NCT03998150已完成不适用
Holmium Laser Enucleation Versus Bipolar Plasmakinetic Enucleation of a Large Volume Benign Prostatic Hyperplasia: a Randomised Controlled Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- hemoglobin drop postoperatively (gm/dL)
研究概览
简要总结
To compare bipolar plasmakinetic enucleation versus holmium laser enucleation for management of large BPH.
详细描述
To compare safety and efficacy of bipolar plasmakinetic enucleation (BPEP) versus holmium laser enucleation (HoLEP) for management of large BPH (>80gm).
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients suffering from LUTS secondary to infravesical obstruction from BPH
- •failed medical treatment
- •International Prostate Symptom Score (IPSS) > 13
- •a peak urinary flow rate (Qmax) < 15 ml/sec
- •a prostate size ≥ 80 gm
排除标准
- •presence of a urethral stricture
- •neurological disorder
- •bladder cancer
- •prostate cancer
- •previous history of bladder neck surgery or TURP
研究组 & 干预措施
BPEP bipolar plasmakinetic enucleation of the prostate
Active Comparator
bipolar plasmakinetic enucleation of the prostate
干预措施: Bipolar plasma kinetic enucleation of the prostate (Procedure)
HoLEP holmium laser enucleation of the prostate
Active Comparator
holmium laser enucleation of the prostate
干预措施: Holmium laser enucleation of the prostate (Procedure)
结局指标
主要结局
hemoglobin drop postoperatively (gm/dL)
时间窗: Immediate postoperatively
difference in hemoglobin concentration postoperatively vs preoperatively
operative time
时间窗: during surgery
operative time in minutes
次要结局
- post-voiding residual urine(one year)
- International prostate symptom score (IPSS)(one year)
- Quality of life (QoL) section of International prostate symptom score (IPSS)(one year)
- urine flow(one year)
- complications (%)(one year)
研究者
Mohammed Said ElSheemy
Professor of Urology
Cairo University
研究点 (2)
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