Evaluation of the Water Vapor Thermal Therapy System for the Treatment of Benign Prostatic Hyperplasia
NCT ID: NCT06725212
Last Updated: 2024-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
126 participants
INTERVENTIONAL
2024-03-26
2026-06-01
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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Treatment group
Subjects with BPH with LUTS will be randomized into the treatment group to receive the Water Vapor Thermal treatment via cystoscope.
Water Vapor Thermal Ablation
The water vapor thermal ablation system injects thermal energy in the form of water vapor into the hyperplastic prostate tissue in controlled doses. The injected water vapor quickly disperses through the gaps between tissue cells. When water vapor comes into contact with tissue, it cools and condenses immediately. The stored heat energy is released, denaturing the cell membrane, causing cell death and eventually being absorbed or shed by the body and excreted through urination, thus improving the lower urinary tract symptoms (LUTS) caused by benign prostatic hyperplasia (BPH).
Sham control group
Subjects with BPH with LUTS will be randomized into the control group to receive a cystoscopy as the sham treatment.
Crossover treatment: 3 months after the sham treatment, qualified subjects in the control group can choose to receive the crossover Water Vapor Thermal treatment via cystoscope.
Water Vapor Thermal Ablation
The water vapor thermal ablation system injects thermal energy in the form of water vapor into the hyperplastic prostate tissue in controlled doses. The injected water vapor quickly disperses through the gaps between tissue cells. When water vapor comes into contact with tissue, it cools and condenses immediately. The stored heat energy is released, denaturing the cell membrane, causing cell death and eventually being absorbed or shed by the body and excreted through urination, thus improving the lower urinary tract symptoms (LUTS) caused by benign prostatic hyperplasia (BPH).
Cystoscopy
Cystoscopy is a procedure that allows the doctor to examine the lining of patient's bladder and the tube that carries urine out of the body (urethra). A hollow tube (cystoscope) equipped with a lens is inserted into your urethra and slowly advanced into the bladder.
Interventions
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Water Vapor Thermal Ablation
The water vapor thermal ablation system injects thermal energy in the form of water vapor into the hyperplastic prostate tissue in controlled doses. The injected water vapor quickly disperses through the gaps between tissue cells. When water vapor comes into contact with tissue, it cools and condenses immediately. The stored heat energy is released, denaturing the cell membrane, causing cell death and eventually being absorbed or shed by the body and excreted through urination, thus improving the lower urinary tract symptoms (LUTS) caused by benign prostatic hyperplasia (BPH).
Cystoscopy
Cystoscopy is a procedure that allows the doctor to examine the lining of patient's bladder and the tube that carries urine out of the body (urethra). A hollow tube (cystoscope) equipped with a lens is inserted into your urethra and slowly advanced into the bladder.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* International Prostate Symptom Score (IPSS) ≥13 points.
* Maximum urinary flow rate (Qmax): ≤15 ml/s, with a minimum urine volume of ≥125 ml.
* Post-urination residual urine volume (PVR): ≤250 ml.
* Prostate volume measured by MRI: 30\~80 cm³ (including 30 cm³ and 80 cm³).
* Voluntarily participate in the clinical trial and sign the informed consent form.
Exclusion Criteria
* Patients with difficulty inserting instruments due to urethral stenosis or bladder neck contracture.
* Severe coagulation disorder.
* Urinary incontinence caused by reduced sphincter function or severe urge urinary incontinence.
* Patients with a history of severe cardiovascular disease, including but not limited to:
* Second/third-degree heart block.
* Severe ischemic heart disease.
* Congestive heart failure with New York Heart Association (NYHA) heart function grade ≥ II (mild physical activity limitation; comfortable at rest, but normal activities can cause fatigue, palpitations, or dyspnea).
* Prostate biopsy within 2 months before enrollment.
* Unstable angina, myocardial infarction, transient ischemic attack, or cerebrovascular accident in the past 6 months.
* Patients with previous invasive prostate treatment, such as:
* Radiofrequency (RF) ablation.
* Balloon dilation.
* Microwave therapy.
* Laser treatment.
* Electroreception.
* Prostate urethral stent.
* Suspension procedures.
* History of previous rectal surgery (except hemorrhoidectomy) or history of rectal disease that affects the treatment method or efficacy evaluation in this study.
* Acute urinary and reproductive system infections that are not effectively controlled.
* Neurogenic bladder or neurological diseases that affect bladder function, sphincter function, or detrusor function, as assessed by the researcher.
* Bladder stones.
* Subjects who cannot undergo MRI examination.
* Subjects who are:
* Currently participating in clinical trials.
* Have participated in other drug clinical trials within 3 months.
* Have participated in other medical device clinical trials within 30 days.
* Other situations that the researcher believes are unsuitable for participation in the study.
45 Years
80 Years
MALE
No
Sponsors
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Medtecx Co Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Xu Zhang, MD
Role: PRINCIPAL_INVESTIGATOR
PLA General Hospital
Locations
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The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Beijing Luhe Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, China
BeiJing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, China
PLA General Hospital
Beijing, Beijing Municipality, China
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
Shanghai First People's Hospital
Shanghai, Shanghai Municipality, China
The Second Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Xianai Wang
Role: primary
Jiaming Liu
Role: primary
Xuan Liu
Role: primary
Fenglin Wang
Role: primary
Chang Shu
Role: primary
Huijie Zhang
Role: primary
Luyi Yu
Role: primary
Yu Liu
Role: primary
Wan Zhu
Role: primary
Shen Zhang
Role: primary
Other Identifiers
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PVAS14002P
Identifier Type: -
Identifier Source: org_study_id