Durable relief with Rezūm™ Water Vapor Therapy

Durable relief with Rezūm™
Water Vapor Therapy

 

The data behind water vapor therapy with Rezūm

Rezūm Water Vapor Therapy is a thermal therapy, which uses convective water vapor to ablate excess prostate tissue in men with moderate-to-severe lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH).1

It is a minimally invasive option for men who may not want to rely on pharmaceutical management of their symptoms. This advanced technology can enable you to achieve significant clinical improvements and a lasting response for your patients.1,2

Rezūm Water Vapor Therapy can deliver benefits in three key areas:

1.
An alternative first-line treatment option    

2.
Durable symptom relief

3.
Potential value for your treatment


Rezūm can be used as a first-line treatment option3. It provides high satisfaction in patients with BPH, according to a 4-year single centre study of 255 men4. For BPH patients that do not want to take medication, Rezūm could be considered as an alternative treatment option3.

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

Backed by data from a randomised, controlled trial2

Rezūm was studied in the Rezūm II pivotal study, a multicentre, randomised, controlled trial in men with moderate-to-severe LUTS due to BPH.2,3 Final surgical and BPH medication retreatment rates were included as outcomes.2 Thermal therapy involved injection of water vapour using Rezūm, into obstructive tissue, potentially including the middle lobe and/or enlarged central zone.3

Patient Profile2

197 subjects ≥ 50 years old

 

*The trial was controlled vs sham until 3 months.

Outcomes Measured

Changes in2:

  • International Prostate Symptom Score (IPSS)
  • Quality of life (QoL)
  • Maximum flow rate (Qmax)
  • BPHII

 

Retreatment of BPH after the index procedure2:

  • Secondary surgical treatment for LUTS/BPH
  • Initiated BPH medication

Patients were randomised 2:1

(Thermal therapy with the Rezūm System: sham control rigid cystoscopy)2

58 men with MLO were treated2
58 men with MLO were treated2

Suitable for patients with median lobe obstruction (MLO)2

With Rezūm, you can treat lateral and central zones without having to learn an advanced technique.2

The Rezūm II pivotal study showed significant improvements in LUTS ≤3 months after Rezūm therapy in the treatment group.2 These improvements were sustained through 5 years without any clinically meaningful impact to erectile or ejaculatory function with Rezūm Water Vapor therapy.3 Furthermore, in the 5-year study, there were no reports of de novo device or procedure-related erectile dysfunction.2

Sustained clinical outcomes through 5 years of follow-up2

Significant symptom relief and quality of life (QoL) improvements were maintained at 5 years.2

Sustained clinical outcomes through 5 years of follow-up

Retreatment rates remained low through 5 years2

 

Sexual function was preserved, and the safety profile remained positive through 5 years.2

 

There were no reports of de novo device or procedure-related erectile dysfunction throughout the duration of the study. No late-related adverse events occurred from years 1 to 5.2

The principal investigator of the Rezūm II pivotal study concluded:

"The positive safety profile, long-term durability and maintenance of sexual function make water vapour thermal therapy an optimal treatment choice for patients with moderate-to-severe LUTS.”

Kevin McVary, MD, FACS Director, Center for Male Health, and Professor of Urology at Stritch School of Medicine, Loyola University Medical Center and Principle Investigator of the Rezūm II pivotal study

Not only does Rezūm possess a minimal learning curve for physicians,1 it can also deliver value to your centre through its short procedural time and length of stay.1,4 In some countries cost modelling estimates that Rezūm is cost saving compared with standard treatments8.Identification of treatments for LUTS/BPH that demonstrate cost-effectiveness is paramount** as reimbursement for patient care moves from volume-based services to value-based services.5

With its durable clinical benefits 1, short procedural time and short length of stay1,4, Rezūm may lead to cost savings 6,7 as well as capacity impact reduction vs standard of care*.7


* for Results from different clinical investigations are not directly comparable. Information provided for education purposes only.
** Dependent on individual clinical situation and healing response. Patient responses can and do vary.

 

Learn more about Rezūm Water Vapor Therapy

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