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

December 4, 2025 updated by: Qing Yuan, Chinese PLA General Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

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

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100853

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rezum
Participants in this group will undergo transurethral thermal vaporization of the prostate.
Procedure: Transurethral Thermal Vaporization of the Prostate
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From enrollment to 6 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prostatic volume change
Time Frame: From enrollment to 6 months after surgery
Changes in prostate volume before and 6 months after surgery
From enrollment to 6 months after surgery
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.
From enrollment to 6 months after surgery
Qmax
Time Frame: From enrollment to 6 months after surgery
Maximum urine flow rate
From enrollment to 6 months after surgery
PVR
Time Frame: From enrollment to 6 months after surgery
Post-Void Residual urine
From enrollment to 6 months after surgery
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.
From the end of the procedure until the catheter is removed.It is estimated that the longest time will not exceed 2 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese PLA General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2025

Primary Completion (Estimated)

December 20, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

February 4, 2025

First Submitted That Met QC Criteria

February 4, 2025

First Posted (Actual)

February 10, 2025

Study Record Updates

Last Update Posted (Actual)

December 5, 2025

Last Update Submitted That Met QC Criteria

December 4, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REZUM2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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