Non Inferiority Clinical Randomized Trial Comparing Disobstrucitve Power in Patients With LUTS by BHP (Evaluated With Invasive Advanced Urodynamic Tests) That Underwent to Aquablation, Holep and PVP
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- BOOI variations
研究概览
简要总结
in the last decade, lots of attemps have been done to identify new technologies able to reply the efficacy of gold standard technique for treating BPH, but with a better safety profile. The introduction of laser techniques allowed to reduce complication rates. Among these, considerable importance had Holep and PVP. Aquablation is a recent technique for LUTS treatment. It is minimally invasive, robot-assisted and ultrasound-guided to ablate the prostate in targeted way and in "heat-free" way. It works with high pression water jet. However, in literature informations about disobstructive capacity of minimally invasive techniques, evaluated with invasive urodynamic tests, are low.
The enrolled subjects will undergo surgical treatment with one of the techniques under study: Aquablation, HoLEP or PVP.
Outpatient visits will be performed at 1, 3 and 6 months after the surgical treatment. During the sixth month visit an invasive urodynamic examination will be performed
详细描述
in the last decade, lots of attemps have been done to identify new technologies able to reply the efficacy of gold standard technique for treating BPH, but with a better safety profile. The introduction of laser techniques allowed to reduce complication rates. Among these, considerable importance had Holep and PVP. Aquablation is a recent technique for LUTS treatment. It is minimally invasive, robot-assisted and ultrasound-guided to ablate the prostate in targeted way and in "heat-free" way. It works with high pression water jet.
However, in literature informations about disobstructive capacity of minimally invasive techniques, evaluated with invasive urodynamic tests, are low.
In particular, about Aquablation, just in one trial is reported the reduction of BOOI, from 49 to 24 in 6 months after surgery, but this information is not associated with standard deviation and statistical significance.
Perreira-Carreia, J.A. et al, in 2012 reported a medium BOOI variation after 6 months by surgery, from 60 to 8,7 (p<0,001) even if procedure was conducted with laser 120 W.
In 2014 Know, O. and coll., reported BOOI reduction after Holep from 54,9 ± 30,2 to 3,4 ± 17,4 (p<0,001).
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)
盲法说明
double blind
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •moderate-to-severe lower urinary tract symptoms (IPSS ≥ 12)
- •poor efficacy or tolerance to medical therapy for BPH
- •transrectal ultrasound prostate volume between 30 and 120 ml
- •ability to express written informed consent.
排除标准
- •previous surgical treatments for BPH
- •indwelling bladder catheter or clean intermittent catheterization
- •bladder stones
- •severe detrusor hypocontractility (BCI <50) or detrusorial acontractility
- •urethral strictures
- •neurological bladder
- •not replaceable anticoagulant or antiplatelet drugs for severe cardiological comorbidity
- •bladder cancer;
- •diagnosis or clinical suspicion of prostatic cancer
结局指标
主要结局
BOOI variations
时间窗: 6 months
non inferiority evaluation of the BOOI variations in patients with LUTS caused by cervico-urethral obstruction by BHP undergone to endoscopic surgery with aquablation versus patients operated with laser endoscopic surgery
次要结局
- IPSS score(1, 3 and 6 months)
- Qmax(1, 3 and 6 months)
- sexual satisfaction(1, 3 and 6 months)
研究者
Paolo Minafra
Resident Doctor
University of Bari