The authors would like to thank all of the patients who participated in the UNBLOCS trial. We also thank the members of the Trial Management Group, Trial Steering Committee and Data Monitoring and Ethics Committee for their ongoing advice and support for the trial, and the principal investigators, research nurses and their teams at the trial sites for all of their hard work and commitment. We would also like to thank our independent assessor, Graham Watson (Consultant Urological Surgeon, Eastbourne), for independently verifying the competence of all trial surgeons in the laser technique. Finally, we would like to thank the National Institute for Health Research and the Health Technology Assessment programme for funding the UNBLOCS trial.
This study was designed and delivered in collaboration with the Bristol Randomised Trials Collaboration, a UKCRC-registered clinical trials unit that, as part of the Bristol Trials Centre, is in receipt of National Institute for Health Research clinical trials unit support funding. The study data were collected and managed using REDCap,60 hosted at the University of Bristol.
UNBLOCS Trial Group
Principal investigators: Rupert Beck, Christopher Blake, Kim Davenport, Hashim Hashim, Oliver Kayes, Tobias Page, Jonathan Sullivan and Satchi Swami.
Trial manager: Jo Worthington.
Trial research associate: Hilary Taylor.
Senior trial manager/Bristol Randomised Trials Collaboration co-director: J Athene Lane.
Trial statisticians: Sara Brookes, Chris Metcalfe and Grace Young.
Urologists: Nicholas Cohen, Mathialagan Murugesan and Anthony Timoney.
Research nurse lead: Lyndsey Johnson.
Site research nurses: Benita Adams, Angela Allan, Carol Brain, Fiona Hammonds, Joan Henderson, Paula Hilltout, Bernadette Kilbane, Leigh Morrison, Wendy Robson, Lorraine Wiseman and Vivian Zinyemba.
Qualitative researchers: Nikki Cotterill, Rafiyah Khan and Alan Uren.
Health economists: Aideen Ahern, Aida Moure Fernandez and Sian Noble.
Administrative support: Tom Steuart-Feilding, Christopher Pawsey, Julie Plant and Barbara Warnes.
Data management: Mai Baquedano and David Carmichael.
Trial sites and principal investigators
The NHS trusts participating as sites in the trial were:
- Gloucestershire Hospitals NHS Foundation Trust (principal investigator, Mr Jonathan Sullivan/Kim Davenport)
- Great Western Hospitals NHS Foundation Trust (principal investigator, Mr Rupert Beck)
- North Bristol NHS Trust (principal investigator, Professor Hashim Hashim)
- NHS Grampian (principal investigator, Mr Satchi Swami)
- Royal Cornwall Hospitals NHS Trust (principal investigator, Mr Christopher Blake)
- Leeds Teaching Hospital NHS Trust (principal investigator, Mr Oliver Kayes)
- Newcastle upon Tyne Hospitals NHS Foundation Trust (principal investigator, Mr Tobias Page).
Study oversight committees
We thank all the members of the study oversight committees for their valued contributions.
UNBLOCS Trial Steering Committee: Professor Tom McNicholas (Chairperson), Mr Malcolm Lucas, Dr Catrin Tudur-Smith, Dr Gordon Taylor and Dr Glyn Hayes.
Data Monitoring and Ethics Committee: Dr Jonathan Cook, Mr Mohammed Belal and Mr Mark Stott.
Trial Management Group: Professor Hashim Hashim, Professor Athene Lane, Dr Sara Brookes, Professor Chris Metcalfe, Dr Sian Noble, Mr Toby Page, Professor Paul Abrams, Dr Nikki Cotterill, Dr Jo Worthington, Lyndsey Johnson and Hilary Taylor.
Contributions of authors
Jo Worthington (Trial Manager) was responsible for managing the trial throughout and contributed to aspects of trial design, as well as preparing the first draft of the report.
J Athene Lane (Professor of Trials Research, Co-Director of the Bristol Randomised Trials Collaboration) was a co-applicant. She contributed to the trial design, was involved in management of the study, and contributed to writing the report.
Hilary Taylor (Research Associate) contributed to aspects of the trial design, and was involved in the day-to-day management of the trial.
Grace Young (Senior Research Associate in Medical Statistics) was the trial statistician. She wrote the statistical analysis plan, conducted the analysis and contributed to writing the report.
Sian M Noble (Senior Lecturer, Health Economics) was a co-applicant, and the lead health economist for the trial. She was involved in designing, managing and conducting the health economic evaluation, and contributed to writing the report.
Paul Abrams (Professor, Consultant Urological Surgeon) was a co-applicant. He contributed to the trial design, was involved in management of the study, and contributed to writing the report.
