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

Inclusion Criteria:

• Men aged 45-80 years (inclusive) with symptoms secondary to BPH and requiringinvasive 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 bladderneck contracture.

• Severe coagulation disorder.

• Urinary incontinence caused by reduced sphincter function or severe urge urinaryincontinence.

• Patients with a history of severe cardiovascular disease, including but not limitedto:

• Second/third-degree heart block.

• Severe ischemic heart disease.

• Congestive heart failure with New York Heart Association (NYHA) heart functiongrade ≥ II (mild physical activity limitation; comfortable at rest, but normalactivities can cause fatigue, palpitations, or dyspnea).

• Prostate biopsy within 2 months before enrollment.

• Unstable angina, myocardial infarction, transient ischemic attack, orcerebrovascular 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 rectaldisease that affects the treatment method or efficacy evaluation in this study.

• Acute urinary and reproductive system infections that are not effectivelycontrolled.

• Neurogenic bladder or neurological diseases that affect bladder function, sphincterfunction, 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 inthe study.