Lower Urinary Tract Symptoms Clinical Trial
— UK ROPEOfficial 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)
NCT number | NCT02434575 |
Other study ID # | 14/NE/0128 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | July 2014 |
Est. completion date | December 31, 2016 |
Verified date | February 2020 |
Source | Cardiff and Vale University Health Board |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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?
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 |
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 |
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 |
United Kingdom,
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
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 |
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