Five-Year Data

 

Results of a five-year clinical trial confirming the long-term durability of the Rezūm System for treatment of benign prostatic hyperplasia (BPH) was published online in the Journal of Urology. The study found the Rezūm System provided significant, sustained improvement of lower urinary tract symptoms (LUTS) and quality of life for patients suffering from BPH out to five years post-procedure.   


 
 
 
 

Study Design

 
This was a multicenter, randomized, controlled trial of water vapor thermal therapy in men with moderate-to-severe lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH), with the inclusion of the final surgical and BPH medication retreatment rates. Thermal therapy involved injection of water vapor, using the Rezūm System, into obstructive tissue, potentially including the middle lobe and/or enlarged central zone.

Patient Profile

197 subjects ≥ 50 years old

International Prostate

Symptom Score (IPSS)

Maximum flow rate

(Qmax)

Prostate volume
≥13
5-15 ml/s 30-80 cc
Patients were randomized 2:1
(Thermal therapy with the Rezūm System: sham control rigid cystoscopy)

Outcomes Measured

  • Changes in:
    • International Prostate Symptom Score (IPSS)
    • Quality of life (QOL)
    • Maximum flow rate (Qmax)
    • BPHII
  • Retreatment of BPH after the index procedure:
    • Secondary surgical treatment for LUTS/BPH
    • Initiated BPH medication (alpha-blocker, or 5-ARIs) 

 

Results

 
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Sustained Improvement of LUTS and QoL at Five Years1,3

mean values shown

  


  

Rezūm II Clinical Trial Retreatment Rates through Five Years1,3

  

"These new five-year results expand upon the growing clinical evidence supporting the long-term durability of the Rezūm System as the leading minimally invasive option for men facing moderate-to-severe BPH-related symptoms."

Kevin McVary, MD, FACS

Director, Center for Male Health, and Professor of Urology at Stritch School of Medicine, Loyola University Medical Center and principal investigator of the Rezūm II clinical trial

 

About the Rezūm System

 

The Rezūm System addresses BPH symptoms directly by reducing adenoma tissue with water vapor through a minimally invasive, in-office procedure, allowing cell remnants to be absorbed directly by the body. The procedure is typically performed during a single visit to the physician's office and does not require general anesthesia or surgical implants. The Rezūm System is included in the American Urological Association's BPH treatment guidelines, with a positive safety profile through five years supporting its continued use for the reduction of the prostate.

 

 

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Indications, Safety and Warnings

References

  1. McVary KT, Roehrborn C. Five year results of the prospective, randomized controlled trial of water vapor thermal therapy for treatment of lower urinary tract symptoms due to benign prostatic hyperplasia. Late-Breaking Abstract. J Urol. 2020 Apr;203(4):e1021.
  2. Roehrborn CG, Barkin J, Gange SN, et al. Five-year results of the prospective randomized controlled prostatic urethral L.I.F.T. study. Can J Urol. 2017 Jun;24(3):8802-13.
  3. Data on File with Boston Scientific. 

The Rezūm System is intended to relieve symptoms, obstructions, and reduce prostate tissue associated with BPH. It is indicated for men ≥ 50 years of age with a prostate volume 30cm3 ≤ 80cm3. The Rezūm System is also indicated for treatment of prostate with hyperplasia of the central zone and/or a median lobe.

Caution: U.S. Federal law restricts this device to sale by or on the order of a physician.
IMPORTANT INFORMATION: These materials are intended to describe common clinical considerations and procedural steps for the use of referenced technologies but may not be appropriate for every patient or case. Decisions surrounding patient care depend on the physician’s professional judgment in consideration of all available information for the individual case. Boston Scientific (BSC) does not promote or encourage the use of its devices outside their approved labeling. Case studies are not necessarily representative of clinical outcomes in all cases as individual results may vary.

All images are the property of Boston Scientific. All trademarks are the property of their respective owners.

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