What this study adds
LUTS, MJD, MM
WEST, PROSTATE
This study developed a standardised and manualised intervention that provided a practical resource to support symptom assessment and conservative treatment for LUTS in men in primary careThe intervention achieved a sustained reduction in LUTS in a UK primary care setting (difference in mean International Prostate Symptom Score of −1.81 at 12 months), which was less than the predefined target reduction of 2.0 pointsThis study was registered prospectively (12 April 2018) before enrolment of the first participant. It was designed and delivered in collaboration with the Bristol Randomised Trials Collaboration (BRTC), a UK Clinical Research Collaboration registered clinical trials unit which, as part of the Bristol Trials Centre, was in receipt of Clinical Trials Unit support funding from the National Institute for Health and Care Research (NIHR). The University of Bristol acted as the sponsor for this trial and the trial was hosted by the NHS Bristol, North Somerset and South Gloucestershire Clinical Commissioning Group. The TRIUMPH research team acknowledges the support of the NIHR Clinical Research Network. Study data were collected and managed using REDCap hosted at the University of Bristol.We thank all participants and the principal investigators and their teams at each of the TRIUMPH study sites for their involvement, and the West of England and Wessex Clinical Research Networks for their role in the study. We also thank the members of the Patient Advisory Group, Trial Steering Committee, and Data Monitoring Committee.Extra material supplied by authorsSupplementary information: Additional tables S1-S3Supplementary information: Administration checklist for study bookletSupplementary information: Intervention booklet: Helping you control your waterworksContributors: MJD was the chief investigator of TRIUMPH; he conceived the study, participated in its design and coordination, and drafted the manuscript. JAL, NC, MF, LM, HH, SJM, MJR, SN, JR, MJD, LAR, and GT assisted with the study design. JW and JF developed the trial procedures, protocol, and manuscript, and managed the coordination of the study. MM and JT assisted with the coordination of the study. SJM designed the statistical analysis, and ES conducted the statistical analysis. MC contributed to the data extraction from general practice medical records. All authors contributed to the oversight of the study via the Trial Management Group, read and commented on drafts of the manuscript, and approved the final version. MJD is the guarantor. The corresponding author attests that all listed authors meet authorship criteria and that no others meeting the criteria have been omitted.Funding: This study was funded by the National Institute for Health and Care Research (NIHR, formerly the National Institute of Health Research), Health Technology Assessment programme (No 16/90/03). The views expressed in this publication are those of the authors and not necessarily those of the National Health Service, NIHR or Department of Health and Social Care. MJR was partially funded by a postdoctoral research fellowship from the NIHR (PDF-2014-07-013) from the start of the study until 31 December 2019. The funder had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.Competing interests: All authors have completed the ICMJE uniform disclosure form at The lead author (MJD) affirms that this manuscript is an honest, accurate, and transparent account of the trial being reported; that no important aspects of the trial have been omitted; and that any discrepancies from the trial as planned (and, if relevant, registered) have been explained.Dissemination to participants and related patient and public communities: Participants of the TRIUMPH study will be informed of the results through its website (Provenance and peer review: Not commissioned; externally peer reviewed.