NCT06725212招募中不适用
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
Medtecx Co Ltd.10 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2024年3月26日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 126
- 试验地点
- 10
- 主要终点
- IPSS (International Prostate Symptom Score)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
IPSS (International Prostate Symptom Score)
时间窗: • Baseline, pre-intervention • 3 months after the initial intervention
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.
次要结局
- The percentage of Water Vapor Ablation treated subjects who reach ≥50% IPSS improvement compared to baseline(• 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)(• 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)(• 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(• 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)(• 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)(• 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)(• Baseline, pre-intervention • 3 months after the initial intervention • 6 months after the initial intervention)
- MSHQ-EjD (Male Sexual Health Questionnaire for Ejaculatory Function)(• Baseline, pre-intervention • 3 months after the initial intervention • 6 months after the initial intervention)
研究者
研究点 (10)
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