Rez?m Water Vapor Thermal Therapy for Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia: 4-Year Results From Randomized Controlled Study - 30/07/19

Doi : 10.1016/j.urology.2018.12.041

Kevin T. McVary ^a,^⁎ , Tyson Rogers ^b, Claus G. Roehrborn ^c
^a Department of Urology, Loyola University Medical Center, Maywood, IL
^b NAMSA, Minneapolis, MN
^c Department of Urology, University of Texas Southwestern Medical Center, Dallas, TX

^⁎Address correspondence to: Kevin T McVary, M.D., F.A.C.S., Department of Urology, Stritch School of Medicine, Loyola University Medical Center, 2160 S. First Avenue, Maywood, IL 60153.Department of UrologyStritch School of Medicine, Loyola University Medical Center2160 S. First AvenueMaywoodIL60153.

Abstract

Objective

To report 4-year outcomes of the randomized controlled trial of water vapor thermal therapy for treatment of moderate to severe lower urinary tract symptoms due to benign prostatic hyperplasia.

Materials and Methods

Total 188 subjects; 135 men ≥50years old, International Prostate Symptom Score ≥ 13, maximum flow rate (Qmax) ≤15 mL/s and prostate volume 30 to 80 cc treated with Rezūm System thermal therapy were followed 4 years; subset of 53 men who requalified for crossover from control to active treatment were followed 3years.

Results

Lower urinary tract symptoms were significantly improved within ≤3 months after thermal therapy and remained consistently durable (International Prostate Symptom Score 47%, quality of life 43%, Qmax 50%, Benign Prostatic Hyperplasia Impact Index 52%) throughout 4years (P <.0001); outcomes were similarly sustained in crossover subjects at 3years. Surgical retreatment rate was 4.4% over 4years. No disturbances in sexual function were reported.

Conclusion

The minimally invasive thermal therapy provides effective symptom relief and improved quality of life that remains durable for over 4years. It is applicable to all prostate zones with procedures performed under local anesthesia in an office setting.

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Plan

MATERIALS AND METHODS

Support: The clinical study was sponsored by NxThera Inc., recently acquired by Boston Scientific Company. NxThera was given the opportunity to review the manuscript for medical and scientific accuracy.

Financial Disclosures: Drs. Kevin McVary and Claus Roehrborn served as co-principle investigators on this clinical trial. Kevin T. McVary, MD: - Clinical study investigator funded by sponsor, NxThera, Inc. - Paid consultant to study sponsor company, NxThera, Inc. (acquired by Boston Scientific) Tyson Rogers: - Biostatistics Consultant, services paid to NAMSA by NxThera Inc. Claus G. Roehrborn, MD: - Clinical study investigator funded by sponsor, NxThera, Inc. - Paid consultant to study sponsor company, NxThera, Inc. (acquired by Boston Scientific) - Financial interest and/or other relationship with NeoTract, Procept, ZenFlow and Meditate, competitors of the device/technology mentioned in the manuscript.