UK ROPE Register study

• Research type

  Research Study

• Full title

  The UK ROPE Register study to analyse data collected in a register on the efficacy and safety of prostate artery embolisation for Lower Urinary Tract Symptoms secondary to Benign Prostatic Enlargement.

• IRAS ID

  147785

• Contact name

  Grace Carolan-Rees

• Contact email

  Grace.Carolan-Rees@wales.nhs.uk

• Sponsor organisation

  Cardiff and Vale University Health Board

• Research summary

  This study aims to answer research questions posed by the National Institute for Health and Care Excellence (NICE) in the Interventional Procedures (IP) Guidance document on Prostatic Artery Embolisation (PAE). The UK-ROPE (Register Of Prostate Embolisation) Register collects data on the treatment of lower urinary tract symptoms (LUTS) benign prostate enlargement (BPE) using prostate artery embolisation (PAE), and is being set up in parallel to this study. Cedar worked alongside NICE, the British Society of Interventional Radiologists (BSIR) and British Association of Urological Surgeons (BAUS) and patient representatives to define the outcome measures required in the UK ROPE Register to answer NICE’s research questions :
  • Is prostate artery embolisation (PAE) a safe and effective treatment option for lower urinary tract symptoms (LUTS) caused by prostate enlargement?
  • How does prostate artery embolisation (PAE) compare with conventional surgical management (Primarily transurethral resection of the prostate (TURP), which is the current standard treatment)?
  • Which patients would most benefit from prostate artery embolisation (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).
  Data will be entered by the patients’ clinical team at baseline, 3 and 12 months post-procedure, and Cedar (Cedar will enter patient-reported data by postal questionnaires at baseline, then 1,3,6 and 12 months post-procedure) to all patients who participate in the study).
  This is a pilot study powered to answer NICE’s two main research questions, update NICE guidance documentation, and do further research with more patients if necessary.

• REC name

  North East - Tyne & Wear South Research Ethics Committee

• REC reference

  14/NE/0128

• Date of REC Opinion

  25 Apr 2014

• REC opinion

  Further Information Favourable Opinion