180-W XPS GreenLight Laser Vaporisation Versus Transurethral Resection of the Prostate for the Treatment of Benign Prostatic Obstruction: 6-Month Safety and Efficacy Results of a European Multicentre Randomised Trial—The GOLIATH Study
Abstract Background The comparative outcome with GreenLight (GL) photoselective vaporisation of the prostate and transurethral resection of the prostate (TURP) in men with lower urinary tract symptoms due to benign prostatic obstruction (BPO) has been questioned. Objective The primary objective of t...
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| creator | Bachmann, Alexander Tubaro, Andrea Barber, Neil d’Ancona, Frank Muir, Gordon Witzsch, Ulrich Grimm, Marc-Oliver Benejam, Joan Stolzenburg, Jens-Uwe Riddick, Antony Pahernik, Sascha Roelink, Herman Ameye, Filip Saussine, Christian Bruyère, Franck Loidl, Wolfgang Larner, Tim Gogoi, Nirjan-Kumar Hindley, Richard Muschter, Rolf Thorpe, Andrew Shrotri, Nitin Graham, Stuart Hamann, Moritz Miller, Kurt Schostak, Martin Capitán, Carlos Knispel, Helmut Thomas, J. Andrew |
| description | Abstract Background The comparative outcome with GreenLight (GL) photoselective vaporisation of the prostate and transurethral resection of the prostate (TURP) in men with lower urinary tract symptoms due to benign prostatic obstruction (BPO) has been questioned. Objective The primary objective of the GOLIATH study was to evaluate the noninferiority of 180-W GL XPS (XPS) to TURP for International Prostate Symptom Score (IPSS) and maximum flow rate (Qmax ) at 6 mo and the proportion of patients who were complication free. Design, setting, and participants Prospective randomised controlled trial at 29 centres in 9 European countries involving 281 patients with BPO. Intervention 180-W GL XPS system or TURP. Outcome measurements and statistical analysis Measurements used were IPSS, Qmax , prostate volume (PV), postvoid residual (PVR) and complications, perioperative parameters, and reintervention rates. Noninferiority was evaluated using one-sided tests at the 2.5% level of significance. The statistical significance of other comparisons was assessed at the (two-sided) 5% level. Results and limitations The study demonstrated the noninferiority of XPS to TURP for IPSS, Qmax , and complication-free proportion. PV and PVR were comparable between groups. Time until stable health status, length of catheterisation, and length of hospital stay were superior with XPS ( p < 0.001). Early reintervention rate within 30 d was three times higher after TURP ( p = 0.025); however, the overall postoperative reintervention rates were not significantly different between treatment arms. A limitation was the short follow-up. Conclusions XPS was shown to be noninferior (comparable) to TURP in terms of IPSS, Qmax , and proportion of patients free of complications. XPS results in a lower rate of early reinterventions but has a similar rate after 6 mo. Trial registration ClinicalTrials.gov, identifier NCT01218672. |
| doi_str_mv | 10.1016/j.eururo.2013.10.040 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_1508943197</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><els_id>S0302283813011354</els_id><sourcerecordid>1508943197</sourcerecordid><originalsourceid>FETCH-LOGICAL-c447t-490be13139dcd572c9d139e11ea9c37e038cedef6795be5a0125e1e79817cda33</originalsourceid><addsrcrecordid>eNqFkstuEzEUhkcIREPhDRDyBonNBJ_xTGaGBVJbhbRSqlRNKOwsx3OmcZjYwRek7HgInpA1D4EnSUFiw8rW8ef_XP6TJC-BDoHC6O16iMEGa4YZBRZDQ5rTR8kAqpKlZTGij5MBZTRLs4pVJ8kz59aUUlbU7GlykuWMARTZIPkFFU0_kc83czKxiHqq7leeTIVDS-7E1ljlhFdGkzu0LjiysEK7YNGvrOjILTqU-2fTEr9CcmON88IjaY3dBxYWhd-g9j1xjlrd6wdISTJbOm_DXuEdGaXXRvsVmYsW_Y4I3ZBx2yop5K5PFDrvehFBxrHrLQpNrmNMyShukdxG3myUwybmVKL7-f3HIuafzKZXZ4tLMveh2T1PnrSic_jieJ4mHz-MFxeX6XQ2ubo4m6Yyz0uf5jVdIjBgdSObosxk3cQ7AqCoJSuRskpig-2orIslFoJCViBgWVdQykYwdpq8Oehurfka0HkeC5PYdUKjCY5DQas6Z1CXEc0PqIxDcRZbvrVqI-yOA-W9z3zNDz7z3uc-Gn2O314dM4TlBps_nx6MjcDrIyCcFF0bbZPK_eWqYpSxvIjc-wOHcR7fFFrupEId-1M2Wssbo_5Xyb8CslM6utZ9wR26tQlWx1lz4C7jlM_7nexXEhgFYEXOfgOO6OGm</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1508943197</pqid></control><display><type>article</type><title>180-W XPS GreenLight Laser Vaporisation Versus Transurethral Resection of the Prostate for the Treatment of Benign Prostatic Obstruction: 6-Month Safety and Efficacy Results of a European Multicentre Randomised Trial—The GOLIATH Study</title><source>MEDLINE</source><source>ScienceDirect Journals (5 years ago - present)</source><creator>Bachmann, Alexander ; Tubaro, Andrea ; Barber, Neil ; d’Ancona, Frank ; Muir, Gordon ; Witzsch, Ulrich ; Grimm, Marc-Oliver ; Benejam, Joan ; Stolzenburg, Jens-Uwe ; Riddick, Antony ; Pahernik, Sascha ; Roelink, Herman ; Ameye, Filip ; Saussine, Christian ; Bruyère, Franck ; Loidl, Wolfgang ; Larner, Tim ; Gogoi, Nirjan-Kumar ; Hindley, Richard ; Muschter, Rolf ; Thorpe, Andrew ; Shrotri, Nitin ; Graham, Stuart ; Hamann, Moritz ; Miller, Kurt ; Schostak, Martin ; Capitán, Carlos ; Knispel, Helmut ; Thomas, J. Andrew</creator><creatorcontrib>Bachmann, Alexander ; Tubaro, Andrea ; Barber, Neil ; d’Ancona, Frank ; Muir, Gordon ; Witzsch, Ulrich ; Grimm, Marc-Oliver ; Benejam, Joan ; Stolzenburg, Jens-Uwe ; Riddick, Antony ; Pahernik, Sascha ; Roelink, Herman ; Ameye, Filip ; Saussine, Christian ; Bruyère, Franck ; Loidl, Wolfgang ; Larner, Tim ; Gogoi, Nirjan-Kumar ; Hindley, Richard ; Muschter, Rolf ; Thorpe, Andrew ; Shrotri, Nitin ; Graham, Stuart ; Hamann, Moritz ; Miller, Kurt ; Schostak, Martin ; Capitán, Carlos ; Knispel, Helmut ; Thomas, J. Andrew</creatorcontrib><description>Abstract Background The comparative outcome with GreenLight (GL) photoselective vaporisation of the prostate and transurethral resection of the prostate (TURP) in men with lower urinary tract symptoms due to benign prostatic obstruction (BPO) has been questioned. Objective The primary objective of the GOLIATH study was to evaluate the noninferiority of 180-W GL XPS (XPS) to TURP for International Prostate Symptom Score (IPSS) and maximum flow rate (Qmax ) at 6 mo and the proportion of patients who were complication free. Design, setting, and participants Prospective randomised controlled trial at 29 centres in 9 European countries involving 281 patients with BPO. Intervention 180-W GL XPS system or TURP. Outcome measurements and statistical analysis Measurements used were IPSS, Qmax , prostate volume (PV), postvoid residual (PVR) and complications, perioperative parameters, and reintervention rates. Noninferiority was evaluated using one-sided tests at the 2.5% level of significance. The statistical significance of other comparisons was assessed at the (two-sided) 5% level. Results and limitations The study demonstrated the noninferiority of XPS to TURP for IPSS, Qmax , and complication-free proportion. PV and PVR were comparable between groups. Time until stable health status, length of catheterisation, and length of hospital stay were superior with XPS ( p < 0.001). Early reintervention rate within 30 d was three times higher after TURP ( p = 0.025); however, the overall postoperative reintervention rates were not significantly different between treatment arms. A limitation was the short follow-up. Conclusions XPS was shown to be noninferior (comparable) to TURP in terms of IPSS, Qmax , and proportion of patients free of complications. XPS results in a lower rate of early reinterventions but has a similar rate after 6 mo. Trial registration ClinicalTrials.gov, identifier NCT01218672.