1780 MIST2: BASELINE PSA AND TOTAL PROSTATE VOLUME PREDICTS CLINICAL RESPONSE TO INTRAPROSTATIC INJECTION OF BOTULINUM TOXIN FOR THE MANAGEMENT OF LUTS

You have accessJournal of UrologyBenign Prostatic Hyperplasia: Medical and Hormonal Therapy1 Apr 20101780 MIST2: BASELINE PSA AND TOTAL PROSTATE VOLUME PREDICTS CLINICAL RESPONSE TO INTRAPROSTATIC INJECTION OF BOTULINUM TOXIN FOR THE MANAGEMENT OF LUTS Kevin McVary, E. David Crawford, Robert Donnell, Kimberly Drews, Steven Kaplan, John Kusek, Claus Roehrborn, and Reginald Bruskewitz Kevin McVaryKevin McVary Chicago, IL More articles by this author , E. David CrawfordE. David Crawford Denver, CO More articles by this author , Robert DonnellRobert Donnell Milwaukee, WI More articles by this author , Kimberly DrewsKimberly Drews Rockville, MD More articles by this author , Steven KaplanSteven Kaplan New York, NY More articles by this author , John KusekJohn Kusek Bethesda, MD More articles by this author , Claus RoehrbornClaus Roehrborn Dallas, TX More articles by this author , and Reginald BruskewitzReginald Bruskewitz Madison, WI More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2010.02.1691AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES The primary objective of the NIDDK multi-center phase II randomized trial (MIST2 Trial) was to determine whether two doses of BoNT-A (100 or 300 units) injected into the prostate demonstrate sufficient improvement in LUTS and in secondary outcomes thought to reflect alterations in LUTS/BPH. This analysis reports on the relationship of baseline PSA and prostate volume (TPV) on AUASS and Qmax. METHODS This phase II study of moderate to severe LUTS (AUASS ≥8) included men ≥50 with LUTS recruited at 7 US sites and equally randomized to receive either 100 or 300 units of BoNT-A injected into the prostate transrectally. The men were seen at 4, 8, and 12 weeks and 12 months post-treatment. At baseline, 12 weeks, and 12 months, total (TPV) and transition zone (TZV) volume of the prostate, serum PSA, AUASS, BPH II, Qmax, and PVR were assessed. RESULTS 134 men were randomized and 108 provided complete outcome data. 63/67 and 53/55 given 100 and 300 units, (respectively). At baseline, mean age = 66.0±8.2, Qmax = 9.8 ml/sec±2.7, AUASS = 19.2±6.0, TPV = 50.1±26.7, TZV = 24.2±19.2, PSA 2.4±2.0. At 12 weeks they had a 37.4% reduction in AUASS (11.1±6.4), Qmax (12.4±5.3, 27.7% increase) without change in TPV, TZV or PSA. At 12 months we noted a significant change in AUASS (12.1±6.3, 35.6% reduction from baseline), Qmax (12.0±4.3, 27.6% increase from baseline) without change in volume or PSA. Tertile response analysis was used to explore predictive response in AUASS and Qmax improvement against baseline PSA and prostate volume measures. When analyzing whether baseline PSA, TPV or TZV predicted AUA changes, baseline PSA (p<0.005, p<0.01) and TPV (p<0.05, p<0.01) were significant at 12 months for absolute and % AUASS change, respectively, while TZV (p<0.01) was significant only at 3 months for absolute AUASS change. For Qmax (absolute and % change) improvement, PSA was significant (p<0.01). CONCLUSIONS The significant changes noted in AUASS and Qmax at 3 and 12 months after treatment occurs without significant changes in TPV, TZV, or PSA. The greatest response in AUASS occurs in those with the lowest PSA and TPV. PSA and TPV significantly correlates with AUASS change and PSA with Qmax (absolute and %) change. © 2010 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 183Issue 4SApril 2010Page: e690 Advertisement Copyright & Permissions© 2010 by American Urological Association Education and Research, Inc.MetricsAuthor Information Kevin McVary Chicago, IL More articles by this author E. David Crawford Denver, CO More articles by this author Robert Donnell Milwaukee, WI More articles by this author Kimberly Drews Rockville, MD More articles by this author Steven Kaplan New York, NY More articles by this author John Kusek Bethesda, MD More articles by this author Claus Roehrborn Dallas, TX More articles by this author Reginald Bruskewitz Madison, WI More articles by this author Expand All Advertisement Advertisement PDF DownloadLoading ...