{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,22]],"date-time":"2026-04-22T20:58:59Z","timestamp":1776891539482,"version":"3.51.2"},"reference-count":15,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2023,3,6]],"date-time":"2023-03-06T00:00:00Z","timestamp":1678060800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["bjui-journals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["BJU International"],"published-print":{"date-parts":[[2023,6]]},"abstract":"<jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>To analyse data from patient information forms (PIFs) submitted to the manufacturer of a new three\u2010piece inflatable penile prosthesis (IPP), the Rigicon Infla10\u00ae, to summarize early outcomes.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>A retrospective review of PIFs from 319 patients implanted with the IPP between 6 January 2019 and 31 December 2021 was performed to assess device durability and rates of reoperation for infection, mechanical failure or medical reasons.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      The mean \u00b1\n                      <jats:sc>sd<\/jats:sc>\n                      (range) follow\u2010up was 21.2\u00a0\u00b1\u200911\u00a0(5\u201336)\u00a0months and the mean \u00b1\n                      <jats:sc>sd<\/jats:sc>\n                      patient age was 58.5\u00a0\u00b1\u20098.7\u2009years. Of the total, 4.4% of devices required removal or revision. Complications included mechanical failure (2.5%) and component migration (0.7%). No infections were observed in this series. One patient (0.4%) required revision for inadequate straightening of Peyronie's disease. Three patients (0.9%) requested device removal because of dissatisfaction. A total of 95.6% of the Rigicon Infla10 devices were free from explant or revision 21\u00a0months after the original implant date. Kaplan\u2013Meier analysis showed the rates of cumulative survival of the device at 12, 24, 36\u00a0months were 95.6%, 94.7% and 93.7%, respectively.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The vast majority of the early Rigicon Infla10 IPPs implanted prior to January 2022 were included in this retrospective analysis of volunteered PIFs. These early results demonstrate initial durability from reoperation equivalent to that of other contemporary devices.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/bju.15960","type":"journal-article","created":{"date-parts":[[2023,1,12]],"date-time":"2023-01-12T05:20:28Z","timestamp":1673500828000},"page":"729-733","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":15,"title":["Initial safety outcomes for the Rigicon Infla10\u00ae inflatable penile prosthesis"],"prefix":"10.1111","volume":"131","author":[{"given":"Steven K.","family":"Wilson","sequence":"first","affiliation":[{"name":"Department of Urology Institute for Urologic Excellence  La Quinta CA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8912-3899","authenticated-orcid":false,"given":"Lexiaochuan","family":"Wen","sequence":"additional","affiliation":[{"name":"Department of Urology Mayo Clinic  Rochester 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