UK ROPE Register Study

Lower Urinary Tract Symptoms Clinical Trial

— UK ROPE  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02434575
• Other study ID #: 14/NE/0128
• Status: Completed
• Start date: July 2014
• Est. completion date: December 31, 2016

Study information

• Verified date: February 2020
• Source: Cardiff and Vale University Health Board
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 318
• Est. completion date: December 31, 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Lower Urinary Tract Symptoms

Locations

Country	Name	City	State
United Kingdom	University Hospitals Birmingham NHS Foundation Trust	Birmingham
United Kingdom	The Royal Bournemouth and Christchurch NHS Foundation Trust	Bournemouth
United Kingdom	East Kent Hospitals University NHS Foundation Trust	Canterbury	Kent
United Kingdom	Colchester Hospital University NHS Foundation Trust	Colchester	Essex
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

Sponsors (4)

Lead Sponsor	Collaborator
Cardiff and Vale University Health Board	British Association of Urological Surgeons, British Society of Interventional Radiologists, National Instutite of Health and Care Excellence

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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 comp — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Results from the UK-ROPE study