Evidence map›Paper›PMID 37794168›Full record

ArticleProstate cancer and prostatic diseases2024

Modeling study of the effect of placebo and medical therapy on storage and voiding symptoms, nocturia, and quality of life in men with prostate enlargement at risk for progression.

Stavros Gravas, Juan Manuel-Palacios, Chandrashekhar Chavan, Claus G Roehrborn, Matthias Oelke, Marcio Augusto Averbeck, Arunangshu Biswas, Llenalia María García, Khadeeja Mohamed, Vanessa Cortes

Open access · hybridAbstract read
In one paragraph

Article in Prostate cancer and prostatic diseases, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.8field-weighted citation impact, top 15% 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

4 citing papers in PubMed, 6 citations in OpenAlex.

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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

10 authors at 7 institutions in 7 countries.

Stavros GravasDepartment of Urology, Medical School, University of Cyprus, Nicosia, Cyprus.
Juan Manuel-PalaciosGlobal Medical Urology, GSK, Madrid, Spain. juan-manuel.m.palacios@gsk.com.
Chandrashekhar ChavanGlobal Medical Urology, GSK, Mumbai, India.ORCID 0000-0002-9188-9575
Claus G RoehrbornDepartment of Urology, University of Texas Southwestern Medical Center, Dallas, TX, USA.
Matthias OelkeDepartment of Urology, St. Antonius-Hospital, Gronau, Germany.
Marcio Augusto AverbeckDepartment of Urology, Moinhos de Vento Hospital, Porto Alegre, Brazil.ORCID 0000-0002-8127-7153
Arunangshu BiswasDevelopment Biostatistics, GSK, Bengaluru, India.
Llenalia María GarcíaAdvanced Analytics, Access Consulting Parexel, Malaga, Spain.
Khadeeja MohamedDevelopment Biostatistics, GSK, Brentford, UK.
Vanessa CortesGlobal Medical Urology, GSK, Bogota, Colombia.
GlaxoSmithKline (India) · INGlaxoSmithKline (Spain) · ESHospital Moinhos de Vento · BRMRC Biostatistics Unit · GBSt.-Antonius-Hospital Gronau · DEThe University of Texas Southwestern Medical Center · USUniversity of Cyprus · CY

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundModeling studies using large datasets from men with lower urinary tract symptoms/benign prostate enlargement (LUTS/BPE) can predict changes in International Prostate Symptom Score (IPSS) and risk of acute urinary retention/surgery under different treatment regimens and according to predictors (baseline characteristics) that commonly define risk of progression. We assessed the impact of treatments on different symptom types (storage, voiding, and nocturia), quality of life (QoL; IPSS Q8), and BPH Impact Index [BII]).

methodsGeneralized least squares models were used to predict each outcome. Data from the CombAT study were used to predict outcomes for active treatments (dutasteride, tamsulosin, combination therapy). Predictors included: age; IPSS total, storage, voiding, nocturia and QoL (IPSS Q8) scores; BII; prostate volume; maximum urine flow rate (Qmax), prostate-specific antigen, postvoid residual urine (PVR); alpha-blocker usage within 12 months. Data from phase III dutasteride monotherapy studies were used to predict placebo outcomes. Results were visualized using an interactive web-based tool ( www.bphtool.com ).

resultsCombination therapy provided greater predicted benefit than either monotherapy for all five outcomes for most patient profiles within the CombAT inclusion criteria. PVR and corresponding subscores were significant predictors of change in both storage and voiding subscores. Alpha-blocker use within 12 months, age (storage subscore), and Qmax (voiding subscore) were also significant predictors. PVR, age, Qmax, and nocturia score were significant predictors of change in nocturia. PVR, Qmax, previous alpha-blocker use, total IPSS, and QoL (IPSS Q8) score were significant predictors of change in QoL (IPSS Q8) score. For BII, significant predictors were PVR, age, total IPSS, and BII score. The multivariable effect of covariates and treatments is best visualized through the interactive web-based tool.

conclusionsThis predictive modeling study informs our understanding of how risk factors for disease progression interact and affect treatment impact on different symptom types and QoL scores.

Indexed as

Disease ProgressionNocturiaProstatic HyperplasiaQuality of LifeAgedDutasterideHumansLower Urinary Tract SymptomsMaleMiddle AgedTamsulosinTreatment OutcomeDutasterideTamsulosin

Identifiers

PMID37794168
PMCPMC11319195
OpenAlexW4387335793

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LicenceCC BY
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Registered trials

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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.