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Article of the Month: The UK‐ROPE Study

Every Month, the Editor-in-Chief selects an Article of the Month from the current issue of BJUI. The abstract is reproduced below and you can click on the button to read the full article, which is freely available to all readers for at least 30 days from the time of this post. retainedfirefighter provides more articles like this one. Follow for more articles like this one songsforromance .

In addition to the article itself, there is an accompanying editorial written by a prominent member of the urological community. This blog is intended to provoke comment and discussion and we invite you to use the comment tools at the bottom of each post to join the conversation.

If you only have time to read one article this week, it should be this one .

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)

 

Alistair F. Ray*, John Powell†‡, Mark J. Speakman§, Nicholas T. LongfordRanan DasGupta**, Timothy Bryant††, Sachin Modi††, Jonathan Dyer‡‡, Mark Harris‡‡Grace Carolan-Rees* and Nigel Hacking††

 

*Cedar, Cardiff University/Cardiff and Vale University Health Board, Cardiff, Centre for Health Technology Evaluation, National Institute for Health and Care Excellence, London, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, §Department of Urology, Taunton and Somerset NHS Trust, Taunton, SNTL Statistics Research and Consulting, Department of Medicine, Imperial College London, **Department of Urology, St. MaryHospital, Imperial College Healthcare NHS Trust, London, ††Department of Interventional Radiology, and ‡‡Department of Urology, Southampton General Hospital, University Hospital Southampton NHS Foundation Trust, Southampton, UK

 

Abstract

Objectives

To assess the efficacy and safety of prostate artery embolization (PAE) for lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) and to conduct an indirect comparison of PAE with transurethral resection of the prostate (TURP).

Patients and Methods

As a joint initiative between the British Society of Interventional Radiologists, the British Association of Urological Surgeons and the National Institute for Health and Care Excellence, we conducted the UK Register of Prostate Embolization (UK‐ROPE) study, which recruited 305 patients across 17 UK urological/interventional radiology centres, 216 of whom underwent PAE and 89 of whom underwent TURP. The primary outcomes were International Prostate Symptom Score (IPSS) improvement in the PAE group at 12 months post‐procedure, and complication data post‐PAE. We also aimed to compare IPSS score improvements between the PAE and TURP groups, using non‐inferiority analysis on propensity‐score‐matched patient pairs. The clinical results and urological measurements were performed at clinical sites. If you want more articles like this one follow us at salbreux-pesage . 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 study database.

Results

The results showed that PAE was clinically effective, producing a median 10‐point IPSS improvement from baseline at 12 months post‐procedure. PAE did 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 the propensity score analysis, in which we formed 65 closely matched pairs of patients who underwent PAE and patients who underwent TURP. In terms of IPSS and quality‐of‐life (QoL) improvement, there was no evidence of PAE being non‐inferior to TURP. Patients in the PAE group had a statistically significant improvement in maximum urinary flow rate and prostate volume reduction at 12 months post‐procedure. PAE had a reoperation rate of 5% before 12 months and 15% after 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 embolization that presented as self‐limiting penile ulcers. Additional patient‐reported outcomes, pain levels and return to normal activities were 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 1 night of hospital stay, and the majority required 2 nights.Here excelpasswordrecovery you can check the best articles of the month.

Conclusion

Our results indicate that PAE provides a clinically and statistically significant improvement in symptoms and QoL, although 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 advantages of reduced length of hospital stay and need for admission after PAE. PAE is an advanced embolization 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 computed tomography is encouraged to improve operator confidence and minimize non‐target embolizations. The place of PAE 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.

 

Editorial: Prostate Artery Embolization

Andrea Tubaro, in his editorial for European Association of Urology 2006 [1], discussed the paradigm shift in the surgical management of BPH from open surgery to TURP, and postulated that more refined and less invasive techniques would further dictate the treatment pathway to reduce cost, manage more high-risk surgical cases and reduce blood loss in a population that increasingly is on antithrombotic and anticoagulant medication, to ease the management of large prostates, and to manage BPH as a day case procedure [1].

