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Eligible patients received FDC of tamsulosin+tadalafil (0.4\u2009+\u20095\u00a0mg) capsules for 12 weeks. The endpoints included treatment-emergent adverse events (TEAEs), total IPSS, IPSS storage and voiding sub-scores, maximum urinary flow rate (Q\n                      <jats:sub>max<\/jats:sub>\n                      ), post-void residual (PVR) volume, IIEF-EF (questions 1\u20135 and 15) score, and IPSS quality of life (QoL) index.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      A total of 172 were enrolled. Overall, 12 TEAEs were reported in 10 (5.81%) patients. None of the TEAEs were severe, serious, life-threatening, or required treatment interruption. A statistically significant improvement (\n                      <jats:italic>p<\/jats:italic>\n                      \u2009&lt;\u20090.0001) in total IPSS after 4, 8, and 12 weeks was observed. Similar improvements from baseline were also observed in IPSS storage and voiding sub-scores, IPSS QoL, Q\n                      <jats:sub>max<\/jats:sub>\n                      , PVR volume, and IIEF-EF (questions 1\u20135 and 15) score (\n                      <jats:italic>p<\/jats:italic>\n                      \u2009&lt;\u20090.05 for each parameter). The proportion of men with normal erectile function significantly increased at week 12 (\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.0003).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>The FDC of tamsulosin and tadalafil was associated with significant improvements in lower urinary tract symptoms and EF over 12 weeks and was well tolerated in Indian men with moderate-severe BPH and ED.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>Prospectively registered at Clinical Trials Registry\u2014India on 10th June 2022 [CTRI\/2022\/06\/043152].<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s00345-026-06306-3","type":"journal-article","created":{"date-parts":[[2026,3,1]],"date-time":"2026-03-01T20:10:06Z","timestamp":1772395806000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["A fixed dose combination of tamsulosin and tadalafil in men with benign prostatic hyperplasia and erectile dysfunction: a prospective, multicenter, phase IV study"],"prefix":"10.1007","volume":"44","author":[{"given":"Chirag","family":"Gupta","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Avinash T.","family":"S.","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dushyant Shamlabhai","family":"Pawar","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Abhay","family":"Khandekar","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"G. 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Authors Chirag Gupta, Avinash TS, Dushyant Shamlabhai Pawar, Abhay Khandekar, G. Ravindra Deshmukh, Vinay Kumar, Ajwani Vikky Ramesh, Shah Ishan Hemantkumar, and Patankar Suresh Balkrishna were the study investigators, and they have received a grant from the sponsor for conducting the study at their respective sites. Authors Dipesh Sonawane, Dipak Patil, Pravin Ghadge, and Suyog Mehta are full-time employees of Sun Pharma Laboratories Limited. Author Mandodari Rajurkar was a full-time employee of Sun Pharma Laboratories Limited during the conduct of the study and interpretation of the study data.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"Written informed consent was obtained from all participants prior to screening for the study.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Informed consent"}},{"value":"The study was reviewed and approved by the Institutional Ethics Committees at all participating study sites. These included Institutional Ethics Committee Jaipur National University Institute for Medical Science & Research Center, Institutional Ethics Committee Sparsh Hospital, Parth Hospital Ethics Committee, Riddhi Medical Nursing Home Institution Ethics Committee, Jasleen Hospital Ethics Committee, Ethics Committee GSVM Medical College, Anand Institutional Ethics Committee, Institutional Ethics Committee Dr. M. K. Shah Medical College and Research Center, and AMAI Trust Ace Hospital.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval"}}],"article-number":"214"}}