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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Chinese PLA General Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Qing Yuan, Doctor of Medicine
• Email: qyuanmd@outlook.com
• Phone: 8601018910980422

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.