MISTER Study Evaluating Rez6bm Steam Therapy for Urinary Symptoms of Enlarged Prostate in Russian Patients

What this Trial Is About

Researchers are studying Rez6bm, a minimally invasive steam therapy used to treat urinary symptoms caused by an enlarged prostate, also known as benign prostatic hyperplasia BPH. This treatment has been FDA approved since 2015 and is recommended for men with moderate-to-severe urinary symptoms, especially those who want to preserve ejaculatory function. The study aims to better understand patient outcomes such as temporary urinary retention, repeat treatments, and changes in ejaculatory function, as well as to develop clear criteria for treatment success. Participants will receive Rez6bm therapy, which is performed transurethrally by specialists using water vapor injections. The number and location of injections, anesthesia type, catheter use, and catheterization duration are determined by the attending physician following standard clinical practice. This is a single-group study conducted in the Russian Federation to evaluate real-world effectiveness of Rez6bm therapy. During the study, participants will be monitored for outcomes including treatment failure rates at 12 months, urinary symptom scores, urine flow rates, prostate volume, PSA levels, erectile function, and rates of new retrograde ejaculation. These assessments occur at 14 days, and at 3, 6, and 12 months after treatment. The study lasts until September 2027, with participant follow-up covering one year after treatment.

MISTER Study: Minimally Invasive Steam Therapy - Russian Effectiveness Registry