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The ‘Prostate Embolisation AS first‐line therapY compAred to meDication in treatment naïVe men with prostAte eNlargement, a randomised ControllEd trial’ (P‐EASY ADVANCE): a randomised controlled trial of prostate embolisation vs medication for BPH

Objective To compare prostate artery embolisation (PAE) to the combination of tamsulosin and dutasteride therapy as a potential first‐line therapy for obstructive benign prostatic hyperplasia (BPH) in treatment‐naïve patients in the ‘Prostate Embolisation AS first‐line therapY compAred to meDication...

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Published in:BJU international 2024-12, Vol.134 (S2), p.38-46
Main Authors: Brown, Nicholas, Kiosoglous, Anthony, Castree, Stephanie, Firouzmand, Sepinoud, McBean, Rhiannon, Walker, Duncan G., Wallace, Sean, Kua, Boon, Gianduzzo, Troy, Esler, Rachel C., Campbell, Peter, Schoeman, Joseph, Yaxley, John
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container_title BJU international
container_volume 134
creator Brown, Nicholas
Kiosoglous, Anthony
Castree, Stephanie
Firouzmand, Sepinoud
McBean, Rhiannon
Walker, Duncan G.
Wallace, Sean
Kua, Boon
Gianduzzo, Troy
Esler, Rachel C.
Campbell, Peter
Schoeman, Joseph
Yaxley, John
description Objective To compare prostate artery embolisation (PAE) to the combination of tamsulosin and dutasteride therapy as a potential first‐line therapy for obstructive benign prostatic hyperplasia (BPH) in treatment‐naïve patients in the ‘Prostate Embolisation AS first‐line therapY compAred to meDication in treatment naïVe men with prostAte eNlargement, a randomised ControllEd trial’ (P‐EASY ADVANCE). Patients and Methods A total of 39 men with enlarged prostates, moderate–severe lower urinary tract symptoms (LUTS) and obstructed/equivocal urodynamic studies (UDS), and who had no prior treatment for BPH, were randomised to receive either combined medical therapy with tamsulosin and dutasteride (medication) or PAE. Follow‐up UDS, International Prostate Symptom Score (IPSS), uroflowmetry and ultrasound were performed at short‐ to medium‐term intervals following interventions and compared to baseline. Results The medication and PAE treatment groups had similar baseline characteristics, including prostate volumes (87.8 and 85.4 mL respectively), maximum urinary flow rate (Qmax; 6.5 and 6.6 mL/s, respectively), IPSS (19.5 and 21, respectively) and obstructed UDS (79% and 74%, respectively). Both interventions improved voiding and bladder outflow obstruction from baseline, with more patients unobstructed after PAE (63%) compared to medication (28%) (P = 0.03). PAE patients had significantly greater reductions in prostate size (P 
doi_str_mv 10.1111/bju.16479
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Patients and Methods A total of 39 men with enlarged prostates, moderate–severe lower urinary tract symptoms (LUTS) and obstructed/equivocal urodynamic studies (UDS), and who had no prior treatment for BPH, were randomised to receive either combined medical therapy with tamsulosin and dutasteride (medication) or PAE. Follow‐up UDS, International Prostate Symptom Score (IPSS), uroflowmetry and ultrasound were performed at short‐ to medium‐term intervals following interventions and compared to baseline. Results The medication and PAE treatment groups had similar baseline characteristics, including prostate volumes (87.8 and 85.4 mL respectively), maximum urinary flow rate (Qmax; 6.5 and 6.6 mL/s, respectively), IPSS (19.5 and 21, respectively) and obstructed UDS (79% and 74%, respectively). Both interventions improved voiding and bladder outflow obstruction from baseline, with more patients unobstructed after PAE (63%) compared to medication (28%) (P = 0.03). PAE patients had significantly greater reductions in prostate size (P &lt; 0.001), incomplete emptying (P = 0.002), total IPSS (P = 0.032), Qmax (P = 0.006) and quality of life (P = 0.001). Altered ejaculation, erectile dysfunction and nausea were more common in the medication group. Conclusion Prostate artery embolisation was more effective than combined medical therapy at reducing urinary obstruction, decreasing prostate volume and improving LUTS in patients with BPH who had not previously been treated. This is the first randomised control study to compare PAE and combined medical therapy in exclusively treatment‐naïve patients and raises the potential of PAE as an alternative early treatment option for BPH. Further randomised comparative trials are planned to further validate the role of PAE in mitigating obstructive BPH.