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No AccessJournal of UrologyAdult Urology1 Sep 2021Reply by Authorsis a reply to letterEditorial CommentEditorial Comment Kevin T. McVary, Marc C. Gittelman, Kenneth A. Goldberg, Kalpesh Patel, Neal D. Shore, Richard M. Levin, Marc Pliskin, J. Randolf Beahrs, David Prall, Jed Kaminetsky, Barrett E. Cowan, Christopher H. Cantrill, Lance A. Mynderse, James C. Ulchaker, Nicholas N. Tadros, Steven N. Gange, and Claus G. Roehrborn Kevin T. McVaryKevin T. McVary *Correspondence: Center for Male Health, Stritch School of Medicine, Loyola University Medical Center, 2160 S. First Ave., Maywood, Illinois 60153 telephone: 708-216-3166; FAX: 708-216-6585; E-mail Address: [email protected] Loyola University Medical Center, Maywood, Illinois Financial interest and/or other relationship with Boston Scientific, NIDDK, Astellas, Olympus, SRS Medical Systems, Medeonbio, Uronext LL. Patent holder: SMA penile prosthesis (US20130131443), magnetic induction SMA (US506777291). More articles by this author , Marc C. GittelmanMarc C. Gittelman South Florida Medical Research, Aventura, Florida Financial interest and/or other relationship with NxThera. More articles by this author , Kenneth A. GoldbergKenneth A. Goldberg University of Texas Southwestern, Lewisville, Texas More articles by this author , Kalpesh PatelKalpesh Patel Arizona Institute of Urology, Tucson, Arizona More articles by this author , Neal D. ShoreNeal D. Shore Carolina Urologic Research Center, Myrtle Beach, South Carolina Financial interest and/or other relationship with NxThera. Financial interest and/or other relationship with Boston Scientific, TELEFLEX, Zenflow, Medeon, GSK. More articles by this author , Richard M. LevinRichard M. Levin Chesapeake Urology Research Associates, Towson, Maryland Financial interest and/or other relationship with Boston Scientific, TELEFLEX, Zenflow, Medeon, GSK. More articles by this author , Marc PliskinMarc Pliskin The Urology Group, Cincinnati, Ohio More articles by this author , J. Randolf BeahrsJ. Randolf Beahrs Minnesota Urology, Woodbury, Minnesota More articles by this author , David PrallDavid Prall Minnesota Urology, Woodbury, Minnesota More articles by this author , Jed KaminetskyJed Kaminetsky Manhattan Medical Research, New York, New York More articles by this author , Barrett E. CowanBarrett E. Cowan Urology Associates of Denver, Englewood, Colorado Financial interest and/or other relationship with Procept Biorobotics. More articles by this author , Christopher H. CantrillChristopher H. Cantrill Urology San Antonio Research, San Antonio, Texas Financial interest and/or other relationship with Boston Scientific, TELEFLEX, Zenflow, Medeon, GSK. More articles by this author , Lance A. MynderseLance A. Mynderse Mayo Clinic, Rochester, Minnesota More articles by this author , James C. UlchakerJames C. Ulchaker Cleveland Clinic, Cleveland, Ohio Financial interest and/or other relationship with Boston Scientific, TELEFLEX, Zenflow, Medeon, GSK. More articles by this author , Nicholas N. TadrosNicholas N. Tadros Southern Illinois University, Springfield, Illinois Financial interest and/or other relationship with NxThera. Financial interest and/or other relationship with Boston Scientific, TELEFLEX, Zenflow, Medeon, GSK. More articles by this author , Steven N. GangeSteven N. Gange Western Urologic Clinic, Salt Lake City, Utah Financial interest and/or other relationship with NeoTract. More articles by this author , and Claus G. RoehrbornClaus G. Roehrborn University of Texas Southwestern, Dallas, Texas Financial interest and/or other relationship with Boston Scientific, TELEFLEX, Zenflow, Medeon, GSK. More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000001778.03AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail "Reply by Authors." The Journal of Urology, 206(3), p. 724 References 1. : Surgical management of lower urinary tract symptoms attributed to benign prostatic hyperplasia: AUA Guideline amendment 2020. J Urol 2020; 204: 799. Link, Google Scholar 2. : Surgical reintervention rate after prostatic urethral lift: systematic review and meta-analysis involving over 2,000 patients. J Urol 2021; 205: 940. Link, Google Scholar © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetailsRelated articlesJournal of Urology2 Jun 2021Editorial CommentJournal of Urology2 Jun 2021Editorial Comment Volume 206Issue 3September 2021Page: 724-724 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information Kevin T. McVary Loyola University Medical Center, Maywood, Illinois *Correspondence: Center for Male Health, Stritch School of Medicine, Loyola University Medical Center, 2160 S. First Ave., Maywood, Illinois 60153 telephone: 708-216-3166; FAX: 708-216-6585; E-mail Address: [email protected] Financial interest and/or other relationship with Boston Scientific, NIDDK, Astellas, Olympus, SRS Medical Systems, Medeonbio, Uronext LL. Patent holder: SMA penile prosthesis (US20130131443), magnetic induction SMA (US506777291). More articles by this author Marc C. Gittelman South Florida Medical Research, Aventura, Florida Financial interest and/or other relationship with NxThera. More articles by this author Kenneth A. Goldberg University of Texas Southwestern, Lewisville, Texas More articles by this author Kalpesh Patel Arizona Institute of Urology, Tucson, Arizona More articles by this author Neal D. Shore Carolina Urologic Research Center, Myrtle Beach, South Carolina Financial interest and/or other relationship with NxThera. Financial interest and/or other relationship with Boston Scientific, TELEFLEX, Zenflow, Medeon, GSK. More articles by this author Richard M. Levin Chesapeake Urology Research Associates, Towson, Maryland Financial interest and/or other relationship with Boston Scientific, TELEFLEX, Zenflow, Medeon, GSK. More articles by this author Marc Pliskin The Urology Group, Cincinnati, Ohio More articles by this author J. Randolf Beahrs Minnesota Urology, Woodbury, Minnesota More articles by this author David Prall Minnesota Urology, Woodbury, Minnesota More articles by this author Jed Kaminetsky Manhattan Medical Research, New York, New York More articles by this author Barrett E. Cowan Urology Associates of Denver, Englewood, Colorado Financial interest and/or other relationship with Procept Biorobotics. More articles by this author Christopher H. Cantrill Urology San Antonio Research, San Antonio, Texas Financial interest and/or other relationship with Boston Scientific, TELEFLEX, Zenflow, Medeon, GSK. More articles by this author Lance A. Mynderse Mayo Clinic, Rochester, Minnesota More articles by this author James C. Ulchaker Cleveland Clinic, Cleveland, Ohio Financial interest and/or other relationship with Boston Scientific, TELEFLEX, Zenflow, Medeon, GSK. More articles by this author Nicholas N. Tadros Southern Illinois University, Springfield, Illinois Financial interest and/or other relationship with NxThera. Financial interest and/or other relationship with Boston Scientific, TELEFLEX, Zenflow, Medeon, GSK. More articles by this author Steven N. Gange Western Urologic Clinic, Salt Lake City, Utah Financial interest and/or other relationship with NeoTract. More articles by this author Claus G. Roehrborn University of Texas Southwestern, Dallas, Texas Financial interest and/or other relationship with Boston Scientific, TELEFLEX, Zenflow, Medeon, GSK. More articles by this author Expand All Advertisement PDF downloadLoading ...

