To present final 5-year outcomes of the multicenter randomized sham-controlled trial of Rezum water vapor therapy for treatment of moderate-to-severe LUTS due to BPH.
Total of 197 subjects >50 years of age, with IPSS ≥13, maximum flow rate (Qmax) ≤15 mL/s and prostate volume 30 to 80 cc were randomized and followed for 5 years. From the 61 subject control arm, 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 LUTS was observed at <3 months post thermal therapy, remaining durable through 5 years in the treatment group (IPSS reduced 48%, QOL increased 45%, Qmax improved 44%, BPHII decreased 48%. Surgical retreatment 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 Rezum water vapor thermal therapy provides significant and durable symptom relief as well as flow rate improvements through 5 years, with low surgical retreatment rates and without impacting sexual function. It is a versatile therapy, providing successful treatment to obstructive lateral and middle lobes.
The Journal of urology. 2021 Apr 19 [Epub ahead of print]
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
Loyola University Medical Center, Maywood, Illinois., South Florida Medical Research, Aventura, Florida., University of Texas Southwestern, Lewisville, Texas., Arizona Institute of Urology, Tucson, Arizona., Carolina Urologic Research Center, Myrtle Beach, South Carolina., Chesapeake Urology Research Associates, Towson, Maryland., The Urology Group, Cincinnati, Ohio., Minnesota Urology, Woodbury, Minnesota., Manhattan Medical Research, New York, New York., Urology Associates of Denver, Englewood, Colorado., Urology San Antonio Research, San Antonio, Texas., Mayo Clinic, Rochester, Minnesota., Cleveland Clinic, Cleveland, Ohio., Southern Illinois University, Springfield, Illinois., Western Urologic Clinic, Salt Lake City, Utah., University of Texas Southwestern, Dallas, Texas.