Evidence map›Paper›PMID 30801782›Full record

ArticleNeurourology and urodynamics2019

Vesomni improves the quality of life in men with lower urinary tract symptoms in routine clinical practice in Europe.

Jonathan Rees, Steve Foley, Moses Huang, José Rosa Arias, René Skoumal, Carien Walters, Yalcin Yavuz, Stefan De Wachter

Abstract readMulticenter Study
In one paragraph

Article in Neurourology and urodynamics, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the 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.

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

3 citing papers in PubMed.

  1. Observational
  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

8 authors.

Jonathan ReesDepartment of Brockway Medical Centre, Tyntesfield Medical Group, Bristol, UK.
Steve FoleyDepartment of Urology, Royal Berkshire Hospital, Reading, RG 1 5AN, Berkshire, UK.
Moses HuangDepartment of European Medical Affairs, Astellas Pharma Europe Ltd., Chertsey, UK.
José Rosa AriasDepartment of Urology, Hospital Santiago Apóstol, Miranda de Ebro-Burgos, Spain.
René SkoumalDepartment of Urology, Urocentrum Brno, Brno, Czechia.
Carien WaltersDepartment of Medical and Clinical Operations EMEA, Astellas Pharma Europe Ltd., Chertsey, UK.
Yalcin YavuzDepartment of Data Science, Formerly with Astellas Pharma Global Development, Leiden, The Netherlands.
Stefan De WachterDepartment of Urology, University Hospital Antwerpen, Edegem, Belgium.ORCID 0000-0002-6183-9251

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimTo evaluate the impact of Vesomni/Urizia/Volutsa, a fixed-dose combination tablet containing 6 mg solifenacin (antimuscarinic) and 0.4 mg tamsulosin (α-blocker), on health-related quality of life (HRQoL) and treatment satisfaction in men with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) in routine clinical practice.

methodsEUROPA was a noninterventional study of men with LUTS/BPH not responding to monotherapy who were prescribed Vesomni in routine clinical practice. Data were collected retrospectively (1 year) and prospectively (1 year). Assessments were performed at baseline, weeks 4 to 8, weeks 9 to 18 (optional), weeks 19 to 39 (optional), and Weeks 40 to 52. The primary endpoint was change from baseline in HRQoL, as assessed by the Overactive Bladder Questionnaire (OAB-q) symptom bother subscale score. Change from baseline in OAB-q total and coping, sleep, and social interaction subscale scores, treatment satisfaction-visual analog scale (TS-VAS), International Prostate Symptom Score (IPSS), and European Quality of Life 5-Dimension-5-Level (EQ-5D-5L) questionnaire were also evaluated.

resultsFive hundred and eighty-nine patients were enrolled. The mean changes in adjusted mean (95% confidence interval [CI]) OAB-q symptom bother subscale scores were -16.40 (-24.31, -8.49) at weeks 4 to 8 and -19.59 (-28.26, -10.92) at weeks 40 to 52; at weeks 40 to 52, changes were clinically meaningful in 84.6% of patients. Adjusted mean (95% CI) change from baseline to weeks 40 to 52 were 15.02 (7.35, 22.69), 19.37 (10.86, 27.89), 18.65 (7.44, 29.86), 9.85 (3.90, 15.81), and 16.09 (9.07, 23.11) for concern, coping, sleep, social interaction, and total, respectively. TS-VAS, IPSS, and EQ-5D-5L all improved, and treatment persistence at weeks 40 to 52 was 77.1%. Urinary retention was reported in four (0.7%) patients.

conclusionsVesomni was well-tolerated and improved HRQoL and treatment satisfaction in patients with LUTS/BPH.

Indexed as

AdultAgedAged, 80 and overDrug CombinationsEuropeHumansLower Urinary Tract SymptomsMaleMiddle AgedPatient SatisfactionProspective StudiesProstatic HyperplasiaQuality of LifeSolifenacin SuccinateSulfonamidesTamsulosinDrug CombinationsSolifenacin SuccinateSulfonamidesTamsulosinUrological Agentsbenign prostatic hyperplasiaEuropelower urinary tract symptomsmalequality of lifetreatment satisfactionVesomni

Identifiers

PMID30801782
PMCPMC6916269

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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.