Randomized Controlled Study Comparing Safety, Efficacy and Short Term Outcomes Of Bipolar Prostate Resection (BPR) Versus Diode Laser Ablation Versus Holmium Laser Enucleation Of Prostate Above 80 Grams With Minimum One Year Follow Up Duration.
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 105
- 主要终点
- time to catheter removal
概览
简要总结
Randomized Controlled Study Comparing Safety, Efficacy and Short Term Outcomes Of Bipolar Prostate Resection (BPR) Versus Diode Laser Ablation Versus Holmium Laser Enucleation Of Prostate Above 80 Grams With Minimum One Year Follow Up Duration.
详细描述
comparing three different techniques for treatment of prostatomegaly (BPH) bipolar resection of the prostate versus diode laser ablation of the prostate versus holmium laser enucleation monitoring preoperative data . intraoperative data , postoperative outcomes and long term outcomes within 1 year of the operation aiming to decide which technique has the superior hand over other regarding large size prostate above 80 grams
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
- 55 Years 至 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Refractory LUTS secondary to benign prostatic hyperplasia (BPH)
- •Acute retention secondary to BPH who failed medical treatment
- •Prostate size above 80 gm in Pelvi-Abdominal ultrasound or Trans-Rectal ultrasound
排除标准
- •Suspected Neurogenic bladder.
- •Suspected Prostatic adenocarcinoma (either by digital rectal examination or high PSA level)
- •Urinary bladder carcinoma
- •urethral stricture. previous bladder, urethral or prostate surgery.
- •Bleeding tendency.
- •Uncontrolled bleeding disorders.
研究组 & 干预措施
patient with prostate size above 80 grams for Bipolar resection
patient with prostate size above 80 grams
干预措施: bipolar resection of the prostate (Procedure)
patient with prostate size above 80 grams for holmium laser enucleation
patient with prostate size above 80 grams for holmium laser enucleation
干预措施: holimum laser enucleation of the prostate (Procedure)
patient with prostate size above 80 grams for Diode laser ablation
patient with prostate size above 80 grams for Diode laser ablation
干预措施: diode laser ablation of the prostate (Procedure)
结局指标
主要结局
time to catheter removal
时间窗: within the first 1 week post-operatively
number of days to catheter removal post-operatively
次要结局
- removed prostatic tisuue(within the first month postoperatively)