Clinical trial NCT02434575: UK ROPE Register Study
Official title: 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lower Urinary Tract Symptoms
Keywords: Lower Urinary Tract Symptoms
Prostatic artery embolisation
Transurethral resection of the prostate
Benign prostatic hyperplasia
Benign prostatic enlargement
Lead sponsor: Cardiff and Vale University Health Board
Sponsor class: OTHER_GOV
Collaborators: name: British Society of Interventional Radiologists
name: British Association of Urological Surgeons
name: National Instutite of Health and Care Excellence
First posted: 2015-05-05
Enrollment: 318
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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?

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.

Eligibility criteria: 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

Primary outcomes:
measure: IPSS change for PAE patients, from baseline 12 months post procedure
timeFrame: 12 months
Secondary outcomes:
measure: IPSS comparison of PAE with TURP, 12 months post-procedure
timeFrame: 12 Months
measure: Safety of PAE procedure - Number of patients with adverse events up to 12 months post-procedure
timeFrame: 12 months
measure: IPSS comparison of other treatments (HoLEP, Open prostatectomy) to PAE, 12 months post-procedure
timeFrame: 12 months
measure: IIEF comparison of TURP, HoLEP and Open prostatectomy to PAE, 12 months post-procedure.
timeFrame: 12 months
measure: Prostate volume comparison of TURP, HoLEP and Open prostatectomy to PAE, 12 months post-procedure.
timeFrame: 12 months
measure: Urinary flow study comparison of TURP, HoLEP and Open prostatectomy to PAE, 12 months post-procedure.
timeFrame: 12 months
Other outcomes:
Locations:
city: Colchester
country: United Kingdom
facility: Colchester Hospital University NHS Foundation Trust
state: Essex
city: Canterbury
country: United Kingdom
facility: East Kent Hospitals University NHS Foundation Trust
state: Kent
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham NHS Foundation Trust
city: Bournemouth
country: United Kingdom
facility: The Royal Bournemouth and Christchurch NHS Foundation Trust
city: Coventry
country: United Kingdom
facility: University Hospitals Coventry & Warwickshire NHS
city: Frimley
country: United Kingdom
facility: Frimley Park Hospital NHS Found Trust
city: Glasgow
country: United Kingdom
facility: NHS Greater Glasgow and Clyde
city: Hull
country: United Kingdom
facility: Hull and East Yorkshire Hospitals NHS Trust
city: London
country: United Kingdom
facility: Guy's and St Thomas' NHS Foundation Trust
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
city: Manchester
country: United Kingdom
facility: Central Manchester University Hospitals NHS Foundation Trust
city: Newcastle-Upon-Tyne
country: United Kingdom
facility: Newcastle upon Tyne Hospitals NHS Foundation Trust
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Trust
city: Plymouth
country: United Kingdom
facility: Plymouth Hospitals NHS Trust
city: Southampton
country: United Kingdom
facility: University Hospital Southampton NHS Foundation Trust
city: Stoke On Trent
country: United Kingdom
facility: University Hospital North Staffordshire NHS Trust
city: Truro
country: United Kingdom
facility: Royal Cornwall Hospitals NHS Trust
Study officials:
References:
citation: 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.
citation: 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.