{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,29]],"date-time":"2026-04-29T21:52:34Z","timestamp":1777499554735,"version":"3.51.4"},"reference-count":21,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2014,3,13]],"date-time":"2014-03-13T00:00:00Z","timestamp":1394668800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["bjui-journals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["BJU International"],"published-print":{"date-parts":[[2014,9]]},"abstract":"\n Objective<\/jats:title>\n \n To evaluate the efficacy and safety of silodosin in a pooled analysis based on individual patients data from three randomised controlled trials (\n RCTs<\/jats:styled-content>\n ) comparing silodosin and placebo.\n <\/jats:p>\n <\/jats:sec>\n \n Patients and methods<\/jats:title>\n \n A pooled analysis of 1494 patients from three 12\u2010week, similarly designed, parallel\u2010group, multicentre, randomised, double\u2010blind, placebo\u2010controlled phase\n III RCTs<\/jats:styled-content>\n (\n SI<\/jats:styled-content>\n 04009,\n SI<\/jats:styled-content>\n 04010,\n KMD<\/jats:styled-content>\n 3213\u2010\n IT\u2010CL<\/jats:styled-content>\n 0215) was performed. Differences from placebo for the mean change from baseline to the end of treatment for the\n I<\/jats:styled-content>\n nternational\n P<\/jats:styled-content>\n rostate\n S<\/jats:styled-content>\n ymptom\n S<\/jats:styled-content>\n core (\n IPSS<\/jats:styled-content>\n ) and uroflowmetry data were tested using an analysis of covariance model.\n <\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n At study end, in the intention\u2010to\u2010treat population, silodosin was significantly more effective than placebo in improving\n IPSS<\/jats:styled-content>\n total score (adjusted means differences [\n AMD<\/jats:styled-content>\n ] 2.7;\n P<\/jats:italic>\n < 0.001). Silodosin was significantly more effective than placebo in improving storage, voiding, and quality\u2010of\u2010life\u2010item subscores (all\n P<\/jats:italic>\n < 0.001). Similarly, silodosin was more effective than placebo in improving maximum urinary flow rate (Q\n max<\/jats:sub>\n ;\n AMD<\/jats:styled-content>\n 0.8;\n P<\/jats:italic>\n = 0.002). The most frequently reported adverse event (\n AE<\/jats:styled-content>\n ) was ejaculatory dysfunction, reported in 186 (22%) patients in the silodosin group and six (0.9%) in the placebo group (odds ratio 28.14;\n P<\/jats:italic>\n < 0.001). Dizziness and orthostatic hypotension rates were similar in silodosin and placebo groups.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n \n Silodosin is an effective treatment for male lower urinary tract symptoms suggestive of benign prostatic hyperplasia. The drug is able to improve total\n IPSS<\/jats:styled-content>\n , all\n IPSS<\/jats:styled-content>\n \u2010related parameters, and\n Q<\/jats:styled-content>\n max<\/jats:sub>\n at uroflowmetry. Ejaculatory dysfunction is the main treatment\u2010related\n AE<\/jats:styled-content>\n , whereas prevalence of cardiovascular\n AEs<\/jats:styled-content>\n was similar to placebo.\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1111\/bju.12712","type":"journal-article","created":{"date-parts":[[2014,2,27]],"date-time":"2014-02-27T03:58:41Z","timestamp":1393473521000},"page":"427-433","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":26,"title":["A pooled analysis of individual patient data from registrational trials of silodosin in the treatment of non\u2010neurogenic male lower urinary tract symptoms (\n LUTS<\/scp>\n ) suggestive of benign prostatic hyperplasia (\n BPH<\/scp>\n )"],"prefix":"10.1111","volume":"114","author":[{"given":"Giacomo","family":"Novara","sequence":"first","affiliation":[{"name":"Department of Oncological, Surgical, and Gastroenterological Sciences, Urology Clinic University of Padua Padua Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Christopher R.","family":"Chapple","sequence":"additional","affiliation":[{"name":"Royal Hallamshire Hospital Sheffield UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Francesco","family":"Montorsi","sequence":"additional","affiliation":[{"name":"Department of Urology, Urological Research Institute Vita Salute San Raffaele University, San Raffaele Scientific Institute Milan Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2014,3,13]]},"reference":[{"key":"e_1_2_6_1_2_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1464-410X.2003.04369.x"},{"key":"e_1_2_6_1_3_1","unstructured":"OelkeM BachmannA DescazeaudAet\u2009al.EAU guidelines on the treatment of non\u2010neurogenic male LUTS 2011. 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