Evidence map›Paper›PMID 37967894›Full record

Trial reportBMJ (Clinical research ed.)2023

Treatment of lower urinary tract symptoms in men in primary care using a conservative intervention: cluster randomised controlled trial.

Marcus J Drake, Jo Worthington, Jessica Frost, Emily Sanderson, Madeleine Cochrane, Nikki Cotterill, Mandy Fader, Lucy McGeagh, Hashim Hashim, Margaret Macaulay and 8 more

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMJ (Clinical research ed.), 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.8field-weighted citation impact, top 15% 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

7 citing papers in PubMed, 6 citations in OpenAlex.

  1. Self-management of male urinary symptoms: qualitative findings from a primary care trial.The British journal of general practice : the journal of the Royal College of General Practitioners · 2026
    Trial
  2. Diagnostic models for male lower urinary tract symptom management in primary care: a prospective, multicentre, diagnostic accuracy study.The British journal of general practice : the journal of the Royal College of General Practitioners · 2026
    Article
  3. Article
  4. The status of health-related quality of life among older adults with overactive bladder: a cross-sectional analysis of the Yamagata Cohort Study in Japan.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2026
    Article
  5. Review
  6. Article
  7. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

18 authors at 7 institutions in 1 country.

Marcus J DrakeDepartment of Surgery and Cancer, Faculty of Medicine, Imperial College, Hammersmith Hospital, London, UK mjdrake@imperial.ac.uk.ORCID 0000-0002-6230-2552
Jo WorthingtonBristol Trials Centre, Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.ORCID 0000-0002-2860-3511
Jessica FrostBristol Trials Centre, Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.ORCID 0000-0002-2454-311X
Emily SandersonBristol Trials Centre, Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.ORCID 0000-0003-2268-4194
Madeleine CochraneBristol Trials Centre, Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.ORCID 0000-0003-2268-4194
Nikki CotterillDepartment of Nursing and Midwifery, Faculty of Health and Applied Sciences, University of the West of England, Bristol, UK.ORCID 0000-0001-6921-2712
Mandy FaderSchool of Health Sciences, University of Southampton, Southampton, UK.ORCID 0000-0002-0801-543X
Lucy McGeaghOxford Institute Nursing, Midwifery and Allied Health Research, Oxford Brookes University, Oxford, UK.ORCID 0000-0002-9226-5115
Hashim HashimBristol Urological Institute, North Bristol NHS Trust, Southmead Hospital, Bristol, UK.ORCID 0000-0003-2467-407X
Margaret MacaulaySchool of Health Sciences, University of Southampton, Southampton, UK.ORCID 0000-0003-1737-4589
Jonathan ReesTyntesfield Medical Group, Brockway Medical Centre, Nailsea, Bristol, UK.ORCID 0000-0001-8014-4407
Luke A RoblesNIHR Bristol Biomedical Research Centre, University Hospitals Bristol and Weston NHS Foundation Trust and the University of Bristol, University Hospitals Bristol Education Centre, Bristol, UK.ORCID 0000-0003-2882-9868
Gordon TaylorPatient representative, UK.ORCID 0000-0002-8029-2503
Jodi TaylorBristol Trials Centre, Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.ORCID 0000-0001-7171-8923
Matthew J RiddCentre of Academic Primary Care, Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.ORCID 0000-0002-7954-8823
Stephanie J MacNeillBristol Trials Centre, Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.ORCID 0000-0001-6553-1433
Sian NoblePopulation Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.ORCID 0000-0002-8011-0722
J Athene LaneBristol Trials Centre, Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.ORCID 0000-0002-7578-4925
University of Bristol · GBUniversity of Southampton · GBHammersmith Hospital · GBNorth Bristol NHS Trust · GBOxford Brookes University · GBUniversity Hospitals Bristol NHS Foundation Trust · GBUniversity of the West of England · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo determine whether a standardised and manualised care intervention in men in primary care could achieve superior improvement of lower urinary tract symptoms (LUTS) compared with usual care.

designCluster randomised controlled trial.

setting30 National Health Service general practice sites in England.

participantsSites were randomised 1:1 to the intervention and control arms. 1077 men (≥18 years) with bothersome LUTS recruited between June 2018 and August 2019: 524 were assigned to the intervention arm (n=17 sites) and 553 were assigned to the usual care arm (n=13 sites).

interventionStandardised information booklet developed with patient and expert input, providing guidance on conservative and lifestyle interventions for LUTS in men. After assessment of urinary symptoms (manualised element), general practice nurses and healthcare assistants or research nurses directed participants to relevant sections of the manual and provided contact over 12 weeks to assist with adherence.

main outcome measuresThe primary outcome was patient reported International Prostate Symptom Score (IPSS) measured 12 months after participants had consented to take part in the study. The target reduction of 2.0 points on which the study was powered reflects the minimal clinically important difference where baseline IPSS is <20. Secondary outcomes were patient reported quality of life, urinary symptoms and perception of LUTS, hospital referrals, and adverse events. The primary intention-to-treat analysis included 887 participants (82% of those recruited) and used a mixed effects multilevel linear regression model adjusted for site level variables used in the randomisation and baseline scores.

resultsParticipants in the intervention arm had a lower mean IPSS at 12 months (adjusted mean difference -1.81 points, 95% confidence interval -2.66 to -0.95) indicating less severe urinary symptoms than those in the usual care arm. LUTS specific quality of life, incontinence, and perception of LUTS also improved more in the intervention arm than usual care arm at 12 months. The proportion of urology referrals (intervention 7.3%, usual care 7.9%) and adverse events (intervention seven events, usual care eight events) were comparable between the arms.

conclusionsA standardised and manualised intervention in primary care showed a sustained reduction in LUTS in men at 12 months. The mean difference of -1.81 points (95% confidence interval -0.95 to -2.66) on the IPSS was less than the predefined target reduction of 2.0 points.

trial registrationISRCTN Registry ISRCTN11669964.

Indexed as

Lower Urinary Tract SymptomsQuality of LifeCost-Benefit AnalysisEnglandHumansMalePrimary Health CareState Medicine

Identifiers

PMID37967894
PMCPMC10646682
OpenAlexW4388696591

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.