Evidence map›Paper›PMID 30557916›Full record

Trial reportInternational journal of urology : official journal of the Japanese Urological Association2019

Efficacy of novel β

Masaki Yoshida, Masayuki Takeda, Momokazu Gotoh, Osamu Yokoyama, Hidehiro Kakizaki, Satoru Takahashi, Naoya Masumori, Shinji Nagai, Keita Hashimoto, Kazuyoshi Minemura

Abstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in International journal of urology : official journal of the Japanese Urological Association, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing 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

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

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. Review
  6. Article
  7. Excessive accumulation of visceral fat is associated with lower urinary symptoms including overactive bladder in female patients.International journal of urology : official journal of the Japanese Urological Association · 2021
    Article
  8. Article
  9. Current pharmacotherapy of overactive bladder.International braz j urol : official journal of the Brazilian Society of Urology
    Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors.

Masaki YoshidaDepartment of Urology, National Centre for Geriatrics and Gerontology, Obu, Aichi, Japan.
Masayuki TakedaDepartment of Urology, Graduate School of Medical Sciences, University of Yamanashi, Kofu, Yamanashi, Japan.
Momokazu GotohDepartment of Urology, Nagoya University Graduate School of Medicine, Nagoya, Aichi, Japan.
Osamu YokoyamaDepartment of Urology, Faculty of Medical Science, University of Fukui, Fukui, Japan.
Hidehiro KakizakiDepartment of Renal and Urologic Surgery, Asahikawa Medical University, Asahikawa, Japan.
Satoru TakahashiDepartment of Urology, Nihon University School of Medicine, Tokyo, Japan.
Naoya MasumoriDepartment of Urology, School of Medicine, Sapporo Medical University, Sapporo, Hokkaido, Japan.
Shinji NagaiKyorin Pharmaceutical, Tokyo, Japan.
Keita HashimotoKyorin Pharmaceutical, Tokyo, Japan.
Kazuyoshi MinemuraKyorin Pharmaceutical, Tokyo, Japan.

Funding

Kissei PharmaceuticalKyorin Pharmaceutical
6 · The paper itself

Abstract

objectivesTo investigate the efficacy of vibegron on nocturia in patients with overactive bladder.

methodsAmong the Japanese overactive bladder patients enrolled in the placebo-controlled, multicenter, randomized, double-blind phase 3 study of vibegron, a total of 669 patients with nocturia (≥1 nocturnal void) were included. Changes from baseline in micturition parameters were compared for vibegron treatment (50 and 100 mg/day) versus placebo. Correlations of hours of undisturbed sleep with the frequency of nocturnal voiding and the volume of the first nocturnal voiding were examined. Demographics and baseline characteristics contributing to reduction in the frequency of nocturnal voiding were also analyzed.

resultsAt week 12, the frequency of nocturnal voiding was reduced from baseline by 0.74 and 0.78, respectively, for the vibegron 50 and 100 mg groups; the reductions were significant when compared with the placebo group (P < 0.05 and P < 0.001, respectively). The mean volume of nocturnal voids and the volume of the first nocturnal voiding were significantly greater in the vibegron groups than in the placebo group. The vibegron groups showed significant correlations of hours of undisturbed sleep with the changes in the frequency of nocturnal voiding and in the volume of the first nocturnal voiding. Vibegron treatment, no previous treatment with anticholinergics, ≥12 voids per day and hours of undisturbed sleep <180 min significantly contributed to a reduction in the frequency of nocturnal voiding.

conclusionsVibegron is a useful therapeutic option for improving nocturia in patients with overactive bladder.

Indexed as

Adrenergic beta-3 Receptor AgonistsAgedDose-Response Relationship, DrugDouble-Blind MethodFemaleHumansMaleMiddle AgedNocturiaPlacebosPyrimidinonesPyrrolidinesQuality of LifeTreatment OutcomeUrinary Bladder, OveractiveAdrenergic beta-3 Receptor AgonistsN-(4-((5-(hydroxy(phenyl)methyl)pyrrolidin-2-yl)methyl)phenyl)-4-oxo-4,6,7,8-tetrahydropyrrolo(1,2-a)pyrimidine-6-carboxamidePlacebosPyrimidinonesPyrrolidineshours of undisturbed sleepnocturiaoveractive bladdervibegronβ3-adrenoreceptor agonist

Identifiers

PMID30557916
PMCPMC6912249

What OpenQuestion holds

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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.