for prolapse by five years in 4.6% of the SSLF group and 8.5% of the ULS group. It does not report an 18% reoperation risk or identify these figures as risks specifically for posthysterectomy vault prolapse. Page numbers are unavailable in our copy. (LLM, conf=0.88)

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Cites

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2 of the 58 references couldn’t be matched to a known paper.

Research works printed but not linked: 2

  1. Committee on Practice Bulletins-Gynecology, American Urogynecologic Society. Practice bulletin No. 185: pelvic organ prolapse. Obstet Gynecol. 2017;130(5):e234-e250.
  2. DeLancey JO, Morley GW, Howard D. Sacrospinous suspension: Michigan 4-wall offers better support. OBG Management. 2001;13 (3):18-29.

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Authors
Jelovsek, J. E., Barber, M. D., Brubaker, L., Norton, P., Gantz, M., Richter, H. E., Weidner, A., Menefee, S., Schaffer, J., Pugh, N., Meikle, S., & for the NICHD Pelvic Floor Disorders Network
Affiliations
  • Cleveland Clinic (US)
  • Loyola University Chicago (US)
  • University of Utah (US)
  • RTI International (US)
  • University of Alabama at Birmingham (US)
  • Duke University (US)
  • Kaiser Permanente (US)
  • The University of Texas Southwestern Medical Center (US)
  • Northwest Physician Group, Amarillo, Texas
Corresponding author
Jelovsek, J. Eric
ORCID
Venue
JAMA
Publisher
American Medical Association (AMA)
Published
2018-04-17
Volume
319
Issue
15
Pages
1554
ISSN
  • 0002-9955 (ISSN-L)
  • 0098-7484
DOI
10.1001/jama.2018.2827
PMC
PMC5933329
OpenAlex
W2799855555
Cited by
256
References
58
Citations by year
2026: 19 · 2025: 26 · 2024: 33 · 2023: 44 · 2022: 40 · 2021: 26 · 2020: 34 · 2019: 23 · 2018: 8 · 2016: 1
FWCI
19.43
Type
journal article
Language
en
Open access
Locations
  • JAMA (publishedVersion)
  • Europe PMC (PubMed Central) (publishedVersion)
  • PubMed Central (publishedVersion)
  • PubMed (publishedVersion)
Funders
  • Office of Research on Women's Health
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (U10HD041261, U10HD054136, U10HD054214, U01HD041249, U10HD054215, U01HD069031, U10HD041267, U10HD054241, U10HD041250, UG1HD054241, U24HD069031)
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
uterosacral ligament suspension, sacrospinous ligament fixation, pelvic organ prolapse, pelvic floor muscle training, behavior therapy, surgical failure, prolapse symptoms, long-term outcomes, OPTIMAL trial
MeSH terms
Aged, Behavior Therapy, Female, Follow-Up Studies, Humans, Ligaments, Middle Aged, Quality of Life, Severity of Illness Index, Gynecologic Surgical Procedures, Urinary Incontinence, Stress, Uterine Prolapse, Vagina, Treatment Failure, Kaplan-Meier Estimate, Suburethral Slings, Pelvic Organ Prolapse

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