Evidence map›Paper›PMID 33620895›Full record

Trial reportFemale pelvic medicine & reconstructive surgery2021

Comparison of 100 U With 200 U of Intradetrusor OnabotulinumToxinA for Nonneurogenic Urgency Incontinence.

Whitney K Hendrickson, Cindy L Amundsen, David D Rahn, Isuzu Meyer, Megan S Bradley, Ariana L Smith, Deborah L Myers, J Eric Jelovsek, Emily S Lukacz

Open access · greenAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Female pelvic medicine & reconstructive surgery, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.5field-weighted citation impact, top 36% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 4 citations in OpenAlex.

  1. Article
  2. 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

9 authors at 6 institutions in 1 country.

Whitney K HendricksonFrom the Division of Urogynecology, Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, NC.
Cindy L AmundsenFrom the Division of Urogynecology, Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, NC.
David D RahnDivision of Female Pelvic Medicine and Reconstructive Surgery, Department of Obstetrics and Gynecology, UT Southwestern Medical Center, Dallas, TX.
Isuzu MeyerDivision of Urogynecology and Pelvic Reconstructive Surgery, Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, AL.
Megan S BradleyDivision of Urogynecology and Pelvic Reconstructive Surgery, Department of Obstetrics, Gynecology and Reproductive Services, School of Medicine, University of Pittsburgh, Pittsburgh, PA.
Ariana L SmithDivision of Urology, Department of Surgery, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.
Deborah L MyersDivision of Urogynecology and Pelvic Reconstructive Surgery, Department of Obstetrics and Gynecology, Brown University, Providence, RI.
J Eric JelovsekFrom the Division of Urogynecology, Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, NC.
Emily S LukaczDivision of Female Pelvic Medicine and Reconstructive Surgery, Department of Obstetrics, Gynecology and Reproductive Sciences, UC San Diego, San Diego, CA.
Duke Medical Center · USBrown University · USSouthwestern Medical Center · USUniversity of Alabama at Birmingham · USUniversity of Pennsylvania · USUniversity of Pittsburgh · 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
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
NICHD Pelvic Floor Disorders Network Clinical Sites (U10)U10HD054241 · NICHD · UT SOUTHWESTERN MEDICAL CENTER · PI SCHAFFER, JOSEPH I · 2006 to 2015
$1.9M
Pelvic Floor Disorders Network Clinical Sites (U10)U10HD069010 · NICHD · UNIVERSITY OF PENNSYLVANIA · PI ARYA, LILY A · 2011 to 2015
$1.7M
NICHD NIH HHS U01 HD041249NICHD NIH HHS U10 HD041250NICHD NIH HHS U10 HD041261NICHD NIH HHS U10 HD041267NICHD NIH HHS U10 HD054136NICHD NIH HHS U10 HD054214NICHD NIH HHS U10 HD054215NICHD NIH HHS U10 HD054241NICHD NIH HHS U10 HD069006NICHD NIH HHS U10 HD069010NICHD NIH HHS U10 HD069013NICHD NIH HHS U10 HD069025NICHD NIH HHS UG1 HD041267NICHD NIH HHS UG1 HD054214NICHD NIH HHS UG1 HD054241NICHD NIH HHS UG1 HD069010
6 · The paper itself

Abstract

objectivesThe objective of this study was to compare efficacy and adverse events between 100 U and 200 U of onabotulinumtoxinA for 6 months in women with nonneurogenic urgency incontinence.

methodsThis is a secondary analysis of 2 multicenter randomized controlled trials assessing efficacy of onabotulinumtoxinA in women with nonneurogenic urgency incontinence; one compared 100 U to anticholinergics and the other 200 U to sacral neuromodulation. Of 307 women who received onabotulinumtoxinA injections, 118 received 100 U, and 189 received 200 U. The primary outcome was mean adjusted change in daily urgency incontinence episodes from baseline over 6 months, measured on monthly bladder diaries. Secondary outcomes included perceived improvement, quality of life, and adverse events. The primary outcome was assessed via a multivariate linear mixed model.

resultsWomen receiving 200 U had a lower mean reduction in urgency incontinence episodes by 6 months compared with 100 U (-3.65 vs -4.28 episodes per day; mean difference, 0.63 episodes per day [95% confidence interval (CI), 0.05-1.20]). Women receiving 200 U had lower perceptions of improvement (adjusted odds ratio, 0.32 [95% CI, 0.14-0.75]) and smaller improvement in severity score (adjusted mean difference, 12.0 [95% CI, 5.63-18.37]). Upon subanalysis of only women who were treated with prior anticholinergic medications, these differences between onabotulinumtoxinA doses were no longer statistically significant. There was no statistically significant difference in adverse events in women receiving 200 U (catheterization, 32% vs 23%; adjusted odds ratio, 1.4 [95% CI, 0.8-2.4]; urinary tract infection, 37% vs 27%; adjusted odds ratio, 1.5 [95% CI, 0.9-2.6]).

conclusionsA higher dose of onabotulinumtoxinA may not directly result in improved outcomes, but rather baseline disease severity may be a more important prediction of outcomes.

Indexed as

AgedBotulinum Toxins, Type ADose-Response Relationship, DrugFemaleFollow-Up StudiesHumansInjections, IntramuscularMiddle AgedQuality of LifeSeverity of Illness IndexSurveys and QuestionnairesTreatment OutcomeUrinary Incontinence, UrgeBotulinum Toxins, Type Aonabotulinum toxin A

Identifiers

PMID33620895
PMCPMC8117667
OpenAlexW3131525915

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.