{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,18]],"date-time":"2026-05-18T13:23:22Z","timestamp":1779110602884,"version":"3.51.4"},"reference-count":13,"publisher":"SAGE Publications","issue":"2","license":[{"start":{"date-parts":[[2022,2,1]],"date-time":"2022-02-01T00:00:00Z","timestamp":1643673600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Journal of Endourology"],"published-print":{"date-parts":[[2022,2]]},"abstract":"<jats:sec>\n                    <jats:title>Purpose:<\/jats:title>\n                    <jats:p>Aquablation, prostatic urethral lift (PUL), and transurethral water vapor therapy (TWVT) have demonstrated efficacy for the treatment of benign prostatic hyperplasia (BPH). Our objective was to describe device malfunctions and complications to help guide procedural selection and performance.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Materials and Methods:<\/jats:title>\n                    <jats:p>The Manufacturer and User Facility Device Experience (MAUDE) database was examined for reports related to the use of these three procedures for the treatment of BPH between January 1, 2015, and July 1, 2020. Reports were evaluated for device malfunctions and surgical complications using a previously described externally validated classification system developed for the MAUDE database. Chi square analysis was used for statistical comparison between groups.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>\n                      A total of 391 adverse events were reported: aquablation (\n                      <jats:italic toggle=\"yes\">n<\/jats:italic>\n                      \u2009=\u2009102), PUL (\n                      <jats:italic toggle=\"yes\">n<\/jats:italic>\n                      \u2009=\u2009132), and TWVT (\n                      <jats:italic toggle=\"yes\">n<\/jats:italic>\n                      \u2009=\u2009157). There were 79 (78%) severe or life-threatening adverse events for aquablation\n                      <jats:italic toggle=\"yes\">vs<\/jats:italic>\n                      69 (52%) for PUL\n                      <jats:italic toggle=\"yes\">vs<\/jats:italic>\n                      24 (15%) for TWVT (\n                      <jats:italic toggle=\"yes\">p<\/jats:italic>\n                      \u2009&lt;\u20090.001). There were 4 cases of rectal perforation with aquablation and 25 cases of the PUL implants needing to be removed or causing a problem with a later procedure. Blood transfusion frequencies were aquablation\u201432 (31%), PUL\u201421 (16%), and TWVT\u20141 (1%). The most common device malfunctions were: aquablation\u2014motion error (\n                      <jats:italic toggle=\"yes\">n<\/jats:italic>\n                      \u2009=\u20098), handpiece fracture\/attachment malfunction (\n                      <jats:italic toggle=\"yes\">n<\/jats:italic>\n                      \u2009=\u20098); PUL\u2014device misfire (\n                      <jats:italic toggle=\"yes\">n<\/jats:italic>\n                      \u2009=\u200927), needle fragmentation (\n                      <jats:italic toggle=\"yes\">n<\/jats:italic>\n                      \u2009=\u200921); TWVT\u2014unresolvable error message (\n                      <jats:italic toggle=\"yes\">n<\/jats:italic>\n                      \u2009=\u200919).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions:<\/jats:title>\n                    <jats:p>In a national database, aquablation and PUL had noteworthy complications or device-related malfunctions such as rectal perforation and the improper placement or failed deployment of the PUL implants. Both patients and providers should be aware of potential risks when selecting these novel BPH treatments.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1089\/end.2021.0455","type":"journal-article","created":{"date-parts":[[2021,7,27]],"date-time":"2021-07-27T13:04:34Z","timestamp":1627391074000},"page":"231-235","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":16,"title":["Aquablation, Prostatic Urethral Lift, and Transurethral Water Vapor Therapy: A Comparison of Device-Related Adverse Events in a National Registry"],"prefix":"10.1177","volume":"36","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1546-3473","authenticated-orcid":false,"given":"Elie","family":"Kaplan-Marans","sequence":"first","affiliation":[{"name":"Division of Urology, Maimonides Medical Center, New York, New York, USA."