Randomized Trial Comparing Holmium Laser Enucleation of the Prostate vs. Greenlight 532nm-laser Vapo-Enucleation of the Prostate vs. Bipolar Transurethral Resection of the Prostate in Management of Moderate/Large Benign Prostate Hyperplasia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 182
- 试验地点
- 2
- 主要终点
- Re treatment
研究概览
简要总结
Most guidelines are not strict for recommending single treatment approach for Moderate to large prostate.
In this study the investigators planned to test the Greenlight (532-nm) laser Photoselective Vapo-Enucleation of the Prostate (PVEP) using (XPS) 180W system compared to bipolar transurethral resection of the prostate (TURis) and Holmium Laser Enucleation of the Prostate (HOLEP) in reduction of lower urinary tract symptoms (LUTS) secondary to BPH in a prospective randomized trial.
详细描述
With a growing body of knowledge on the promising advancements and recent clinical data of the third generations of the Greenlight XPS, it seems to be a real contender in the world of MIS. Contenders of Greenlight laser technology includes bipolar as well as Holmium laser technology.
In this study the investigators planned to test the Greenlight (532-nm) laser Photoselective Vapo-Enucleation of the Prostate (PVEP) using (XPS) 180W system compared to bipolar transurethral resection of the prostate (TURis) and Holmium Laser Enucleation of the Prostate (HOLEP) in reduction of LUTS secondary to BPH in a prospective randomized trial.
Furthermore, all peri-operative parameters, urinary flow parameters, prostate size changes and complications associated with the procedures were compared. The prostate size limitations will be assessed in relation to the outcome measures.
Moderate to large size prostate (80-120 ml TRUS estimated volume) will be randomized to PVEP vs. Bipolar TURP vs. HoLEP.
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
- Double (Participant, Outcomes Assessor)
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
- •LUTS secondary to BOO due to BPH who failed medical treatment
- •International prostate symptom scores 8 (IPSS) >15 and bother score 8 (QOL) ≥ 3 (according to IPSS question 8)
- •Peak urinary flow rate (Qmax) <15 ml/sec with at least 125 ml voided volume or Patients with acute urine retention secondary to BPH who failed trial of voiding on medical treatment.
- •ASA (American society of anaesthesiologists) score ≤
- •TRUS prostate size (>/=80ml)
排除标准
- •Patient with neurological disorder which might affect bladder function as cerebrovascular stroke, Parkinson disease
- •Active urinary tract infection,
- •Presence of active 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
Greenlight (532nm-laser) PVEP
532nm-laser photoselective vapo-enucleation of the prostate)
干预措施: 532nm-laser photoselective vapo-enucleation of the prostate) (Procedure)
Holmium laser enucleation of prostate
Holmium-Yag laser enucleation of the prostate
干预措施: Holmium laser enucleation of prostate (Procedure)
Bipolar TURP
Bipolar transurethral resection of the prostate in saline
干预措施: Bipolar TURP (Procedure)
结局指标
主要结局
Re treatment
时间窗: 3 YEARs
need for retreatment for recurrent infravesical obstruction following primary surgery
次要结局
- change in symptoms score(3 year)
- Urine Flow rate (ml/sec)(3 year)