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

Launched by CHINESE PLA GENERAL HOSPITAL · Feb 4, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to treat benign prostatic hyperplasia (BPH), a condition where the prostate gland becomes enlarged, causing urinary problems. The study will use a technique called prostate thermal vapor ablation, which is guided by advanced imaging methods (MRI and TRUS). The main goals are to see if this treatment can effectively relieve urinary symptoms and to check for any safety concerns that might arise during the procedure.

To participate in this trial, men aged 45 to 85 who have moderate to severe urinary symptoms may be eligible. They should have not responded well to other medications or chosen not to take them. Participants will undergo some tests before the procedure and will receive the treatment while being closely monitored afterward to track their recovery and improvement in symptoms. It’s important to note that certain conditions, like severe urinary tract infections or a history of prostate cancer, may prevent someone from joining the study. This trial is currently not recruiting participants, but it aims to provide valuable insights into a promising treatment for BPH.

Gender

MALE

Eligibility criteria

• 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.