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)

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?

Study Overview

• Status: Completed
• Conditions: Lower Urinary Tract Symptoms

Detailed Description

This is a study protocol for the UK ROPE Register for Lower Urinary Tract Symptoms (LUTS). This register 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? 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.

• Study Type: Observational
• Enrollment (Actual): 318

Contacts and Locations

Study Locations

• United Kingdom
  • Birmingham, United Kingdom
    • University Hospitals Birmingham NHS Foundation Trust
  • Bournemouth, United Kingdom
    • The Royal Bournemouth and Christchurch NHS Foundation Trust
  • Coventry, United Kingdom
    • University Hospitals Coventry & Warwickshire NHS
  • Frimley, United Kingdom
    • Frimley Park Hospital NHS Found Trust
  • Glasgow, United Kingdom
    • NHS Greater Glasgow and Clyde
  • Hull, United Kingdom
    • Hull and East Yorkshire Hospitals NHS Trust
  • London, United Kingdom
    • Imperial College Healthcare NHS Trust
  • London, United Kingdom
    • Guy's and St Thomas' NHS Foundation Trust
  • Manchester, United Kingdom
    • Central Manchester University Hospitals NHS Foundation Trust
  • Newcastle-Upon-Tyne, United Kingdom
    • Newcastle Upon Tyne Hospitals NHS Foundation Trust
  • Oxford, United Kingdom
    • Oxford University Hospitals NHS Trust
  • Plymouth, United Kingdom
    • Plymouth Hospitals NHS Trust
  • Southampton, United Kingdom
    • University Hospital Southampton NHS Foundation Trust
  • Stoke On Trent, United Kingdom
    • University Hospital North Staffordshire NHS Trust
  • Truro, United Kingdom
    • Royal Cornwall Hospitals NHS Trust
  • Essex
    • Colchester, Essex, United Kingdom
      • Colchester Hospital University NHS Foundation Trust
  • Kent
    • Canterbury, Kent, United Kingdom
      • East Kent Hospitals University NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Men with LUTS BPE who have consented to PAE, TURP, Open prostatectomy or laser surgery at a participating UK site.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Not able to read, write or understand English
• Not able/willing to provide informed written consent

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
IPSS comparison of PAE with TURP, 12 months post-procedure	Comparison of IPSS score changes between PAE and TURP cases, 12 months post-procedure. Non inferiority study.	12 Months
Safety of PAE procedure - Number of patients with adverse events up to 12 months post-procedure	Any anticipated complications of PAE should be recorded on the ROPE Register up to 12 months post-procedure. These include: Local dissection, non-target embolisation, groin haematoma, sepsis, transfusion, TUR syndrome, bladder wall injury, antibiotics needed post-PAE (implying infection), and catheterisation. Patient-reported complications include pain, haematuria, haematospermia, retrograde ejaculation, catheterisation, and hospital re-admission.	12 months
IPSS comparison of other treatments (HoLEP, Open prostatectomy) to PAE, 12 months post-procedure	Descriptive statistics for comparison of PAE with other treatments (HoLEP, Open prostatectomy) using IPSS.	12 months
IIEF comparison of TURP, HoLEP and Open prostatectomy to PAE, 12 months post-procedure.	Descriptive statistics for comparison of PAE with other treatments (Open Prostatectomy or laser surgery) using IIEF.	12 months
Prostate volume comparison of TURP, HoLEP and Open prostatectomy to PAE, 12 months post-procedure.	Descriptive statistics for comparison of PAE with other treatments (TURP, Open Prostatectomy or HoLEP) using prostate volume.	12 months
Urinary flow study comparison of TURP, HoLEP and Open prostatectomy to PAE, 12 months post-procedure.	Descriptive statistics for comparison of PAE with other treatments (TURP, Open Prostatectomy or HoLEP) using urinary flow studies.	12 months

Collaborators and Investigators

• Sponsor: Cardiff and Vale University Health Board
• Collaborators: British Society of Interventional Radiologists; British Association of Urological Surgeons; National Instutite of Health and Care Excellence

Publications and helpful links

General Publications

• 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.

Helpful Links

• Results from the UK-ROPE study

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 31, 2016

Study Registration Dates

• First Submitted: March 20, 2015
• First Submitted That Met QC Criteria: May 4, 2015
• First Posted (Estimate): May 5, 2015

Study Record Updates

• Last Update Posted (Actual): February 7, 2020
• Last Update Submitted That Met QC Criteria: February 6, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Lower Urinary Tract Symptoms; Benign prostatic hyperplasia; Benign prostatic enlargement; Transurethral resection of the prostate; Prostatic artery embolisation
• Additional Relevant MeSH Terms: Urological Manifestations; Lower Urinary Tract Symptoms
• Other Study ID Numbers: 14/NE/0128