Water vapor thermal therapy (Rezūm System) in patients with large prostates: results from a prospective comparative study.

Background: Rezūm is a novel minimally invasive surgical technique (MIST) useful for BPH patients with medium-sized prostate (30-80 cm³) refractory to medical treatment. The aim of this study was to evaluate the efficacy and safety of Rezūm as a treatment option in large-sized prostates (>80 cm³).

Methods: We performed a prospective, comparative, single-center study from June 2022 to June 2023, including consecutive patients undergoing surgery with the Rezūm System. Enrolled men were classified into two subgroups based on prostate size: medium prostate (MP) (30-80 cm³) and large prostate (LP) (≥80 cm³). Inclusion criteria included an International Prostate Symptom Score (IPSS) Total score of ≥ 8 points. International Prostate Symptom Score (IPSS), maximum urinary flow rate (Qmax), post-void residual (PVR), and International Index of Erectile Function 5-item version (IIEF-5) were collected at baseline and at three, six, and 12 months post-procedure. Ejaculation presence was assessed at 3 months. Post-operative complications were described using the Clavien-Dindo (CD) classification. The primary outcome was the IPSS-Total score, with intraoperative and postoperative CD grade ≥III complications as secondary outcomes.

Results: One hundred and twenty-one patients (PV 78.2±32.1 mL) were included in the study, 51 large prostate (LP) and 70 medium prostate (MP). The IPSS-Total score and Qmax showed a statistically significant (P<0.0001) improvement at 3, 6, and 12 months respectively. PVR decreased at 3, 6, and 12 months; however, only at 3 months this variation was statistically significant (P<0.0001). At 3-month follow-up, anejaculation was detected in (3; 5.8% and 1; 1.4%) patients in LP and MP group respectively (P=0.86). IIEF-5 significantly improved 3 months after surgery in the LP subgroup (P<0.0001).

Conclusions: Rezūm water vapor therapy appears to be effective for treating BPH in larger prostates. Additionally, it demonstrates a low risk of impairing sexual function, indicating a favorable safety profile.