{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,21]],"date-time":"2026-10-21T18:19:05Z","timestamp":1792606745778,"version":"4.5.0"},"reference-count":23,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2021,12,20]],"date-time":"2021-12-20T00:00:00Z","timestamp":1639958400000},"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":[[2022,4]]},"abstract":"<jats:sec><jats:title>Objectives<\/jats:title><jats:p>To evaluate the efficacy of intravesical KRP\u2010116D, 50% dimethyl sulfoxide solution, in interstitial cystitis\/bladder pain syndrome patients with Hunner lesions (Hunner\u2010type interstitial cystitis), and to evaluate the correlations between efficacy variables and global response assessment to determine what constitutes a minimal clinically important change.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>We performed a post hoc analysis of the Japanese phase III trial of KRP\u2010116D. Changes at Week 12 from baseline in objective and subjective outcomes were compared between the KRP\u2010116D and placebo groups in Hunner\u2010type interstitial cystitis or non\u2010Hunner\u2010type interstitial cystitis patients. Correlations between efficacy variables at Week 12 and global response assessment were analyzed. Area under the receiver operating characteristic curve and the cut\u2010off value of efficacy valuables were calculated to determine clinically meaningful changes.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The effectiveness of intravesical treatment with KRP\u2010116D was demonstrated in Hunner\u2010type interstitial cystitis, but not in non\u2010Hunner\u2010type interstitial cystitis patients. Global response assessment was closely correlated with subjective outcomes including O\u2019Leary\u2010Sant Interstitial Cystitis Symptom Index, O\u2019Leary\u2010Sant Interstitial Cystitis Problem Index, and a numeric rating scale for bladder pain, but was less correlated with voiding variables including micturition frequency, voided volume, and maximum voided volume. In the receiver operating characteristic curve analyses, the cut\u2010off value for the O\u2019Leary\u2010Sant Interstitial Cystitis Symptom Index was \u22125 (sensitivity 81.3%, specificity 83.3%).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Clinical benefit of intravesical KRP\u2010116D in Hunner\u2010type interstitial cystitis patients was confirmed in this post hoc analysis. A five\u2010point reduction in O\u2019Leary\u2010Sant Interstitial Cystitis Symptom Index is a clinically meaningful indicator for assessing patient satisfaction with KRP\u2010116D treatment in patients with Hunner\u2010type interstitial cystitis.<\/jats:p><\/jats:sec>","DOI":"10.1111\/iju.14765","type":"journal-article","created":{"date-parts":[[2021,12,20]],"date-time":"2021-12-20T23:14:57Z","timestamp":1640042097000},"page":"289-296","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":12,"title":["The O'Leary\u2010Sant Interstitial Cystitis Symptom Index is a clinically useful indicator of treatment outcome in patients with interstitial cystitis\/bladder pain syndrome with Hunner lesions: A post hoc analysis of the Japanese phase III trial of KRP\u2010116D, 50% dimethyl sulfoxide solution"],"prefix":"10.1111","volume":"29","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8070-1664","authenticated-orcid":false,"given":"Naoki","family":"Yoshimura","sequence":"first","affiliation":[{"name":"Department of Urology University of Pittsburgh School of Medicine Pittsburgh Pennsylvania USA"},{"name":"Department of Urology Ueda Clinic Kyoto Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takashi","family":"Uno","sequence":"additional","affiliation":[{"name":"Clinical Development Center Kyorin Pharmaceutical Co., Ltd. Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mitsuru","family":"Sasaki","sequence":"additional","affiliation":[{"name":"Clinical Development Center Kyorin Pharmaceutical Co., Ltd. Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Akira","family":"Ohinata","sequence":"additional","affiliation":[{"name":"Clinical Development Center Kyorin Pharmaceutical Co., Ltd. Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shigeki","family":"Nawata","sequence":"additional","affiliation":[{"name":"Clinical Development Center Kyorin Pharmaceutical Co., Ltd. Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tomohiro","family":"Ueda","sequence":"additional","affiliation":[{"name":"Department of Urology Ueda Clinic Kyoto Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2021,12,20]]},"reference":[{"key":"e_1_2_13_2_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1442-2042.2008.02208.x"},{"key":"e_1_2_13_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.juro.2011.03.064"},{"key":"e_1_2_13_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.eururo.2007.09.019"},{"key":"e_1_2_13_5_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00404-017-4364-2"},{"key":"e_1_2_13_6_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1442-2042.2009.02326.x"},{"key":"e_1_2_13_7_1","doi-asserted-by":"publisher","DOI":"10.1002\/nau.20847"},{"key":"e_1_2_13_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.juro.2015.06.112"},{"key":"e_1_2_13_9_1","doi-asserted-by":"publisher","DOI":"10.1111\/iju.13969"},{"key":"e_1_2_13_10_1","doi-asserted-by":"publisher","DOI":"10.1111\/iju.13971"},{"key":"e_1_2_13_11_1","unstructured":"The Society of Interstitial Cystitis of Japan and The Japanese Urological Association.Clinical guideline for Interstitial cystitis\/bladder pain syndrome. 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