Evidence map›Paper›PMID 19701041›Full record

Trial reportObstetrics and gynecology2009

Defining success after surgery for pelvic organ prolapse.

Matthew D Barber, Linda Brubaker, Ingrid Nygaard, Thomas L Wheeler, Joeseph Schaffer, Zhen Chen, Cathie Spino, Pelvic Floor Disorders Network

4 registry-linked trialsOpen access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Obstetrics and gynecology, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 226 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
226citing papers in PubMed, 6 pooled it
18.4field-weighted citation impact, top 1% 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.

NCT00065845 phase3completednot on this map

CARE: A Randomized Trial of Colpopexy and Urinary Reduction Efforts

TypeinterventionalSponsorEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Ran2002 to 2007Enrolled322ConditionsUrinary Incontinence, Stress, Uterine Prolapse, Vaginal ProlapseArmsBurch urethropexy at time of sacrocolpopexy
NCT03715803 completednot on this mapstarted 2018, after this paper: background citation

Calistar A vs. Calistar S - Cohort Retrospective Analysis

TypeobservationalSponsorAgustin SampietroRan2018 to 2019Enrolled217ConditionsPelvic Organ ProlapseArmsCalistar A mesh to treat anterior and apical POP, Calistar S mesh to treat anterior and apical POP
NCT04658784 nacompletednot on this mapstarted 2020, after this paper: background citation

Barbed Suture Versus Non-Barbed Suture for Posterior Colporrhaphy: A Randomized Controlled Trial

TypeinterventionalSponsorWake Forest University Health SciencesRan2020 to 2022Enrolled72ConditionsRectoceleArms2-0 dioxanone, glycolide and trimethylene carbonate, 2-0 polydioxanone
NCT06391372 phase3active not recruitingnot on this mapstarted 2024, after this paper: background citation

Effect of Local Estriol Treatment Before Vaginal Repair Surgery on Vaginal Tissues and Early Postoperative Pelvic Floor Functions

TypeinterventionalSponsorHatice Tukenmez KurnazRan2024 to 2025Enrolled36ConditionsPelvic Organ Prolapse, Pelvic Floor Disorders, Menopause, Vaginal AtrophyArmsestriol cream
3 · Its place in the literature

Who cites it

226 citing papers in PubMed, 6 syntheses or guidelines pooled it, 493 citations in OpenAlex.

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  9. Defining success after surgical treatment of stress urinary incontinence.American journal of obstetrics and gynecology · 2024
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  10. 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
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  18. Surgical interventions for uterine prolapse and for vault prolapse: the two VUE RCTs.Health technology assessment (Winchester, England) · 2020
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166 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 5 institutions in 1 country.

Matthew D BarberFrom the Obstetrics, Gynecology, and Women's Health Institute, Cleveland Clinic, Cleveland, Ohio; Departments of Obstetrics & Gynecology and Urology, Loyola University Chicago, Illinois; Department of Obstetrics and Gynecology, University of Utah, Salt Lake City, Utah; Department of Obstetrics and Gynecology, University of Alabama-Birmingham, Birmingham, Alabama; Department of Obstetrics and Gynecology, University of Texas-Southwestern, Dallas, Texas; Data Coordinating Center, University of Michigan, Ann Arbor, Michigan.
Linda Brubaker
Ingrid Nygaard
Thomas L Wheeler
Joeseph Schaffer
Zhen Chen
Cathie Spino
Pelvic Floor Disorders Network
Cleveland Clinic · USUniversity of Alabama at Birmingham · USLoyola University Chicago · USThe University of Texas Southwestern Medical Center · USUniversity of Utah · US