Interventional radiology has been at the forefront of minimally invasive procedures. In 1953, Seldinger [2] published his ingenious method of introducing a catheter into the vascular system after obtaining needle access and, 10 years later, Dotter recognized the potential of catheters to be used in performing intravascular surgery [3]. Superselective prostate artery embolization (PAE) was first described by DeMeritt et al. [4]. Pisco et al. [5] from Portugal and Carnevale et al. [6] from Brazil have rightly been credited with the development of the clinical service for PAE in BPH. The study by Pisco et al. in 2016, in 630 consecutive patients with moderate to severe LUTS refractory to medical therapy for at least 6 months, showed 81.9% medium-term and 76.3% long-term clinical success rates, with no urinary incontinence or sexual dysfunction reported. Carnevale et al. [6], in 2014, described a modified PAE technique that can lead to greater ischaemia and infarction of the prostate gland with the possibility of better clinical outcomes [6].

In this edition of BJUI, the UK Register of Prostate Embolization (ROPE) study [7] provides evidence for the efficacy and safety for PAE for LUTS secondary to BPH and makes an indirect comparison with TURP. What is strikingly unique and to be applauded in this registry is the collaboration between the British Society of Interventional Radiology, the BAUS and National Institute of Clinical Excellence (NICE).

A total of 305 patients across 17 UK centres were enrolled, and results were analysed over 12 months. They noted that patients who underwent PAE had a statistically significant improvement in urinary flow rate and reduction in prostate volume after the procedure. In terms of IPSS and quality-of-life improvement, there was no evidence of PAE being non-inferior to TURP. Seventy-one percent of PAE cases were performed as outpatients or day cases. By contrast, 80% of TURPs required at least one night of hospital stay and a majority two nights [7].

In April 2018, NICE revised their guidelines and have now approved PAE with certain recommendations [8].

The key to successful PAE, in our opinion, is careful patient selection. At our centre, we receive tertiary referrals of patients with very large prostates, many of whom are comorbid and elderly. We embraced the option of PAE and were delighted to be able to contribute a number of cases to the ROPE study. Our overall experience is now in excess of 200 cases and we are aware that some patients will do well, others less well. It is becoming clearer who those patients may be; those who do well tend to be those with the larger prostate with large lateral lobes and adenomatous predominant BPH, without a significant middle lobe, with big prostate vessels and with lower risk of significant renal insufficiency. The large middle lobes can ball-valve and still obstruct, and preoperative arterial CT could identify those with heavily calcified, severely diseased internal iliac arteries that may be difficult to embolize. Nonetheless, those patients who are at highest risk from surgery and those who wish to minimize the risks of sexual dysfunction or incontinence may justifiably opt for PAE as a less invasive outpatient procedure. And why should they not? For many, simply the opportunity to avoid long-term medication with a-blockers or 5-a-reductase inhibitors is the real benefit, and undergoing PAE does not exclude one from surgery afterwards.

Level 1 evidence is of course a fundamental requirement for a change in definitive practice; the ROPE study is a comparative cohort of two fundamentally different procedures. Our institute is a surgical centre for the management of massive BPH and we are convinced that PAE has a place in the management of some of our patients, but could prevention be better than cure? Ambitious it may be, but who is to say whether early PAE in symptomatic patients might reduce the progression of clinical BPH, avoiding the morbidity and cost of long-term medical treatment culminating in surgery. Perhaps the real challenge highlighted by the ROPE study is that the time has come to consider a randomized controlled trial of prostate embolization vs early non-surgical treatment of BPH (short title ‘PREVENT-BPH’), with randomization to PAE or either a-blockers and/or 5-a-reductase inhibitors or placebo. The ROPE study suggests that PAE at the least deserves a randomized controlled trial including it vs other non-invasive treatments.