</description><identifier>ISSN: 0302-2838</identifier><identifier>EISSN: 1873-7560</identifier><identifier>DOI: 10.1016/j.eururo.2013.10.040</identifier><identifier>PMID: 24331152</identifier><identifier>CODEN: EUURAV</identifier><language>eng</language><publisher>Kidlington: Elsevier B.V</publisher><subject>Adult ; Adverse events ; Aged ; Aged, 80 and over ; Benign prostatic obstruction (BPO) ; Biological and medical sciences ; Clavien-Dindo classification ; Efficacy ; Europe ; Follow-Up Studies ; GreenLight XPS 180-W laser ; Hemorrhage - etiology ; Humans ; Intention to Treat Analysis ; Laser Therapy - adverse effects ; Length of Stay ; Male ; Medical sciences ; Middle Aged ; Nephrology. Urinary tract diseases ; Organ Size ; Photoselective vaporisation of the prostate (PVP) ; Prospective Studies ; Prostate - pathology ; Prostate-Specific Antigen - blood ; Prostatectomy - adverse effects ; Prostatic Hyperplasia - blood ; Prostatic Hyperplasia - complications ; Prostatic Hyperplasia - surgery ; Prostatism - etiology ; Prostatism - physiopathology ; Safety ; Severity of Illness Index ; Time Factors ; Transurethral surgery ; TURP ; Urinary Catheterization ; Urinary Incontinence - etiology ; Urinary Retention - etiology ; Urodynamics ; Urology</subject><ispartof>European urology, 2014-05, Vol.65 (5), p.931-942</ispartof><rights>2013</rights><rights>2015 INIST-CNRS</rights><rights>Copyright © 2013. Published by Elsevier B.V.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c447t-490be13139dcd572c9d139e11ea9c37e038cedef6795be5a0125e1e79817cda33</citedby><cites>FETCH-LOGICAL-c447t-490be13139dcd572c9d139e11ea9c37e038cedef6795be5a0125e1e79817cda33</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.eururo.2013.10.040$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,780,784,3550,27924,27925,45995</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=28562345$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/24331152$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Bachmann, Alexander</creatorcontrib><creatorcontrib>Tubaro, Andrea</creatorcontrib><creatorcontrib>Barber, Neil</creatorcontrib><creatorcontrib>d’Ancona, Frank</creatorcontrib><creatorcontrib>Muir, Gordon</creatorcontrib><creatorcontrib>Witzsch, Ulrich</creatorcontrib><creatorcontrib>Grimm, Marc-Oliver</creatorcontrib><creatorcontrib>Benejam, Joan</creatorcontrib><creatorcontrib>Stolzenburg, Jens-Uwe</creatorcontrib><creatorcontrib>Riddick, Antony</creatorcontrib><creatorcontrib>Pahernik, Sascha</creatorcontrib><creatorcontrib>Roelink, Herman</creatorcontrib><creatorcontrib>Ameye, Filip</creatorcontrib><creatorcontrib>Saussine, Christian</creatorcontrib><creatorcontrib>Bruyère, Franck</creatorcontrib><creatorcontrib>Loidl, Wolfgang</creatorcontrib><creatorcontrib>Larner, Tim</creatorcontrib><creatorcontrib>Gogoi, Nirjan-Kumar</creatorcontrib><creatorcontrib>Hindley, Richard</creatorcontrib><creatorcontrib>Muschter, Rolf</creatorcontrib><creatorcontrib>Thorpe, Andrew</creatorcontrib><creatorcontrib>Shrotri, Nitin</creatorcontrib><creatorcontrib>Graham, Stuart</creatorcontrib><creatorcontrib>Hamann, Moritz</creatorcontrib><creatorcontrib>Miller, Kurt</creatorcontrib><creatorcontrib>Schostak, Martin</creatorcontrib><creatorcontrib>Capitán, Carlos</creatorcontrib><creatorcontrib>Knispel, Helmut</creatorcontrib><creatorcontrib>Thomas, J. Andrew</creatorcontrib><title>180-W