The UK Register of Prostate Embolisation (UK ROPE) study aimed to assess the efficacy and safety of Prostate Artery Embolisation (PAE) for Lower Urinary Tract Symptoms secondary to Benign Prostatic Hyperplasia (LUTS/BPH) patients. The main secondary aim was an indirect comparison with transurethral resection of the prostate (TURP).
As a joint initiative between BSIR, BAUS and NICE, this study recruited 305 patients across 17 UK urological / interventional radiology centres: 216 PAE, 89 TURP. The primary outcomes were IPSS improvement in PAE patients at 12 months post-procedure, and complication data post-PAE. We also aimed to compare IPSS score improvements between PAE and TURP, using non-inferiority analysis on propensity-score matched patient pairs. The clinical results and urological measurements were performed at clinical sites. IPSS and other questionnaire-based results were mailed by patients directly to the trial unit managing the study. All data were uploaded centrally to the UK ROPE database.
PAE is clinically effective, producing a median 10 point IPSS improvement from baseline at 12 months post-procedure. PAE does not appear to be as effective as TURP, which produced a median 15 point IPSS score improvement at 12 months post-procedure. These findings are further supported by propensity score analysis, in which we formed 65 closely matched pairs of PAE and TURP patients. In terms of IPSS and quality of life improvement, there was no evidence of PAE being non-inferior to TURP. PAE patients made a statistically significant improvement in Qmax and prostate volume reduction at 12 months post-procedure. PAE has a reoperation rate of 5% before 12 months and 15% past 12 months (20% total rate), and a low complication rate. Of 216 patients, one had sepsis, one required a blood transfusion, four had local arterial dissection and four had a groin haematoma. Two patients had non-target embolisation that presented as self-limiting penile ulcers. Additional patient-reported outcomes, pain levels and return to normal activities are very encouraging for PAE. Seventy-one percent of PAE cases were performed as outpatient or day cases. In contrast, 80% of TURP cases required at least one night of hospital stay, and a majority required two nights.
Our results indicate that PAE provides a clinically and statistically significant improvement in symptoms and quality of life, though some of these improvements were greater in the TURP arm. The safety profile and quicker return to normal activities may be seen as highly beneficial by patients considering PAE as an alternative treatment to TURP, with the concomitant advantage of reduced length of hospital stay and need for admission following PAE. PAE is an advanced embolisation technique demanding a high level of expertise, and should be performed by experienced interventional radiologists who have been trained and proctored appropriately. The use of cone beam CT is encouraged in order to improve operator confidence and minimise non-target embolisations. PAE's place in the care pathway is between that of drugs and surgery, allowing the clinician to tailor treatment to individual patients' symptoms, requirements and anatomical variation. This article is protected by copyright. All rights reserved.
BJU international. 2018 Apr 12 [Epub ahead of print]
A F Ray, J Powell, M J Speakman, N T Longford, R DasGupta, T Bryant, S Modi, J Dyer, M Harris, G Carolan-Rees, N Hacking
Cedar, Cardiff University/Cardiff & Vale University Health Board, Cardiff, UK., Centre for Health Technology Evaluation, National Institute for Health and Care Excellence, London, UK. Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK., Department of Urology, Taunton and Somerset NHS Trust, Taunton, UK., SNTL Statistics Research and Consulting, Department of Medicine, Imperial College London., Department of Urology, St. Mary's Hospital, Imperial College Healthcare NHS Trust, London, UK., Department of Interventional Radiology, Southampton General Hospital, University Hospital Southampton NHS Foundation Trust, Southampton, UK., Department of Urology, Southampton General Hospital, University Hospital Southampton NHS Foundation Trust, Southampton, UK.