Selective Retrograde Venography and Sclerotherapy of Internal Spermatic Veins and Associated Venous Bypasses and Retro-Peritoneal Collateral in Patients With Varicocele and Hypertrophy of Prostate
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Safety performance of the procedure. Reduction of above 20% in prostatic calculated volume.
研究概览
简要总结
In varicocele the venous pressure in the prostatic bed is increased .This may result in raised hydrostatic pressure which in turn may stimulate prostatic hypertrophy.
Restoring normal venous drainage is expected to lower hydrostatic pressure followed by inhibition of prostatic growth and possibly leading regression in prostatic dimensions.
详细描述
35 male patients, aged 45 years or older, with documented benign prostatic hypertrophy (BPH)and varicocele as visualized by ultrasound and/or termography examination will be enrolled.
Each patient will undergo a full urologic examination to exclude possible malignancy as well as a thorough medical examination to establish eligibility for treatment.
In all selected patients the varicocele will be obliterated by means of embolization of the spermatic veins.
The patients will be followed every three months by abdominal ultrasound as well as by serial PSA for a period of 6-12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age > 45 < 80 years
- •Bilateral varicocele.
排除标准
- •Coagulation disturbance
- •Malignancy
- •Renal failure.
结局指标
主要结局
Safety performance of the procedure. Reduction of above 20% in prostatic calculated volume.
时间窗: 1 year
次要结局
- Reduction of above 20% in nocturia(1 year)