Evidence map›Paper›PMID 20479459›Full record

Trial reportThe New England journal of medicine2010

Retropubic versus transobturator midurethral slings for stress incontinence.

Holly E Richter, Michael E Albo, Halina M Zyczynski, Kimberly Kenton, Peggy A Norton, Larry T Sirls, Stephen R Kraus, Toby C Chai, Gary E Lemack, Kimberly J Dandreo and 21 more

6 registry-linked trialsOpen access · bronzeAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in The New England journal of medicine, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 6 registered trials, which are not on this map. Cited by 220 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
220citing papers in PubMed, 8 pooled it
38.6field-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.

NCT00325039 phase4completednot on this map

TOMUS-Trial Of Mid-Urethral Slings

TypeinterventionalSponsorCarelon ResearchRan2006 to 2013Enrolled597ConditionsUrinary IncontinenceArmsretropubic mid-urethral sling (TVT), transobturator mid-urethral sling (TVT-O and the Monarc)
NCT01124916 nacompletednot on this map

Abdominal Colpopexy: Comparison of Endoscopic Surgical Strategies

TypeinterventionalSponsorLoyola UniversityRan2009 to 2013Enrolled84ConditionsPelvic Organ ProlapseArmsRobotic assisted laparoscopic abdominal sacrocolpopexy, Standard laparoscopic abdominal sacrocolpopexy
NCT04843995 completednot on this mapstarted 2012, after this paper: background citation

The Effect of Mid-urethral Sling on the Urethral Dynamic Shape and Motion

TypeobservationalSponsorEndeavor HealthRan2012 to 2021Enrolled190ConditionsStress Urinary IncontinenceArmsMid-urethral sling
NCT04881721 unknown statusnot on this mapstarted 2021, after this paper: background citation

Mesh-free Suture Urethropexy for Treating Stress Urinary Incontinence, Efficacy and Durability Trial

TypeobservationalSponsorEndeavor HealthRan2021 to 2023Enrolled15ConditionsStress Urinary IncontinenceArmsUrethropexy
NCT04985799 nacompletednot on this mapstarted 2021, after this paper: background citation

A Randomized Controlled Trial Comparing Retropubic KIM Sling to TVT Exact Midurethral Sling

TypeinterventionalSponsorUniversity of North Carolina, Chapel HillRan2021 to 2024Enrolled147ConditionsStress Urinary IncontinenceArmsGynecare TVT Exact Continence System, Neomedic KIM (Knotless Incontinence Mesh)
NCT05842005 naunknown statusnot on this mapstarted 2023, after this paper: background citation

Mesh-Reduced Sling For Treating Stress Urinary Incontinence, Efficacy and Durability Trial

TypeinterventionalSponsorEndeavor HealthRan2023 to 2024Enrolled15ConditionsStress Urinary IncontinenceArmsMesh-reduced Sling
3 · Its place in the literature

Who cites it

220 citing papers in PubMed, 8 syntheses or guidelines pooled it, 685 citations in OpenAlex.

  1. Pooled it
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  4. Surgical Treatment for Stress Urinary Incontinence in Women: A Systematic Review and Meta-analysis.Revista brasileira de ginecologia e obstetricia : revista da Federacao Brasileira das Sociedades de Ginecologia e Obstetricia · 2018
    Pooled it
  5. Mid-urethral sling operations for stress urinary incontinence in women.The Cochrane database of systematic reviews · 2017
    Pooled it
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  20. What is the optimal length for single-incision tape?International urogynecology journal · 2019
    Trial

160 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

31 authors at 16 institutions in 1 country.

Holly E RichterDepartment of Obstetrics and Gynecology, University of Alabama at Birmingham, 1700 6th Ave. South, Suite 10382, Birmingham, AL 35233, USA. hrichter@uabmc.edu
Michael E Albo
Halina M Zyczynski
Kimberly Kenton
Peggy A Norton
Larry T Sirls
Stephen R Kraus
Toby C Chai
Gary E Lemack
Kimberly J Dandreo
R Edward Varner
Shawn Menefee
Chiara Ghetti
Linda Brubaker
Ingrid Nygaard
Salil Khandwala
Thomas A Rozanski
Harry Johnson
Joseph Schaffer
Anne M Stoddard
Robert L Holley
Charles W Nager
Pamela Moalli
Elizabeth Mueller
Amy M Arisco
Marlene Corton
Sharon Tennstedt
T Debuene Chang
E Ann Gormley
Heather J Litman
Urinary Incontinence Treatment Network
New England Research Institutes · USLoyola University Chicago · USThe University of Texas at San Antonio · USThe University of Texas Southwestern Medical Center · USUniversity of Alabama at Birmingham · USMagee-Womens Hospital · USUniversity of California, San Diego · USUniversity of Utah · USBeaumont Hospital, Dearborn · USBeaumont Hospital, Royal Oak · USDartmouth–Hitchcock Medical Center · USKaiser Permanente · USNational Institutes of Health · USUniversity of Baltimore · USUniversity of Maryland, Baltimore · USUniversity of Pittsburgh · US

