Evidence map›Paper›PMID 41363221›Full record

Trial reportNeurourology and urodynamics2026

Bladder Function and Safety of Vibegron in Men With Overactive Bladder Receiving Treatment for Benign Prostatic Hyperplasia: Outcomes From the Phase 3 Randomized Controlled COURAGE Trial.

Eric S Rovner, Janet Owens-Grillo, Elizabeth Thomas, Sender Herschorn, Kenneth M Peters, David Staskin, Salim Mujais

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in Neurourology and urodynamics, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03902080 (A Phase 3 Double-Blind, Randomized, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy, Safety and Tolerability of Vibegron in Men With Overactive Bladder), which is not on this map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
–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.

NCT03902080 phase3completednot on this map

A Phase 3 Double-Blind, Randomized, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy, Safety and Tolerability of Vibegron in Men With Overactive Bladder (OAB) Symptoms on Pharmacological Therapy for Benign Prostatic Hyperplasia (BPH)

TypeinterventionalSponsorUrovant Sciences GmbHRan2019 to 2023Enrolled1,105ConditionsOveractive BladderArmsVibegron, Placebo
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Review
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

7 authors.

Eric S RovnerMedical University of South Carolina, Charleston, South Carolina, USA.ORCID https://orcid.org/0000-0003-3950-8752
Janet Owens-GrilloSumitomo Pharma America, Inc, Marlborough, Massachusetts, USA.ORCID https://orcid.org/0009-0003-2457-2214
Elizabeth ThomasSumitomo Pharma America, Inc, Marlborough, Massachusetts, USA.
Sender HerschornSunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada.ORCID https://orcid.org/0000-0001-8666-8236
Kenneth M PetersOakland University William Beaumont School of Medicine, Rochester, Michigan, USA.ORCID https://orcid.org/0000-0001-9020-598X
David StaskinTufts University School of Medicine, Boston, Massachusetts, USA.ORCID https://orcid.org/0000-0003-4972-765X
Salim MujaisSumitomo Pharma America, Inc, Marlborough, Massachusetts, USA.

Funding

This study and medical writing support for the preparation of this manuscript were funded by Sumitomo Pharma America Inc. (Marlborough, MA).
6 · The paper itself

Abstract

purposeVibegron was associated with improvements in efficacy versus placebo and was well tolerated in men with overactive bladder (OAB) on pharmacotherapy for benign prostatic hyperplasia (BPH) in the COURAGE trial (NCT03902080). Additional safety, bladder function, and urodynamics data are provided.

methodsThis 24-week, phase 3, double-blind, placebo-controlled trial randomized men ≥ 45 years with OAB and BPH receiving α-blocker ± 5α-reductase inhibitors to once-daily vibegron or placebo (1:1). From the safety analysis set (SAF), postvoid residual urine volume (PVR), maximum urinary flow rate (Uroflow-Q

resultsIn the SAF, differences between vibegron (n = 553) and placebo (n = 551) in PVR and Uroflow-Q

conclusionsThere were no safety signals related to bladder function identified by urodynamics; risk of protocol-defined AEs of urinary retention or residual urine volume increase was not increased with vibegron compared with placebo in this population. CLINICAL

trial registrationThis study is registered at www. CLINICALTRIALS: gov. The registration identification number is NCT03902080.

Indexed as

Prostatic HyperplasiaPyrimidinonesUrinary BladderUrinary Bladder, Overactive5-alpha Reductase InhibitorsAgedDouble-Blind MethodHumansMaleMiddle AgedPyrrolidinesTreatment OutcomeUrodynamics5-alpha Reductase InhibitorsN-(4-((5-(hydroxy(phenyl)methyl)pyrrolidin-2-yl)methyl)phenyl)-4-oxo-4,6,7,8-tetrahydropyrrolo(1,2-a)pyrimidine-6-carboxamidePyrimidinonesPyrrolidinesanticholinergicsbenign prostatic hyperplasiabeta‐3 adrenergic agonistoveractive bladder

Identifiers

PMID41363221
PMCPMC12893031

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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.