{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,4]],"date-time":"2026-11-04T03:33:42Z","timestamp":1793763222006,"version":"4.6.1"},"reference-count":25,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2021,7,20]],"date-time":"2021-07-20T00:00:00Z","timestamp":1626739200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100007819","name":"Allergan","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100007819","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Neurourology and Urodynamics"],"published-print":{"date-parts":[[2021,9]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Aims<\/jats:title><jats:p>Two phase 2 studies were conducted to assess the efficacy and safety of lidocaine\u2010releasing intravesical system (LiRIS) in patients with interstitial cystitis\/bladder pain syndrome (IC\/BPS) with (Study 001; NCT02395042) or without, (Study 002; NCT02411110) Hunner lesions (HL).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Both were multicenter, randomized, double\u2010blind, placebo\u2010controlled, and enrolled women aged \u226518 years. In Study 001, patients were randomized 2:1:1 to LiRIS 400\u2009mg\/LiRIS 400\u2009mg, placebo\/LiRIS 400\u2009mg, or placebo\/placebo for a continuous 28 (2\u2009\u00d7\u200914)\u2010day period. In Study 002, patients were randomized 1:1 to LiRIS 400\u2009mg or placebo for a continuous (single treatment) 14\u2010day period.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>In total, 59 and 131 patients received treatment in Studies 001 and 002, respectively. There was no statistically significant difference in the primary endpoint, the change from baseline to Week 4 of follow\u2010up post\u2010removal in mean daily average bladder numeric rating scale (NRS) pain score in either study (Study 001: placebo\/placebo, \u22121.6; LiRIS\/LiRIS, \u22122.7, <jats:italic>p\u2009=\u20090<\/jats:italic>.142; placebo\/LiRIS, \u22122.5, <jats:italic>p<\/jats:italic>\u2009=\u20090.319; Study 002: LiRIS \u22121.2; placebo, \u22121.5, <jats:italic>p<\/jats:italic>\u2009=\u20090.505). There was no statistically significant difference between groups in daily worst NRS pain score, number of micturitions\/day or urgency episodes\/day. There was no clear trend for reduction in number of HL for LiRIS vs placebo. The frequency of treatment\u2010emergent adverse events was similar between treatment groups in both studies; most were mild or moderate intensity.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>These studies did not demonstrate a treatment effect of LiRIS 400\u2009mg compared with placebo, either in patients with IC\/BPS with HL, or in those without HL.<\/jats:p><\/jats:sec>","DOI":"10.1002\/nau.24702","type":"journal-article","created":{"date-parts":[[2021,7,20]],"date-time":"2021-07-20T12:59:27Z","timestamp":1626785967000},"page":"1730-1739","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":11,"title":["Safety, tolerability, and efficacy of LiRIS 400\u2009mg in women with interstitial cystitis\/bladder pain syndrome with or without Hunner lesions"],"prefix":"10.1002","volume":"40","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3012-7152","authenticated-orcid":false,"given":"Robert","family":"Evans","sequence":"first","affiliation":[{"name":"Urology Wake Forest Baptist Hospital  Winston\u2010Salem North Carolina USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2568-6662","authenticated-orcid":false,"given":"Alfred","family":"Kohan","sequence":"additional","affiliation":[{"name":"Bethpage Division Advanced Urology Centers of New York  Bethpage New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2603-9160","authenticated-orcid":false,"given":"Robert","family":"Moldwin","sequence":"additional","affiliation":[{"name":"Urologic Infectious\/Inflammatory Diseases The Arthur Smith Institute for Urology  Lake Success New York 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