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

Not Applicable

Not yet recruiting

• Conditions: Benign Prostatic Hyperplasia (BPH)

• Registration Number: NCT06817733
• Lead Sponsor: Chinese PLA General Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-04
• Study First Submitted QC: 2025-02-04
• Last Update Submitted: 2025-02-04
• Study First Posted: 2025-02-10
• Last Update Posted: 2025-02-10
• Study Start: 2025-02-15
• Primary Completion: 2025-10-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

• 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 Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Volume changes in the prostate transition zone	From enrollment to 6 months after surgery	The volume of the transitional zone measured by MRI before and 6 months after surgery

Secondary Outcome Measures

Name	Time	Method
IPSS	From enrollment to 6 months after surgery	International Prostate Symptom Score.The minimum IPSS score was 0, the maximum was 35, and the higher the score, the more severe the lower urinary tract symptoms were. 0-7 was classified as mild symptoms, 8-19 as moderate symptoms, and 20-35 as severe symptoms.
Qmax	From enrollment to 6 months after surgery	Maximum urine flow rate
PVR	From enrollment to 6 months after surgery	Post-Void Residual urine
Duration of postoperative indwelling urinary catheter	From the end of the procedure until the catheter is removed.It is estimated that the longest time will not exceed 2 months.
Prostatic volume change	From enrollment to 6 months after surgery	Changes in prostate volume before and 6 months after surgery