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

Objective of the Clinical Trial The objective of this clinical trial is to preliminarily assess the feasibility and safety of performing precise prostate thermal vapor ablation under MRI/TURS guidance. The primary questions it aims to address are: Can precise prostate thermal vapor ablation under MRI/TURS guidance effectively treat benign prostatic hyperplasia (BPH) and alleviate lower urinary tract symptoms (LUTS)? What safety issues may arise in participants after undergoing prostate thermal vapor ablation? Study Procedures Participants Preoperative Evaluation: Participants will undergo comprehensive preoperative assessments, including clinical examinations and laboratory tests. Procedure: Participants will receive precise prostate thermal vapor ablation under MRI/TURS guidance. Postoperative Follow-up: Regular follow-up to reassess prostate volume. Periodic completion of the International Prostate Symptom Score (IPSS) questionnaire. Regular measurement of maximum urinary flow rate (Qmax) and post-void residual urine volume (PVR). Research Team The research team will conduct precise prostate thermal vapor ablation under MRI/TURS guidance for the participants and manage their follow-up assessments.

NCT Number	NCT06817733
Lead Sponsor	Chinese PLA General Hospital
Conditions	Benign Prostatic Hyperplasia (BPH)
Enrollment	30 participants
Start Date	2025-04-15
Primary Completion	2026-12-30 (estimated)
Study Completion	2027-06-30 (estimated)
Updated on ClinicalTrials.gov	2026-08-11