Holmium Laser Enucleation vs Bipolar Resection of a Large Volume BPH: a Randomised Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 145
- 试验地点
- 2
- 主要终点
- operative duration in minutes
研究概览
简要总结
To compare bipolar resection versus holmium laser enucleation for management of large BPH.
详细描述
To compare safety and efficacy of bipolar resection (BPRP) versus holmium laser enucleation (HoLEP) for management of large BPH (> 75 gm).
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
- 45 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 ≥ 75 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
holmium laser enucleation of the prostate
holmium laser enucleation of the prostate (HoLEP)
干预措施: holmium laser enucleation of the prostate (Procedure)
bipolar resection of the prostate
bipolar resection of the prostate (BPEP)
干预措施: Bipolar resection of the prostate (Procedure)
结局指标
主要结局
operative duration in minutes
时间窗: during surgery
operative duration
Hospital stay in days
时间窗: immediately after surgery
Hospital stay
hemoglobin drop postoperatively (gm/dL)
时间窗: Immediate postoperatively
difference in hemoglobin concentration postoperatively vs preoperatively
次要结局
- urine flow(Two years)
- post-voiding residual urine(Two years)
- complications (%)(Two years)
- International prostate symptom score (IPSS)(Two years)
- Quality of life (QoL)(Two years)
- Catheter duration(immediate postoperatively)
研究者
Mohammed Said ElSheemy
Professor of Urology
Cairo University