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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age45-85
SponsorChinese PLA General Hospital

About this trial

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.

Eligibility criteria

Qualifiers

Age 45-85 years;

International Prostate Symptom Score (IPSS) ≥ 8, indicating moderate to severe Lower Urinary Tract Symptoms (LUTS) that significantly impact quality of life;

Poor response to pharmacological treatment or refusal of pharmacological treatment;

Prostate volume 30-80 mL;

Disqualifiers

Prostate volume < 30 mL or > 80 mL;

Severe urinary tract infection;

Preoperative definitive diagnosis of prostate cancer;

Known neurogenic bladder, detrusor muscle weakness, urethral stricture, or other non-BPH causes of urinary obstruction;

Trial design

Treatments tested in this trial

  • Transurethral Thermal Vaporization of the Prostate

Treatment groups

30 Participants
are divided into 1 treatment group

Sponsors and collaborators