XPS GreenLight Laser Vaporisation Versus Transurethral Resection of the Prostate for the Treatment of Benign Prostatic Obstruction: 6-Month Safety and Efficacy Results of a European Multicentre Randomised Trial—The GOLIATH Study</title><title>European urology</title><addtitle>Eur Urol</addtitle><description>Abstract Background The comparative outcome with GreenLight (GL) photoselective vaporisation of the prostate and transurethral resection of the prostate (TURP) in men with lower urinary tract symptoms due to benign prostatic obstruction (BPO) has been questioned. Objective The primary objective of the GOLIATH study was to evaluate the noninferiority of 180-W GL XPS (XPS) to TURP for International Prostate Symptom Score (IPSS) and maximum flow rate (Qmax ) at 6 mo and the proportion of patients who were complication free. Design, setting, and participants Prospective randomised controlled trial at 29 centres in 9 European countries involving 281 patients with BPO. Intervention 180-W GL XPS system or TURP. Outcome measurements and statistical analysis Measurements used were IPSS, Qmax , prostate volume (PV), postvoid residual (PVR) and complications, perioperative parameters, and reintervention rates. Noninferiority was evaluated using one-sided tests at the 2.5% level of significance. The statistical significance of other comparisons was assessed at the (two-sided) 5% level. Results and limitations The study demonstrated the noninferiority of XPS to TURP for IPSS, Qmax , and complication-free proportion. PV and PVR were comparable between groups. Time until stable health status, length of catheterisation, and length of hospital stay were superior with XPS ( p < 0.001). Early reintervention rate within 30 d was three times higher after TURP ( p = 0.025); however, the overall postoperative reintervention rates were not significantly different between treatment arms. A limitation was the short follow-up. Conclusions XPS was shown to be noninferior (comparable) to TURP in terms of IPSS, Qmax , and proportion of patients free of complications. XPS results in a lower rate of early reinterventions but has a similar rate after 6 mo. Trial registration ClinicalTrials.gov, identifier NCT01218672.</description><subject>Adult</subject><subject>Adverse events</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Benign prostatic obstruction (BPO)</subject><subject>Biological and medical sciences</subject><subject>Clavien-Dindo classification</subject><subject>Efficacy</subject><subject>Europe</subject><subject>Follow-Up Studies</subject><subject>GreenLight XPS 180-W laser</subject><subject>Hemorrhage - etiology</subject><subject>Humans</subject><subject>Intention to Treat Analysis</subject><subject>Laser Therapy - adverse effects</subject><subject>Length of Stay</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Nephrology. Urinary tract diseases</subject><subject>Organ Size</subject><subject>Photoselective vaporisation of the prostate (PVP)</subject><subject>Prospective Studies</subject><subject>Prostate - pathology</subject><subject>Prostate-Specific Antigen - blood</subject><subject>Prostatectomy - adverse effects</subject><subject>Prostatic Hyperplasia - blood</subject><subject>Prostatic Hyperplasia - complications</subject><subject>Prostatic Hyperplasia - surgery</subject><subject>Prostatism - etiology</subject><subject>Prostatism - physiopathology</subject><subject>Safety</subject><subject>Severity of Illness Index</subject><subject>Time Factors</subject><subject>Transurethral