MRI/TRUS fusion–guided thermal vapor ablation for benign prostatic enlargement

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

This will try a targeted steam (thermal vapor) treatment guided by MRI and ultrasound to reduce urinary symptoms in men 45–85 with moderate to severe BPH who have not responded to or declined medications.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 45 Years to 85 Years
• Sex: Male
• Sponsor: Chinese PLA General Hospital (other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06817733 on ClinicalTrials.gov

What this trial studies

This interventional protocol uses MRI/TRUS fusion imaging to guide transurethral thermal vapor ablation aimed at precisely destroying obstructing prostate tissue. Eligible men (age 45–85) with moderate–severe lower urinary tract symptoms, prostate volume 30–80 mL, low maximum urinary flow, and inadequate response to medication will receive preoperative clinical and laboratory assessments followed by the image‑guided ablation. Participants will be followed with the IPSS questionnaire, measurements of prostate volume and peak urinary flow (Qmax), and monitoring for adverse events to describe feasibility and safety. Key exclusions include prostate cancer, severe infection, neurogenic bladder, prior invasive prostate procedures, and significant cardiopulmonary disease.

Who should consider this trial

Good fit: Men aged 45–85 with BPH causing moderate to severe LUTS (IPSS ≥8), prostate volume 30–80 mL, Qmax <15 mL/s, and who have not responded to or refuse medical therapy are the intended candidates.

Not a fit: Those with confirmed prostate cancer, prostate size outside the 30–80 mL range, severe urinary infection, neurogenic bladder, prior invasive prostate interventions, or major comorbidities are unlikely to benefit from this approach.

Why it matters

Potential benefit: If successful, the procedure could reduce prostate obstruction and improve urinary symptoms while minimizing collateral damage by using more precise image guidance.

How similar studies have performed: Thermal vapor therapies such as Rezum have shown symptom improvement in men with BPH, but applying MRI/TRUS fusion for guidance is less established and represents a relatively novel refinement.

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.

Where this trial is running

Beijing, Beijing Municipality

• Chinese PLA General Hospital — Beijing, Beijing Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Qing Yuan, Doctor of Medicine

Conditions: Benign Prostatic Hyperplasia, Benign prostatic hyperplasia, Rezum, MRI-TRUS