NCT01952912已完成不适用
Comparison of Plasmakinetic Enucleation of the Prostate With Open Prostatectomy for the Treatment of Benign Prostatic Hypertrophy Patients With Large Prostate
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Qmax at one year postoperatively
研究概览
简要总结
The investigators hypothesize that Plasmakinetic Enucleation of the Prostate (PkEP) might yield functional results comparable to OP but with lower perioperative morbidity, and have equivalent long-term efficacy with OP for large prostates. The first objective was to demonstrate the non-inferiority of PKEP compared to OP concerning Qmax at one year postoperatively.
To explore the long-term efficacy, we compared the efficacy, safety, and morbidity of PkEP with those of OP in BPH patients with prostate glands larger than 100 g over a follow-up period of 6 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- ••Qmax < 12 mL/s, IPSS >19
- •Age between 50 and 70 years
- •Prostate volume larger than 100 mL, as determined by TRUS post-void residual urine volume greater than 50 ml medical therapy failure.
排除标准
- ••severe pulmonary disease or heart disease, coagulopathy, neurogenic bladder, bladder calculus, bladder cancer, prostate cancer, urethral stricture and previous prostate or urethral surgery
结局指标
主要结局
Qmax at one year postoperatively
时间窗: 1 year postoperatively
次要结局
- Qmax at other time points after surgery(1, 3, 6, 24, 36, 48, 60 and 72 months postoperatively)
- blood loss(perioperatively and on the first postoperative day)
- duration of catheterization(after the operation)
- length of postoperative hospital stay(after the operation)
- PVR(1, 3, 6, 12, 24, 36, 48, 60 and 72 months postoperatively)
- resected adenoma weight(right after the operation)
- operation time(during the operation)
- postoperative International Prostate Symptom Score(1, 3, 6, 12, 24, 36, 48, 60 and 72 months postoperatively)
- QOL(1, 3, 6, 12, 24, 36, 48, 60 and 72 months postoperatively)
研究者
研究点 (1)
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