Evidence map›Paper›PMID 38708869›Full record

Trial reportThe Journal of urology2024

Efficacy and Safety of Vibegron for Persistent Symptoms of Overactive Bladder in Men Being Pharmacologically Treated for Benign Prostatic Hyperplasia: Results From the Phase 3 Randomized Controlled COURAGE Trial.

David Staskin, Janet Owens-Grillo, Elizabeth Thomas, Eric Rovner, Kevin Cline, Salim Mujais

Abstract readRandomized Controlled TrialClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in The Journal of urology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing 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.

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

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

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  16. Round up.Indian journal of urology : IJU : journal of the Urological Society of India
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

6 authors.

David StaskinDepartment of Urology, Tufts University School of Medicine, Boston, Massachusetts.
Janet Owens-GrilloSumitomo Pharma America, Inc, Marlborough, Massachusetts.
Elizabeth ThomasSumitomo Pharma America, Inc, Marlborough, Massachusetts.
Eric RovnerDepartment of Urology, Medical University of South Carolina, Charleston, South Carolina.
Kevin ClineDepartment of Urology, Louisiana State University Health, Shreveport, Louisiana.
Salim MujaisSumitomo Pharma America, Inc, Marlborough, Massachusetts.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe efficacy and safety of vibegron, a β MATERIALS AND

methodsMen ≥ 45 years with OAB symptoms and BPH, treated with α-blocker with/without 5α-reductase inhibitors, were randomized 1:1 to vibegron or placebo for 24 weeks. Coprimary end points were change from baseline at week 12 in mean daily micturitions and urgency episodes. Secondary end points were change from baseline at week 12 in mean nightly nocturia and daily urge urinary incontinence episodes, International Prostate Symptom Score‒storage score, and volume voided per micturition. Safety was evaluated via adverse events (AEs).

resultsOf 1105 participants randomized, 965 (87.3%) completed the trial. At week 12, vibegron was associated with significant reductions vs placebo in daily micturitions (least squares mean difference [95% CI], -0.74 [-1.02, -0.46];

conclusionsIn this trial, vibegron met all primary and secondary end points and was safe and well tolerated in men with OAB symptoms and pharmacologically treated BPH.

Indexed as

anticholinergicsbenign prostatic hyperplasiabeta-3 adrenergic agonistoveractive bladder

Identifiers

PMID38708869
PMCPMC12721610

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.