surgery</subject><subject>TURP</subject><subject>Urinary Catheterization</subject><subject>Urinary Incontinence - etiology</subject><subject>Urinary Retention - etiology</subject><subject>Urodynamics</subject><subject>Urology</subject><issn>0302-2838</issn><issn>1873-7560</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2014</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkstuEzEUhkcIREPhDRDyBonNBJ_xTGaGBVJbhbRSqlRNKOwsx3OmcZjYwRek7HgInpA1D4EnSUFiw8rW8ef_XP6TJC-BDoHC6O16iMEGa4YZBRZDQ5rTR8kAqpKlZTGij5MBZTRLs4pVJ8kz59aUUlbU7GlykuWMARTZIPkFFU0_kc83czKxiHqq7leeTIVDS-7E1ljlhFdGkzu0LjiysEK7YNGvrOjILTqU-2fTEr9CcmON88IjaY3dBxYWhd-g9j1xjlrd6wdISTJbOm_DXuEdGaXXRvsVmYsW_Y4I3ZBx2yop5K5PFDrvehFBxrHrLQpNrmNMyShukdxG3myUwybmVKL7-f3HIuafzKZXZ4tLMveh2T1PnrSic_jieJ4mHz-MFxeX6XQ2ubo4m6Yyz0uf5jVdIjBgdSObosxk3cQ7AqCoJSuRskpig-2orIslFoJCViBgWVdQykYwdpq8Oehurfka0HkeC5PYdUKjCY5DQas6Z1CXEc0PqIxDcRZbvrVqI-yOA-W9z3zNDz7z3uc-Gn2O314dM4TlBps_nx6MjcDrIyCcFF0bbZPK_eWqYpSxvIjc-wOHcR7fFFrupEId-1M2Wssbo_5Xyb8CslM6utZ9wR26tQlWx1lz4C7jlM_7nexXEhgFYEXOfgOO6OGm</recordid><startdate>20140501</startdate><enddate>20140501</enddate><creator>Bachmann, Alexander</creator><creator>Tubaro, Andrea</creator><creator>Barber, Neil</creator><creator>d’Ancona, Frank</creator><creator>Muir, Gordon</creator><creator>Witzsch, Ulrich</creator><creator>Grimm, Marc-Oliver</creator><creator>Benejam, Joan</creator><creator>Stolzenburg, Jens-Uwe</creator><creator>Riddick, Antony</creator><creator>Pahernik, Sascha</creator><creator>Roelink, Herman</creator><creator>Ameye, Filip</creator><creator>Saussine, Christian</creator><creator>Bruyère, Franck</creator><creator>Loidl, Wolfgang</creator><creator>Larner, Tim</creator><creator>Gogoi, Nirjan-Kumar</creator><creator>Hindley, Richard</creator><creator>Muschter, Rolf</creator><creator>Thorpe, Andrew</creator><creator>Shrotri, Nitin</creator><creator>Graham, Stuart</creator><creator>Hamann, Moritz</creator><creator>Miller, Kurt</creator><creator>Schostak, Martin</creator><creator>Capitán, Carlos</creator><creator>Knispel, Helmut</creator><creator>Thomas, J. 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Andrew</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c447t-490be13139dcd572c9d139e11ea9c37e038cedef6795be5a0125e1e79817cda33</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2014</creationdate><topic>Adult</topic><topic>Adverse events</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Benign prostatic obstruction (BPO)</topic><topic>Biological and medical sciences</topic><topic>Clavien-Dindo classification</topic><topic>Efficacy</topic><topic>Europe</topic><topic>Follow-Up Studies</topic><topic>GreenLight XPS 180-W laser</topic><topic>Hemorrhage - etiology</topic><topic>Humans</topic><topic>Intention to Treat Analysis</topic><topic>Laser Therapy - adverse effects</topic><topic>Length of Stay</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Nephrology. Urinary tract diseases</topic><topic>Organ Size</topic><topic>Photoselective vaporisation of the prostate (PVP)</topic><topic>Prospective Studies</topic><topic>Prostate - pathology</topic><topic>Prostate-Specific Antigen - blood</topic><topic>Prostatectomy - adverse effects</topic><topic>Prostatic Hyperplasia - blood</topic><topic>Prostatic Hyperplasia - complications</topic><topic>Prostatic Hyperplasia - surgery</topic><topic>Prostatism - etiology</topic><topic>Prostatism - physiopathology</topic><topic>Safety</topic><topic>Severity of Illness Index</topic><topic>Time Factors</topic><topic>Transurethral surgery</topic><topic>TURP</topic><topic>Urinary Catheterization</topic><topic>Urinary Incontinence - etiology</topic><topic>Urinary Retention - etiology</topic><topic>Urodynamics</topic><topic>Urology</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Bachmann, Alexander</creatorcontrib><creatorcontrib>Tubaro, Andrea</creatorcontrib><creatorcontrib>Barber, Neil</creatorcontrib><creatorcontrib>d’Ancona, Frank</creatorcontrib><creatorcontrib>Muir, Gordon</creatorcontrib><creatorcontrib>Witzsch, Ulrich</creatorcontrib><creatorcontrib>Grimm, Marc-Oliver</creatorcontrib><creatorcontrib>Benejam, Joan</creatorcontrib><creatorcontrib>Stolzenburg, Jens-Uwe</creatorcontrib><creatorcontrib>Riddick, Antony</creatorcontrib><creatorcontrib>Pahernik, Sascha</creatorcontrib><creatorcontrib>Roelink, Herman</creatorcontrib><creatorcontrib>Ameye, Filip</creatorcontrib><creatorcontrib>Saussine, Christian</creatorcontrib><creatorcontrib>Bruyère, Franck</creatorcontrib><creatorcontrib>Loidl, Wolfgang</creatorcontrib><creatorcontrib>Larner, Tim</creatorcontrib><creatorcontrib>Gogoi, Nirjan-Kumar</creatorcontrib><creatorcontrib>Hindley, Richard</creatorcontrib><creatorcontrib>Muschter, Rolf</creatorcontrib><creatorcontrib>Thorpe, Andrew</creatorcontrib><creatorcontrib>Shrotri, Nitin</creatorcontrib><creatorcontrib>Graham, Stuart</creatorcontrib><creatorcontrib>Hamann, Moritz</creatorcontrib><creatorcontrib>Miller, Kurt</creatorcontrib><creatorcontrib>Schostak, Martin</creatorcontrib><creatorcontrib>Capitán, Carlos</creatorcontrib><creatorcontrib>Knispel, Helmut</creatorcontrib><creatorcontrib>Thomas, J. Andrew</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>European urology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Bachmann, Alexander</au><au>Tubaro, Andrea</au><au>Barber, Neil</au><au>d’Ancona, Frank</au><au>Muir, Gordon</au><au>Witzsch, Ulrich</au><au>Grimm, Marc-Oliver</au><au>Benejam, Joan</au><au>Stolzenburg, Jens-Uwe</au><au>Riddick, Antony</au><au>Pahernik, Sascha</au><au>Roelink, Herman</au><au>Ameye, Filip</au><au>Saussine, Christian</au><au>Bruyère, Franck</au><au>Loidl, Wolfgang</au><au>Larner, Tim</au><au>Gogoi, Nirjan-Kumar</au><au>Hindley, Richard</au><au>Muschter, Rolf</au><au>Thorpe, Andrew</au><au>Shrotri, Nitin</au><au>Graham, Stuart</au><au>Hamann, Moritz</au><au>Miller, Kurt</au><au>Schostak, Martin</au><au>Capitán, Carlos</au><au>Knispel, Helmut</au><au>Thomas, J. Andrew</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>180-W XPS GreenLight Laser Vaporisation Versus Transurethral Resection of the Prostate for the Treatment of Benign Prostatic Obstruction: 6-Month Safety and Efficacy Results of a European Multicentre Randomised Trial—The GOLIATH Study</atitle><jtitle>European urology</jtitle><addtitle>Eur Urol</addtitle><date>2014-05-01</date><risdate>2014</risdate><volume>65</volume><issue>5</issue><spage>931</spage><epage>942</epage><pages>931-942</pages><issn>0302-2838</issn><eissn>1873-7560</eissn><coden>EUURAV</coden><abstract>Abstract Background The comparative outcome with GreenLight (GL) photoselective vaporisation of the prostate and transurethral resection of the prostate (TURP) in men with lower urinary tract symptoms due to benign prostatic obstruction (BPO) has been questioned. Objective The primary objective of the GOLIATH study was to evaluate the noninferiority of 180-W GL XPS (XPS) to TURP for International Prostate Symptom Score (IPSS) and maximum flow rate (Qmax ) at 6 mo and the proportion of patients who were complication free. Design, setting, and participants Prospective randomised controlled trial at 29 centres in 9 European countries involving 281 patients with BPO. Intervention 180-W GL XPS system or TURP. Outcome