Rezūm shows greater 1-year BPH symptom relief vs pharmacotherapy

Results from the VAPEUR-RCT trial (NCT04838769) have been published in European Urology Focus, showing that water vapor thermal therapy (WVTT) provided superior symptom relief and greater quality of life improvement at 1 year compared with combination pharmacotherapy in sexually active men with symptomatic benign prostatic obstruction (BPO).¹

The results were initially presented at the 41st Annual Congress of the European Association of Urology in London, United Kingdom.

Trial design and findings

VAPEUR was a post-market, multicenter, open-label, randomized controlled trial comparing WVTT using the Rezūm System with combination pharmacotherapy in sexually active men with symptomatic BPO whose symptoms were refractory to α-blocker monotherapy. The trial randomly assigned 151 men aged 45 and older to WVTT (n = 75) and combination therapy (n = 76). The combination-therapy group received an α-blocker and 5-ARI per standard first-line management.

The co-primary outcomes were change from baseline to 1 year in the International Prostate Symptom Score (IPSS) and Male Sexual Health Questionnaire (MSHQ) score. At 1 year, mean IPSS improved by 10.8 points (SD, 6.8) with WVTT compared with 6.2 points (SD, 7.7) with combination pharmacotherapy. The adjusted mean between-group difference was −4.6 points (97.5% CI, −7.6 to −1.6; P < .001), favoring WVTT.

Sexual function, assessed using the MSHQ, remained broadly stable in the WVTT group, with a mean change of +1.1 points (SD, 16.9), compared with a mean decline of 5.2 points (SD, 16.4) in the pharmacotherapy group. However, the investigators did not demonstrate superiority of WVTT for preservation of sexual function when multiple imputation was used. Individual sexual adverse effects were more frequent with combination therapy, including libido changes in 11% of patients vs none with WVTT. In the combination pharmacotherapy arm, there were also 9 cases of de novo erectile dysfunction compared with 2 cases after WVTT.

Improvement in quality of life was also greater with WVTT. Mean IPSS quality-of-life scores improved by 2.7 points (SD, 1.8) with WVTT compared with 1.8 points (SD, 2.0) with combination therapy (P = .01). Qmax improved in both treatment arms, although the greater early improvement after WVTT narrowed over time while the pharmacotherapy arm continued to improve. Post-void residual also improved with WVTT and remaining stable with pharmacotherapy.

Retreatment and adverse events

The study also evaluated treatment failure and retreatment. Surgical retreatment occurred in 1.3% of patients in the WVTT group compared with 9.2% of those receiving combination pharmacotherapy. An IPSS worsening of at least 4 points occurred in 2.7% and 13% of patients, respectively. No WVTT-treated patients required catheterization beyond 90 days, compared with 1.3% of patients receiving pharmacotherapy.

Pharmacologic retreatment was more common after WVTT: 12% of patients resumed medication compared with 1.3% of those assigned to combination pharmacotherapy. When surgical and medical retreatment were combined, the hazard ratio was 0.52 (CI, 0.25 to 1.1; P = .08) for the composite secondary end point.

Treatment-related adverse events were more frequent with WVTT than with combination pharmacotherapy, occurring in 40% and 28% of patients, respectively. Serious adverse events occurred in 12% of patients treated with WVTT compared with 1.3% of those receiving medication. The investigators reported that WVTT-related events were predominantly procedure related and occurred early, whereas adverse events in the pharmacotherapy group were more often associated with medication effects and occurred throughout follow-up. At 1 year, 93% of AEs were resolved in the WVTT arm vs 60% in the combination pharmacotherapy arm.

Interpretations and limitations

The authors acknowledged several limitations of the study, including its open-label design, the reliance on self-reported medication adherence, and the short duration of follow-up. They note that longer follow-up is needed to confirm the benefits of WPTT in reducing disease progression.

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