</description><identifier>ISSN: 1464-4096</identifier><identifier>ISSN: 1464-410X</identifier><identifier>EISSN: 1464-410X</identifier><identifier>DOI: 10.1111/bju.16479</identifier><identifier>PMID: 39139009</identifier><language>eng</language><publisher>England: Wiley Subscription Services, Inc</publisher><subject>5-alpha Reductase Inhibitors - therapeutic use ; Adrenergic alpha-1 Receptor Antagonists - therapeutic use ; Aged ; benign prostatic hyperplasia ; Clinical trials ; Drug Therapy, Combination ; Dutasteride - therapeutic use ; Ejaculation ; embolisation ; Embolization ; Embolization, Therapeutic - methods ; Enlargement ; Erectile dysfunction ; Humans ; Hyperplasia ; Lower Urinary Tract Symptoms - drug therapy ; Lower Urinary Tract Symptoms - etiology ; Lower Urinary Tract Symptoms - therapy ; Male ; medical therapy ; Middle Aged ; Original ; Patients ; Prostate ; Prostate - blood supply ; Prostate - pathology ; Prostatic Hyperplasia - complications ; Prostatic Hyperplasia - therapy ; Quality of life ; Tamsulosin - therapeutic use ; Treatment Outcome ; Urinary tract ; urinary tract symptoms ; urodynamics ; Urological Society of Australia and New Zealand</subject><ispartof>BJU international, 2024-12, Vol.134 (S2), p.38-46</ispartof><rights>2024 The Author(s). published by John Wiley &amp; Sons Ltd on behalf of BJU International.</rights><rights>2024 The Author(s). BJU International published by John Wiley &amp; Sons Ltd on behalf of BJU International.</rights><rights>2024. This article is published under http://creativecommons.org/licenses/by-nc/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><orcidid>0000-0001-6566-9037 ; 0000-0002-8683-1897</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,780,784,885,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/39139009$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Brown, Nicholas</creatorcontrib><creatorcontrib>Kiosoglous, Anthony</creatorcontrib><creatorcontrib>Castree, Stephanie</creatorcontrib><creatorcontrib>Firouzmand, Sepinoud</creatorcontrib><creatorcontrib>McBean, Rhiannon</creatorcontrib><creatorcontrib>Walker, Duncan G.</creatorcontrib><creatorcontrib>Wallace, Sean</creatorcontrib><creatorcontrib>Kua, Boon</creatorcontrib><creatorcontrib>Gianduzzo, Troy</creatorcontrib><creatorcontrib>Esler, Rachel C.</creatorcontrib><creatorcontrib>Campbell, Peter</creatorcontrib><creatorcontrib>Schoeman, Joseph</creatorcontrib><creatorcontrib>Yaxley, John</creatorcontrib><title>The ‘Prostate Embolisation AS first‐line therapY compAred to meDication in treatment naïVe men with prostAte eNlargement, a randomised ControllEd trial’ (P‐EASY ADVANCE): a randomised controlled trial of prostate embolisation vs medication for BPH</title><title>BJU international</title><addtitle>BJU Int</addtitle><description>Objective To compare prostate artery embolisation (PAE) to the combination of tamsulosin and dutasteride therapy as a potential first‐line therapy for obstructive benign prostatic hyperplasia (BPH) in treatment‐naïve patients in the ‘Prostate Embolisation AS first‐line therapY compAred to meDication in treatment naïVe men with prostAte eNlargement, a randomised ControllEd trial’ (P‐EASY ADVANCE). Patients and Methods A total of 39 men with enlarged prostates, moderate–severe lower urinary tract symptoms (LUTS) and obstructed/equivocal urodynamic studies (UDS), and who had no prior treatment for BPH, were randomised to receive either combined