An interventional study of Procedure/Surgery: MRI/TRUS Fusion-Guided Transurethral Water Vapor Thermal Therapy and Rezūm Water Vapor Thermal Therapy System with MRI/TRUS Fusion and Electromagnetic Navigation in Benign Prostatic Hyperplasia (BPH), sponsored by Chinese PLA General Hospital. Recruiting at 1 site in China. Open to male participants aged 45 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Chinese PLA General Hospital · Not applicable, Interventional, and Treatment
This study evaluates a new imaging-guided approach for treating benign prostatic hyperplasia (BPH), also known as enlarged prostate.
BPH is a common condition in older men that can cause bothersome urinary symptoms. Water vapor thermal therapy (Rezūm) is an FDA-approved and NMPA-approved treatment that uses steam to shrink the enlarged prostate. Traditionally, this procedure is performed using ultrasound guidance alone.
This study uses an advanced imaging technique that combines MRI (magnetic resonance imaging) with real-time ultrasound and electromagnetic navigation. This combination allows doctors to see the prostate more clearly and deliver the steam treatment more precisely to the areas that need it.
The study will examine:
Objective of the Clinical Trial
This is a prospective, single-arm exploratory study to evaluate the safety and preliminary efficacy of MRI/TRUS fusion-guided water vapor thermal therapy with electromagnetic navigation for the treatment of benign prostatic hyperplasia (BPH).
Conventional water vapor thermal therapy relies solely on transrectal ultrasound (TRUS) guidance, which may have limitations in accurately targeting hyperplastic prostatic tissue, particularly in the transition zone. This study introduces an innovative approach by integrating preoperative multiparametric MRI with real-time TRUS using electromagnetic navigation technology. This fusion imaging technique enables more precise identification of target tissue and more accurate delivery of thermal energy, potentially resulting in more uniform ablation of hyperplastic tissue and improved clinical outcomes.
The primary questions this study aims to address are:
Study Procedures
Preoperative Evaluation:
Participants will undergo comprehensive preoperative assessments, including:
Procedure:
Participants will receive precise prostate water vapor thermal therapy under MRI/TRUS fusion guidance with electromagnetic navigation. The preoperative MRI will be registered and fused with intraoperative transrectal ultrasound images in real-time, allowing the surgical team to accurately identify target tissue and deliver thermal energy to predetermined treatment zones. The electromagnetic navigation system tracks the position of the treatment device, ensuring precise needle placement and optimal distribution of water vapor throughout the hyperplastic tissue.
Postoperative Follow-up:
Participants will be followed at regular intervals: 1 week, 1 month, 3 months, and 6 months after surgery. Follow-up assessments will include:
Research Team
A multidisciplinary research team at Chinese PLA General Hospital, consisting of urologists, radiologists, and medical imaging specialists, will perform the MRI/TRUS fusion-guided water vapor thermal therapy procedures and conduct comprehensive follow-up assessments for all participants.
827 studies on the registry are indexed under Prostatic Hyperplasia; 179 are open to participants now.
This study's planned enrollment of 30 is below the median of 92 across 626 interventional studies indexed under Prostatic Hyperplasia.
Browse Prostatic Hyperplasia studies →Chinese PLA General Hospital is the lead sponsor of 570 studies on the registry; 207 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this group will undergo transurethral thermal vaporization of the prostate.
Procedure: Procedure/Surgery: MRI/TRUS Fusion-Guided Transurethral Water Vapor Thermal Therapy · Device: Rezūm Water Vapor Thermal Therapy System with MRI/TRUS Fusion and Electromagnetic Navigation
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 deployment delivers steam for 9 seconds, and multiple injections are performed to achieve comprehensive coverage of the hyperplastic tissue. The entire treatment is typically completed within 3-5 minutes after the first needle insertion.
The Rezūm System is an FDA-cleared and NMPA-approved transurethral water vapor thermal therapy device for the treatment of benign prostatic hyperplasia (BPH). The system delivers thermal energy in the form of water vapor to ablate hyperplastic prostate tissue. In this study, the Rezūm treatment is performed using an integrated image guidance platform that combines: 1. Preoperative multiparametric MRI for detailed visualization and treatment planning 2. Real-time transrectal ultrasound (TRUS) for intraoperative imaging 3. Electromagnetic navigation technology for real-time tracking of instrument position 4. Image fusion software that registers and merges preoperative MRI with intraoperative TRUS images This integrated approach enables precise targeting of hyperplastic tissue, accurate needle placement, and optimal distribution of thermal energy throughout the treatment zone.
Volume changes in the prostate transition zone
Change in prostate transition zone volume measured by MRI from baseline to 6 months post-treatment. This outcome assesses the ablative efficacy of MRI/TRUS fusion-guided water vapor therapy. The hypothesis is that precise image-guided targeting will result in more uniform thermal energy distribution and more effective volume reduction compared to historical data from conventional TRUS-guided approaches.
Time frame: From enrollment to 6 months after surgery
Prostatic volume change
Changes in prostate volume before and 6 months after surgery
Time frame: From enrollment to 6 months after surgery
IPSS
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.
Time frame: From enrollment to 6 months after surgery
Qmax
Maximum urine flow rate
Time frame: From enrollment to 6 months after surgery
PVR
Post-Void Residual urine
Time frame: 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.
Quality of Life Score
Quality of life related to urinary symptoms, assessed using the International Prostate Symptom Score Quality of Life (IPSS-QoL) questionnaire. The QoL score ranges from 0 (delighted) to 6 (terrible), with higher scores indicating worse quality of life.
Time frame: From enrollment to 6 months after surgery
Prostate Transition Zone Volume Measured by Transrectal Ultrasound
Changes in prostate transition zone volume measured by transrectal ultrasound (TRUS) before and after surgery. Volume is calculated using the ellipsoid formula and measured in milliliters (mL).
Time frame: Baseline, 1 week, 1 month, 3 months, and 6 months after surgery
Total Prostate Volume Measured by Transrectal Ultrasound
Changes in total prostate volume measured by transrectal ultrasound (TRUS) before and after surgery. Volume is calculated using the ellipsoid formula and measured in milliliters (mL).
Time frame: Baseline, 1 week, 1 month, 3 months, and 6 months after surgery
Plan to share: No
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