MP09-07 SIX- AND TWELVE-MONTH OUTCOMES OF A PROSPECTIVE TRIAL OF WATER VAPOR THERMAL THERAPY FOR TREATMENT OF LOWER URINARY TRACT SYMPTOMS DUE TO BENIGN PROSTATIC HYPERPLASIA IN SUBJECTS WITH LARGE PROSTATES

Abstract

You have accessJournal of UrologyBenign Prostatic Hyperplasia: Surgical Therapy & New Technology II (MP09)1 Sep 2021MP09-07 SIX- AND TWELVE-MONTH OUTCOMES OF A PROSPECTIVE TRIAL OF WATER VAPOR THERMAL THERAPY FOR TREATMENT OF LOWER URINARY TRACT SYMPTOMS DUE TO BENIGN PROSTATIC HYPERPLASIA IN SUBJECTS WITH LARGE PROSTATES Henry Woo, Richard Levin, Christopher Cantrill, Shaw Zhou, Donald Neff, Mark Sutton, James Bailen, and Michael Darson Henry WooHenry Woo More articles by this author , Richard LevinRichard Levin More articles by this author , Christopher CantrillChristopher Cantrill More articles by this author , Shaw ZhouShaw Zhou More articles by this author , Donald NeffDonald Neff More articles by this author , Mark SuttonMark Sutton More articles by this author , James BailenJames Bailen More articles by this author , and Michael DarsonMichael Darson More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000001982.07AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: We report the twelve-month results of a multicenter, single arm trial of water vapor thermal therapy in men with symptomatic lower urinary tract symptoms due to benign prostatic hyperplasia (BPH) in subjects with prostate volume >80 cm3 and ≤150 cm3. METHODS: 47 subjects >50 years old with International Prostate Symptom Score (IPSS) ≥13, maximum flow rate (Qmax) 5-12 ml/s with minimum voided volume of >125 mL and prostate volume >80 cm3 and ≤150 cm3 were treated with Rezūm Water Vapour Thermotherapy System. Treatment involved injection of water vapor into lateral lobes and, where necessary, central zone and median lobe. The primary efficacy endpoint was the proportion of subjects with an IPSS improvement ≥30% post-treatment compared to baseline at 6 months, and the secondary endpoint was absolute IPSS improvement at 6-months greater than 6 points. The primary safety endpoint was the proportion of subjects with one or more safety composite events within 6 months post-procedure, defined as perforation of the rectum or genitourinary tract, fistula formation between the rectum and urethra, permanent damage to the bladder, trigone or ureteral orifices requiring intervention, or Grade 2 hydronephrosis. Ancillary endpoints included change in IPSS-quality of life (QoL), BPHII, Qmax and post-void residual (PVR) at 6 and 12 months. RESULTS: At 6 months post-procedure, the responder rate was 83% (39/47) with a 95% confidence interval (CI) lower bound of 69.2%. There was a significant improvement in absolute IPSS with mean improvement at 6 months of 11.9 ± 7.5 points (95% CI, 9.7 to 14.1); Baseline was 20.6 ± 5.2 points, and 6 months was 8.7 ± 7.4 points. No composite safety events occurred within 6 months post-procedure (95% CI, 0.0% to 7.5%). Qmax was higher than baseline at 6- and 12-months post-procedure (table 1) with a mean improvement at 12 months of 7.1 ± 7.0mL/sec (95% CI, 4.9 to 9.3). There was a reduction from baseline of IPSS-QoL, BPHII and PVR at 6 months which was durable through 12 months (table 1). CONCLUSIONS: These results provide supportive scientific evidence of the safety, effectiveness, and clinical benefit of the Rezūm System to successfully treat the symptoms of BPH in men with larger prostates >80 cm3 and ≤150 cm3. Source of Funding: Boston Scientific © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e161-e162 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information Henry Woo More articles by this author Richard Levin More articles by this author Christopher Cantrill More articles by this author Shaw Zhou More articles by this author Donald Neff More articles by this author Mark Sutton More articles by this author James Bailen More articles by this author Michael Darson More articles by this author Expand All Advertisement Loading ...