Funding

Pelvic floor Disorders Network-Data Coordinating CenterU01HD041249 · NICHD · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI WEI, JOHN T · 2001 to 2010
$19.8M
Perioperative Pelvic Floor Rehab: A Rrandomized TrialU10HD041261 · NICHD · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI RICHTER, HOLLY E · 2001 to 2015
$5.1M
UNC Pelvic Floor Disorders Research CollaborativeU10HD041267 · NICHD · UNIV OF NORTH CAROLINA CHAPEL HILL · PI VISCO, ANTHONY G · 2001 to 2015
$5.0M
The Pelvic Floor Disorders NetworkU10HD041250 · NICHD · LOYOLA UNIVERSITY CHICAGO · PI BRUBAKER, LINDA · 2001 to 2015
$3.8M
Pelvic Floor Disorders NetworkU10HD054214 · NICHD · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI LUKACZ, EMILY S. · 2006 to 2015
$3.3M
The Cleveland Clinic Clinical SiteU10HD054215 · NICHD · CLEVELAND CLINIC LERNER COM-CWRU · PI BARBER, MATTHEW D · 2006 to 2015
$3.2M
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 Collab Reconstructive Pelvic Surgery ProgramU10HD041263 · NICHD · MAGEE-WOMEN'S RES INST AND FOUNDATION · PI ZYCZYNSKI, HALINA M · 2001 to 2005
$2.3M
Treatment Investigation for Posterior ProlapseU10HD041268 · NICHD · JOHNS HOPKINS UNIVERSITY · PI CUNDIFF, GEOFFREY WILLIAM · 2001 to 2005
$2.0M
Iowa Pelvic Floor Disorders Clinical Trials NetworkU10HD041248 · NICHD · UNIVERSITY OF IOWA · PI KREDER, KARL J · 2001 to 2005
$1.9M
NICHD Pelvic Floor Disorders Network Clinical Sites (U10)U10HD054241 · NICHD · UT SOUTHWESTERN MEDICAL CENTER · PI SCHAFFER, JOSEPH I · 2006 to 2015
$1.9M
UTAH PELVIC FLOOR DISORDERS NETWORKU10HD054136 · NICHD · UNIVERSITY OF UTAH · PI NYGAARD, INGRID E · 2006 to 2015
$1.6M
NICHD NIH HHS U01 HD041249NICHD NIH HHS U01 HD 41249NICHD NIH HHS U10 HD041248NICHD NIH HHS U10 HD041250NICHD NIH HHS U10 HD041261NICHD NIH HHS U10 HD041263NICHD NIH HHS U10 HD041267NICHD NIH HHS U10 HD041268NICHD NIH HHS U10 HD041269NICHD NIH HHS U10 HD054136NICHD NIH HHS U10 HD054214NICHD NIH HHS U10 HD054215NICHD NIH HHS U10 HD054241NICHD NIH HHS U10 HD 41250NICHD NIH HHS U10 HD 41261NICHD NIH HHS U10 HD 41267NICHD NIH HHS U10 HD 54136NICHD NIH HHS U10 HD 54214NICHD NIH HHS U10 HD 54215NICHD NIH HHS U10 HD 54241NICHD NIH HHS UG1 HD041267
6 · The paper itself

Abstract

objectivesTo describe pelvic organ prolapse surgical success rates using a variety of definitions with differing requirements for anatomic, symptomatic, or re-treatment outcomes.

methodsEighteen different surgical success definitions were evaluated in participants who underwent abdominal sacrocolpopexy within the Colpopexy and Urinary Reduction Efforts trial. The participants' assessments of overall improvement and rating of treatment success were compared between surgical success and failure for each of the definitions studied. The Wilcoxon rank sum test was used to identify significant differences in outcomes between success and failure.

resultsTreatment success varied widely depending on definition used (19.2-97.2%). Approximately 71% of the participants considered their surgery "very successful," and 85.2% considered themselves "much better" than before surgery. Definitions of success requiring all anatomic support to be proximal to the hymen had the lowest treatment success (19.2-57.6%). Approximately 94% achieved surgical success when it was defined as the absence of prolapse beyond the hymen. Subjective cure (absence of bulge symptoms) occurred in 92.1% while absence of re-treatment occurred in 97.2% of participants. Subjective cure was associated with significant improvements in the patient's assessment of both treatment success and overall improvement, more so than any other definition considered (P<.001 and <.001, respectively). Similarly, the greatest difference in symptom burden and health-related quality of life as measured by the Pelvic Organ Prolapse Distress Inventory and Pelvic Organ Prolapse Impact Questionnaire scores between treatment successes and failures was noted when success was defined as subjective cure (P<.001).

conclusionThe definition of success substantially affects treatment success rates after pelvic organ prolapse surgery. The absence of vaginal bulge symptoms postoperatively has a significant relationship with a patient's assessment of overall improvement, while anatomic success alone does not. LEVEL OF EVIDENCE: II.

Indexed as

AdultFemaleFollow-Up StudiesHumansOutcome Assessment, Health CarePatient SatisfactionPelvic FloorQuality of LifeRetreatmentSurgical MeshUterine ProlapseVisceral Prolapse

Identifiers

PMID19701041
PMCPMC2904469
OpenAlexW2070502906

What OpenQuestion holds

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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.