{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,22]],"date-time":"2026-09-22T10:02:28Z","timestamp":1790071348232,"version":"4.0.1"},"reference-count":29,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2021,2,12]],"date-time":"2021-02-12T00:00:00Z","timestamp":1613088000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Int J of Urology"],"published-print":{"date-parts":[[2021,5]]},"abstract":"<jats:sec><jats:title>Objective<\/jats:title><jats:p>To evaluate the efficacy and safety of intravesical KRP\u2010116D, 50% dimethyl sulfoxide solution compared with placebo, in interstitial cystitis\/bladder pain syndrome patients.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Japanese interstitial cystitis\/bladder pain syndrome patients with an O\u2019Leary\u2010Sant Interstitial Cystitis Symptom Index score of \u22659, who exhibited the bladder\u2010centric phenotype of interstitial cystitis\/bladder pain syndrome diagnosed by cystoscopy and bladder\u2010derived pain, were enrolled. Patients were allocated to receive either KRP\u2010116D (<jats:italic>n<\/jats:italic>\u00a0=\u00a049) or placebo (<jats:italic>n<\/jats:italic>\u00a0=\u00a047). The study drug was intravesically administered every 2\u00a0weeks for 12\u00a0weeks.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>For the primary endpoint, the change in the mean O\u2019Leary\u2010Sant Interstitial Cystitis Symptom Index score from baseline to week 12 was \u22125.2 in the KRP\u2010116D group and \u22123.4 in the placebo group. The estimated difference between the KRP\u2010116D and placebo groups was \u22121.8 (95% confidence interval \u22123.3, \u22120.3; <jats:italic>P<\/jats:italic>\u00a0=\u00a00.0188). Statistically significant improvements for KRP\u2010116D were also observed in the secondary endpoints including O\u2019Leary\u2010Sant Interstitial Cystitis Problem Index score, micturition episodes\/24\u00a0h, voided volume\/micturition, maximum voided volume\/micturition, numerical rating scale score for bladder pain, and global response assessment score. The adverse drug reactions were mild to moderate, and manageable.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>This first randomized, double\u2010blind, placebo\u2010controlled trial shows that KRP\u2010116D improves symptoms, voiding parameters, and global response assessment, compared with placebo, and has a well\u2010tolerated safety profile in interstitial cystitis\/bladder pain syndrome patients with the bladder\u2010centric phenotype.<\/jats:p><\/jats:sec>","DOI":"10.1111\/iju.14505","type":"journal-article","created":{"date-parts":[[2021,2,14]],"date-time":"2021-02-14T15:27:37Z","timestamp":1613316457000},"page":"545-553","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":40,"title":["Efficacy and safety of intravesical instillation of KRP\u2010116D (50% dimethyl sulfoxide solution) for interstitial cystitis\/bladder pain syndrome in Japanese patients: A multicenter, randomized, double\u2010blind, placebo\u2010controlled, clinical study"],"prefix":"10.1111","volume":"28","author":[{"given":"Naoki","family":"Yoshimura","sequence":"first","affiliation":[{"name":"Department of Urology University of Pittsburgh School of Medicine Pittsburgh PA USA"},{"name":"Department of Urology Ueda Clinic Kyoto Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yukio","family":"Homma","sequence":"additional","affiliation":[{"name":"Japanese Red Cross Medical Center Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hikaru","family":"Tomoe","sequence":"additional","affiliation":[{"name":"Department of Pelvic Reconstructive Surgery\/Urology Tokyo Women\u2019s Medical University Medical Center East Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Atsushi","family":"Otsuka","sequence":"additional","affiliation":[{"name":"Department of Urology Hamamatsu University School of Medicine Shizuoka 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