{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,14]],"date-time":"2026-07-14T11:57:58Z","timestamp":1784030278629,"version":"3.55.0"},"reference-count":25,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2020,1,16]],"date-time":"2020-01-16T00:00:00Z","timestamp":1579132800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Ion-03 National Institute of Aging","award":["R44DK093279"],"award-info":[{"award-number":["R44DK093279"]}]},{"name":"Ion Channel Innovations, LLC"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Neurourology and Urodynamics"],"published-print":{"date-parts":[[2020,2]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Aims<\/jats:title>\n                    <jats:p>Two phase 1 trials were performed in healthy women with the overactive bladder (OAB) syndrome and urodynamically demonstrated detrusor overactivity (DO), with the aim to demonstrate the safety and potential efficacy of URO\u2010902, which comprises a gene therapy plasmid vector expressing the human big potassium channel \u03b1 subunit.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>ION\u201002 (intravesical instillation) and ION\u201003 (direct injection) were double\u2010blind, placebo\u2010controlled, multicenter studies without overlap in enrollment between studies. Active doses were administered and evaluated sequentially (lowest dose first) for safety. ION\u201002 participants received either 5000\u2009\u00b5g or 10\u2009000\u2009\u00b5g URO\u2010902, or placebo. ION\u201003 participants received either 16\u2009000 or 24\u2009000\u2009\u00b5g URO\u2010902, or placebo, injected directly into the bladder wall using cystoscopy. Primary outcome variables were safety parameters occurring subsequent to URO\u2010902 administration; secondary efficacy variables also were evaluated.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Among the safety outcomes, there were no dose\u2010limiting toxicities or significant adverse events (AEs) preventing dose escalation during either trial, and no participants withdrew due to AEs. For efficacy, in ION\u201002 (\n                      <jats:italic>N<\/jats:italic>\n                      \u2009=\u200921), involuntary detrusor contractions on urodynamics at 24 weeks in patients receiving URO\u2010902 (\n                      <jats:italic>P<\/jats:italic>\n                      \u2009&lt;\u2009.0508 vs placebo) and mean urgency incontinence episodes in the 5000\u2009\u00b5g group (\n                      <jats:italic>P<\/jats:italic>\n                      \u2009=\u2009.0812 vs placebo) each showed a downward trend. In ION\u201003 (\n                      <jats:italic>N<\/jats:italic>\n                      \u2009=\u200913), significant reduction versus placebo in urgency episodes (16\u2009000\u2009\u00b5g,\n                      <jats:italic>P<\/jats:italic>\n                      \u2009=\u2009.036; 24\u2009000\u2009\u00b5g,\n                      <jats:italic>P<\/jats:italic>\n                      \u2009=\u2009.046) and number of voids (16\u2009000\u2009\u00b5g, \u22122.16,\n                      <jats:italic>P<\/jats:italic>\n                      \u2009=\u2009.044; 24\u2009000\u2009\u00b5g, \u22122.73,\n                      <jats:italic>P<\/jats:italic>\n                      \u2009=\u2009.047) were observed 1 week after injection.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Promising safety and efficacy results in these preliminary phase 1 studies suggest gene transfer may be a promising therapy for OAB\/DO, warranting further investigation.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/nau.24272","type":"journal-article","created":{"date-parts":[[2020,1,16]],"date-time":"2020-01-16T13:25:02Z","timestamp":1579181102000},"page":"744-753","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":33,"title":["Evaluating the safety and potential activity of URO\u2010902 (hMaxi\u2010K) gene transfer by intravesical instillation or direct injection into the bladder wall in female participants with idiopathic (non\u2010neurogenic) overactive bladder syndrome and detrusor overactivity from two double\u2010blind, imbalanced, placebo\u2010controlled randomized phase 1 trials"],"prefix":"10.1002","volume":"39","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3950-8752","authenticated-orcid":false,"given":"Eric","family":"Rovner","sequence":"first","affiliation":[{"name":"Department of Urology Medical University of South Carolina Charleston South Carolina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8189-9518","authenticated-orcid":false,"given":"Toby C.","family":"Chai","sequence":"additional","affiliation":[{"name":"Department of Urology Boston University School of Medicine Boston Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sharon","family":"Jacobs","sequence":"additional","affiliation":[{"name":"Ion Channel Innovations, LLC  New York New York"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"George","family":"Christ","sequence":"additional","affiliation":[{"name":"Department of Orthopaedics University of Virginia Medical School  Charlottesville Virginia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karl\u2010Erik","family":"Andersson","sequence":"additional","affiliation":[{"name":"Department of Urology Wake Forest School of Medicine Winston\u2010Salem North Carolina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mitchell","family":"Efros","sequence":"additional","affiliation":[{"name":"Accumed Research Associates  Garden City New York"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Victor","family":"Nitti","sequence":"additional","affiliation":[{"name":"Departments of Urology and Obstetrics and Gynecology David Geffen School of Medicine at UCLA Los Angeles California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kelvin","family":"Davies","sequence":"additional","affiliation":[{"name":"Department of Urology Albert Einstein College of Medicine New York New York"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrew R.","family":"McCullough","sequence":"additional","affiliation":[{"name":"Department of Urology Tufts University School of Medicine Boston Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4213-9794","authenticated-orcid":false,"given":"Arnold","family":"Melman","sequence":"additional","affiliation":[{"name":"Department of Urology Albert Einstein College of Medicine New York New York"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2020,1,16]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1002\/nau.10052"},{"issue":"2","key":"e_1_2_8_3_1","first-page":"103","article-title":"Mechanisms of disease: central nervous system involvement in overactive bladder syndrome","volume":"1","author":"Andersson KE","year":"2004","journal-title":"NatClinPract 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