medical therapy with tamsulosin and dutasteride (medication) or PAE. Follow‐up UDS, International Prostate Symptom Score (IPSS), uroflowmetry and ultrasound were performed at short‐ to medium‐term intervals following interventions and compared to baseline. Results The medication and PAE treatment groups had similar baseline characteristics, including prostate volumes (87.8 and 85.4 mL respectively), maximum urinary flow rate (Qmax; 6.5 and 6.6 mL/s, respectively), IPSS (19.5 and 21, respectively) and obstructed UDS (79% and 74%, respectively). Both interventions improved voiding and bladder outflow obstruction from baseline, with more patients unobstructed after PAE (63%) compared to medication (28%) (P = 0.03). PAE patients had significantly greater reductions in prostate size (P &lt; 0.001), incomplete emptying (P = 0.002), total IPSS (P = 0.032), Qmax (P = 0.006) and quality of life (P = 0.001). Altered ejaculation, erectile dysfunction and nausea were more common in the medication group. Conclusion Prostate artery embolisation was more effective than combined medical therapy at reducing urinary obstruction, decreasing prostate volume and improving LUTS in patients with BPH who had not previously been treated. This is the first randomised control study to compare PAE and combined medical therapy in exclusively treatment‐naïve patients and raises the potential of PAE as an alternative early treatment option for BPH. Further randomised comparative trials are planned to further validate the role of PAE in mitigating obstructive BPH.</description><subject>5-alpha Reductase Inhibitors - therapeutic use</subject><subject>Adrenergic alpha-1 Receptor Antagonists - therapeutic use</subject><subject>Aged</subject><subject>benign prostatic hyperplasia</subject><subject>Clinical trials</subject><subject>Drug Therapy, Combination</subject><subject>Dutasteride - therapeutic use</subject><subject>Ejaculation</subject><subject>embolisation</subject><subject>Embolization</subject><subject>Embolization, Therapeutic - methods</subject><subject>Enlargement</subject><subject>Erectile dysfunction</subject><subject>Humans</subject><subject>Hyperplasia</subject><subject>Lower Urinary Tract Symptoms - drug therapy</subject><subject>Lower Urinary Tract Symptoms - etiology</subject><subject>Lower Urinary Tract Symptoms - therapy</subject><subject>Male</subject><subject>medical therapy</subject><subject>Middle Aged</subject><subject>Original</subject><subject>Patients</subject><subject>Prostate</subject><subject>Prostate - blood supply</subject><subject>Prostate - pathology</subject><subject>Prostatic Hyperplasia - complications</subject><subject>Prostatic Hyperplasia - therapy</subject><subject>Quality of life</subject><subject>Tamsulosin - therapeutic use</subject><subject>Treatment Outcome</subject><subject>Urinary tract</subject><subject>urinary tract symptoms</subject><subject>urodynamics</subject><subject>Urological Society of Australia and New Zealand</subject><issn>1464-4096</issn><issn>1464-410X</issn><issn>1464-410X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><sourceid>24P</sourceid><recordid>eNpdUs1u1DAQDghE24UDL4AscSlSt7XjrLPpBaXbQEFVWak_oifLSSZdrxw7OE6r3vYROMJT8BC8yT4J3r-qxZcZeb75vm9GEwRvCd4n_h3k026fsChOngfbJGJRPyL4-4tNjhO2Fey07RRj_8EGr4ItmhCaYJxsPwsuJoDms19ja1onHKCszo2SrXDSaJSeo0ra1s1nP5XUgNwErGiuUWHqJrVQImdQDceyWMGlRs6CcDVoh7T4--cKfFmjO-kmqFkopF4BzpSwN7AA7SGBrNClqWXr2UZGO2uUyjyxlULNZ7_R7tiLZ-n5NUqPr9KzUfbh8GlTsW6CdRMy1UprMQ08nua29W7KjdnKWHQ0PnkdvKyEauHNOvaCy0_Zxeikf_rt85dRetpvqF9UnyRFSXDOcD4gNCxygDgSAwgxGbKQFZRQJjCOyjCicVkNqzAX4XAQF3nk0VGR0F7wccXbdLl3UfjprVC8sbIW9p4bIfnTipYTfmNuOSEMU4KxZ9hdM1jzo4PWcb-AApQSGkzXcoqTcBiH4RL6_j_o1HRW-_m4d0oHLGY-9oJ3jy09eNlchwccrAB3UsH9Q51gvjg77s-OL8-OH329XCb0H5gd0bg</recordid><startdate>202412</startdate><enddate>202412</enddate><creator>Brown, Nicholas</creator><creator>Kiosoglous, Anthony</creator><creator>Castree, Stephanie</creator><creator>Firouzmand, Sepinoud</creator><creator>McBean, Rhiannon</creator><creator>Walker, Duncan G.