Analysis of the Tolerance and Safety of the Rezum System for the Treatment of Benign Prostatic Hyperplasia

Benign prostatic hyperplasia (BPH) is a condition prevalent in men over 50 years old and characterised by benign prostatic obstruction and lower urinary tract symptoms. The Rezum^TM system, a minimally invasive technique based on thermal ablation using water vapor, aims to provide an effective treatment with reduced surgical effect and preserved quality of life.

A bibliographic review was conducted on publications indexed in PUBMED and SCOPUS from 2015 to 2023. Sixteen studies, including clinical trials and multicentre experiences, on the adverse effects (AEs) and tolerance to Rezum^TM treatment were selected. Data were organised in accordance with Clavien-Dindo criteria and compared with bipolar transurethral resection of the prostate (TURP).

The main AEs associated with Rezum^TM include haematuria (1.7%-71.7%), dysuria (1.79%-64.5%), frequency/urgency (3.2%-50%), acute urinary retention (4.4%-33.8%) and urinary tract infection (2%-20%). These events are generally mild to moderate (Clavien-Dindo I-II) and tend to resolve spontaneously or with symptomatic treatment. Erectile dysfunction was reported in less than 5.56% of all reviewed studies, highlighting its limited impact on sexual function. Re-treatment rates were within the range of 4.4%-8.33%, associated with the conservative therapeutic strategy.

The Rezum^TM system demonstrates a favourable safety profile with mild/moderate and manageable AEs and high tolerability (100% across reviewed studies). It is an effective and minimally invasive alternative for managing BPH, particularly for patients seeking to minimise surgical risk and preserve sexual function.