Holmium Laser Versus Thulium Laser Versus Bipolar Enucleation of the Prostate for Treatment of Large Sized Benign Prostatic Enlargement. A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 155
- 试验地点
- 1
- 主要终点
- urinary functional outcomes using uroflowmetry
研究概览
简要总结
Because of the diversity of the studies and deficiency of those comparing various techniques of EEP for treatment of LUTs secondary to BPO in patients with large sized prostate, we aim in this study at testing the non-inferiority of PKEP and ThuLEP to HoLEP in relieving LUTs secondary to BPO in patients prostate size >80ml. Our hypothesis is to present an evidence that enucleation is a technique rather than a power dependent procedure through a RCT.
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 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients' age >50 years
- •Lower urinary tract symptoms LUTS secondary benigh prostatic obstruction BPO who failed medical treatment
- •International prostate symptom scores (IPSS) >15 and bother score quality of life (QOL) > 3 (according to IPSS question 8)
- •Maximum urinary flow rate (Q max) <15 ml/sec with at least 150 ml voided volume or cases with acute urine retention secondary to BPO who failed trial of voiding on medical treatment.
- •Transrectal ultrasound TRUS estimated total prostate size 80-250cc
排除标准
- •Patient with neurological disorder which might affect bladder function as cerebrovascular stroke, Parkinson disease
- •Active urinary tract infection (positive urine culture) till treatment
- •Presence of bladder cancer (within the last 2 years)
- •Known prostate cancer patients will be excluded preoperatively on the basis of digital rectal examination, prostate specific antigen level, and TRUS imaging followed by prostate biopsies if necessary.
研究组 & 干预措施
Holmium Laser
holmium laser enucleation of the prosteate
干预措施: Holmium Laser (Procedure)
Thulium Laser
Thulium laser enucleation of the prosteate
干预措施: Thulium Laser (Procedure)
Bipolar Enucleation
Bipolar enucleation of the prosteate
干预措施: Bipolar diathermy (Procedure)
结局指标
主要结局
urinary functional outcomes using uroflowmetry
时间窗: 2 years
assessed by maximum flow rate (Q-max) measured using uroflowmetry by ml/sec, better outcome above 15ml/sec
次要结局
- patient symptoms(2 years)
- perioperative complications(2 years)
研究者
Fady kamal Ghobrial
principal investigator
Mansoura University