Evidence map›Paper›PMID 35298833›Full record

Trial reportJournal of endocrinological investigation2022

Testosterone does not affect lower urinary tract symptoms while improving markers of prostatitis in men with benign prostatic hyperplasia: a randomized clinical trial.

G Rastrelli, S Cipriani, F Lotti, I Cellai, P Comeglio, S Filippi, V Boddi, P A Della Camera, R Santi, L Boni and 5 more

Open access · hybridAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of endocrinological investigation, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
2.2field-weighted citation impact, top 13% 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.

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

6 citing papers in PubMed, 11 citations in OpenAlex.

  1. Trial
  2. Review
  3. Review
  4. Article
  5. Article
  6. 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

15 authors at 4 institutions in 1 country.

G RastrelliDepartment of Experimental Clinical and Biomedical Sciences "Mario Serio", University of Florence, Viale Pieraccini, 6, 50139, Florence, Italy.
S CiprianiDepartment of Experimental Clinical and Biomedical Sciences "Mario Serio", University of Florence, Viale Pieraccini, 6, 50139, Florence, Italy.
F LottiDepartment of Experimental Clinical and Biomedical Sciences "Mario Serio", University of Florence, Viale Pieraccini, 6, 50139, Florence, Italy.
I CellaiDepartment of Experimental Clinical and Biomedical Sciences "Mario Serio", University of Florence, Viale Pieraccini, 6, 50139, Florence, Italy.
P ComeglioDepartment of Experimental Clinical and Biomedical Sciences "Mario Serio", University of Florence, Viale Pieraccini, 6, 50139, Florence, Italy.
S FilippiInterdepartmental Laboratory of Functional and Cellular Pharmacology of Reproduction, Department of Neuroscience, Psychology, Pharmacology and Child Health, University of Florence, Viale Pieraccini, 6, 50139, Florence, Italy.
V BoddiDepartment of Experimental Clinical and Biomedical Sciences "Mario Serio", University of Florence, Viale Pieraccini, 6, 50139, Florence, Italy.
P A Della CameraUrology Unit, Azienda Ospedaliera Universitaria Careggi, Largo Piero Palagi, 1, 50139, Florence, Italy.
R SantiPathological Anatomy Unit, Careggi University Hospital, Largo Piero Palagi, 1, 50139, Florence, Italy.
L BoniUnit of Clinical Epidemiology, IRCCS Policlinico San Martino, Largo Rosanna Benzi, 10, 16132, Genoa, Italy.
G NesiDepartment of Health Sciences, University of Florence, Viale Pieraccini, 6, 50139, Florence, Italy.
S SerniUrology Unit, Azienda Ospedaliera Universitaria Careggi, Largo Piero Palagi, 1, 50139, Florence, Italy.
M GacciUrology Unit, Azienda Ospedaliera Universitaria Careggi, Largo Piero Palagi, 1, 50139, Florence, Italy.
M MaggiDepartment of Experimental Clinical and Biomedical Sciences "Mario Serio", University of Florence, Viale Pieraccini, 6, 50139, Florence, Italy.
L VignozziDepartment of Experimental Clinical and Biomedical Sciences "Mario Serio", University of Florence, Viale Pieraccini, 6, 50139, Florence, Italy. linda.vignozzi@unifi.it.ORCID http://orcid.org/0000-0003-0907-0630
University of Florence · ITAzienda Ospedaliero-Universitaria Careggi · ITIstituto Nazionale Biostrutture e Biosistemi · ITOspedale Policlinico San Martino · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeBenign Prostatic Hyperplasia (BPH) is a result of prostate inflammation, frequently occurring in metabolic syndrome (MetS). Low testosterone is common in MetS. A randomized clinical trial was designed to evaluate if 24 weeks of testosterone therapy (TTh) in BPH men with MetS and low testosterone improve urinary symptoms and prostate inflammation.

methodsOne-hundred-twenty men with MetS waitlisted for BPH surgery were enrolled. They were categorized into normal testosterone (TT ≥ 12 nmol/L and cFT ≥ 225 pmol/L; n = 48) and testosterone deficient (TD) (TT < 12 nmol/L and/or cFT < 225 pmol/L; n = 72) then randomized to testosterone gel 2% (5 g/daily) or placebo for 24 weeks. At baseline and follow-up, questionnaires for urinary symptoms and trans-rectal ultrasound were performed. Prostate tissue was collected for molecular and histopathological analyses.

resultsNo differences in the improvement of urinary symptoms were found between TTh and placebo (OR [95% CI] 0.96 [0.39; 2.37]). In TD + TTh, increase in prostate but not adenoma volume was observed (2.64 mL [0.07; 5.20] and 1.82 mL [- 0.46; 0.41], respectively). Ultrasound markers of inflammation were improved. In a subset of 61 men, a hyper-expression of several pro-inflammatory genes was found in TD + placebo when compared with normal testosterone. TTh was able to counteract this effect. For 80 men, the inflammatory infiltrate was higher in TD + placebo than in normal testosterone (0.8 points [0.2; 1.4]) and TD + TTh men (0.9 points [0.2; 1.5]).

conclusionsTwenty-four weeks of TTh in TD men with BPH and MetS improves ultrasound, molecular and histological proxies of prostate inflammation. This does not result in symptom improvement.

Indexed as

Lower Urinary Tract SymptomsMetabolic SyndromeProstatic HyperplasiaProstatitisBiomarkersHumansInflammationMaleTestosteroneBiomarkersTestosteroneBenign prostatic hyperplasiaHypogonadismLUTSMetabolic syndromeProstatitis-like symptomsTestosterone therapy

Identifiers

PMID35298833
PMCPMC9184417
OpenAlexW4221120123

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.