Rezum™

The VAPEUR Randomized Controlled Trial is a clinical study comparing Rezūm™ Water Vapor Therapy to dual drug therapy, also referred to as combination therapy, for the treatment of symptomatic benign prostatic hyperplasia (BPH) in sexually active men.  
 
The primary endpoints of the study measured: 

• lower urinary tract symptoms (LUTS) relief, assessed by measuring the International Prostate Symptom Score (IPSS) change from baseline to 12 months. 
• sexual function, measured using the Men’s Sexual Health Questionnaire (MSHQ) total score change from baseline to 12 months, which evaluates erectile and ejaculatory function as well as satisfaction.   

Data from the VAPEUR study demonstrated that Rezūm Therapy provides superior BPH symptom relief outcomes versus combination therapy in sexually active men, while preserving sexual function. 

• At one year, LUTS symptom relief (measured by IPSS) was superior with Rezūm Therapy compared to combination therapy (mean difference between therapies, -4.6 points, p=0.0004).  
• At one year, preservation of sexual function, measured by MSHQ scores, remained stable with Rezūm Therapy (+1.1±16.9) and decreased with combination therapy (-5.2±16.4). Rezūm Therapy superiority over combination therapy in preserving sexual function was demonstrated using last observation carried forward analysis (p=0.006) but not multiple imputation (p=0.022). 

The secondary endpoint of the trial assessed the occurrence of any of the following:  

• surgical retreatment for BPH;  
• urinary retention requiring a catheter for more than three months post-treatment; 
• a worsening IPSS score of four points or more from baseline; or  
• introduction of additional medications. 

There was no statistically significant difference in this endpoint with Rezūm Therapy compared to combination therapy.  
 
Data from the VAPEUR study demonstrates: 

• the effectiveness and safety of Rezūm Therapy in patients who would otherwise be directed to combination therapy, underscoring the value of adopting Rezūm Therapy into routine practice.  
• that Rezūm Therapy can serve as a potential first-line alternative to combination therapy, after alpha blockers fail, for the treatment of symptomatic BPH in sexually active men.