We present final 5-year outcomes of the multicenter randomized sham-controlled trial of a water vapor therapy (Rezūm™) for treatment of moderate to severe lower urinary tract symptoms due to benign prostatic hyperplasia.

A total of 197 subjects >50 years of age with International Prostate Symptom Score ≥13, maximum flow rate ≤15 ml/second and prostate volume 30 to 80 cc were randomized and followed for 5 years. From the control arm of 61 subjects, a subset of 53 subjects requalified and after 3 months received treatment as part of the crossover group and were also followed for 5 years. The total number of vapor treatments to each lobe of the prostate was determined by length of prostatic urethra and included middle lobe treatment per physician discretion.

Significant improvement of lower urinary tract symptoms was observed at <3 months post-thermal therapy, remaining durable through 5 years in the treatment group (International Prostate Symptom Score reduced 48%, quality of life increased 45%, maximum flow rate improved 44%, Benign Prostatic Hyperplasia Impact Index decreased 48%). Surgical re-treatment rate was 4.4% with no reports of device or procedure related sexual dysfunction or sustained de novo erectile dysfunction. Results within the crossover group were similar through 5 years.

Minimally invasive treatment with water vapor thermal therapy provides significant and durable symptom relief as well as flow rate improvements through 5 years, with low surgical re-treatment rates and without impacting sexual function. It is a versatile therapy, providing successful treatment to obstructive lateral and middle lobes.

We assessed the ability of men with bothersome urinary symptoms to use an over-the-counter tamsulosin (0.4 mg) product concordant with the information in the proposed drug facts label in a simulated over-the-counter setting.

Eligibility for this 24-week study was determined by a phone interview. Men who reported not using (nonprescription users) or using (prescription users) a prescription medicine for benign prostatic hyperplasia at screening/baseline reviewed the proposed over-the-counter tamsulosin product. They could then choose to purchase this product and enter the actual use phase. The primary objective was to assess the proportion of nonprescription users compliant with "stop use" directions (performance threshold upper bound of 95% CI 10% or less). Secondary objectives included assessing the proportion of nonRx users compliant with other prespecified instructions on the proposed drug facts label and evaluating adverse events. Analyses were based on outcomes mitigated by a panel of urologists.

Of the 4,508 men screened 3,929 were eligible for product review and 1,117 entered the home use phase. Overall 1,074 men (nonprescription users 924, prescription users 150) purchased and used tamsulosin. Mean±SD age was 62.6±10.7 and 66.5±8.8 years, respectively. The primary end point was met, as only 2 of 924 nonprescription users (0.2%, 95% CI 0.0-0.8) reported a "stop use" condition within the first 12 weeks and did not appropriately stop use or initiate contact with a doctor. No unexpected safety concerns were observed.

Results indicate that self-directed use by men interested in using an over-the-counter tamsulosin product was in line with the drug facts label instructions implemented in this study and no unexpected safety concerns were identified.