Evaluation of the Water Vapor Thermal Therapy System for the Treatment of Benign Prostatic Hyperplasia

Medtecx Co Ltd.126 enrolled

Overview

To evaluate the efficacy and safety of the Water Vapor Thermal Therapy system for the treatment of Benign Prostatic Hyperplasia under the premise of ensuring the safety of the subjects and ensuring the scientific nature of the clinical trial. The primary safety endpoint will be device-related (serious) adverse events. The primary effectiveness endpoint will be changes (treatment group vs control group) from baseline in International Prostate Symptom Score (IPSS) 3 months after medical device intervention.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

126

Conditions

Benign Prostatic Hyperplasia

Interventions

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).

Eligibility

Sex: MALEMin age: 45 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Men aged 45-80 years (inclusive) with symptoms secondary to BPH and requiring invasive intervention. * 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: * Malignant lesions of the urinary system, such as prostate cancer or bladder cancer, or other systemic advanced malignant tumors (e.g., gastric cancer, liver cancer, lung cancer). * 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.

Locations (10)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

RECRUITING

Beijing Luhe Hospital Affiliated to Capital Medical University

Beijing, Beijing Municipality, China

RECRUITING

BeiJing Tsinghua Changgung Hospital

Beijing, Beijing Municipality, China

RECRUITING

PLA General Hospital

Beijing, Beijing Municipality, China

RECRUITING

Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, China

RECRUITING

The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

RECRUITING

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

RECRUITING

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

RECRUITING

Shanghai First People's Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

The Second Hospital of Tianjin Medical University

Tianjin, Tianjin Municipality, China

RECRUITING

Outcomes

Primary Outcomes

IPSS (International Prostate Symptom Score)

The IPSS (International Prostate Symptom Score) is an eight-question written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of benign prostatic hyperplasia (BPH). It's minimum value is 0, and maximum value is 35. Lower scores mean a better outcome.

Time frame: • Baseline, pre-intervention • 3 months after the initial intervention

Secondary Outcomes

The percentage of Water Vapor Ablation treated subjects who reach ≥50% IPSS improvement compared to baseline

The International Prostate Symptom Score (IPSS) is an eight-question written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of benign prostatic hyperplasia (BPH).