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

Kevin T McVary ¹,
Marc C Gittelman ²,
Kenneth A Goldberg ³,
Kalpesh Patel ⁴,
Neal D Shore ⁵,
Richard M Levin ⁶,
Marc Pliskin ⁷,
J Randolf Beahrs ⁸,
David Prall ⁸,
Jed Kaminetsky ⁹,
Barrett E Cowan ¹⁰,
Christopher H Cantrill ¹¹,
Lance A Mynderse ¹²,
James C Ulchaker ¹³,
Nicholas N Tadros ¹⁴,
Steven N Gange ¹⁵,
Claus G Roehrborn ¹⁶

¹ Loyola University Medical Center, Maywood, Illinois, USA ² South Florida Medical Research, Aventura, Florida, USA ³ University of Texas Southwestern, Lewisville, Texas, USA ⁴ Arizona Institute of Urology, Tucson, Arizona, USA ⁵ Carolina Urologic Research Center, Myrtle Beach, South Carolina, USA ⁶ Chesapeake Urology Research Associates, Towson, Maryland, USA ⁷ The Urology Group, Cincinnati, Ohio, USA ⁸ Minnesota Urology, Woodbury, Minnesota, USA ⁹ Manhattan Medical Research, New York, New York, USA ¹⁰ Urology Associates of Denver, Englewood, Colorado, USA ¹¹ Urology San Antonio Research, San Antonio, Texas, USA ¹² Mayo Clinic, Rochester, Minnesota, USA ¹³ Cleveland Clinic, Cleveland, Ohio, USA ¹⁴ Southern Illinois University, Springfield, Illinois, USA ¹⁵ Western Urologic Clinic, Salt Lake City, Utah, USA ¹⁶ University of Texas Southwestern, Dallas, Texas, USA

Abstract

https://www.auajournals.org/doi/10.1097/JU.0000000000001778

Objective

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.

Materials and Methods

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.

Results

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.

Conclusion

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.