{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,12]],"date-time":"2026-03-12T02:02:37Z","timestamp":1773280957901,"version":"3.50.1"},"reference-count":10,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2017,11,2]],"date-time":"2017-11-02T00:00:00Z","timestamp":1509580800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"name":"Solace Therapeutics, Inc"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Neurourology and Urodynamics"],"published-print":{"date-parts":[[2018,1]]},"abstract":"Aims<\/jats:title>The SUCCESS trial is a phase III study of the Vesair\u00ae balloon in the United States for female stress urinary incontinence (SUI). The purpose of this manuscript is to present the 3 month primary efficacy and tolerability outcome data.<\/jats:p><\/jats:sec>Methods<\/jats:title>The SUCCESS trial is a multi\u2010center, prospective, single blind, randomized, sham\u2010controlled study. Subjects were randomized on a 2.33:1 basis to either Vesair balloon placement or placebo. The primary efficacy endpoint was a composite of both a >50% reduction from baseline on 1\u2009h provocative pad weight test and a \u226510\u2010point improvement in symptoms on the Incontinence Quality of Life Survey (I\u2010QOL) questionnaire assessed at the 3 month study visit.<\/jats:p><\/jats:sec>Results<\/jats:title>A total of 221 subjects were randomized, including 157 treatment arm subjects and 64 controls. The 3 month composite primary efficacy endpoint was achieved in 42.1% of treatment group subjects compared with 28.1% of controls on intention\u2010to\u2010treat analysis (p<\/jats:italic>\u2009=\u20090.046). Treatment arm subjects were significantly more likely to report at least a 50% reduction in incontinence frequency on 7\u2010day voiding diary (55.2% vs 32.3%, P<\/jats:italic>\u2009=\u20090.002, ITT) and more commonly reported their incontinence was improved on Patient Global Impression of Improvement in Incontinence (PGI\u2010I) at 3 months compared with controls (58.0% vs 37.7%, P<\/jats:italic>\u2009=\u20090.007, ITT). No device\u2010 or procedure\u2010related serious adverse events nor unanticipated adverse events were reported and no cases of urinary retention were observed. All adverse events fully resolved following balloon removal.<\/jats:p><\/jats:sec>Conclusions<\/jats:title>In this phase three trial, the Vesair intravesical balloon achieved 3 month primary and secondary endpoints both objectively and subjectively.<\/jats:p><\/jats:sec>","DOI":"10.1002\/nau.23324","type":"journal-article","created":{"date-parts":[[2017,11,2]],"date-time":"2017-11-02T16:20:13Z","timestamp":1509639613000},"page":"440-448","source":"Crossref","is-referenced-by-count":3,"title":["Three\u2010month primary efficacy data for the SUCCESS Trial; a phase III, multi\u2010center, prospective, randomized, controlled study treating female stress urinary incontinence with the vesair intravesical balloon"],"prefix":"10.1002","volume":"37","author":[{"given":"Kurt","family":"McCammon","sequence":"first","affiliation":[{"name":"Urology of Virginia Virginia Beach Virginia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Karny","family":"Jacoby","sequence":"additional","affiliation":[{"name":"Integrity Medical Research Mountlake Terrace Washington"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Susan","family":"Kalota","sequence":"additional","affiliation":[{"name":"Urological Associates of Southern Arizona Tucson Arizona"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jeffrey","family":"Snyder","sequence":"additional","affiliation":[{"name":"Genitourinary Surgical Consultants Denver Colorado"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kevin","family":"Cline","sequence":"additional","affiliation":[{"name":"Regional Urology Associates Shreveport Louisiana"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kaiser","family":"Robertson","sequence":"additional","affiliation":[{"name":"Chesapeake Urology Associates Glen Burnie Maryland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Charles","family":"Rardin","sequence":"additional","affiliation":[{"name":"Women & Infants Hospital of Rhode Island Providence Rhode Island"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Randall","family":"Kahan","sequence":"additional","affiliation":[{"name":"WomanCare Arlington Heights Illinois"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lonny","family":"Green","sequence":"additional","affiliation":[{"name":"Virginia Women's Center Richmond Virginia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jack","family":"Zuckerman","sequence":"additional","affiliation":[{"name":"Naval Medical Center San Diego California"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Eric","family":"Rovner","sequence":"additional","affiliation":[{"name":"MUSC Department of Urology Charleston South Carolina"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2017,11,2]]},"reference":[{"key":"e_1_2_8_2_1","volume-title":"Incontinence: 4th International Consultation on Incontinence","author":"Abrams PCL","year":"2008"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1007\/BF02202013"},{"key":"e_1_2_8_4_1","volume-title":"Advanced water distribution modeling and management","author":"Walski TM","year":"2003"},{"key":"e_1_2_8_5_1","volume-title":"Fluid transients in systems","author":"Wylie EB","year":"1993"},{"key":"e_1_2_8_6_1","unstructured":"BaxleyJ.Guidance for industry and food and drug administration staff\u2010clinical investigations of devices indicated for the treatment of urinary incontinence.2011. Available at:https:\/\/www.fda.gov\/downloads\/MedicalDevices\/DeviceRegulationandGuidance\/GuidanceDocuments\/ucm070854.pdf."},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1002\/nau.22708"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1464-410X.2010.09993.x"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.juro.2013.06.042"},{"key":"e_1_2_8_10_1","first-page":"CD003881","article-title":"Urethral injection therapy for urinary incontinence in women","author":"Kirchin V","year":"2012","journal-title":"Cochrane Database Syst Rev"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00192-012-1825-9"}],"container-title":["Neurourology and Urodynamics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Fnau.23324","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/nau.23324","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/nau.23324","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/nau.23324","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,9]],"date-time":"2023-09-09T07:17:51Z","timestamp":1694243871000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/nau.23324"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2017,11,2]]},"references-count":10,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2018,1]]}},"alternative-id":["10.1002\/nau.23324"],"URL":"https:\/\/doi.org\/10.1002\/nau.23324","archive":["Portico"],"relation":{},"ISSN":["0733-2467","1520-6777"],"issn-type":[{"value":"0733-2467","type":"print"},{"value":"1520-6777","type":"electronic"}],"subject":[],"published":{"date-parts":[[2017,11,2]]}}}