Clinical Study on Prostate Thermal Vapor Ablation Guided by MRI/TRUS Fusion Imaging
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Volume changes in the prostate transition zone
研究概览
简要总结
Objective of the Clinical Trial
The objective of this clinical trial is to preliminarily assess the feasibility and safety of performing precise prostate thermal vapor ablation under MRI/TURS guidance. The primary questions it aims to address are:
Can precise prostate thermal vapor ablation under MRI/TURS guidance effectively treat benign prostatic hyperplasia (BPH) and alleviate lower urinary tract symptoms (LUTS)? What safety issues may arise in participants after undergoing prostate thermal vapor ablation? Study Procedures Participants Preoperative Evaluation: Participants will undergo comprehensive preoperative assessments, including clinical examinations and laboratory tests.
Procedure: Participants will receive precise prostate thermal vapor ablation under MRI/TURS guidance.
Postoperative Follow-up:
Regular follow-up to reassess prostate volume. Periodic completion of the International Prostate Symptom Score (IPSS) questionnaire.
Regular measurement of maximum urinary flow rate (Qmax) and post-void residual urine volume (PVR).
Research Team The research team will conduct precise prostate thermal vapor ablation under MRI/TURS guidance for the participants and manage their follow-up assessments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age 45-85 years;
- •International Prostate Symptom Score (IPSS) ≥ 8, indicating moderate to severe Lower Urinary Tract Symptoms (LUTS) that significantly impact quality of life;
- •Poor response to pharmacological treatment or refusal of pharmacological treatment;
- •Prostate volume 30-80 mL;
- •Maximum urinary flow rate (Qmax) < 15 mL/s;
- •Post-void residual urine volume (PVR) < 300 mL;
- •Willingness to provide informed consent and participate in postoperative follow-up.
排除标准
- •Prostate volume < 30 mL or > 80 mL;
- •Severe urinary tract infection;
- •Preoperative definitive diagnosis of prostate cancer;
- •Known neurogenic bladder, detrusor muscle weakness, urethral stricture, or other non-BPH causes of urinary obstruction;
- •Patients with prostatitis;
- •History of invasive prostate interventions, such as radiofrequency ablation, laser therapy, or microwave treatment;
- •Patients with severe cardiovascular disease, chronic obstructive pulmonary disease, severe diabetes, hepatic or renal dysfunction, or systemic bleeding disorders, as assessed by the investigator to be unsuitable for surgery.
研究组 & 干预措施
Rezum
Participants in this group will undergo transurethral thermal vaporization of the prostate.
干预措施: Transurethral Thermal Vaporization of the Prostate (Procedure)
Rezum
Participants in this group will undergo transurethral thermal vaporization of the prostate.
干预措施: Rezūm Water Vapor Thermal Therapy System (Device)
结局指标
主要结局
Volume changes in the prostate transition zone
时间窗: From enrollment to 6 months after surgery
The volume of the transitional zone measured by MRI before and 6 months after surgery
次要结局
- Prostatic volume change(From enrollment to 6 months after surgery)
- IPSS(From enrollment to 6 months after surgery)
- Qmax(From enrollment to 6 months after surgery)
- PVR(From enrollment to 6 months after surgery)
- Duration of postoperative indwelling urinary catheter(From the end of the procedure until the catheter is removed.It is estimated that the longest time will not exceed 2 months.)
- Quality of Life Score(From enrollment to 6 months after surgery)
- Prostate Transition Zone Volume Measured by Transrectal Ultrasound(Baseline, 1 week, 1 month, 3 months, and 6 months after surgery)
- Total Prostate Volume Measured by Transrectal Ultrasound(Baseline, 1 week, 1 month, 3 months, and 6 months after surgery)
研究者
Qing Yuan
Professor
Chinese PLA General Hospital