{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,13]],"date-time":"2026-08-13T15:33:11Z","timestamp":1786635191261,"version":"build-2736575974"},"reference-count":22,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2026,2,10]],"date-time":"2026-02-10T00:00:00Z","timestamp":1770681600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2026,2,10]],"date-time":"2026-02-10T00:00:00Z","timestamp":1770681600000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["bjui-journals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["BJU International"],"published-print":{"date-parts":[[2026,4]]},"abstract":"<jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>To evaluate the efficacy and safety of a fixed\u2010dose combination (FDC) of dutasteride and tadalafil vs monotherapy in patients with benign prostatic hyperplasia (BPH).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Patients and Methods<\/jats:title>\n                    <jats:p>This phase III trial enrolled 667 patients. After screening and washout, eligible patients were stratified by the baseline International Prostate Symptom Score (IPSS) and randomised (1:1:1) to receive FDC dutasteride 0.5\u2009mg\/tadalafil 5\u2009mg (FDC 0.5\/5\u2009mg), dutasteride 0.5\u2009mg, or tadalafil 5\u2009mg for 48\u2009weeks. The primary endpoint was the change in total IPSS from baseline to Week 48. Efficacy and safety were assessed at 4, 12, 24, 36, and 48\u2009weeks.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      In total, 619 patients were analysed for efficacy. The least squares (LS) mean (standard error [\n                      <jats:sc>se]<\/jats:sc>\n                      ) change in total IPSS at 48\u2009weeks from baseline was \u22129.49\u2009(0.37) for the FDC 0.5\/5\u2009mg group vs \u20134.40\u2009(0.37) for dutasteride 0.5\u2009mg group (LS mean difference [LSMD] \u20135.09, 95% confidence interval [CI] \u22126.13 to \u22124.50;\n                      <jats:italic>P<\/jats:italic>\n                      \u2009&lt;\u20090.001), and \u22129.53\u2009(0.36) for the FDC 0.5\/5\u2009mg group vs \u20134.24\u2009(0.37) for tadalafil 5\u2009mg group (LSMD \u20135.29, 95% CI \u22126.30 to \u22124.27;\n                      <jats:italic>P<\/jats:italic>\n                      \u2009&lt;\u20090.001). The FDC 0.5\/5\u2009mg group demonstrated the most pronounced improvement in quality of life. Although the maximum urinary flow rate and post\u2010void residual volume improved in all groups, differences were not statistically significant. In the comparison between the FDC 0.5\/5\u2009mg and dutasteride 0.5\u2009mg groups, the LSMD (95% CI) of change from baseline to Week 48 in the international index of erectile function \u2010 erectile function (IIEF \u2010 EF)\u00a0total score was 4.03\u2009(2.35 to \u20135.71) (\n                      <jats:italic>P<\/jats:italic>\n                      \u2009&lt;\u20090.05). Among the 655 patients analysed for safety, treatment\u2010emergent adverse events occurred in 32.88% (FDC 0.5\/5\u2009mg) vs 21.20% (dutasteride 0.5\u2009mg) and 26.48% (tadalafil 5\u2009mg), with few serious adverse events observed.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The FDC 0.5\/5\u2009mg demonstrated superior efficacy, and an acceptable safety profile compared with dutasteride and tadalafil monotherapies in patients with BPH.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/bju.70163","type":"journal-article","created":{"date-parts":[[2026,2,11]],"date-time":"2026-02-11T00:54:53Z","timestamp":1770771293000},"page":"698-707","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Combined therapy with dutasteride and tadalafil vs dutasteride or tadalafil monotherapy in benign prostatic hyperplasia: a randomised phase\n                    <scp>III<\/scp>\n                    trial"],"prefix":"10.1111","volume":"137","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7602-7977","authenticated-orcid":false,"given":"Seung Wook","family":"Lee","sequence":"first","affiliation":[{"name":"Department of Urology, Hanyang University Guri Hospital Hanyang University College of Medicine  Guri South Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Seung Hwan","family":"Lee","sequence":"additional","affiliation":[{"name":"Department of Urology Yonsei University College of Medicine  Seoul South Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4490-3610","authenticated-orcid":false,"given":"Jae Heon","family":"Kim","sequence":"additional","affiliation":[{"name":"Department of Urology Soonchunhyang University College of Medicine  Seoul South Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joon Hwa","family":"Noh","sequence":"additional","affiliation":[{"name":"Department of Urology Kwangju Christian Hospital  Gwangju South Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jun Ho","family":"Lee","sequence":"additional","affiliation":[{"name":"Department of Urology, Nowon Eulji Medical Center Eulji University School of Medicine  Seoul South Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9352-3411","authenticated-orcid":false,"given":"U\u2010Syn","family":"Ha","sequence":"additional","affiliation":[{"name":"Department of Urology, Seoul St. Mary's Hospital, College of Medicine The Catholic University of Korea  Seoul South Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cheol Young","family":"Oh","sequence":"additional","affiliation":[{"name":"Department of Urology, Hallym University Pyeongchon Sacred Heart Hospital Hallym University College of Medicine  Anyang South Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Taek Won","family":"Kang","sequence":"additional","affiliation":[{"name":"Department of Urology Chonnam National University College of Medicine  Gwangju South Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kyung Seop","family":"Lee","sequence":"additional","affiliation":[{"name":"Department of Urology, Keimyung University Dongsan Hospital Keimyung University College of Medicine  Daegu South Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sangchul","family":"Lee","sequence":"additional","affiliation":[{"name":"Department of Urology, Seoul National University Bundang Hospital Seoul National University College of Medicine  Seongnam South Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Deok Hyun","family":"Han","sequence":"additional","affiliation":[{"name":"Department of Urology Samsung Medical Center  Seoul South Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8452-1916","authenticated-orcid":false,"given":"Jun Hyun","family":"Han","sequence":"additional","affiliation":[{"name":"Department of Urology, Hallym University Dongtan Sacred Heart Hospital Hallym University College of Medicine  Hwaseong South Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sang Hoon","family":"Song","sequence":"additional","affiliation":[{"name":"Department of Urology, Asan Medical Center University of Ulsan College of Medicine  Seoul South Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hyun Jun","family":"Park","sequence":"additional","affiliation":[{"name":"Department of Urology Pusan National University School of Medicine  Busan South Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9817-3660","authenticated-orcid":false,"given":"Byung Ha","family":"Chung","sequence":"additional","affiliation":[{"name":"Department of Urology, Gangnam Severance Hospital Yonsei University College of Medicine  Seoul South Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gyeong Eun","family":"Min","sequence":"additional","affiliation":[{"name":"Department of Urology Kyung Hee University College of Medicine at Gangdong  Seoul South Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4093-832X","authenticated-orcid":false,"given":"In Gab","family":"Jeong","sequence":"additional","affiliation":[{"name":"Department of Urology, Asan Medical Center University of Ulsan College of Medicine  Seoul South Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kyung Hyun","family":"Moon","sequence":"additional","affiliation":[{"name":"Department of Urology, Ulsan University Hospital Ulsan University College of Medicine  Ulsan South 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