Evidence map›Paper›PMID 26231052›Full record

Trial reportHealth and quality of life outcomes2015

Psychometric properties of the incontinence utility index among patients with idiopathic overactive bladder: data from two multicenter, double-blind, randomized, Phase 3, placebo-controlled clinical trials.

Nacho Castejón, Kristin Khalaf, Quanhong Ni, Jesús Cuervo, Donald L Patrick

2 registry-linked trialsAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Health and quality of life outcomes, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
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.

NCT00910520 phase3completednot on this map

Botulinum Toxin Type A for the Treatment of Patients With Idiopathic Overactive Bladder With Urinary Incontinence

TypeinterventionalSponsorAllerganRan2009 to 2011Enrolled548ConditionsOveractive BladderArmsonabotulinumtoxinA, normal saline
NCT00910845 phase3completednot on this map

Study of Botulinum Toxin Type A for the Treatment of Patients With Idiopathic Overactive Bladder With Urinary Incontinence

TypeinterventionalSponsorAllerganRan2009 to 2011Enrolled557ConditionsOveractive BladderArmsonabotulinumtoxinA, normal saline
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Article
  3. 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

5 authors.

Nacho CastejónLA-SER Outcomes, C/ Azcárraga 12 A 33010 Oviedo, Asturias, Spain. nacho.castejon@la-ser.com.
Kristin KhalafAllergan Inc., Irvine, CA, USA. Kristin.mariek@gmail.com.
Quanhong NiAllergan Inc., Bridgewater, NJ, USA. QuanhongNi@yahoo.com.
Jesús CuervoLA-SER Outcomes, C/ Azcárraga 12 A 33010 Oviedo, Asturias, Spain. Jesus.Cuervo@la-ser.com.
Donald L PatrickDepartment of Health Services, University of Washington, Seattle, WA, USA. donald@uw.edu.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundOveractive bladder is a prevalent and burdensome condition. Generic utility measures may fail to reflect its full impact on patients' health status. The Incontinence Utility Index (IUI) is a community-based preference index derived from the Incontinence Quality of Life Questionnaire (I-QOL) developed to value health states related to urinary symptoms in patients with neurogenic detrusor overactivity. This study assessed the measurement properties of the IUI in patients with idiopathic overactive bladder (OAB).

methodsData were used from two clinical trials which recruited patients with OAB whose symptoms were inadequately managed with ≥ 1 anticholinergic medication. Psychometric evaluation included: Differential Item Functioning (DIF) analysis, concordance between I-QOL and IUI (Intraclass correlation coefficient [ICC], criterion and convergent validity according to relevant patient reported outcomes and clinical variables (Spearman's correlation coefficient, rho), responsiveness, and agreement between utility measures (ICC and Bland-Altman method).

resultsA total of 1,105 idiopathic OAB patients were included. Mean age (range) was 60.4 years (18-90), 87.8% (n = 970) were female. DIF was identified in 3 items, none of which are contained in the IUI. ICC (CI95%) was 0.944 (0.936-0.950). Statistically significant differences (p < 0.001) were found in IUI scores for patients improving according to the Treatment Benefit Scale (TBS). Moderate to strong correlations (rho > |0.6|) were found in the expected direction with daily incontinence, urgency episodes and disease-specific domains of King's Health Questionnaire (KHQ). Low to moderate correlations (rho:<|0.6|) were found with Short Form version 2 (SF-12v2) summary components. A large effect size was found for patients reporting improvement (0.98-1.21) or great improvement (1.87-2.56) in the TBS, as well as in patients responding to treatment (1.19-2.40). Across utility measures, directional trends were consistent with OAB symptom profile, however, a lack of agreement in absolute values was observed.

conclusionsThe IUI presents good psychometric properties for valuing the impact of UI-related problems in idiopathic OAB patients.

trial registrationClinicalTrials.gov: NCT00910845 and NCT00910520.

Indexed as

Severity of Illness IndexAdultAgedDouble-Blind MethodFemaleHealth StatusHumansMaleMiddle AgedPsychometricsQuality of LifeSurveys and QuestionnairesUrinary Bladder, OveractiveUrinary IncontinenceYoung Adult

Identifiers

PMID26231052
PMCPMC4522067

What OpenQuestion holds

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LicenceCC BY
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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.