Lower Urinary Tract SymptomsUK ROPENCT02434575
UK ROPE Register Study
An observational study of Lower Urinary Tract Symptoms, run by Cardiff and Vale University Health Board at 17 sites in United Kingdom.
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… Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Lower Urinary Tract Symptoms
- How many people
- 318 participants
- Where
- 17 sitesUnited Kingdom
- Study dates
- Jul 2014to 31 Dec 2016
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Men with LUTS BPE who have consented to PAE, TURP, Open prostatectomy or laser surgery at a participating UK site.
Who may be able to join
- 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
Who cannot join
- Not able to read, write or understand English
- Not able/willing to provide informed written consent
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United Kingdom17 sites
University Hospitals Birmingham NHS Foundation Trust
Birmingham
The Royal Bournemouth and Christchurch NHS Foundation Trust
Bournemouth
East Kent Hospitals University NHS Foundation Trust
Canterbury, Kent
Colchester Hospital University NHS Foundation Trust
Colchester, Essex
University Hospitals Coventry & Warwickshire NHS
Coventry
Frimley Park Hospital NHS Found Trust
Frimley
NHS Greater Glasgow and Clyde
Glasgow
Hull and East Yorkshire Hospitals NHS Trust
Hull
Guy's and St Thomas' NHS Foundation Trust
London
Imperial College Healthcare NHS Trust
London
Central Manchester University Hospitals NHS Foundation Trust
Manchester
Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne
Oxford University Hospitals NHS Trust
Oxford
Plymouth Hospitals NHS Trust
Plymouth
University Hospital Southampton NHS Foundation Trust
Southampton
University Hospital North Staffordshire NHS Trust
Stoke-on-Trent
Royal Cornwall Hospitals NHS Trust
Truro
About this 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)
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?
Read the 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.
- Conditions
- Lower Urinary Tract Symptoms
- Keywords
- Lower Urinary Tract Symptoms, Prostatic artery embolisation, Transurethral resection of the prostate, Benign prostatic hyperplasia, Benign prostatic enlargement
- Medical subject headings
- Lower Urinary Tract Symptoms, Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
IPSS change for PAE patients, from baseline 12 months post procedure
Comparison of IPSS questionnaire score at baseline at 12 months post-PAE procedure
Measured: 12 months
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2015 (estimated)
- Study startJul 2014
- Primary completionDec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lower Urinary Tract SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 318 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Cardiff and Vale University Health Board
- Sponsor type
- Other government
- Collaborators
- British Society of Interventional Radiologists, British Association of Urological Surgeons, National Instutite of Health and Care Excellence
- Responsible party
- Principal investigator, Dr Grace Carolan-Rees, Cardiff and Vale University Health Board
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02434575
- Sponsor's protocol ID
- 14/NE/0128
- Acronym
- UK ROPE
- Status last verified
- Feb 2020
- First submitted
- 20 Mar 2015
- Last updated
- 7 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 29645352Patel 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.
PubMed 35047801
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02434575
- Acronym / sponsor ID
- UK ROPE / 14/NE/0128
- Conditions
- Lower Urinary Tract Symptoms
- Keywords
- Lower Urinary Tract Symptoms, Prostatic artery embolisation, Transurethral resection of the prostate, Benign prostatic hyperplasia, Benign prostatic enlargement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 318 participants (actual)
- Lead sponsor
- Cardiff and Vale University Health BoardOther government
- Collaborators
- British Society of Interventional Radiologists, British Association of Urological Surgeons, National Instutite of Health and Care Excellence
- Study start
- Jul 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 5 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Men with LUTS BPE who have consented to PAE, TURP, Open prostatectomy or laser surgery at a participating UK site.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Not able to read, write or understand English
- Not able/willing to provide informed written consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
IPSS change for PAE patients, from baseline 12 months post procedure
Time frame: 12 months
Comparison of IPSS questionnaire score at baseline at 12 months post-PAE procedure
6 secondary outcomes
IPSS comparison of PAE with TURP, 12 months post-procedure
Time frame: 12 Months
Safety of PAE procedure - Number of patients with adverse events up to 12 months post-procedure
Time frame: 12 months
IPSS comparison of other treatments (HoLEP, Open prostatectomy) to PAE, 12 months post-procedure
Time frame: 12 months
IIEF comparison of TURP, HoLEP and Open prostatectomy to PAE, 12 months post-procedure.
Time frame: 12 months
Prostate volume comparison of TURP, HoLEP and Open prostatectomy to PAE, 12 months post-procedure.
Time frame: 12 months
Urinary flow study comparison of TURP, HoLEP and Open prostatectomy to PAE, 12 months post-procedure.
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2020.
- Results publication: PubMed 29645352Ray 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.
- Derived from this study: PubMed 35047801Patel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lower Urinary Tract Symptoms, run by Cardiff and Vale University Health Board at 17 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IPSS change for PAE patients, from baseline 12 months post procedure (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02434575, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2020; AzTrials last refreshed its copy on 27 Oct 2026.