Tarun Sabharwal and Rick Popert
Guy’s and St Thomas’ Hospital, London, UK

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References

  1. Tubaro A. BPH treatment: a paradigm shift. Eur Urol 2006; 49: 939–41
  2. Seldinger SI. Catheter replacement of the needle in percutaneous arteriography; a new technique. Acta Radiol 1953; 39: 368–76
  3. Dotter CT, Judkins MP. Transluminal treatment of atherosclerotic obstructions: description of a new technique and preliminary report of its applications. Circulation 1964; 30: 654–70
  4. DeMeritt JS, Elmasri FF, Esposito MP, Rosenberg GS. Relief of benign prostatic hyperplasia-related bladder outlet obstruction after transarterial polyvinyl alcohol prostate embolization. J Vasc Interv Radiol 2000; 11: 767–70
  5. Pisco JM, Bilhim T, Pinheiro LC et al. Medium-and long-term outcome of prostate artery embolization for patients with benign prostatic hyperplasia: results in 630 patients. J Vasc Interv Radiol 2016; 27: 1115–22
  6. Carnevale FC, Moreira AM, Antunes AA. The “PErFecTED Technique”: proximal embolisation first, then embolise distal for benign prostatic hyperplasia. Cardiovasc Intervent Radiol 2014; 37: 1602–5
  7. Ray AF, Powell J, Speakman MJ et al. 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; 122: 270–82
  8. NICE Guidance. Prostate artery embolisation for lower urinary tract symptoms caused by benign prostatic hyperplasia. BJU Int 2018;121: 825-34

 

Infographic: The UK‐ROPE Study

Infographic: 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)

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Residents’ Podcast: UK‐ROPE Study

Maria Uloko is a Urology Resident at the University of Minnesota Hospital and Giulia Lane is a Female Pelvic Medicine and Reconstructive Surgery Fellow at the University of Michigan

In this podcast they discuss the BJUI Article of the Month ‘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)’

 

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)

 

Alistair F. Ray*, John Powell†‡, Mark J. Speakman§, Nicholas T. LongfordRanan DasGupta**, Timothy Bryant††, Sachin Modi††, Jonathan Dyer‡‡, Mark Harris‡‡Grace Carolan-Rees* and Nigel Hacking††

 

*Cedar, Cardiff University/Cardiff and Vale University Health Board, Cardiff, Centre for Health Technology Evaluation, National Institute for Health and Care Excellence, London, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, §Department of Urology, Taunton and Somerset NHS Trust, Taunton, SNTL Statistics Research and Consulting, Department of Medicine, Imperial College London, **Department of Urology, St. MaryHospital, Imperial College Healthcare NHS Trust, London, ††Department of Interventional Radiology, and ‡‡Department of Urology, Southampton General Hospital, University Hospital Southampton NHS Foundation Trust, Southampton, UK

 

Read the full article

Abstract

Objectives

To assess the efficacy and safety of prostate artery embolization (PAE) for lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) and to conduct an indirect comparison of PAE with transurethral resection of the prostate (TURP).

Patients and Methods

As a joint initiative between the British Society of Interventional Radiologists, the British Association of Urological Surgeons and the National Institute for Health and Care Excellence, we conducted the UK Register of Prostate Embolization (UK‐ROPE) study, which recruited 305 patients across 17 UK urological/interventional radiology centres, 216 of whom underwent PAE and 89 of whom underwent TURP. The primary outcomes were International Prostate Symptom Score (IPSS) improvement in the PAE group at 12 months post‐procedure, and complication data post‐PAE. We also aimed to compare IPSS score improvements between the PAE and TURP groups, 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 study database.

Results

The results showed that PAE was clinically effective, producing a median 10‐point IPSS improvement from baseline at 12 months post‐procedure. PAE did 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 the propensity score analysis, in which we formed 65 closely matched pairs of patients who underwent PAE and patients who underwent TURP. In terms of IPSS and quality‐of‐life (QoL) improvement, there was no evidence of PAE being non‐inferior to TURP. Patients in the PAE group had a statistically significant improvement in maximum urinary flow rate and prostate volume reduction at 12 months post‐procedure. PAE had a reoperation rate of 5% before 12 months and 15% after 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 embolization that presented as self‐limiting penile ulcers. Additional patient‐reported outcomes, pain levels and return to normal activities were 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 1 night of hospital stay, and the majority required 2 nights.

Conclusion

Our results indicate that PAE provides a clinically and statistically significant improvement in symptoms and QoL, although 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 advantages of reduced length of hospital stay and need for admission after PAE. PAE is an advanced embolization 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 computed tomography is encouraged to improve operator confidence and minimize non‐target embolizations. The place of PAE 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.

Read more articles of the week

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