Optimized Water Vapor Thermal Therapy for Benign Prostatic Hyperplasia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 58
- 主要终点
- International Prostate Symptom Score (IPSS) change from baseline to 3 months.
研究概览
简要总结
Water vapor thermal therapy (Rezum) is a minimally invasive treatment for benign prostatic hyperplasia (BPH) that uses injections of sterile water vapor directly into the prostate for tissue ablation.
详细描述
For BPH, open or transurethral anatomical enucleation is recommended. Open prostatectomy has a higher risk of bleeding and slower postoperative recovery, with a higher probability of requiring blood transfusion. The incidence of urinary incontinence after transurethral enucleation ranges from 3.33% to 20%, possibly due to excessive traction and compression on the external urethral sphincter, leading to partial muscle fiber rupture. The rate of erectile dysfunction after enucleation is 8.82%, while retrograde ejaculation occurs in 6.37% of cases, especially for patients with larger prostates. Once these complications occur, they are often difficult to recover from and severely impact the patient's quality of life. In our center, the technique of Rezum has been further improved by incorporating ultrasound and MRI imaging guidance. The investigators design a reasonable and comprehensive ablation plan that ensures accurate positioning of enlarged prostate glands for complete and thorough ablation while ensuring efficacy and safety. The optimized methods mainly include ablation optimization and combined imaging techniques.
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
- •Male subjects ≥ 45 years of age who have obstructive symptoms secondary to BPH requiring invasive intervention.
- •IPSS score of ≥
- •Qmax: Peak flow rate ≤ 15 ml/sec.
- •Post-void residual (PVR) < 300 ml.
- •Prostate volume > 30 ml.
- •Subject able to complete the study protocol in the opinion of the Principal Investigator.
排除标准
- •History of any illness or surgery that in the opinion of the Principal Investigator may confound the results of the study.
- •Any prior minimally invasive intervention or surgical intervention for the symptoms of BPH.
- •Currently enrolled in another clinical trial.
- •Confirmed or suspected malignancy of prostate or bladder.
- •Documented active urinary tract infection by culture or bacterial prostatitis.
- •Neurogenic bladder or sphincter abnormalities.
- •Urethral strictures, bladder neck contracture or muscle spasms.
- •Bleeding disorder (note that use of anti-platelet medication is not an exclusion criterion).
- •Subjects who are interested in maintaining fertility.
- •Significant urge incontinence.
- •Unable or unwilling to sign the Informed Consent Form.
- •Any cognitive disorder that interferes with or precludes a subject from directly and accurately communicating with the Principal Investigator regarding the study.
结局指标
主要结局
International Prostate Symptom Score (IPSS) change from baseline to 3 months.
时间窗: 3 months
International prostate symptom score (IPSS) is a questionnaire used to indicate the severity of LUTS symptoms, There are 7 questions relating to different symptoms subjects be experiencing. 7 questions about patients' urinating include Incomplete emptying, Frequency, Intermittency, Urgency, Weak stream, Straining and Nocturia, every question have 0-5 scores according to Prostate Symptom, the higher score mean patient have more severe the symptoms. IPSS total score: the minimum score is 0 and maximum score are 35. IPSS total 0-7 scores are mild symptoms, IPSS total 8-19 scores are moderate symptoms and IPSS total 20-35 scores are severe symptoms. International Prostate Symptom Score (IPSS) scores were recorded at baseline to 3 months. The mean change in IPSS was calculated.
次要结局
- International Prostate Symptom Score (IPSS) change from baseline to 1 month, 3 months, 6 months, 1 year, then annually to 3 years.(1 month, 3 months, 6 months, 1 year, then annually to 3 years)
- The change of peak flow rate (Qmax)(1 month, 3 months, 6 months, 1 year, then annually to 3 years)
- Post void residual urine volume (PVR）(1 month, 3 months, 6 months, 1 year, then annually to 3 years)
- Quality of life (QoL) questionnaire(1 month, 3 months, 6 months, 1 year, then annually to 3 years)
- Ejective function (MSHQ-EjD)(1 month, 3 months, 6 months, 1 year, then annually to 3 years)
- The change of International Index of Erectile Function (IIEF)(1 month, 3 months, 6 months, 1 year, then annually to 3 years)