{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,3]],"date-time":"2026-10-03T16:44:31Z","timestamp":1791045871617,"version":"4.1.0"},"reference-count":30,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2024,4,18]],"date-time":"2024-04-18T00:00:00Z","timestamp":1713398400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Neurourology and Urodynamics"],"published-print":{"date-parts":[[2024,9]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Overactive bladder (OAB) affects one in six adults in Europe and the United States and impairs the quality of life of millions of individuals worldwide. When conservative management fails, third\u2010line treatments including tibial neuromodulation (TNM) is often pursued. TNM has traditionally been accomplished percutaneously in clinic.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>A minimally invasive implantable device activated by a battery\u2010operated external wearable unit has been developed for the treatment of urgency urinary incontinence (UUI), mitigating the burden of frequent clinic visits and more invasive therapies that are currently commercially available.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>A prospective, multicenter, single\u2010arm, open\u2010label, pivotal study evaluated the safety and effectiveness of the device in adult females with UUI (i.e., wet OAB) (BlueWind Implantable Tibial Neuromodulation [iTNM] system; IDE number #G200013; NCT03596671). Results with the device were previously published under the name RENOVA iStim, which has been since renamed as the Revi\u2122 System. Approximately 1\u2010month post\u2010implantation of the device, participants delivered therapy at their convenience and completed a 7\u2010day voiding diary before visits 6\u2010 and 12\u2010months post\u2010treatment initiation. The primary efficacy and safety endpoints were the proportion of responders to therapy (\u2009\u2265\u200950% improvement on average number of urgency\u2010related incontinence episodes) and incidence of adverse events from implantation to 12\u2010month post\u2010activation.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>A total of 151 participants, mean age 58.8 (SD: 12.5), were implanted; 144 and 140 completed the 6\u2010 and 12\u2010month visits, respectively. The participants demonstrated mean baseline of 4.8\u2009UUI\/day (SD 2.9) and 10 voids\/day (SD 3.3). Six and 12\u2010months post\u2010activation, 76.4% and 78.4% of participants, respectively, were responders to therapy in an intent\u2010to\u2010treat analysis. Of the 139 participants with completed 12\u2010month diaries, 82% were responders, 50% were classified as \u201cdry\u201d (on at least 3 consecutive diary days), and 93.5% of participants reported that their symptoms improved. No implanted participant experienced an SAE related to the procedure or device.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>iTNM, delivered and powered by a patient\u2010controlled external wearable communicating with an implant, demonstrated clinically meaningful and statistically significant improvement in UUI symptoms and a high safety profile. This therapy highlights the value of patient\u2010centric therapy for the treatment of UUI.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/nau.25477","type":"journal-article","created":{"date-parts":[[2024,4,18]],"date-time":"2024-04-18T06:54:17Z","timestamp":1713423257000},"page":"1491-1503","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":20,"title":["A prospective study to assess the effectiveness and safety of the BlueWind System in the treatment of patients diagnosed with urgency urinary incontinence"],"prefix":"10.1002","volume":"43","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1570-1945","authenticated-orcid":false,"given":"John P. F. A.","family":"Heesakkers","sequence":"first","affiliation":[{"name":"Department of Urology Maastricht UMC Maastricht The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Philip","family":"Toozs\u2010Hobson","sequence":"additional","affiliation":[{"name":"Birmingham Women's and Children's NHS Foundation Trust Birmingham UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Suzette E.","family":"Sutherland","sequence":"additional","affiliation":[{"name":"Department of Urology, UW Medicine Pelvic Health Center University of Washington Seattle Washington USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3914-8147","authenticated-orcid":false,"given":"Alex","family":"Digesu","sequence":"additional","affiliation":[{"name":"St Mary's Hospital Imperial College NHS Trust London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cindy L.","family":"Amundsen","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology, Division of Urogynecology and Reconstructive Pelvic Surgery Duke University Durham North Carolina USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rebecca J.","family":"McCrery","sequence":"additional","affiliation":[{"name":"Adult Pediatric Urology &amp; Urogynecology Omaha Nebraska USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6183-9251","authenticated-orcid":false,"given":"Stefan","family":"De Wachter","sequence":"additional","affiliation":[{"name":"Department of Urology, ASTARC Faculty of Medicine and Health Sciences University of Antwerp Edegem Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emily R.","family":"Kean","sequence":"additional","affiliation":[{"name":"Adult Pediatric Urology &amp; Urogynecology Omaha Nebraska USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5883-7116","authenticated-orcid":false,"given":"Frank","family":"Martens","sequence":"additional","affiliation":[{"name":"Department of Urology Radboud University Medical Center Nijmegen The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kevin","family":"Benson","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology, FPMRS Division, Sanford Health University of South Dakota School of Medicine Sioux Falls South Dakota USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kimberly L.","family":"Ferrante","sequence":"additional","affiliation":[{"name":"Kaiser Permanente San Diego California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kevin J.","family":"Cline","sequence":"additional","affiliation":[{"name":"Louisiana State University Medical Center Shreveport Louisiana USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Osvaldo F.","family":"Padron","sequence":"additional","affiliation":[{"name":"Florida Urology Partners Tampa Florida USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laura","family":"Giusto","sequence":"additional","affiliation":[{"name":"Chesapeake Urology Research Associates Baltimore Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Felicia L.","family":"Lane","sequence":"additional","affiliation":[{"name":"Urogynecology and Reconstructive Surgery University of California, Irvine Irvine California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roger R.","family":"Dmochowski","sequence":"additional","affiliation":[{"name":"BlueWind Medical Inc. 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