</creator><creator>Wallace, Sean</creator><creator>Kua, Boon</creator><creator>Gianduzzo, Troy</creator><creator>Esler, Rachel C.</creator><creator>Campbell, Peter</creator><creator>Schoeman, Joseph</creator><creator>Yaxley, John</creator><general>Wiley Subscription Services, Inc</general><general>John Wiley and Sons Inc</general><scope>24P</scope><scope>WIN</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>7QP</scope><scope>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0001-6566-9037</orcidid><orcidid>https://orcid.org/0000-0002-8683-1897</orcidid></search><sort><creationdate>202412</creationdate><title>The ‘Prostate Embolisation AS first‐line therapY compAred to meDication in treatment naïVe men with prostAte eNlargement, a randomised ControllEd trial’ (P‐EASY ADVANCE): a randomised controlled trial of prostate embolisation vs medication for BPH</title><author>Brown, Nicholas ; Kiosoglous, Anthony ; Castree, Stephanie ; Firouzmand, Sepinoud ; McBean, Rhiannon ; Walker, Duncan G. ; Wallace, Sean ; Kua, Boon ; Gianduzzo, Troy ; Esler, Rachel C. ; Campbell, Peter ; Schoeman, Joseph ; Yaxley, John</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-p3009-19cd10b60b5132cbee74a5e2018626c3136a004d2437df8f2ba2857cb432c4c93</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>5-alpha Reductase Inhibitors - therapeutic use</topic><topic>Adrenergic alpha-1 Receptor Antagonists - therapeutic use</topic><topic>Aged</topic><topic>benign prostatic hyperplasia</topic><topic>Clinical trials</topic><topic>Drug Therapy, Combination</topic><topic>Dutasteride - therapeutic use</topic><topic>Ejaculation</topic><topic>embolisation</topic><topic>Embolization</topic><topic>Embolization, Therapeutic - methods</topic><topic>Enlargement</topic><topic>Erectile dysfunction</topic><topic>Humans</topic><topic>Hyperplasia</topic><topic>Lower Urinary Tract Symptoms - drug therapy</topic><topic>Lower Urinary Tract Symptoms - etiology</topic><topic>Lower Urinary Tract Symptoms - therapy</topic><topic>Male</topic><topic>medical therapy</topic><topic>Middle Aged</topic><topic>Original</topic><topic>Patients</topic><topic>Prostate</topic><topic>Prostate - blood supply</topic><topic>Prostate - pathology</topic><topic>Prostatic Hyperplasia - complications</topic><topic>Prostatic Hyperplasia - therapy</topic><topic>Quality of life</topic><topic>Tamsulosin - therapeutic use</topic><topic>Treatment Outcome</topic><topic>Urinary tract</topic><topic>urinary tract symptoms</topic><topic>urodynamics</topic><topic>Urological Society of Australia and New Zealand</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Brown, Nicholas</creatorcontrib><creatorcontrib>Kiosoglous, Anthony</creatorcontrib><creatorcontrib>Castree, Stephanie</creatorcontrib><creatorcontrib>Firouzmand, Sepinoud</creatorcontrib><creatorcontrib>McBean, Rhiannon</creatorcontrib><creatorcontrib>Walker, Duncan G.</creatorcontrib><creatorcontrib>Wallace, Sean</creatorcontrib><creatorcontrib>Kua, Boon</creatorcontrib><creatorcontrib>Gianduzzo, Troy</creatorcontrib><creatorcontrib>Esler, Rachel C.</creatorcontrib><creatorcontrib>Campbell, Peter</creatorcontrib><creatorcontrib>Schoeman, Joseph</creatorcontrib><creatorcontrib>Yaxley, John</creatorcontrib><collection>Wiley Open Access</collection><collection>Wiley Online Library Free Content</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>Calcium &amp; Calcified Tissue Abstracts</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>BJU international</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Brown, Nicholas</au><au>Kiosoglous, Anthony</au><au>Castree, Stephanie</au><au>Firouzmand, Sepinoud</au><au>McBean, Rhiannon</au><au>Walker, Duncan G.</au><au>Wallace, Sean</au><au>Kua, Boon</au><au>Gianduzzo, Troy</au><au>Esler, Rachel C.