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| Name | Class |
|---|---|
| British Society of Interventional Radiologists | UNKNOWN |
| British Association of Urological Surgeons | UNKNOWN |
| National Instutite of Health and Care Excellence | UNKNOWN |
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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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Men with LUTS BPE who have consented to PAE, TURP, Open prostatectomy or laser surgery at a participating UK site.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Colchester Hospital University NHS Foundation Trust | Colchester | Essex | United Kingdom | |||
| East Kent Hospitals University NHS Foundation Trust |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29645352 | Result | 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. | |
| 35047801 |
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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 |
| Canterbury |
| Kent |
| United Kingdom |
| University Hospitals Birmingham NHS Foundation Trust | Birmingham | United Kingdom |
| The Royal Bournemouth and Christchurch NHS Foundation Trust | Bournemouth | 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 | United Kingdom |
| Derived |
| 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. |
| ID | Term |
|---|---|
| D059411 | Lower Urinary Tract Symptoms |
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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