Evidence map›Paper›PMID 28974250›Full record

Trial reportTrials2017

Statistical analysis plan for the Urodynamics for Prostate Surgery Trial; Randomised Evaluation of Assessment Methods (UPSTREAM).

Grace J Young, Amanda L Lewis, J Athene Lane, Helen L Winton, Marcus J Drake, Peter S Blair

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02193451 (Urodynamics for Prostate Surgery Trial; Randomised Evaluation of Assessment Methods), which is not on this map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
2.3field-weighted citation impact, top 12% 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.

NCT02193451 naunknown statusnot on this map

Urodynamics for Prostate Surgery Trial; Randomised Evaluation of Assessment Methods (UPSTREAM) for Diagnosis and Management of Bladder Outlet Obstruction in Men

TypeinterventionalSponsorNorth Bristol NHS TrustRan2014 to 2022Enrolled820ConditionsLower Urinary Tract Symptoms, Voiding Dysfunction, Benign Prostate Obstruction, Detrusor UnderactivityArmsUrodynamics, Usual care
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 21 citations in OpenAlex.

  1. Trial
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  9. New Diagnostics for Male Lower Urinary Tract Symptoms.Current bladder dysfunction reports · 2019
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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

6 authors at 2 institutions in 1 country.

Grace J YoungPopulation Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK.
Amanda L LewisPopulation Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK.
J Athene LanePopulation Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK.
Helen L WintonPopulation Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK.
Marcus J DrakeNorth Bristol NHS Trust, Bristol Urological Institute, Level 3, Learning and Research Building, Southmead Hospital, Bristol, BS10 5NB, UK. marcus.drake@bristol.ac.uk.
Peter S BlairPopulation Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK.
University of Bristol · GBSouthmead Hospital · GB

Funding

Department of Health 12/140/01
6 · The paper itself

Abstract

backgroundCurrent management for men with lower urinary tract symptoms (LUTS) is a pathway that results in prostate surgery in a significant proportion. While helpful in relieving benign prostatic obstruction (BPO), surgery may be ineffective for men suffering from difficulties not relating to BPO. The UPSTREAM trial started recruitment in October 2014 with the aim of establishing whether a care pathway including urodynamics (a diagnostic tool for BPO and thus an indication of whether surgery is needed) is no worse for men, in terms of symptomatic outcome, than one without (routine care). METHODS/

designThis analysis plan outlines the main outcomes of the study and specific design choices, such as non-inferiority margins. The trial is currently recruiting in 26 hospitals across the UK, randomising men to either urodynamics or routine care, with recruitment set to end on the 31 December 2016. All outcomes will be measured 18 months after randomisation to allow sufficient time for surgical procedures and recovery. The primary outcome is based on a non-inferiority design with a margin of 1 point on the International Prostate Symptom Score (IPSS) scale. The key secondary outcome for this trial is surgery rate per arm, which is estimated to be at least 18% lower in the urodynamics arm. Surgery rates, adverse events, flow rate, urinary symptoms and sexual symptoms are secondary outcomes to be assessed for superiority. This is an update to the UPSTREAM protocol, which has already been published in this journal. DISCUSSION: This a priori statistical analysis plan aims to reduce reporting bias by allowing access to the trial's objectives and plans in advance of recruitment end. The results of the trial are expected to be published soon after the trial end date of 30 September 2018.

trial registrationISRCTN registry, ISRCTN56164274 . Registered on 8 April 2014.

Indexed as

Clinical Decision-MakingDecision Support TechniquesPatient SelectionProstatectomyUrodynamicsClinical ProtocolsData Interpretation, StatisticalHumansLower Urinary Tract SymptomsMaleModels, StatisticalPredictive Value of TestsProstatic HyperplasiaResearch DesignRisk FactorsSurveys and QuestionnairesLower urinary tract symptomsNon-inferiority trialRandomised controlled trialStatistical analysis planUrodynamics

Identifiers

PMID28974250
PMCPMC5627464
OpenAlexW2762114468

What OpenQuestion holds

Textmetadata
LicenceCC BY
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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.