Funding

University of Pittsburgh Clinical and Translational Science InstituteUL1TR000005 · NCATS · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI REIS, STEVEN E · 2012 to 2015
$50.8M
Urinary Incontinence Treatment Network: DCCU01DK058229 · NIDDK · NEW ENGLAND RESEARCH INSTITUTES, INC. · PI TENNSTEDT, SHARON L · 2000 to 2012
$16.1M
UAB Continence Treatment Center U01DK060380 · NIDDK · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI RICHTER, HOLLY E · 2001 to 2009
$3.9M
Urinary Incontinence Treatment NetworkU01DK058225 · NIDDK · MAGEE-WOMEN'S RES INST AND FOUNDATION · PI ZYCZYNSKI, HALINA M · 2000 to 2009
$3.8M
UCSD INCONTINENCE TREATMENT CENTERU01DK060401 · NIDDK · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI ALBO, MICHAEL · 2001 to 2010
$3.6M
Continuation of the Urinary Incontinence Treatment Network (UITN)U01DK060379 · NIDDK · LOYOLA UNIVERSITY CHICAGO · PI BRUBAKER, LINDA · 2001 to 2009
$3.6M
UTAH URINARY INCONTINENCE TREATMENT NETWORK (UUITN)U01DK060393 · NIDDK · UNIVERSITY OF UTAH · PI NORTON, PEGGY A · 2001 to 2009
$3.4M
Urinary Incontinence Treatment NetworkU01DK058231 · NIDDK · WILLIAM BEAUMONT HOSPITAL RESEARCH INST · PI SIRLS, LARRY T · 2000 to 2009
$3.3M
Urinary Incontinence Treatment Network (UITN)U01DK060397 · NIDDK · UNIVERSITY OF MARYLAND BALTIMORE · PI CHAI, TOBY C · 2001 to 2010
$2.7M
Urinary Incontinence Treatment NetworkU01DK060395 · NIDDK · UT SOUTHWESTERN MEDICAL CENTER · PI ZIMMERN, PHILIPPE E · 2001 to 2009
$2.4M
The Urinary Incontinence Treatment NetworkU01DK058234 · NIDDK · UNIVERSITY OF TEXAS HLTH SCIENCE CENTER · PI KRAUS, STEPHEN R · 2000 to 2009
$2.3M
NCATS NIH HHS UL1 TR000005NIDDK NIH HHS U01 DK058225NIDDK NIH HHS U01 DK058229NIDDK NIH HHS U01 DK058231NIDDK NIH HHS U01 DK058234NIDDK NIH HHS U01 DK060379NIDDK NIH HHS U01 DK060380NIDDK NIH HHS U01 DK060393NIDDK NIH HHS U01 DK060395NIDDK NIH HHS U01 DK060397NIDDK NIH HHS U01 DK060401NIDDK NIH HHS U01 DK 58225NIDDK NIH HHS U01 DK58225NIDDK NIH HHS U01 DK58229NIDDK NIH HHS U01 DK58231NIDDK NIH HHS U01 DK58234NIDDK NIH HHS U01 DK60379NIDDK NIH HHS U01 DK60380NIDDK NIH HHS U01 DK60393NIDDK NIH HHS U01 DK60395NIDDK NIH HHS U01 DK60397NIDDK NIH HHS U01 DK60401
6 · The paper itself

Abstract

backgroundMidurethral slings are increasingly used for the treatment of stress incontinence, but there are limited data comparing types of slings and associated complications.

methodsWe performed a multicenter, randomized equivalence trial comparing outcomes with retropubic and transobturator midurethral slings in women with stress incontinence. The primary outcome was treatment success at 12 months according to both objective criteria (a negative stress test, a negative pad test, and no retreatment) and subjective criteria (self-reported absence of symptoms, no leakage episodes recorded, and no retreatment). The predetermined equivalence margin was +/-12 percentage points.

resultsA total of 597 women were randomly assigned to a study group; 565 (94.6%) completed the 12-month assessment. The rates of objectively assessed treatment success were 80.8% in the retropubic-sling group and 77.7% in the transobturator-sling group (3.0 percentage-point difference; 95% confidence interval [CI], -3.6 to 9.6). The rates of subjectively assessed success were 62.2% and 55.8%, respectively (6.4 percentage-point difference; 95% CI, -1.6 to 14.3). The rates of voiding dysfunction requiring surgery were 2.7% in those who received retropubic slings and 0% in those who received transobturator slings (P=0.004), and the respective rates of neurologic symptoms were 4.0% and 9.4% (P=0.01). There were no significant differences between groups in postoperative urge incontinence, satisfaction with the results of the procedure, or quality of life.

conclusionsThe 12-month rates of objectively assessed success of treatment for stress incontinence with the retropubic and transobturator approaches met the prespecified criteria for equivalence; the rates of subjectively assessed success were similar between groups but did not meet the criteria for equivalence. Differences in the complications associated with the two procedures should be discussed with patients who are considering surgical treatment for incontinence. (ClinicalTrials.gov number, NCT00325039.)

Indexed as

Suburethral SlingsComparative Effectiveness ResearchFemaleFollow-Up StudiesHumansIntention to Treat AnalysisIntraoperative ComplicationsMiddle AgedPatient SatisfactionPostoperative ComplicationsTreatment OutcomeUrinary Incontinence, StressUrination DisordersUrodynamicsUrologic Surgical Procedures

Identifiers

PMID20479459
PMCPMC2962585
OpenAlexW2167919035

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.