{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,28]],"date-time":"2026-09-28T19:15:21Z","timestamp":1790622921077,"version":"4.1.0"},"reference-count":16,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2025,12,9]],"date-time":"2025-12-09T00:00:00Z","timestamp":1765238400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2025,12,9]],"date-time":"2025-12-09T00:00:00Z","timestamp":1765238400000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Neurourology and Urodynamics"],"published-print":{"date-parts":[[2026,2]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Purpose<\/jats:title>\n                    <jats:p>Vibegron was associated with improvements in efficacy versus placebo and was well tolerated in men with overactive bladder (OAB) on pharmacotherapy for benign prostatic hyperplasia (BPH) in the COURAGE trial (NCT03902080). Additional safety, bladder function, and urodynamics data are provided.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      This 24\u2010week, phase 3, double\u2010blind, placebo\u2010controlled trial randomized men \u2265\u200945 years with OAB and BPH receiving \u03b1\u2010blocker \u00b1 5\u03b1\u2010reductase inhibitors to once\u2010daily vibegron or placebo (1:1). From the safety analysis set (SAF), postvoid residual urine volume (PVR), maximum urinary flow rate (Uroflow\u2010Q\n                      <jats:sub>max<\/jats:sub>\n                      ), International Prostate Symptom Score (IPSS) total score, and urologic\u2010related adverse events (AEs) were collected throughout the trial. Q\n                      <jats:sub>max<\/jats:sub>\n                      and detrusor pressure at Q\n                      <jats:sub>max<\/jats:sub>\n                      (P\n                      <jats:sub>det<\/jats:sub>\n                      Q\n                      <jats:sub>max<\/jats:sub>\n                      ) were collected at baseline and week 12 in a urodynamics substudy (urodynamics evaluable set [UES]).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      In the SAF, differences between vibegron (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u2009553) and placebo (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u2009551) in PVR and Uroflow\u2010Q\n                      <jats:sub>max<\/jats:sub>\n                      were minimal at baseline, week 12, and week 24. Mean (SD) change from baseline (CFB) at week 24 in IPSS total score was \u22127.3 (6.96) with vibegron and \u22125.7 (7.14) with placebo. Urinary retention was reported as an AE for 5 (0.9%) and 4 (0.7%) participants receiving vibegron and placebo, respectively. In the UES (vibegron,\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200921; placebo,\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200922), least squares mean difference (95% CI) between vibegron and placebo in CFB at week 12 was 2.75 (0.16, 5.34) mL\/s in Q\n                      <jats:sub>max<\/jats:sub>\n                      and 2.86 (\u201313.52, 19.25) cmH\n                      <jats:sub>2<\/jats:sub>\n                      O in P\n                      <jats:sub>det<\/jats:sub>\n                      Q\n                      <jats:sub>max<\/jats:sub>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>There were no safety signals related to bladder function identified by urodynamics; risk of protocol\u2010defined AEs of urinary retention or residual urine volume increase was not increased with vibegron compared with placebo in this population.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Clinical Trial Registration<\/jats:title>\n                    <jats:p>\n                      This study is registered at\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"https:\/\/www.clinicaltrials.gov\">www.clinicaltrials.gov<\/jats:ext-link>\n                      . The registration identification number is NCT03902080.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/nau.70199","type":"journal-article","created":{"date-parts":[[2025,12,9]],"date-time":"2025-12-09T11:46:57Z","timestamp":1765280817000},"page":"299-304","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Bladder Function and Safety of Vibegron in Men With Overactive Bladder Receiving Treatment for Benign Prostatic Hyperplasia: Outcomes From the Phase 3 Randomized Controlled COURAGE Trial"],"prefix":"10.1002","volume":"45","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3950-8752","authenticated-orcid":false,"given":"Eric S.","family":"Rovner","sequence":"first","affiliation":[{"name":"Medical University of South Carolina Charleston South Carolina USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0003-2457-2214","authenticated-orcid":false,"given":"Janet","family":"Owens\u2010Grillo","sequence":"additional","affiliation":[{"name":"Sumitomo Pharma America, Inc Marlborough Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elizabeth","family":"Thomas","sequence":"additional","affiliation":[{"name":"Sumitomo Pharma America, Inc Marlborough Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8666-8236","authenticated-orcid":false,"given":"Sender","family":"Herschorn","sequence":"additional","affiliation":[{"name":"Sunnybrook Health Sciences Centre University of Toronto Toronto Ontario Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9020-598X","authenticated-orcid":false,"given":"Kenneth M.","family":"Peters","sequence":"additional","affiliation":[{"name":"Oakland University William Beaumont School of Medicine Rochester Michigan USA"},{"name":"Corewell Health William Beaumont University Hospital Royal Oak Michigan USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4972-765X","authenticated-orcid":false,"given":"David","family":"Staskin","sequence":"additional","affiliation":[{"name":"Tufts University School of Medicine Boston Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Salim","family":"Mujais","sequence":"additional","affiliation":[{"name":"Sumitomo Pharma America, Inc Marlborough Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,12,9]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.1097\/JU.0000000000002183"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1097\/JU.0000000000003985"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1002\/nau.23897"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/S2666-7568(22)00213-6"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.1002\/nau.24348"},{"key":"e_1_2_11_7_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1464-410X.2004.05039.x"},{"key":"e_1_2_11_8_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.296.19.2319"},{"key":"e_1_2_11_9_1","volume-title":"Full Prescribing Information","author":"Sumitomo Pharma America Inc. 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