Evidence map›Paper›PMID 32146521›Full record

Trial reportInternational urogynecology journal2020

Outcomes of native tissue transvaginal apical approaches in women with advanced pelvic organ prolapse and stress urinary incontinence.

Isuzu Meyer, Ryan E Whitworth, Emily S Lukacz, Ariana L Smith, Vivian W Sung, Anthony G Visco, Mary F Ackenbom, Clifford Y Wai, Donna Mazloomdoost, Marie G Gantz and 2 more

Registry-linked trialOpen access · greenAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in International urogynecology journal, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01166373 (Long-Term Effectiveness Of Sacrospinous Ligament Fixation vs Uterosacral Ligament Suspension With and Without Perioperative Behavioral Therapy/Pelvic Muscle Training), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.6field-weighted citation impact, top 17% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01166373 nacompletednot on this map

Long-Term Effectiveness Of Sacrospinous Ligament Fixation vs Uterosacral Ligament Suspension With and Without Perioperative Behavioral Therapy/Pelvic Muscle Training: Extended Operations & Pelvic Muscle Training Of Apical Support Loss Study

TypeinterventionalSponsorNICHD Pelvic Floor Disorders NetworkRan2010 to 2016Enrolled285ConditionsPelvic Organ ProlapseArmsEnrollment video, SSLF, ULS, PMT, Usual Care
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 18 citations in OpenAlex.

  1. Efficacy of Sacrospinous Fixation or Uterosacral Ligament Suspension for Pelvic Organ Prolapse in Stages III and IV: Randomized Clinical Trial.Revista brasileira de ginecologia e obstetricia : revista da Federacao Brasileira das Sociedades de Ginecologia e Obstetricia · 2023
    Trial
  2. Trial
  3. Review
  4. Observational
  5. Article
  6. Article
  7. Update in native tissue vaginal vault prolapse repair.International urogynecology journal · 2020
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 9 institutions in 1 country.

Isuzu MeyerDivision of Urogynecology and Pelvic Reconstructive Surgery, Department of Obstetrics and Gynecology, University of Alabama at Birmingham, 619 19th Street South, Birmingham, AL, 35249, USA. imeyer@uabmc.edu.ORCID http://orcid.org/0000-0003-1425-9614
Ryan E WhitworthRTI International, 3040 E Cornwallis Rd, Research Triangle Park, NC, USA.
Emily S LukaczDepartment of Reproductive Medicine, University of California-San Diego Health Systems, San Diego, CA, USA.
Ariana L SmithDepartment of Surgery, Division of Urology, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.
Vivian W SungDivision of Urogynecology and Reconstructive Pelvic Surgery, Alpert Medical School of Brown University, Providence, RI, USA.
Anthony G ViscoDivision of Urogynecology, Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, NC, USA.
Mary F AckenbomDepartment of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh, Pittsburgh, PA, USA.
Clifford Y WaiDivision of Female Pelvic Medicine and Reconstructive Surgery, Department of Obstetrics and Gynecology, University of Texas Southwestern Medical Center, Dallas, TX, USA.
Donna MazloomdoostThe Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD, USA.
Marie G GantzRTI International, 3040 E Cornwallis Rd, Research Triangle Park, NC, USA.
Holly E RichterDivision of Urogynecology and Pelvic Reconstructive Surgery, Department of Obstetrics and Gynecology, University of Alabama at Birmingham, 619 19th Street South, Birmingham, AL, 35249, USA.
NICHD Pelvic Floor Disorders Network and the National Institutes of Health Office of Research on Women’s Health
RTI International · USUniversity of Alabama at Birmingham · USBrown University · USDuke Medical Center · USNational Institutes of Health · USThe University of Texas Southwestern Medical Center · USUC San Diego Health System · USUniversity of Pennsylvania · USUniversity of Pittsburgh · US

