Five-Year Data

 

The final 5-year outcomes of the Rezūm™ Water Vapor Therapy pivotal trial, led by urologists Kevin McVary, MD, and Claus Roehrborn, MD, have been published in the Journal of Urology. Study results demonstrate Rezūm Water Vapor Therapy is a safe and efficient in-office BPH treatment that effectively relieves symptoms and preserves sexual function out to five years.1

 

Read the 5-year data study

  

Study Design

 
This was a multicenter (15 sites), randomized, sham-controlled trial of Rezūm Water Vapor 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, 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
 ≤ 15 ml/s 30-80 cc
Patients were randomized 2:1
(Thermal therapy with the Rezūm System: sham control rigid cystoscopy)
All Rezūm Therapies were completed in the office or ambulatory-surgery center. 

  

Long-term Durability

 

5-Year Surgical Retreatment Rate

Rezūm retreatment rates chart
*Results from different clinical investigations are not directly comparable. Information provided for educational purposes only.

  

Sustained Symptom Relief and QOL Improvements

International Prostate
Symptom Score
Peak Urinary
Flow Rate
Quality of Life
Improvement

  

Versatile to Treat Middle Lobe Obstruction (MLO)

  • Rezūm Therapy can treat lateral and central zones without physicians having to learn an advanced technique
  • Unlike other BPH MISTs, Rezūm Therapy is recommended by the AUA for the treatment of MLO7

  

Proven Safety Profile, Preserves Sexual Function

  • No thermal effect outside the targeted treatment zone
  • No late related adverse events occurred from years 1 to 5
  • No related de novo device or procedure-related erectile dysfunction throughout the duration of the study

 

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"Rezūm Therapy has been embraced by urology practices, health technology assessment bodies, and urologic societies throughout the US and Europe. This adoption is attributed to the evidence of its clinical advantages, including sustained relief of LUTS, enhanced quality of life, and durability of treatment response."1

 

  

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 obstructive prostate tissue. 

 

Learn More  

  

  

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Join the 500+ urologists who offer Rezūm Therapy to their patients.

 

 

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Indications, Safety and Warnings

References

  1. McVary KT, Gittelman MC, Goldberg KA, et al. 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. J Urol. 2021 Apr 19. Online ahead of print.
  2. Roehrborn CG, Barkin J, Gange SM, 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. Zlotta, A.R., et al., Long-term evaluation of transurethral needle ablation of the prostate (TUNA) for treatment of symptomatic benign prostatic hyperplasia: clinical outcome up to five years from three centers. Eur Urol, 2003. 44(1): p. 89-93.
  4. Rosario, D.J., J.T. Phillips, and C.R. Chapple, Durability and cost-effectiveness of transurethral needle ablation of the prostate as an alternative to transurethral resection of the prostate when alpha-adrenergic antagonist therapy fails. J Urol, 2007. 177(3): p. 1047-51; discussion 1051.
  5. Hill, B., et al., Transurethral needle ablation versus transurethral resection of the prostate for the treatment of symptomatic benign prostatic hyperplasia: 5-year results of a prospective, randomized, multicenter clinical trial. J Urol, 2004. 171(6 Pt 1): p. 2336-40.
  6. Miller PD, Kastner C, Ramsey EW, et al. Cooled thermotherapy for the treatment of benign prostatic hyperplasia: durability of results obtained with the Targis system. Urology. 2003 Jun;61(6):1160-4.
  7. Parsons JK, Dahm P, Köhler TS, et al. Surgical management of lower urinary tract symptoms attributed to benign prostatic hyperplasia: AUA Guideline Amendment 2020. J Urol. 2020 Oct;204(4):799-804.

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. Potential risks associated with Rezūm Water Vapor Therapy include but are not limited to dysuria, hematuria, hematospermia, decrease in ejaculatory volume, suspected urinary tract infection (UTI), urinary frequency, and retention or urgency. 

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.

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