What Is New with Rezūm Water Vapor Thermal Therapy for LUTS/BPH?
Sai K Doppalapudi, Nikhil Gupta
https://pubmed.ncbi.nlm.nih.gov/33403529Actively Recruiting
Phase Not Applicable
Age: 45Years - 85Years
MALE
ID06817733
Clinical Study on Prostate Thermal Vapor Ablation Guided by MRI/TRUS Fusion Imaging
Led by Chinese PLA General Hospital · Updated on 2025-12-05
30
Participants Needed
1
Research Sites
1 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the feasibility and safety of precise prostate thermal vapor ablation guided by MRI and transrectal ultrasound fusion imaging for treating benign prostatic hyperplasia (BPH) and relieving lower urinary tract symptoms (LUTS). This clinical trial aims to understand whether this targeted procedure can effectively reduce prostate size and improve urinary function while monitoring possible safety concerns after treatment. Participants will undergo transurethral thermal vaporization of the prostate under anesthesia, with real-time image fusion used to guide needle placement. The procedure involves delivering thermal vapor to the prostate tissue, with each needle treatment lasting about 8 seconds and the entire treatment completed within approximately 200 seconds. Preoperative evaluations are performed, and postoperative follow-up includes repeated assessments to monitor prostate volume and urinary symptoms. During the study, participants will have regular follow-up visits to measure changes in prostate volume, complete the International Prostate Symptom Score (IPSS) questionnaire, and assess urinary flow rate (Qmax) and post-void residual urine volume (PVR). The duration of any postoperative urinary catheter use will also be recorded, with the longest expected time not exceeding two months. The total follow-up period for these assessments is six months after surgery.
CONDITIONS
Brief Title
Clinical Study on Prostate Thermal Vapor Ablation Guided by MRI/TRUS Fusion Imaging
Who Can Participate
Age: 45Years - 85Years
MALE
Eligibility Criteria
You may qualify if you...
- Age 45 to 85 years
- International Prostate Symptom Score (IPSS) of 8 or higher indicating moderate to severe symptoms
- Poor response to or refusal of pharmacological treatment for BPH
- Prostate volume between 30 and 80 milliliters
- Maximum urinary flow rate (Qmax) less than 15 mL/s
- Post-void residual urine volume (PVR) less than 300 mL
- Willingness to provide informed consent and participate in postoperative follow-up
You will not qualify if you...
- Prostate volume less than 30 mL or greater than 80 mL
- Severe urinary tract infection
- Confirmed diagnosis of prostate cancer before surgery
- Known neurogenic bladder, detrusor muscle weakness, urethral stricture, or other non-BPH urinary obstruction causes
- Presence of prostatitis
- History of invasive prostate treatments such as radiofrequency ablation, laser therapy, or microwave treatment
- Severe cardiovascular disease, chronic obstructive pulmonary disease, severe diabetes, liver or kidney dysfunction, or bleeding disorders making surgery unsuitable as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Procedure completed within a single day
Participants undergo transurethral thermal vaporization of the prostate guided by MRI/TRUS fusion imaging under anesthesia.
1 procedure visit (in-person)
Post-operative Follow-up
Duration - Up to 6 months after surgery
Participants are monitored after the procedure, including management of the urinary catheter and assessment of prostate volume and urinary symptoms.
Approximately 6 post-operative visits
Trial Site Locations
Total: 1 location
1
Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 100853
Actively Recruiting
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Research Team
Q
Qing Yuan, Doctor of Medicine
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Published Research Related To This Trial
Real-world evidence with The Rezūm System: A retrospective study and comparative analysis on the efficacy and safety of 12 month outcomes across a broad range of prostate volumes.
Matthew Ines, Mustufa Babar, Sandeep Singh...
https://pubmed.ncbi.nlm.nih.gov/34254333Final 5-Year Outcomes of the Multicenter Randomized Sham-Controlled Trial of a Water Vapor Thermal Therapy for Treatment of Moderate to Severe Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia.
Kevin T McVary, Marc C Gittelman, Kenneth A Goldberg...
https://pubmed.ncbi.nlm.nih.gov/33872051Minimally Invasive Prostate Convective Water Vapor Energy Ablation: A Multicenter, Randomized, Controlled Study for the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia.
Kevin T McVary, Steven N Gange, Marc C Gittelman...
https://pubmed.ncbi.nlm.nih.gov/26614889Rezūm Water Vapor Thermal Therapy for Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia: 4-Year Results From Randomized Controlled Study.
Kevin T McVary, Tyson Rogers, Claus G Roehrborn
https://pubmed.ncbi.nlm.nih.gov/30677455Management of Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia (BPH): AUA Guideline Amendment 2023.
Jaspreet S Sandhu, Brooke R Bixler, Philipp Dahm...
https://pubmed.ncbi.nlm.nih.gov/37706750Prevalence of lower urinary tract symptoms suggestive of benign prostatic hyperplasia (LUTS/BPH) in China: results from the China Health and Retirement Longitudinal Study.
Weiyu Zhang, Xiaopeng Zhang, Haibin Li...
https://pubmed.ncbi.nlm.nih.gov/31221864The global burden of lower urinary tract symptoms suggestive of benign prostatic hyperplasia: A systematic review and meta-analysis.
Shaun Wen Huey Lee, Esther Mei Ching Chan, Yin Key Lai
https://pubmed.ncbi.nlm.nih.gov/28801563