Bipolar Transurethral Enucleation (BipolEP) vs Bipolar Transurethral Resection of the Prostate: A Prospective Interventional Multi-center Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 84
- 试验地点
- 4
- 主要终点
- Long-term outcome - Change in IPSS (Difference in IPSS before and 12 months after surgery)
研究概览
简要总结
The aim of this study is to compare two different surgical methods for treating benign prostatic obstruction (BPO).
The investigators are going to compare the risks and benefits of bipolar transurethral resection of the prostate (TURP) and bipolar transurethral enucleation of the prostate (BipolEP). Furthermore, the investigators are going to compare the amount of tissue resected per minute, in order to assess the efficiency of each surgical method.
It is a prospective, interventional, multi-centre (2 centres total), randomized trial.
Approximately 84 patients will be included
详细描述
Overview:
The aim of this study is to compare two different surgical methods for treating benign prostatic obstruction (BPO).
The investigators are going to compare the risks and benefits of bipolar transurethral resection of the prostate (TURP) and bipolar transurethral enucleation of the prostate (BipolEP). Furthermore, the investigators are going to compare the amount of tissue resected per minute, in order to assess the efficiency of each surgical method.
All patients will be followed up for 12 months. All the examinations used to assess the risks and benefits of BipolEP and TURP are listed below:
- Dysuria visual analogue scale (at 1 month)
- I-PSS (international prostate symptom score), QOL (quality of life), Qmax (maximum flow rate of urine) and PVR (post void residual bladder volume) before surgery and at 1, 4 and 12 months
- IIEF-15 (international index of erectile function) and PSA (prostate specific antigen) (before surgery and at 4 and 12 months)
- TRUS (transrectal ultrasonography) for prostate size before surgery and at 4 months
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
- •Refractory LUTS (lower urinary tract symptoms) secondary to BPH benign prostate hyperplasia)
- •I-PSS greater than 15
- •QOL score 3 or greater
- •Qmax less than 15 ml per second or patients with acute urinary retention secondary to BPH in whom trial of voiding failed
- •Prostate size on preoperative TRUS of 40 to 150 ml
排除标准
- •Patients with neurological disorder
- •Active urinary tract infection, active bladder or prostate cancer
研究组 & 干预措施
BipolEP
includes all patients undergoing BipolEP surgery
干预措施: BipolEP (Procedure)
TURP
includes all patients undergoing TURP surgery
干预措施: bipolarTURP (Procedure)
结局指标
主要结局
Long-term outcome - Change in IPSS (Difference in IPSS before and 12 months after surgery)
时间窗: Start: before the surgery End: 356 days after surgery
The long-term outcome will be measured by comparing the change in IPSS (International Prostate Symptom Score) before and 12 months after surgery. The IPSS is based on the answers to seven questions concerning urinary symptoms (Incomplete emptying, Frequency, Intermittency, Urgency, Weak Stream, Straining, Nocturia) and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic) Question eight refers to the patient's perceived quality of life.
次要结局
- Efficiency of surgical intervention (tissue resected intraoperatively per minute)(Intraoperative)
研究者
Dr. Thomas Kunit
Vice Chairman, Department of Urology and Andrology
Salzburger Landeskliniken