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NCT Number: NCT06817733

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

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.

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Key information

Conditions

Benign Prostatic Hyperplasia (BPH) Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases

Age range

45 year–85 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transurethral Thermal Vaporization of the Prostate

Procedure

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.

Primary outcomes

  1. Volume changes in the prostate transition zone

    Time frame: From enrollment to 6 months after surgery

    The volume of the transitional zone measured by MRI before and 6 months after surgery

Secondary outcomes

  1. Prostatic volume change

    Time frame: From enrollment to 6 months after surgery

    Changes in prostate volume before and 6 months after surgery

  2. IPSS

    Time frame: 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.

  3. Qmax

    Time frame: From enrollment to 6 months after surgery

    Maximum urine flow rate

  4. PVR

    Time frame: From enrollment to 6 months after surgery

    Post-Void Residual urine

  5. Duration of postoperative indwelling urinary catheter

    Time frame: From the end of the procedure until the catheter is removed.It is estimated that the longest time will not exceed 2 months.

Study contacts

Contact information is provided by the study sponsor or research team.

Qing Yuan, Doctor of Medicine

CONTACT

[email protected]

8601018910980422

Sponsors and collaborators

Lead sponsor

Chinese PLA General Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 10, 2025
Registry last updated
Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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