RecruitingNot ApplicableNCT06817733

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

Sponsor

Chinese PLA General Hospital

Enrollment

30 participants

Start Date

Feb 15, 2025

Study Type

INTERVENTIONAL

Conditions

Benign Prostatic Hyperplasia (BPH)

Summary

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

Sex: MALEMin Age: 45 YearsMax Age: 85 Years

Inclusion Criteria7

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;
Maximum urinary flow rate (Qmax) \< 15 mL/s;
Post-void residual urine volume (PVR) \< 300 mL;
Willingness to provide informed consent and participate in postoperative follow-up.

Exclusion Criteria7

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;
Patients with prostatitis;
History of invasive prostate interventions, such as radiofrequency ablation, laser therapy, or microwave treatment;
Patients with severe cardiovascular disease, chronic obstructive pulmonary disease, severe diabetes, hepatic or renal dysfunction, or systemic bleeding disorders, as assessed by the investigator to be unsuitable for surgery.

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Interventions

PROCEDURETransurethral Thermal Vaporization of the Prostate

After anesthesia, the patient is placed in the lithotomy position, and standard aseptic preparation and draping are performed. A cystoscope and a transrectal ultrasound (TRUS) probe are inserted. Following real-time image fusion and localization according to the preoperative plan, needles are inserted to deliver thermal vaporization to the prostate. Each needle treatment lasts 8 seconds, and the entire procedure is completed within 200 seconds after activation of the needle pathway.