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

Official title

A Prospective, Multicenter, Randomized Controlled Clinical Trial to Evaluate the Efficacy and Safety of a Water Vapor Thermal Ablation System for the Treatment of Benign Prostatic Hyperplasia

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.

Interventions

• Device 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 th
• Device 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.

Primary outcome measures

• IPSS (International Prostate Symptom Score) [Time frame: • Baseline, pre-intervention • 3 months after the initial intervention]

Secondary outcome measures (8)

• The percentage of Water Vapor Ablation treated subjects who reach ≥50% IPSS improvement compared to baseline [Time frame: • Baseline, pre-intervention • 1 month after the initial intervention • 3 months after the initial intervention • 6 months after the initial intervention]
• Qmax (Peak Urinary Flow Rate) [Time frame: • Baseline, pre-intervention • 1 month after the initial intervention • 3 months after the initial intervention • 6 months after the initial intervention]
• PVR (Post-void Residual) [Time frame: • Baseline, pre-intervention • 1 month after the initial intervention • 3 months after the initial intervention • 6 months after the initial intervention]
• Prostate Volume via MRI (Magnetic Resonance Imaging) measurement [Time frame: • Baseline, pre-intervention • 1 month after the initial intervention • 3 months after the initial intervention • 6 months after the initial intervention]
• QoL (Quality of Life) [Time frame: • Baseline, pre-intervention • 1 month after the initial intervention • 3 months after the initial intervention • 6 months after the initial intervention]
• BPHII (Benign Prostatic Hyperplasia Impact Index) [Time frame: • Baseline, pre-intervention • 1 month after the initial intervention • 3 months after the initial intervention • 6 months after the initial intervention]
• IIEF-5 (International Index of Erectile Function-5) [Time frame: • Baseline, pre-intervention • 3 months after the initial intervention • 6 months after the initial intervention]
• MSHQ-EjD (Male Sexual Health Questionnaire for Ejaculatory Function) [Time frame: • Baseline, pre-intervention • 3 months after the initial intervention • 6 months after the initial intervention]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Single blind

Primary purpose

Treatment

Study locations

China · 10 centers

• The First Affiliated Hospital of Anhui Medical University — Hefei
• Beijing Luhe Hospital Affiliated to Capital Medical University — Beijing
• BeiJing Tsinghua Changgung Hospital — Beijing
• PLA General Hospital — Beijing
• Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and — Wuhan
• The Second Affiliated Hospital of Nanjing Medical University — Nanjing
• The First Affiliated Hospital of Nanchang University — Nanchang
• The First Affiliated Hospital of Xi'an Jiaotong University — Xi'an
• … and 2 more centers

Identifiers

NCT: NCT06725212 · PVAS14002P

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