UK ROPE Register Study
UK ROPE
ROPE Registry Project to Determine the Safety and Efficacy of Prostate Artery Embolisation (PAE) for Lower Urinary Tract Symptoms Secondary to Benign Prostatic Enlargement (LUTS BPE)
1 other identifier
observational
318
1 country
17
Brief Summary
This registry study enables us to collect data on the treatment of LUTS using prostate artery embolisation (PAE), and other surgical methods to answer the following questions posed by NICE in 2013:
- 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?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2014
Typical duration for all trials
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 20, 2015
CompletedFirst Posted
Study publicly available on registry
May 5, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2016
CompletedFebruary 7, 2020
February 1, 2020
2.4 years
March 20, 2015
February 6, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
IPSS change for PAE patients, from baseline 12 months post procedure
Comparison of IPSS questionnaire score at baseline at 12 months post-PAE procedure
12 months
Secondary Outcomes (6)
IPSS comparison of PAE with TURP, 12 months post-procedure
12 Months
Safety of PAE procedure - Number of patients with adverse events up to 12 months post-procedure
12 months
IPSS comparison of other treatments (HoLEP, Open prostatectomy) to PAE, 12 months post-procedure
12 months
IIEF comparison of TURP, HoLEP and Open prostatectomy to PAE, 12 months post-procedure.
12 months
Prostate volume comparison of TURP, HoLEP and Open prostatectomy to PAE, 12 months post-procedure.
12 months
- +1 more secondary outcomes
Study Arms (3)
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.
TURP
Men with LUTS BPE who have consented to TURP at a participating site, and have consented to the UK ROPE Register Study.
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.
Eligibility Criteria
Men with LUTS BPE who have consented to PAE, TURP, Open prostatectomy or laser surgery at a participating UK site.
You may qualify if:
- Men with LUTS who have consented for PAE, TURP, open prostatectomy or laser surgery at a participating site
- Able to read, write and understand English
- Capable of giving informed written consent
You may not qualify if:
- Not able to read, write or understand English
- Not able/willing to provide informed written consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
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
Related Publications (2)
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.
PMID: 29645352RESULTPatel 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.
PMID: 35047801DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Target Duration
- 12 Months
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Cedar Director
Study Record Dates
First Submitted
March 20, 2015
First Posted
May 5, 2015
Study Start
July 1, 2014
Primary Completion
December 1, 2016
Study Completion
December 31, 2016
Last Updated
February 7, 2020
Record last verified: 2020-02