UK ROPE Register Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Lower Urinary Tract Symptoms

Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PAE<br>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<br>Men with LUTS BPE who have consented to TURP at a participating site, and have consented to the UK ROPE Register Study. | |
| Other<br>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?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lower Urinary Tract Symptoms, Prostatic artery embolisation, Transurethral resection of the prostate, Benign prostatic hyperplasia, Benign prostatic enlargement