Green Light Laser (XPS) Photoselective Vaporization of the Prostate (PVP) Versus Bipolar Transurethral Vaporization (B.TUVP) of the Prostate for Treatment of Small to Moderate Sized Benign Prostate Hyperplasia: A Randomized Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- IPSS change
研究概览
简要总结
With a growing body of knowledge on the promising advancements and recent clinical data of the third generations of the Greenlight PVP/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 PVP using (XPS) 180W system compared to bipolar electro-vaporization, in reduction of LUTS secondary to small to moderate sized BPH in a prospective randomized trial.
详细描述
Patients with LUTS due to BPH seen through the outpatient prostate clinic in the Mansoura UNC were assessed to evaluate if the patient is eligible to the study inclusion criteria. Patients who are meeting these criteria were asked to participate in this randomized comparative study and were provided with an informed consent form. Study participants were enrolled and randomized, and the appropriate scheduled procedures were performed.
Preoperatively, all patients were thoroughly evaluated by medical history and physical exam, digital rectal exam (DRE), prostate specific antigen (PSA), urinalysis and urine culture, international index of prostate symptom score (IPSS), Quality of Life (QOL), transrectal ultrasound (TRUS) measurement of prostatic volume and biopsy whenever indicated, measurement of post-void residual assessment (PVR), and maximum urinary flow rate (Qmax). Preoperative flexible urethrocystoscopy was done when hematuria was the presenting symptom.
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
- Single (Participant)
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 (IPSS) >15 and bother score (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 (from 30 to 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 laser PVP
Greenlight (532-nm) laser Photoselective vaporization of the prostate using (XPS) 180W system
干预措施: Greenlight laser PVP (Procedure)
Bipolar TUVP
Bipolar transurethral vaporization of the prostate using bipolar system
干预措施: Bipolar TUVP (Procedure)
结局指标
主要结局
IPSS change
时间窗: two years
change in the symptoms score over two years post procedure
次要结局
- Reoperation rate(4 years)
- biopsy(one month)
- Q.max(2 years)
研究者
Ahmed Elshal
Lecturer of Urology
Mansoura University