Cited by 67Pelvic floor disorders treatmentsUterine Myomas and TreatmentsGynecological conditions and treatments

Effect of sacrospinous hysteropexy with graft vs vaginal hysterectomy with uterosacral ligament suspension on treatment failure in women with uterovaginal prolapse: 5-year results of a randomized clinical trial

Open access
Nager, Charles W., Visco, Anthony G., Richter, Holly E., Rardin, Charles R., Komesu, Yuko, Harvie, Heidi S., Zyczynski, Halina M., Paraiso, Marie Fidela R. +3 more·2021·American Journal of Obstetrics and Gynecology

Abstract

Background Vaginal hysterectomy with suture apical suspension is commonly performed for uterovaginal prolapse. Sacrospinous hysteropexy with graft (vaginal mesh hysteropexy) is an alternative, although in 2019 the Food and Drug Administration removed this mesh product from the United States market.Objective Our objective was to compare the efficacy and adverse events of these 2 procedures.Study design At 9 clinical sites in the United States National Institutes of Health and National Institute of Child Health and Human Development Pelvic Floor Disorders Network, 183 postmenopausal women requesting vaginal surgery for symptomatic uterovaginal prolapse were enrolled in a multisite randomized superiority clinical trial, comparing a sacrospinous hysteropexy with graft (hysteropexy) with a vaginal hysterectomy with uterosacral ligament suspension (hysterectomy). Participants consented to remain masked to treatment assignment for the study duration. Study visits were conducted at 6-month intervals through 60 months. The primary treatment failure composite outcome (retreatment of prolapse, prolapse beyond the hymen, or prolapse symptoms) was evaluated with survival modeling. Secondary outcomes included complications or adverse events, individual anatomic measures of the pelvic organ prolapse quantification examination, and presence, severity, and impact and bother of prolapse, urinary, bowel, and pain symptoms as measured by validated questionnaires. The 3-year published results suggested better primary outcomes with sacrospinous hysteropexy with graft, but the differences were not statistically significant (P=.06). This study reports the 5-year outcomes.Results A total of 183 women with a mean age of 66 years were randomized between April 2013 and February 2015; 93 were randomized to hysteropexy and 90 were randomized to hysterectomy. Notably, 175 were included in the trial, and 156 (89%) completed the 5-year follow-up. The primary outcome showed fewer failures for hysteropexy than hysterectomy through 5 years (adjusted hazard ratio, 0.58; 95% confidence interval, 0.36-0.94; P=.03), with failure rates of 37% vs 54%, respectively, resulting in a difference of -18% (95% confidence interval, -33% to -3%) at 5 years. With the exception of the Urogenital Distress Inventory, no group differences were demonstrated in patient-reported pelvic floor symptoms, prolapse symptoms, bowel function symptoms, general quality of life, body image, or pelvic pain. At their last visit through 5 years, 70% of participants (129 of 183) reported they remained masked to their treatment with no difference in masking between groups. Adverse events for hysteropexy vs hysterectomy included mesh exposure (8% vs 0%), granulation tissue after 12 weeks (1% vs 12%), and suture exposure after 12 weeks (3% vs 21%), respectively.Conclusion Among women with symptomatic uterovaginal prolapse undergoing vaginal surgery, sacrospinous hysteropexy with graft resulted in a lower composite failure rate than vaginal hysterectomy through 5 years. There were no meaningful differences in patient-reported outcomes between groups. Our results suggest that this vaginal mesh hysteropexy procedure should be made available to patients.

The claims and statistics of this paper haven’t been checked yet.

Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.

A few free checks a day · papers already verified open instantly · results are public

Integrity signals

Registry

Crossref · 10.1016/j.ajog.2021.03.012

Cites

24 of 24 references verified0 citation errors · 0 not checkable

Statistics

Claims the paper makes

The claims and statistics of this paper haven’t been checked yet.

Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.

A few free checks a day · papers already verified open instantly · results are public

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

Self-check

Percentages, sums and reported differences re-computed from the paper’s own numbers.

The self-check needs the paper’s full text.

Cites

Flagged first, then by citations

Research works printed but not linked: 1

  1. [25]Hopwood P, Fletcher I, Lee A, Al Ghazal S. A body image scale for use with cancer patients. European Journal of Cancer 2001; 37: 189– 97. 11166145

Cited by

Sorted by citations

Authors
Nager, C. W., Visco, A. G., Richter, H. E., Rardin, C. R., Komesu, Y., Harvie, H. S., Zyczynski, H. M., Paraiso, M. F. R., Mazloomdoost, D., Sridhar, A., & Thomas, S.
Affiliations
  • UC San Diego Health System (US)
  • Duke Medical Center (US)
  • University of Alabama at Birmingham (US)
  • Brown University (US)
  • University of New Mexico (US)
  • University of Pennsylvania (US)
  • Magee-Womens Research Institute (US)
  • Cleveland Clinic (US)
  • National Institutes of Health (US)
  • RTI International (US)
Corresponding author
Nager, Charles W.
Venue
American Journal of Obstetrics and Gynecology
Publisher
Elsevier BV
Published
2021-08
Volume
225
Issue
2
Pages
153.e1-153.e31
ISSN
0002-9378 (ISSN-L)
OpenAlex
W3137134282
Cited by
67
References
24
Citations by year
2026: 5 · 2025: 12 · 2024: 12 · 2023: 14 · 2022: 22 · 2021: 2
FWCI
9.40
Type
journal article
Language
en
Open access
Locations
  • American Journal of Obstetrics and Gynecology (acceptedVersion)
  • PubMed (publishedVersion)
  • PubMed Central (acceptedVersion)
Funders
  • Boston Scientific Corp
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development
Topics
  • Health Sciences › Medicine › Rheumatology › Pelvic floor disorders treatments
  • Health Sciences › Medicine › Obstetrics and Gynecology › Uterine Myomas and Treatments
  • Health Sciences › Medicine › Obstetrics and Gynecology › Gynecological conditions and treatments
Keywords
uterovaginal prolapse, vaginal hysterectomy, uterosacral ligament suspension, treatment failure, postmenopausal women, long-term outcomes, POP-Q, surgical complications, mesh removal, pelvic floor dysfunction, randomized controlled trials
MeSH terms
Patient Reported Outcome Measures, Aged, Female, Humans, Hysterectomy, Vaginal, Ligaments, Middle Aged, Sacrum, Gynecologic Surgical Procedures, Surgical Mesh, Suture Techniques, Uterine Prolapse, Treatment Failure, Plastic Surgery Procedures

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

What counts as a claim ›How we measure confidence ›How we check this ›

Are you an author, or do you see a problem with this page? Request a review