VAPEUR-RCT: Water Vapour Thermal Therapy (Rezum) Superior to Combination Drug Therapy in Benign Prostatic Enlargement

KEY FINDINGS

• Trial: The results of VAPEUR-RCT (NCT04838769) were published in European Urology Focus; the data were first presented at the 41st EAU Annual Congress (London).
• Symptom control: Water vapour thermal therapy (WVTT / Rezum) produced an improvement of 10.8 points in IPSS at year 1; with combination drug therapy this figure was 6.2 points (adjusted difference -4.6; 97.5% CI -7.6 to -1.6; p<0.001).
• Quality of life: The improvement in IPSS-QoL significantly favoured WVTT (2.7 versus 1.8 points; p=0.01).
• Sexual function: The MSHQ score remained stable in the WVTT arm (+1.1 points) and declined by 5.2 points in the drug arm; however, superiority could not be statistically confirmed in the multiple imputation analysis.
• Retreatment: The need for surgical retreatment was 1.3% in the WVTT arm and 9.2% in the combination drug arm.
• Safety: Treatment-related adverse events were more frequent in the WVTT arm (40% versus 28%), as was the rate of serious adverse events (12% versus 1.3%); however, WVTT events were procedure-related and early, and 93% had resolved completely at year 1.

Background: The Decision Point in the Alpha-Blocker-Resistant Patient

Lower urinary tract symptoms (LUTS) due to benign prostatic enlargement (benign prostatic obstruction, BPO) are among the urological problems that most affect quality of life in men over 50. In the classical treatment algorithm the first step is alpha-blockers; when symptoms do not improve sufficiently on this treatment, the most frequently taken route is to move to a combination of alpha-blocker plus 5-alpha reductase inhibitor (5-ARI).

However, this approach has two fundamental problems. First, 5-ARIs take months to show their effect and symptom improvement can remain limited. Second, and often underestimated in clinical practice, is the adverse effect of this drug class on sexual function: loss of libido, erectile dysfunction and ejaculatory disorders seriously undermine adherence, particularly in sexually active men.

Water vapour thermal therapy (Rezum) is a minimally invasive, outpatient method that injects controlled water vapour into prostate tissue transurethrally, achieving targeted tissue ablation through convective heat transfer. Most of the evidence to date has come from sham-controlled trials and observational series. VAPEUR-RCT is the first pragmatic randomized trial comparing this treatment directly with combination drug therapy.

Study Design

VAPEUR-RCT is a post-marketing, multicentre, open-label, pragmatic randomized controlled trial. The lead author is Dr Sébastien Vincendeau.

Methodological note: Because the trial had two co-primary endpoints, the threshold of statistical significance was set at the 97.5% confidence interval level. Superiority was clearly demonstrated for the IPSS endpoint; for the MSHQ endpoint superiority could not be confirmed in sensitivity analyses.

Key Results

Uroflowmetry and residual volume

Maximum urinary flow rate (Qmax) improved in both arms. While the advantage that was clear in the early period in the WVTT arm narrowed over time, improvement in the pharmacotherapy arm continued gradually throughout follow-up - consistent with the known late-onset effect profile of 5-ARIs. Post-void residual volume improved after WVTT and remained stable in the drug arm.

Implications for Clinical Practice

1. Clear superiority in symptom control

The 4.6-point difference in IPSS is not only statistical but clinically meaningful; in the BPH literature the minimal clinically important difference is generally accepted as 3 points.

2. A protective signal in terms of disease progression

The roughly sevenfold difference in the rate of surgical retreatment (1.3% versus 9.2%) and the difference in the rate of symptom worsening indicate that WVTT may slow the natural course of the disease at an early stage.

3. Sexual function: to be interpreted carefully

Although the raw MSHQ data and the distribution of adverse events show a strong trend favouring WVTT, superiority could not be confirmed in sensitivity analysis. The correct message is this: WVTT does not improve sexual function, but it prevents the deterioration caused by combination drug therapy - and that in itself is an important gain for sexually active patients.

4. The risk-benefit balance must be struck for the individual patient

The higher rate of serious adverse events in the WVTT arm cannot be ignored. However, that these events were procedure-related, emerged early and were largely reversible, whereas side effects in the drug arm persisted throughout treatment, is a critical distinction that must be shared with the patient.

5. Expectation management

It should be remembered that 12% of patients returned to drug therapy after WVTT. The procedure should not be presented as a promise of complete independence from medication in all patients.

Limitations

The authors explicitly state the principal limitations of the trial: the open-label design (in an unblinded trial an expectation effect on patient-reported symptom scores is unavoidable), reliance on patient report for drug adherence, and the short duration of follow-up. Long-term follow-up data are needed to establish whether disease progression is genuinely slowed.

Conclusion

VAPEUR-RCT establishes at randomized level that in sexually active men with symptomatic BPO resistant to alpha-blockers, water vapour thermal therapy provides stronger symptom control, better quality of life and a markedly lower need for surgical retreatment at year 1 compared with combination drug therapy.

These findings require us to rethink the position of minimally invasive surgical treatments in the treatment algorithm. For many years these methods have been positioned as options to be considered "after drug therapy has failed"; VAPEUR-RCT shows that in selected patients - particularly men who prioritise preserving sexual function - these interventions can be put on the table earlier, as an alternative to adding a drug at the second step. The final decision should be shaped through shared decision-making in the light of prostate volume, anatomical configuration, comorbidities and, most importantly, the patient's own priorities.

References

• Vincendeau S, Xylinas E, Fourmarier M, et al. Water vapor thermal therapy with Rezum versus combination pharmacotherapy for male lower urinary tract symptoms due to benign prostatic obstruction: 1-yr results from VAPEUR-RCT. Eur Urol Focus. 2026. doi:10.1016/j.euf.2026.08.001
• Urology Times. Rezum shows greater 1-year BPH symptom relief vs pharmacotherapy. 21 August 2026.
• ClinicalTrials.gov. VAPEUR-RCT (NCT04838769).
• EAU Guidelines. Management of Non-neurogenic Male LUTS.