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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

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.