Study of MRITRUS-Guided Thermal Vapor Ablation for Treating Benign Prostatic Hyperplasia in Men Aged 45 to 85

What this Trial Is About

This clinical trial evaluates the feasibility and safety of precise prostate thermal vapor ablation guided by MRI and transrectal ultrasound TRUS fusion imaging for treating benign prostatic hyperplasia BPH and relieving lower urinary tract symptoms LUTS. The study aims to determine whether this targeted ablation can effectively reduce prostate volume and improve urinary symptoms, while also monitoring any safety concerns in participants after the procedure. Participants receive transurethral thermal vaporization of the prostate using the Rezum Water Vapor Thermal Therapy System, which delivers thermal energy via water vapor to ablate excess prostate tissue. The procedure is performed under anesthesia with real-time imaging guidance to precisely target the prostate. Each needle treatment lasts about 8 seconds, with the entire treatment completed within approximately 200 seconds. This device is FDA-cleared and NMPA-approved for BPH treatment. Throughout the study, participants undergo preoperative assessments including clinical exams and laboratory tests. After the procedure, they are regularly followed up with evaluations of prostate volume, urinary flow rate, post-void residual volume, and symptom questionnaires such as the International Prostate Symptom Score IPSS. The study measures changes from enrollment up to 6 months after surgery, including quality of life and duration of catheter use. Follow-up includes transrectal ultrasound measurements at multiple time points to monitor treatment effects and safety.

Clinical Study on Prostate Thermal Vapor Ablation Guided by MRI/TRUS Fusion Imaging