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

ConditionBenign Prostatic Hyperplasia (BPH)

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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

Transurethral Thermal Vaporization of the Prostate
Procedure/Surgery
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.
Rezūm Water Vapor Thermal Therapy System
Device
The Rezūm System is an FDA-cleared and NMPA-approved transurethral water vapor thermal therapy device for the treatment of benign prostatic hyperplasia (BPH). The system delivers thermal energy in the form of water vapor to ablate hyperplastic prostate tissue. The treatment is performed under cystoscopic and transrectal ultrasound (TRUS) guidance with electromagnetic navigation.

Treatment groups

30 Participants

are divided into 1 treatment group

Group A: RezumExperimental treatment 2 interventions

Trial outcomes