</au><au>Campbell, Peter</au><au>Schoeman, Joseph</au><au>Yaxley, John</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>The ‘Prostate Embolisation AS first‐line therapY compAred to meDication in treatment naïVe men with prostAte eNlargement, a randomised ControllEd trial’ (P‐EASY ADVANCE): a randomised controlled trial of prostate embolisation vs medication for BPH</atitle><jtitle>BJU international</jtitle><addtitle>BJU Int</addtitle><date>2024-12</date><risdate>2024</risdate><volume>134</volume><issue>S2</issue><spage>38</spage><epage>46</epage><pages>38-46</pages><issn>1464-4096</issn><issn>1464-410X</issn><eissn>1464-410X</eissn><abstract>Objective To compare prostate artery embolisation (PAE) to the combination of tamsulosin and dutasteride therapy as a potential first‐line therapy for obstructive benign prostatic hyperplasia (BPH) in treatment‐naïve patients in the ‘Prostate Embolisation AS first‐line therapY compAred to meDication in treatment naïVe men with prostAte eNlargement, a randomised ControllEd trial’ (P‐EASY ADVANCE). Patients and Methods A total of 39 men with enlarged prostates, moderate–severe lower urinary tract symptoms (LUTS) and obstructed/equivocal urodynamic studies (UDS), and who had no prior treatment for BPH, were randomised to receive either combined medical therapy with tamsulosin and dutasteride (medication) or PAE. Follow‐up UDS, International Prostate Symptom Score (IPSS), uroflowmetry and ultrasound were performed at short‐ to medium‐term intervals following interventions and compared to baseline. Results The medication and PAE treatment groups had similar baseline characteristics, including prostate volumes (87.8 and 85.4 mL respectively), maximum urinary flow rate (Qmax; 6.5 and 6.6 mL/s, respectively), IPSS (19.5 and 21, respectively) and obstructed UDS (79% and 74%, respectively). Both interventions improved voiding and bladder outflow obstruction from baseline, with more patients unobstructed after PAE (63%) compared to medication (28%) (P = 0.03). PAE patients had significantly greater reductions in prostate size (P &lt; 0.001), incomplete emptying (P = 0.002), total IPSS (P = 0.032), Qmax (P = 0.006) and quality of life (P = 0.001). Altered ejaculation, erectile dysfunction and nausea were more common in the medication group. Conclusion Prostate artery embolisation was more effective than combined medical therapy at reducing urinary obstruction, decreasing prostate volume and improving LUTS in patients with BPH who had not previously been treated. This is the first randomised control study to compare PAE and combined medical therapy in exclusively treatment‐naïve patients and raises the potential of PAE as an alternative early treatment option for BPH. Further randomised comparative trials are planned to further validate the role of PAE in mitigating obstructive BPH.</abstract><cop>England</cop><pub>Wiley Subscription Services, Inc</pub><pmid>39139009</pmid><doi>10.1111/bju.16479</doi><tpages>9</tpages><orcidid>https://orcid.org/0000-0001-6566-9037</orcidid><orcidid>https://orcid.org/0000-0002-8683-1897</orcidid><oa>free_for_read</oa></addata></record>
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subjects 5-alpha Reductase Inhibitors - therapeutic use
Adrenergic alpha-1 Receptor Antagonists - therapeutic use
Aged
benign prostatic hyperplasia
Clinical trials
Drug Therapy, Combination
Dutasteride - therapeutic use
Ejaculation
embolisation
Embolization
Embolization, Therapeutic - methods
Enlargement
Erectile dysfunction
Humans
Hyperplasia
Lower Urinary Tract Symptoms - drug therapy
Lower Urinary Tract Symptoms - etiology
Lower Urinary Tract Symptoms - therapy
Male
medical therapy
Middle Aged
Original
Patients
Prostate
Prostate - blood supply
Prostate - pathology
Prostatic Hyperplasia - complications
Prostatic Hyperplasia - therapy
Quality of life
Tamsulosin - therapeutic use
Treatment Outcome
Urinary tract
urinary tract symptoms
urodynamics
Urological Society of Australia and New Zealand
title The ‘Prostate Embolisation AS first‐line therapY compAred to meDication in treatment naïVe men with prostAte eNlargement, a randomised ControllEd trial’ (P‐EASY ADVANCE): a randomised controlled trial of prostate embolisation vs medication for BPH
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