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8301-7569","authenticated-orcid":false,"given":"Mariela","family":"Martinez","sequence":"additional","affiliation":[{"name":"Division of Urology, Maimonides Medical Center, New York, New York, USA."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Andrew","family":"Wood","sequence":"additional","affiliation":[{"name":"Division of Urology, Maimonides Medical Center, New York, New York, USA."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9514-9366","authenticated-orcid":false,"given":"James","family":"Cochran","sequence":"additional","affiliation":[{"name":"Division of Urology, Maimonides Medical Center, New York, New York, USA."},{"name":"SUNY Downstate College of Medicine, New York, New York, USA."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Elliot","family":"Dubowitch","sequence":"additional","affiliation":[{"name":"Division of Urology, Maimonides Medical Center, New York, New York, USA."},{"name":"Division of Urology, Duke Raleigh Hospital, Raleigh, North Carolina, USA."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ariel","family":"Schulman","sequence":"additional","affiliation":[{"name":"Division of Urology, Maimonides Medical Center, New York, New York, USA."}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2022,2,1]]},"reference":[{"key":"e_1_3_3_2_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.juro.2016.11.045"},{"key":"e_1_3_3_3_2","first-page":"2","article-title":"Benign prostatic hyperplasia: An update on minimally invasive therapy including Aquablation","volume":"27","author":"Das AK","year":"2020","unstructured":"Das AK, , Han TM, , Uhr A, , Roehrborn CG. Benign prostatic hyperplasia: An update on minimally invasive therapy including Aquablation. Can J Urol, 2020; 27:2\u201310.","journal-title":"Can J Urol"},{"key":"e_1_3_3_4_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.juro.2017.12.065"},{"key":"e_1_3_3_5_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.juro.2015.10.181"},{"key":"e_1_3_3_6_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.eururo.2015.04.024"},{"key":"e_1_3_3_7_2","doi-asserted-by":"publisher","DOI":"10.2147\/RRU.S143679"},{"key":"e_1_3_3_8_2","unstructured":"U.S. Food and Drug Administration. MAUDE\u2014Manufacturer and User Facility Device Experience. Published 2021. https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfmaude\/search.cfm (accessed July11 2021)."},{"key":"e_1_3_3_9_2","doi-asserted-by":"publisher","DOI":"10.1089\/end.2016.0396"},{"key":"e_1_3_3_10_2","doi-asserted-by":"publisher","DOI":"10.1089\/end.2019.0067"},{"key":"e_1_3_3_11_2","first-page":"8802","article-title":"Five year results of the prospective randomized controlled prostatic urethral L.I.F.T. study","volume":"24","author":"Roehrborn CG","year":"2017","unstructured":"Roehrborn CG, , Barkin J, , Gange SN, et al. Five year results of the prospective randomized controlled prostatic urethral L.I.F.T. study. Can J Urol, 2017; 24:8802\u20138813.","journal-title":"Can J Urol"},{"key":"e_1_3_3_12_2","author":"Weiss JK","unstructured":"Weiss JK, , Santucci NM, , Sajadi KP, , Chouhan JD. Post-surgical complications after bladder outlet reducing surgery: An analysis of the FDA Manufacturer and User Facility Device Experience (MAUDE) database. Urology 2021. Available online May 8, 2021. In Press.","journal-title":"Urology"},{"key":"e_1_3_3_13_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.urology.2019.11.040"},{"key":"e_1_3_3_14_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.urology.2019.08.015"}],"container-title":["Journal of Endourology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1089\/end.2021.0455","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1089\/end.2021.0455","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1089\/end.2021.0455","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,28]],"date-time":"2026-04-28T20:14:03Z","timestamp":1777407243000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1089\/end.2021.0455"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,2]]},"references-count":13,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2022,2]]}},"alternative-id":["10.1089\/end.2021.0455"],"URL":"https:\/\/doi.org\/10.1089\/end.2021.0455","relation":{},"ISSN":["0892-7790","1557-900X"],"issn-type":[{"value":"0892-7790","type":"print"},{"value":"1557-900X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,2]]}}}