Evidence map›Paper›PMID 21925636›Full record

Trial reportAmerican journal of obstetrics and gynecology2011

Adverse events over two years after retropubic or transobturator midurethral sling surgery: findings from the Trial of Midurethral Slings (TOMUS) study.

Linda Brubaker, Peggy A Norton, Michael E Albo, Toby C Chai, Kimberly J Dandreo, Keith L Lloyd, Jerry L Lowder, Larry T Sirls, Gary E Lemack, Amy M Arisco and 3 more

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

Trial report in American journal of obstetrics and gynecology, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 63 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
63citing papers in PubMed, 2 pooled it
9.0field-weighted citation impact, top 2% 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)
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
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

63 citing papers in PubMed, 2 syntheses or guidelines pooled it, 191 citations in OpenAlex.

  1. Pooled it
  2. Mid-urethral sling operations for stress urinary incontinence in women.The Cochrane database of systematic reviews · 2017
    Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Article
  10. Article
  11. Article
  12. Article
  13. Article
  14. Review
  15. Article
  16. Article
  17. Article
  18. Article
  19. Article
  20. Article

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

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

13 authors at 11 institutions in 1 country.

Linda BrubakerDepartment of Obstetrics and Gynecology, Stritch School of Medicine, Loyola University Chicago, Chicago, IL, USA.
Peggy A Norton
Michael E Albo
Toby C Chai
Kimberly J Dandreo
Keith L Lloyd
Jerry L Lowder
Larry T Sirls
Gary E Lemack
Amy M Arisco
Yan Xu
John W Kusek
Urinary Incontinence Treatment Network
New England Research Institutes · USBeaumont Hospital, Royal Oak · USLoyola University Chicago · USNational Institutes of Health · USThe University of Texas at San Antonio · USThe University of Texas Southwestern Medical Center · USUniversity of Alabama at Birmingham · USUniversity of California, San Diego · USUniversity of Maryland, Baltimore · USUniversity of Pittsburgh · USUniversity of Utah · US

Funding

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
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
NIDDK 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 DK060397
6 · The paper itself

Abstract

objectiveTo describe surgical complications in 597 women over a 24-month period after randomization to retropubic or transobturator midurethral slings. STUDY

designDuring the Trial of Midurethral Slings study, the Data Safety Monitoring Board regularly reviewed summary reports of all adverse events using the Dindo Surgical Complication Scale. Logistic regression models were created to explore associations between clinicodemographic factors and surgical complications.

resultsA total of 383 adverse events were observed among 253 of the 597 women (42%). Seventy-five adverse events (20%) were classified as serious (serious adverse events); occurring in 70 women. Intraoperative bladder perforation (15 events) occurred exclusively in the retropubic group. Neurologic adverse events were more common in the transobturator group than in retropubic (32 events vs 20 events, respectively). Twenty-three (4%) women experienced mesh complications, including delayed presentations, in both groups.

conclusionAdverse events vary by procedure, but are common after midurethral sling. Most events resolve without significant sequelae.

Indexed as

AdultFemaleFollow-Up StudiesHumansPostoperative ComplicationsSuburethral SlingsTreatment OutcomeUrinary Bladder DiseasesUrinary Incontinence, StressUrologic Surgical Procedures

Identifiers

PMID21925636
PMCPMC3205289
OpenAlexW2027656895

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.