Evidence map›Paper›PMID 19635587›Full record

Trial reportContemporary clinical trials2009

Design of the Value of Urodynamic Evaluation (ValUE) trial: A non-inferiority randomized trial of preoperative urodynamic investigations.

Charles W Nager, Linda Brubaker, Firouz Daneshgari, Heather J Litman, Kimberly J Dandreo, Larry Sirls, Gary E Lemack, Holly E Richter, Wendy Leng, Peggy Norton and 7 more

Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Contemporary clinical trials, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00803959 (A Randomized Trial of Urodynamic Testing Before Stress-Incontinence Surgery), which is not on this map. Cited by 20 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 1 pooled it
4.4field-weighted citation impact, top 6% 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.

NCT00803959 phase4completednot on this map

A Randomized Trial of Urodynamic Testing Before Stress-Incontinence Surgery

TypeinterventionalSponsorCarelon ResearchRan2008 to 2010Enrolled630ConditionsUrinary IncontinenceArmsOffice evaluation, UDS
3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 1 synthesis or guideline pooled it, 51 citations in OpenAlex.

  1. Pooled it
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  9. Article
  10. Article
  11. Article
  12. Article
  13. Predicting urinary incontinence after surgery for pelvic organ prolapse.Current opinion in obstetrics & gynecology · 2016
    Review
  14. Article
  15. Review
  16. What is an evidence-based appropriate workup?Canadian Urological Association journal = Journal de l'Association des urologues du Canada · 2012
    Article
  17. Article
  18. Novel biomarkers for overactive bladder.Nature reviews. Urology · 2011
    Review
  19. Review
  20. 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

17 authors at 13 institutions in 1 country.

Charles W NagerDepartment of Reproductive Medicine, University of California, San Diego, San Diego, CA, United States. cnager@ucsd.edu
Linda Brubaker
Firouz Daneshgari
Heather J Litman
Kimberly J Dandreo
Larry Sirls
Gary E Lemack
Holly E Richter
Wendy Leng
Peggy Norton
Stephen R Kraus
Toby C Chai
Debuene Chang
Cindy L Amundsen
Anne M Stoddard
Sharon L Tennstedt
Urinary Incontinence Treatment Network
New England Research Institutes · USBeaumont Hospital, Royal Oak · USDuke University · USLoyola University Chicago · USNational Institute of Diabetes and Digestive and Kidney Diseases · USSUNY Upstate Medical University · USThe University of Texas Health Science Center at San Antonio · USThe University of Texas Southwestern Medical Center · USUniversity of Alabama at Birmingham · USUniversity of California, San Diego · USUniversity of Maryland, College Park · 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
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
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 DK060397NIDDK NIH HHS U01 DK060401NIDDK 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

background and purposeUrodynamic studies (UDS) are routinely obtained prior to surgery for stress urinary incontinence (SUI) despite a lack of evidence that UDS information has an actual impact on outcome. The primary aim of this non-inferiority randomized clinical trial is to determine whether women with symptomatic, uncomplicated SUI who undergo only a basic office evaluation (BOE) prior to SUI surgery (No UDS arm) have non-inferior treatment outcomes compared to women who have BOE and UDS (UDS arm). Secondary aims are: 1) to determine how often physicians use preoperative UDS results to alter clinical and surgical decision-making, 2) to compare the amount of improvement in incontinence outcomes, and 3) to determine the incremental cost and utility of performing UDS compared with not performing UDS.

methodsAfter an initial basic office evaluation, women planning surgery for uncomplicated SUI who consent to study participation will be randomized to receive preoperative UDS or No UDS. Treatment will be planned and performed by the surgeon utilizing all the data available to them. We will compare results from the basic office evaluation (No UDS) with results from the basic office evaluation and preoperative UDS.

resultsThe primary outcome will be measured at 12 months using responses to the Urogenital Distress Inventory and the Patient Global Index-Improvement.

conclusionsRandomized trials comparing the effects of different diagnostic alternatives on treatment outcomes pose study design challenges. A non-inferiority design is appropriate when comparing a less invasive and less expensive alternative with a standard of care approach.

Indexed as

Preoperative PeriodUrodynamicsFemaleHumansOutcome Assessment, Health CareResearch DesignUrinary Incontinence, Stress

Identifiers

PMID19635587
PMCPMC3057197
OpenAlexW2049919747

What OpenQuestion holds

Textmetadata
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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.