Evidence map›Paper›PMID 26049866›Full record

Trial reportWorld journal of urology2016

Cranberry fruit powder (Flowens™) improves lower urinary tract symptoms in men: a double-blind, randomized, placebo-controlled study.

Ales Vidlar, Vladimir Student, Jitka Vostalova, Emilie Fromentin, Marc Roller, Vilím Simanek, Vladimir Student

2 registry-linked trialsAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in World journal of urology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
1.6field-weighted citation impact, top 18% 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.

NCT04146103 nacompletednot on this mapstarted 2018, after this paper: background citation

Prospective Multicenter Open-label One Arm Trial Investigating a Pumpkin Seed, Isoflavonoid and Cranberry Mix in Lower Urinary Tract Symptoms/Benign Prostatic Hyperplasia

TypeinterventionalSponsorSaint-Joseph UniversityRan2018 to 2019Enrolled163ConditionsBenign Prostatic HyperplasiaArmsNovex
NCT05557279 phase2completednot on this mapstarted 2023, after this paper: background citation

Urinary Microbiome Changes Following Administration of 500 mg of NDS-446 in Women With Dry OAB at 12 Weeks - a Single-center Study

TypeinterventionalSponsorLoyola UniversityRan2023 to 2025Enrolled53ConditionsOveractive BladderArms500 mg NDS-446
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 17 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Adherence of UropathogenicJournal of veterinary research · 2023
    Article
  6. Review
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors at 3 institutions in 2 countries.

Ales VidlarDepartment of Urology, University Hospital, Olomouc, Czech Republic.
Vladimir StudentDepartment of Urology, University Hospital, Olomouc, Czech Republic.
Jitka VostalovaDepartment of Medical Chemistry and Biochemistry, Faculty of Medicine and Dentistry, Palacky University, Olomouc, Czech Republic.
Emilie FromentinNATUREX-DBS, 375 Huyler Street, South Hackensack, NJ, USA. e.fromentin@naturex.com.
Marc RollerNATUREX SA, 250 Rue Pierre Bayle, 84911, Avignon, France.
Vilím SimanekDepartment of Medical Chemistry and Biochemistry, Faculty of Medicine and Dentistry, Palacky University, Olomouc, Czech Republic.
Vladimir StudentDepartment of Urology, University Hospital, Olomouc, Czech Republic.
University Hospital Olomouc · CZPalacký University Olomouc · CZNaturex (France) · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundLower urinary tract symptoms (LUTS) and benign prostatic hyperplasia increase with age. To date, several medications are available to treat LUTS, including herbal remedies which offer less side effects but lack robust efficacy studies.

methodsThis 6-month, randomized, double-blind, placebo-controlled study aimed at evaluating the dose effect of 250 or 500 mg cranberry powder (Flowens™) on LUTS and uroflowmetry in men over the age of 45. A total of 124 volunteers with PSA levels <2.5 ng/mL and an international prostate symptoms score (IPSS) score ≥8 were recruited and randomized. The primary outcome measure was the IPSS, evaluated at 3 and 6 months. Secondary outcome measures included quality of life, bladder volume (Vol), maximum urinary flow rate (Q max), average urinary flow rate (Q ave), ultrasound-estimated post-void residual urine volume (PVR), serum prostate-specific antigen, selenium, interleukin 6, and C-reactive protein at 6 months.

resultsAfter 6 months, subjects in both Flowens™ groups had a lower IPSS (-3.1 and -4.1 in the 250- and 500-mg groups, p = 0.05 and p < 0.001, respectively) versus the placebo group (-1.5), and a dose-response effect was observed. There were significant differences in Q max, Q ave, PVR, and Vol in the Flowens™ 500-mg group versus baseline (p < 0.05). A dose-dependent effect on Vol was observed, as well as on PVR, for participants with a nonzero PVR. There was no effect on clinical chemistry or hematology markers.

conclusionsFlowens™ showed a clinically relevant, dose-dependent, and significant reduction in LUTS in men over 45.

Indexed as

FruitVaccinium macrocarponDouble-Blind MethodFollow-Up StudiesHumansLower Urinary Tract SymptomsMaleMiddle AgedPhytotherapyPowdersProstatic HyperplasiaTime FactorsTreatment OutcomeUrinationPowdersBenign prostatic hyperplasiaCranberryIPSSLower urinary tract symptomsVaccinium macrocarpon

Identifiers

PMID26049866
OpenAlexW565128682

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.