{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,6]],"date-time":"2026-10-06T22:55:00Z","timestamp":1791327300858,"version":"4.3.1"},"reference-count":16,"publisher":"Wiley","issue":"13","license":[{"start":{"date-parts":[[2021,7,12]],"date-time":"2021-07-12T00:00:00Z","timestamp":1626048000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["The Prostate"],"published-print":{"date-parts":[[2021,9]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>To provide 12\u2010month unbiased outcomes with The Rez\u016bm System (Rez\u016bm), a convective water vapor thermal therapy for patients with lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). Results from this retrospective, real\u2010world evidence (RWE) study were compared to those of previous studies with the aim to evaluate the device's safety and efficacy in a real\u2010world patient population.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Patients 45 years or older with an International Prostate Symptom Score (IPSS) score \u22658, prostate volume (PV) between 20cc and 120cc, who were 12 months posttreatment, and had at least one follow\u2010up were included. Patients were broken into groups based on baseline PV; 30\u201380cc, &lt;30cc, and &gt;80cc. IPSS, PV, quality of life (QoL), maximum urinary flow rate (Qmax), adverse events (AE), postvoid residual, prostate\u2010specific antigen, BPH medication usage, and International Index of Erectile Function were collected and analyzed at baseline, 1, 3, 6, and\/or 12 months.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>A total of 179 patients were included in a retrospective study. IPSS, QoL, and Qmax significantly improved at follow\u2010up time points (<jats:italic>p<\/jats:italic>\u2009&lt;\u2009.05). There were no significant differences at 12 months in IPSS and QoL point reduction or Qmax improvement between the previous studies and any of the RWE groups. BPH medication reduction was seen at 3 months and remained durable up to 12 months. When compared to previous studies, the RWE study had similar rates of urinary retention, urinary tract infection, and dysuria but significantly higher rates of hematuria for the 30\u201380cc (71.7%), &lt;30cc (58.8%), and &gt;80cc (80.0%) groups (<jats:italic>p<\/jats:italic>\u2009&lt;\u2009.001).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>The RWE study shows rapid and durable relief in LUTS, consistent with that observed in literature. Although Rez\u016bm had a reasonably acceptable AEs profile, patients should be counseled preoperatively for AEs. As a first line therapy, Rez\u016bm is an attractive option for men with BPH irrespective of their prostate size.<\/jats:p><\/jats:sec>","DOI":"10.1002\/pros.24191","type":"journal-article","created":{"date-parts":[[2021,7,13]],"date-time":"2021-07-13T06:35:30Z","timestamp":1626158130000},"page":"956-970","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":29,"title":["Real\u2010world evidence with The Rez\u016bm System: A retrospective study and comparative analysis on the efficacy and safety of 12 month outcomes across a broad range of prostate volumes"],"prefix":"10.1002","volume":"81","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0364-7398","authenticated-orcid":false,"given":"Matthew","family":"Ines","sequence":"first","affiliation":[{"name":"Department of Clinical Research DSS Urology Queens Village New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8490-2260","authenticated-orcid":false,"given":"Mustufa","family":"Babar","sequence":"additional","affiliation":[{"name":"Department of Clinical Research DSS Urology Queens Village New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sandeep","family":"Singh","sequence":"additional","affiliation":[{"name":"Department of Clinical Research DSS Urology Queens Village New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nazifa","family":"Iqbal","sequence":"additional","affiliation":[{"name":"Department of Clinical Research DSS Urology Queens Village New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Ciatto","sequence":"additional","affiliation":[{"name":"Department of Clinical Research DSS Urology Queens Village New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2021,7,12]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1097\/01.ju.0000155709.37840.fe"},{"key":"e_1_2_9_3_1","first-page":"90","article-title":"The cost of treating the 10 most prevalent diseases in men 50 years of age or older","volume":"12","author":"Fenter TC","year":"2006","journal-title":"Am J Manag Care"},{"key":"e_1_2_9_4_1","volume-title":"National Ambulatory Medical Care Survey: 2016 National Summary Tables. [Internet]","author":"Rui P","year":"2020"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1097\/01.ju.0000152318.79184.6f"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.juro.2011.01.074"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.eururo.2013.03.004"},{"key":"e_1_2_9_8_1","first-page":"207","article-title":"Two\u2010year results after convective radiofrequency water vapor thermal therapy of symptomatic benign prostatic hyperplasia","volume":"8","author":"Dixon CM","year":"2016","journal-title":"Res Rep Urol"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.juro.2015.10.181"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.juro.2016.12.045"},{"key":"e_1_2_9_11_1","first-page":"159","article-title":"Procedural techniques and multicenter postmarket experience using minimally invasive convective radiofrequency thermal therapy with Rez\u016bm system for treatment of lower urinary tract symptoms due to benign prostatic hyperplasia","volume":"9","author":"Darson MF","year":"2017","journal-title":"Res Rep Urol"},{"key":"e_1_2_9_12_1","unstructured":"Boston Scientific. Product Illustration \u2010 Before During and After Rezum Procedure [Image on the internet]. [updated 2020 Jul;2020Oct 31]. Available from:https:\/\/www.bostonscientific.com\/en-US\/products\/lithotripsy\/rezum-water-vapor-therapy\/healthcare-professionals-resources\/media-kit-templates.html"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.1097\/SLA.0b013e3181b13ca2"},{"key":"e_1_2_9_14_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1751-7176.2008.00006.x"},{"key":"e_1_2_9_15_1","doi-asserted-by":"publisher","DOI":"10.1038\/ijir.2008.52"},{"key":"e_1_2_9_16_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11934-015-0544-4"},{"key":"e_1_2_9_17_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.juro.2015.06.091"}],"container-title":["The Prostate"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/pros.24191","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/pros.24191","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/pros.24191","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,8,29]],"date-time":"2023-08-29T14:50:28Z","timestamp":1693320628000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/pros.24191"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,7,12]]},"references-count":16,"journal-issue":{"issue":"13","published-print":{"date-parts":[[2021,9]]}},"alternative-id":["10.1002\/pros.24191"],"URL":"https:\/\/doi.org\/10.1002\/pros.24191","archive":["Portico"],"relation":{},"ISSN":["0270-4137","1097-0045"],"issn-type":[{"value":"0270-4137","type":"print"},{"value":"1097-0045","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,7,12]]},"assertion":[{"value":"2021-01-30","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2021-06-29","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2021-07-12","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}