measurements and statistical analysis Measurements used were IPSS, Qmax , prostate volume (PV), postvoid residual (PVR) and complications, perioperative parameters, and reintervention rates. Noninferiority was evaluated using one-sided tests at the 2.5% level of significance. The statistical significance of other comparisons was assessed at the (two-sided) 5% level. Results and limitations The study demonstrated the noninferiority of XPS to TURP for IPSS, Qmax , and complication-free proportion. PV and PVR were comparable between groups. Time until stable health status, length of catheterisation, and length of hospital stay were superior with XPS ( p < 0.001). Early reintervention rate within 30 d was three times higher after TURP ( p = 0.025); however, the overall postoperative reintervention rates were not significantly different between treatment arms. A limitation was the short follow-up. Conclusions XPS was shown to be noninferior (comparable) to TURP in terms of IPSS, Qmax , and proportion of patients free of complications. XPS results in a lower rate of early reinterventions but has a similar rate after 6 mo. Trial registration ClinicalTrials.gov, identifier NCT01218672.</abstract><cop>Kidlington</cop><pub>Elsevier B.V</pub><pmid>24331152</pmid><doi>10.1016/j.eururo.2013.10.040</doi><tpages>12</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0302-2838 |
| ispartof | European urology, 2014-05, Vol.65 (5), p.931-942 |
| issn | 0302-2838 1873-7560 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_1508943197 |
| source | MEDLINE; ScienceDirect Journals (5 years ago - present) |
| subjects | Adult Adverse events Aged Aged, 80 and over Benign prostatic obstruction (BPO) Biological and medical sciences Clavien-Dindo classification Efficacy Europe Follow-Up Studies GreenLight XPS 180-W laser Hemorrhage - etiology Humans Intention to Treat Analysis Laser Therapy - adverse effects Length of Stay Male Medical sciences Middle Aged Nephrology. Urinary tract diseases Organ Size Photoselective vaporisation of the prostate (PVP) Prospective Studies Prostate - pathology Prostate-Specific Antigen - blood Prostatectomy - adverse effects Prostatic Hyperplasia - blood Prostatic Hyperplasia - complications Prostatic Hyperplasia - surgery Prostatism - etiology Prostatism - physiopathology Safety Severity of Illness Index Time Factors Transurethral surgery TURP Urinary Catheterization Urinary Incontinence - etiology Urinary Retention - etiology Urodynamics Urology |
| title | 180-W XPS GreenLight Laser Vaporisation Versus Transurethral Resection of the Prostate for the Treatment of Benign Prostatic Obstruction: 6-Month Safety and Efficacy Results of a European Multicentre Randomised Trial—The GOLIATH Study |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-06T20%3A14%3A21IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=180-W%20XPS%20GreenLight%20Laser%20Vaporisation%20Versus%20Transurethral%20Resection%20of%20the%20Prostate%20for%20the%20Treatment%20of%20Benign%20Prostatic%20Obstruction:%206-Month%20Safety%20and%20Efficacy%20Results%20of%20a%20European%20Multicentre%20Randomised%20Trial%E2%80%94The%20GOLIATH%20Study&rft.jtitle=European%20urology&rft.au=Bachmann,%20Alexander&rft.date=2014-05-01&rft.volume=65&rft.issue=5&rft.spage=931&rft.epage=942&rft.pages=931-942&rft.issn=0302-2838&rft.eissn=1873-7560&rft.coden=EUURAV&rft_id=info:doi/10.1016/j.eururo.2013.10.040&rft_dat=%3Cproquest_cross%3E1508943197%3C/proquest_cross%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=1508943197&rft_id=info:pmid/24331152&rft_els_id=S0302283813011354&rfr_iscdi=true |