Aideen Ahern (Research Associate, Health Economics) was involved in the conduct and analysis of the economic evaluation.
Sara T Brookes (Senior Lecturer, Health Services Research and Medical Statistics) was a co-applicant. She contributed to trial design, was the lead statistician for the majority of the trial, and contributed to writing the report.
Nikki Cotterill (Associate Professor in Continence Care) was a co-applicant, and the lead qualitative researcher on the trial. She was involved in designing, managing and conducting the qualitative analysis, and contributing to writing the report.
Lyndsey Johnson (Lead Research Nurse, Urology) was the research nurse lead for the trial, as well as being involved in conducting the study at her respective study site.
Rafiyah Khan (Research Assistant, Qualitative Research) was involved in the conduct of the qualitative study.
Aida Moure Fernandez (Research Associate, Health Economics) was involved in the design and conduct of the economic evaluation.
Tobias Page (Consultant Urological Surgeon) was a co-applicant. He contributed to the trial design and management, as well as being a principal investigator responsible for implementation at his respective study site.
Satchi Swami (Consultant Urological Surgeon) was a co-applicant. He contributed to trial conduct issues, as well as being a principal investigator responsible for implementation in his respective study site.
Hashim Hashim (Professor, Consultant Urological Surgeon) was chief investigator and clinical lead for the trial and, as such, participated in its design, was responsible for oversight of the trial and was involved in writing the report.
All authors read and approved and/or commented on the final report.
Publications
Ahern A, Worthington J, Hashim H, Lane JA, Taylor H, Young G, et al. The cost-effectiveness of thulium laser transurethral vaporesection of the prostate versus transurethral resection of the prostate. Conference abstract, The British Association of Urological Surgeons Annual Scientific Meeting 2019, 24–26 June 2019, Glasgow, UK.
Cotterill N, Khan R, Uren A, Abrams P, Brookes S, Lane A, et al. “I have a life back” – the patient experience of urinary obstruction interventions in the UNBLOCS randomised controlled trial. Podium presentation, International Continence Society Annual Meeting 2019, 3–6 September 2019, Gothenburg, Sweden.
Hashim H, Lane JA, Worthington J, Noble S, Brooks S, Cotterill N, et al. Thulium laser transurethral vaporesection of the prostate versus transurethral resection of the prostate: results of the UNBLOCS randomized controlled trial. Poster presentation, EAU Conference (EAU 2019), 15–19 March 2019, Barcelona, Spain.
Hashim H, Lane JA, Worthington J, Taylor H, Young G, Noble SM, et al. Thulium laser transurethral vaporesection of the prostate versus transurethral resection of the prostate: results of the UNBLOCS randomised controlled trial. Podium presentation, American Urological Association Annual Meeting, 3–6 May 2019, Chicago, IL, USA.
Hashim H, Worthington J, Abrams P, Young G, Taylor H, Noble SM, et al. Thulium laser transurethral vaporesection of the prostate versus transurethral resection of the prostate for men with lower urinary tract symptoms or urinary retention (UNBLOCS): a randomised controlled trial. Lancet 2020;396:50–61.
Noble SM, Ahern AM, Worthington J, Hashim H, Taylor H, Young GJ, et al. The cost-effectiveness of transurethral resection of the prostate vs thulium laser transurethral vaporesection of the prostate in the UNBLOCS randomised controlled trial for benign prostatic obstruction. BJUI Int 2020.
Data-sharing statement
All data requests should be submitted to the corresponding author for consideration. Access to anonymised data may be granted following review.
Patient data
This work uses data provided by patients and collected by the NHS as part of their care and support. Using patient data is vital to improve health and care for everyone. There is huge potential to make better use of information from people’s patient records, to understand more about disease, develop new treatments, monitor safety, and plan NHS services. Patient data should be kept safe and secure, to protect everyone’s privacy, and it’s important that there are safeguards to make sure that it is stored and used responsibly. Everyone should be able to find out about how patient data are used. #datasaveslives You can find out more about the background to this citation here: https://understandingpatientdata.org.uk/data-citation.
Disclaimers
This report presents independent research funded by the National Institute for Health Research (NIHR). The views and opinions expressed by authors in this publication are those of the authors and do not necessarily reflect those of the NHS, the NIHR, NETSCC, the HTA programme or the Department of Health and Social Care. If there are verbatim quotations included in this publication the views and opinions expressed by the interviewees are those of the interviewees and do not necessarily reflect those of the authors, those of the NHS, the NIHR, NETSCC, the HTA programme or the Department of Health and Social Care.