Success and failure are dynamic, recurrent event states after surgical treatment for pelvic organ prolapse
Open accessAbstract
Background The ideal measure of success after surgery for pelvic organ prolapse has long been debated. Historically, strict definitions based on anatomic perfection have dominated the literature. However, the importance of patient-centered perception of outcomes is equally or more important when comparing the success of various prolapse surgeries. Understanding the limitations of existing outcome definitions will guide surgical outcome reporting and comparisons of pelvic organ prolapse surgeries.Objective This study aimed to describe the relationships and overlap among the participants who met the anatomic, subjective, and retreatment definitions of success or failure after pelvic organ prolapse surgery; demonstrate rates of transition between success and failure over time; and compare scores from the Pelvic Organ Prolapse Distress Inventory, Short-Form Six-Dimension health index, and quality-adjusted life years among these definitions.Study design Definitions of surgical success were evaluated at 3 or 6, 12, 24, 36, 48, and 60 months after surgery for ≥stage II pelvic organ prolapse in a cohort of women (N=1250) from 4 randomized clinical trials conducted by the Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network. Surgical failure was defined by a composite measure requiring 1 or more of (1) anatomic failure (Pelvic Organ Prolapse Quantification point Ba, Bp, or C of >0), (2) subjective failure (presence of bothersome vaginal bulge symptoms), or (3) pessary or surgical retreatment for pelvic organ prolapse. Pelvic Organ Prolapse Distress Inventory, Short-Form Six-Dimension health index, and quality-adjusted life years were compared among participants who met a variety of definitions of success and failure including novel "intermittent" success and failure over time.Results Among the 433 of 1250 women (34.6%) who had surgical failure outcomes at ≥1 time point, 85.5% (370 of 433) met only 1 component of the composite outcome at the assessment of initial failure (anatomic failure, 46.7% [202 of 433]; subjective failure, 36.7% [159 of 433]; retreatment, 2.1% [9 of 433]). Only 12.9% (56 of 433) met the criteria for both for anatomic and subjective failure. Despite meeting the criteria for failure in primary study reporting, 24.2% of these (105 of 433) transitioned between success and failure during follow-up, of whom 83.8% (88 of 105) met the criteria for success at their last follow-up. There were associations between success or failure classification and the 1- and 2-year quality-adjusted life years and a time-varying group effect on Pelvic Organ Prolapse Distress Inventory and Short-Form Six-Dimension health index scores.Conclusion True failure rates after prolapse surgery may be overestimated in the current literature. Only 13% of clinical trial subjects initially met both subjective and objective criteria for failure. Approximately one-quarter of failures were intermittent and transitioned between success and failure over time, with most intermittent failures being in a state of "surgical success" at their last follow-up. Current composite definitions of success or failure may result in the overestimation of surgical failure rates, potentially explaining, in part, the discordance with low retreatment rates after pelvic organ prolapse surgery.
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In the CARE trial, when success was defined as absence of prolapse beyond the hymen (POP-Q ≥ stage 2), 94.3% achieved surgical success.
“In the same trial, when success was defined as the absence of prolapse beyond the hymen (POP‐Q ≥ stage 2) 94.3% achieved surgical success.”
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 [7]
The Material and Methods section defines anatomic failure as prolapse beyond the hymen, so the cited paper supports that part of the claim. Its Results report outcomes across four trials, including CARE/E-CARE, but do not report a 94.3% CARE success rate under that definition (searched for “94.3” and CARE anatomic success). (LLM, conf=0.82)
Experimental — accuracy not yet measuredIn the CARE trial of abdominal sacrocolpopexy, applying two definitions of optimal anatomical outcome to 2-year follow-up data, the lowest treatment success was 19.2%-57.6%.
“When applying these two definitions to outcome data from 2‐year follow‐up of women participating in the Colpopexy and Urinary Reduction Efforts (CARE) trial of abdominal sacrocolpopexy, the lowest treatment ‘success’ (19.2%–57.6%) was achieved [7].”
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 [7]
The Introduction (page unavailable) describes an earlier analysis of different success definitions in 322 women after abdominal sacrocolpopexy, and the Methods identify the CARE trial and its 2-year follow-up. Our copy does not report two definitions of optimal anatomical outcome or a treatment-success range of 19.2%–57.6%. (LLM, conf=0.84)
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- Authors
- Jelovsek, J. E., Gantz, M. G., Lukacz, E., Sridhar, A., Zyczynski, H., Harvie, H. S., Dunivan, G., Schaffer, J., Sung, V., Varner, R. E., Mazloomdoost, D., & Barber, M. D.
- Affiliations
- Duke University (US)
- RTI International (US)
- University of California San Diego (US)
- University of Pittsburgh (US)
- University of Pennsylvania (US)
- University of New Mexico (US)
- The University of Texas Southwestern Medical Center (US)
- Brown University (US)
- University of Alabama at Birmingham (US)
- National Institutes of Health (US)
- Duke Medical Center (US)
- Corresponding author
- Jelovsek, J. Eric
- ORCID
- Venue
- American Journal of Obstetrics and Gynecology
- Publisher
- Elsevier BV
- Published
- 2021-04
- Volume
- 224
- Issue
- 4
- Pages
- 362.e1-362.e11
- ISSN
- 0002-9378 (ISSN-L)
- PMC
- PMC8009767
- OpenAlex
- W3091856558
- Cited by
- 28
- References
- 22
- Citations by year
- 2026: 6 · 2025: 5 · 2024: 3 · 2023: 10 · 2022: 3 · 2021: 1
- FWCI
- 2.63
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Licence
- Locations
- American Journal of Obstetrics and Gynecology (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- Funders
- National Institutes of Health
- Office of Research on Women's Health
- Boston Scientific Corporation
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (HD041250, HD041261, HD041263, HD041267, HD041269, HD054136, HD054214, HD054215, HD054241, HD069006, HD069010, HD069013, HD069025, HD069031)
- 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
- pelvic organ prolapse, surgical failure, surgical retreatment, quality-adjusted life years, patient-centered outcomes, women's health, randomized controlled trials, pelvic floor dysfunction
- MeSH terms
- Aged, Female, Follow-Up Studies, Humans, Middle Aged, Retrospective Studies, Multicenter Studies as Topic, Randomized Controlled Trials as Topic, Treatment Failure, Quality-Adjusted Life Years, Retreatment, Pelvic Organ Prolapse, Patient Outcome Assessment
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