Funding

Pelvic Floor Disorders Network Data Coordinating Center Administrative Supplement: ODSS CDE FundingU24HD069031 · NICHD · RESEARCH TRIANGLE INSTITUTE · PI MARIE G GANTZ · 2016 to 2026
$35.8M
OB/GYN FACULTY RESEARCH CAREER DEVELOPMENT PROGRAMK12HD001258 · NICHD · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI JENKINS, TODD R · 1999 to 2019
$5.6M
UNC Pelvic Floor Disorders Research CollaborativeU10HD041267 · NICHD · UNIV OF NORTH CAROLINA CHAPEL HILL · PI VISCO, ANTHONY G · 2001 to 2015
$5.0M
Brown/WIH Pelvic Floor Disorders Network Site (UG1)UG1HD069013 · NICHD · WOMEN AND INFANTS HOSPITAL-RHODE ISLAND · PI Vivian W Sung · 2016 to 2026
$3.1M
Pelvic Floor Disorders Network 2021UG1HD054241 · NICHD · UT SOUTHWESTERN MEDICAL CENTER · PI David Dwight Rahn · 2016 to 2026
$3.0M
Pelvic Floor Disorders Network Clinical Sites (UG1)UG1HD069010 · NICHD · UNIVERSITY OF PENNSYLVANIA · PI Heidi S Harvie · 2016 to 2026
$3.0M
Pelvic Floor Disorders Network Clinical Site Application: The San Diego PelvicFloor ConsortiumUG1HD054214 · NICHD · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI EMILY S. LUKACZ, Shawn A Menefee · 2016 to 2026
$2.9M
Duke University Medical Center (DUMC) Pelvic Floor Disorders Network (PFDN) Clinical SiteUG1HD041267 · NICHD · DUKE UNIVERSITY · PI NAZEMA Y SIDDIQUI · 2016 to 2026
$2.8M
Pittsburgh Pelvic Floor Research ProgramUG1HD069006 · NICHD · MAGEE-WOMEN'S RES INST AND FOUNDATION · PI ZYCZYNSKI, HALINA M · 2016 to 2021
$1.5M
University of Alabama at Birmingham: Pelvic Floor Disorders NetworkUG1HD041261 · NICHD · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI RICHTER, HOLLY E · 2016 to 2021
$1.4M
Eunice Kennedy Shriver National Institute of Child Health and Human Development UG1 HD054241, UG1 HD041261, UG1 HD054214, UG1 HD041267, UG1 HD069010, UG1 HD069006, UG1 HD069013, U24 HD069031NICHD NIH HHS K12 HD001258NICHD NIH HHS U10 HD041267NICHD NIH HHS U24 HD069031NICHD NIH HHS UG1 HD041261NICHD NIH HHS UG1 HD041267NICHD NIH HHS UG1 HD054214NICHD NIH HHS UG1 HD054241NICHD NIH HHS UG1 HD069006NICHD NIH HHS UG1 HD069010NICHD NIH HHS UG1 HD069013
6 · The paper itself

Abstract

introduction and hypothesisLimited data exist comparing different surgical approaches in women with advanced vaginal prolapse. This study compared 2-year surgical outcomes of uterosacral ligament suspension (ULS) and sacrospinous ligament fixation (SSLF) in women with advanced prolapse (stage III-IV) and stress urinary incontinence.

methodsThis was a secondary analysis of a multicenter 2 × 2 factorial randomized trial comparing (1) ULS versus SSLF and (2) behavioral therapy with pelvic floor muscle training versus usual care. Of 374 subjects, 117/188 (62.7%) in the ULS and 113/186 (60.7%) in the SSLF group had advanced prolapse. Two-year surgical success was defined by the absence of (1) apical descent > 1/3 into the vaginal canal, (2) anterior/posterior wall descent beyond the hymen, (3) bothersome bulge symptoms, and (4) retreatment for prolapse. Secondary outcomes included individual success outcome components, symptom severity measured by the Pelvic Organ Prolapse Distress Inventory, and adverse events. Outcomes were also compared in women with advanced prolapse versus stage II prolapse.

resultsSuccess did not differ between groups (ULS: 58.2% [57/117] versus SSLF: 58.5% [55/113], aOR 1.0 [0.5-1.8]). No differences were detected in individual success components (p > 0.05 for all components). Prolapse symptom severity scores improved in both interventions with no intergroup differences (p = 0.82). Serious adverse events did not differ (ULS: 19.7% versus SSLF: 16.8%, aOR 1.2 [0.6-2.4]). Success was lower in women with advanced prolapse compared with stage II (58.3% versus 73.2%, aOR 0.5 [0.3-0.9]), with no retreatment in stage II.

conclusionsSurgical success, symptom severity, and overall serious adverse events did not differ between ULS and SSLF in women with advanced prolapse. ClinicalTrials.gov Identifier: NCT01166373.

Indexed as

Pelvic Organ ProlapseSuburethral SlingsUrinary Incontinence, StressUterine ProlapseFemaleGynecologic Surgical ProceduresHumansTreatment OutcomeAdvanced prolapsePelvic organ prolapseProlapse repairSacrospinous ligament fixationUterosacral ligament suspensionVaginal prolapse repair

Identifiers

PMID32146521
PMCPMC7483223
OpenAlexW3010207102

What OpenQuestion holds

Textmetadata
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.