{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,4]],"date-time":"2026-11-04T00:27:04Z","timestamp":1793752024657,"version":"4.6.1"},"reference-count":18,"publisher":"Springer Science and Business Media LLC","issue":"10","license":[{"start":{"date-parts":[[2026,6,22]],"date-time":"2026-06-22T00:00:00Z","timestamp":1782086400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2026,6,22]],"date-time":"2026-06-22T00:00:00Z","timestamp":1782086400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Int Urogynecol J"],"published-print":{"date-parts":[[2026,10]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Introduction and Hypothesis<\/jats:title>\n                    <jats:p>Urgency urinary incontinence (UUI) is associated with significant impairments to quality of life (QoL) and overall social well-being. The aim of this analysis was to assess the impact of the Intibia System implantable tibial nerve stimulation (ITNS) device on QoL in patients with UUI and compare with a sham control.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      The Intibia Pivotal Study was a prospective, randomized, sham-controlled, double-blind trial across the USA and the Netherlands. A total of 208 subjects were randomized to either an ITNS treatment group (ITNS-ON,\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u2009139) or a sham control group (ITNS-SHAM,\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200969). ITNS-SHAM subjects crossed over after 3\u00a0months. Disease-specific questionnaires regarding QoL and patient-reported outcomes were used to assess the impact of the Intibia System at 3, 6, and 12 months post-implant.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      At 3\u00a0months, significantly more ITNS-ON subjects reported feeling \u201cmuch better\u201d or \u201cvery much better\u201d than ITNS-SHAM subjects (29.2% vs 13.4%,\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.0133); ITNS-ON subjects also exceeded the minimally clinically important difference (MCID) at a higher rate than the ITNS-SHAM group for the Overactive Bladder Questionnaire Short Form Symptom Bother (62.8% vs 41.8%;\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.0046) and Health-Related Quality of Life sub-scales (57.4% vs 42.4%;\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.0463). At 12\u00a0months, 83% of ITNS-ON subjects reported any level of improvement compared with baseline. Significant improvements within the ITNS-ON group were observed in the International Consultation on Incontinence Questionnaire \u2013 Urinary Incontinence Short Form over 12\u00a0months, with 71.5% of subjects exceeding the MCID.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The Intibia System demonstrated statistically and clinically meaningful improvements in self-reported, disease-specific QoL measures in patients with UUI compared with sham at 3\u00a0months and compared with baseline at 12\u00a0months.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s00192-026-06636-1","type":"journal-article","created":{"date-parts":[[2026,6,22]],"date-time":"2026-06-22T14:24:19Z","timestamp":1782138259000},"page":"3621-3630","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Randomized, Sham-Controlled, Double-Blind Trial of the Intibia System in Urge Urinary Incontinence: Quality-of-Life Outcomes"],"prefix":"10.1007","volume":"37","author":[{"ORCID":"https:\/\/orcid.org\/0009-0005-8755-1052","authenticated-orcid":false,"given":"Jeffrey","family":"Mangel","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kevin","family":"Miller","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ty","family":"Erickson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexis","family":"Dieter","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jan-Paul","family":"Roovers","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Catherine A.","family":"Matthews","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,6,22]]},"reference":[{"issue":"2","key":"6636_CR1","doi-asserted-by":"publisher","first-page":"433","DOI":"10.1002\/nau.23897","volume":"38","author":"C D\u2019Ancona","year":"2019","unstructured":"D\u2019Ancona C, Haylen B, Oelke M, Abranches-Monteiro L, Arnold E, Goldman H, et al. 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IRB Tracking Number: 20216197.","order":1,"name":"Ethics","label":"Ethical\/Institutional Review Board Approval","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"All authors are investigators in the Intibia Pivotal Study. C.M. reports grant support from Coloplast and Boston Scientific; being a Consultant for Coloplast; being on the Advisory Board for Boston Scientific; being an Expert Witness for Johnson & Johnson; being Associate Editor for\n                      International Urogynecology Journal\n                      . J.M.M., K.M., and T.E. are paid consultants for Coloplast Corp. A.D. reports research support from Reia Health; being on the Editorial Board for\n                      Obstetrics & Gynecology\n                      .","order":2,"name":"Ethics","label":"Conflicts of Interest","group":{"name":"EthicsHeading","label":"Declarations"}}]}}