Does a patients' cohort treated with Water Vapor Therapy fitting randomized clinical trial criteria have better urinary and sexual outcomes than an unselected cohort?

Introduction Water vapour intraprostatic injection (Rezum procedure) for benign prostatic hyperplasia (BPH) is one of the more promising minimally invasive surgical treatment. The 5-year outcomes from the multicentre Randomized Controlled Trial (RCT) demonstrated significant and durable urinary and sexual functional results in selected patients. We assessed the sexual and urinary outcomes of this procedure between patients satisfying inclusion criteria for the RCT and real-life patients. Materials and Methods We prospectively followed all patients with symptomatic BPH who underwent Rezum therapy at 8 institutions and analyzed the functional results. Patients were divided into two groups based on clinical characteristics ("selected patients" satisfied the pre-operative inclusion criteria of the 5-year RCT and the "real-life patients"). The pre-and post-operative data, complications, the presence of antegrade ejaculation, the urinary and sexual outcomes were periodically recorded. Results 426 patients were eligible for the study, 232 of these had the inclusion criteria of the RCT (Group A) and 194 were real life patients (Group B). Patients in group B had higher ASA, score, prostate volume and post-void residual measurement (PVR). No difference was found in terms of pre-operative IPSS, IIEF, Qmax and PSA. Longer operative time and number of more vapour injections were required in group B, with no differences in hospital stay, injection density and complications rate. In both groups all the urinary and sexual outcomes improved with no differences between the two groups. The re-intervention rate at the latest follow-up visit was 2.6% in Group A and 3.1% in group B Conclusions In our series, the water vapour intraprostatic injections is a safe, effective and well tolerated procedure in all type of patients.