Final 5-Year Outcomes of the Multicenter Randomized Sham-Controlled Trial of a Water Vapor Thermal Therapy for Treatment of Moderate to Severe Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia

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, Claus G. Roehrborn

Research output: Contribution to journalArticlepeer-review

25 Scopus citations

Abstract

PURPOSE: 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. MATERIALS AND METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Original languageEnglish (US)
Pages (from-to)715-724
Number of pages10
JournalThe Journal of Urology
Volume206
Issue number3
DOIs
StatePublished - Sep 1 2021

Keywords

  • minimally invasive surgical procedures
  • prostate
  • prostatic hyperplasia
  • urologic surgical procedures, male

ASJC Scopus subject areas

  • Urology

Fingerprint

Dive into the research topics of 'Final 5-Year Outcomes of the Multicenter Randomized Sham-Controlled Trial of a Water Vapor Thermal Therapy for Treatment of Moderate to Severe Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia'. Together they form a unique fingerprint.

Cite this