Boston Scientific Corporation today announced positive 12-month primary endpoint results from the VAPEUR clinical trial comparing Rezūm Water Vapour Therapy to dual drug therapy, also referred to as combination therapy, for the treatment of symptomatic benign prostatic hyperplasia (BPH) in sexually active men.
Key findings from the study, presented at the annual European Association of Urology (EAU) Congress in London, demonstrate that Rezūm Therapy provides superior BPH symptom relief versus combination therapy while preserving sexual function.
Jean-Nicolas Cornu is professor of urology, Hospital Centre University De Rouen.
Cornu told Health Tech World: “Symptom improvement is greater with Rezūm than with established combination therapy.
“For patients, this represents a real change because they do not experience the secondary and adverse events associated with those medications, which are very well known.”
BPH, or an enlarged prostate, is a common condition in which the prostate grows and presses on the urethra.
In some patients, this growth causes bothersome symptoms like obstruction of the urine flow, a weak stream or difficulty starting urination.
By age 60, approximately half of men have BPH, and by age 85, the proportion reaches 90 percent.1 One treatment option for BPH is combination therapy, a treatment that consists of an alpha blocker and 5-alpha reductase inhibitor (5-ARI).
While this therapy has shown to be effective at reducing lower urinary tract symptoms (LUTS) associated with BPH, it can cause side effects like dizziness, fatigue, a drop in blood pressure or impairments to sexual function.
Rezūm Therapy is a minimally invasive procedure that uses controlled convective water vapour energy to ablate prostate tissue that is causing urinary symptoms due to BPH.
The therapy can be performed in various care settings and has been demonstrated to preserve sexual function while providing meaningful symptom relief.
The open-label, randomised trial includes 151 patients across France and Australia. Participants were sexually active men 45 years and older with a prostate volume ≥ 30 ml with moderate to severe LUTS that persists despite a single drug therapy approach. Patients were randomly assigned to Rezūm Therapy or combination therapy.
Key findings from the primary endpoints at one year include:
- LUTS relief, measured by International Prostate Symptom Score (IPSS), was superior with Rezūm Therapy compared to combination therapy (mean difference between therapies, -4.6 points, p=0.0004).
- Preservation of sexual function, measured by Men’s Sexual Health Questionnaire (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 90 days post-treatment;
- a worsening IPSS score of four points or more from baseline; or
- introduction of new medications for the treatment of BPH.
There was no statistically significant difference (p=0.0784) in this endpoint with Rezūm Therapy compared to combination therapy.
Dr Ron Morton is chief medical officer, Urology, Boston Scientific.
Morton said: “Boston Scientific is committed to advancing clinical research to support physicians in their evidence-based decision-making process for the treatment of urologic conditions.
“Data from the VAPEUR trial support use of Rezūm Therapy as a potential first-line alternative to combination therapy.
“The study builds on the body of clinical evidence demonstrating the effectiveness of Rezūm Therapy in sexually active patients who would otherwise be directed to combination therapy, underscoring the value of adopting Rezūm Therapy into routine practice.”
