Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
318 participants
OBSERVATIONAL
2014-07-31
2016-12-31
Brief Summary
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* Is PAE a safe and effective treatment option for LUTS caused by prostate enlargement?
* How does PAE compare with conventional surgical treatments? This will primarily be a surgical procedure called transurethral resection of the prostate (TURP) (see below).
* Which patients would most benefit from PAE over the other treatment options?
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Detailed Description
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* Is PAE a safe and effective treatment option for LUTS caused by prostate enlargement?
* How does PAE compare with conventional surgical treatments? This will primarily be a surgical procedure called transurethral resection of the prostate (TURP) (see below).
* Which patients would most benefit from PAE over the other treatment options? This study involves populating the UK ROPE Register with data from patients who have undergone prostate artery embolisation (PAE) and the current standard treatment in the UK, transurethral resection of the prostate (TURP). All consecutive patients receiving PAE in UK sites taking part in this study over the course of 12 months (from the date that the first patient is enrolled) will be invited to join the UK ROPE register. At least 150 PAE patients will be enrolled into this study, and a comparable number of TURP patients (at least 150 patients also) from a maximum of 18 sites in the UK. It is anticipated that each site will enrol between 10 and 30 PAE patients in 12 months. Enrolment will only continue past 12 months until 150 PAE patients have been added to the register.
NICE has suggested keeping a registry or database of patients who have undergone this procedure in the UK. so that we can find out more about how safe and effective it is for patients and how it compares to the other established treatments available such as surgery. The UK ROPE Register will be owned and hosted by the British Society of Interventional Radiologists (BSIR) and the British Association of Urological Surgeons (BAUS). The register will be built by Dendrite, a commercial company that specialise in making medical registers and databases. Cedar, a consortium of Cardiff \& Vale UHB and Cardiff University and an External Assessment Centre (EAC) to NICE, was commissioned to facilitate the registry research. Cedar's role is to work with the steering group (consisting of BSIR, BAUS, and NICE representatives) to help build the ROPE Register and ensure that the right data points are collected to answer research questions for NICE. Cedar will also perform the data analysis from the ROPE Register and will publish the results in a peer-reviewed scientific journal.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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PAE
Men with LUTS BPE who have opted for PAE at a participating site, and have consented to take part in the UK ROPE Register Study.
No interventions assigned to this group
TURP
Men with LUTS BPE who have consented to TURP at a participating site, and have consented to the UK ROPE Register Study.
No interventions assigned to this group
Other
Men with LUTS BPE who have had an Open Prostatectomy or laser surgery at a participating site, and have consented to the UK ROPE Study.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Able to read, write and understand English
* Capable of giving informed written consent
Exclusion Criteria
* Not able/willing to provide informed written consent
MALE
No
Sponsors
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British Society of Interventional Radiologists
UNKNOWN
British Association of Urological Surgeons
UNKNOWN
National Instutite of Health and Care Excellence
UNKNOWN
Cardiff and Vale University Health Board
OTHER_GOV
Responsible Party
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Dr Grace Carolan-Rees
Cedar Director
Locations
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Colchester Hospital University NHS Foundation Trust
Colchester, Essex, United Kingdom
East Kent Hospitals University NHS Foundation Trust
Canterbury, Kent, United Kingdom
University Hospitals Birmingham NHS Foundation Trust
Birmingham, , United Kingdom
The Royal Bournemouth and Christchurch NHS Foundation Trust
Bournemouth, , United Kingdom
University Hospitals Coventry & Warwickshire NHS
Coventry, , United Kingdom
Frimley Park Hospital NHS Found Trust
Frimley, , United Kingdom
NHS Greater Glasgow and Clyde
Glasgow, , United Kingdom
Hull and East Yorkshire Hospitals NHS Trust
Hull, , United Kingdom
Guy's and St Thomas' NHS Foundation Trust
London, , United Kingdom
Imperial College Healthcare NHS Trust
London, , United Kingdom
Central Manchester University Hospitals NHS Foundation Trust
Manchester, , United Kingdom
Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, , United Kingdom
Oxford University Hospitals NHS Trust
Oxford, , United Kingdom
Plymouth Hospitals NHS Trust
Plymouth, , United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton, , United Kingdom
University Hospital North Staffordshire NHS Trust
Stoke-on-Trent, , United Kingdom
Royal Cornwall Hospitals NHS Trust
Truro, , United Kingdom
Countries
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References
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Ray AF, Powell J, Speakman MJ, Longford NT, DasGupta R, Bryant T, Modi S, Dyer J, Harris M, Carolan-Rees G, Hacking N. Efficacy and safety of prostate artery embolization for benign prostatic hyperplasia: an observational study and propensity-matched comparison with transurethral resection of the prostate (the UK-ROPE study). BJU Int. 2018 Aug;122(2):270-282. doi: 10.1111/bju.14249. Epub 2018 May 6.
Patel N, Yung N, Vigneswaran G, de Preux L, Maclean D, Harris M, Somani B, Bryant T, Hacking N, Modi S. 1-year cost-utility analysis of prostate artery embolization (PAE) versus transurethral resection of the prostate (TURP) in benign prostatic hyperplasia (BPH). BMJ Surg Interv Health Technol. 2021 Nov 10;3(1):e000071. doi: 10.1136/bmjsit-2020-000071. eCollection 2021.
Other Identifiers
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14/NE/0128
Identifier Type: -
Identifier Source: org_study_id
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