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临床试验/NCT04560907
NCT04560907招募中不适用

Aquablation vs. Holmium Laser Enucleation of the Prostate in the Treatment of Benign Prostatic Hyperplasia in Medium to Large Size Prostates: A Prospective Randomized Trial

Dr. med. Gautier Müllhaupt2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2021年1月5日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
120
试验地点
2
主要终点
International Prostate Symptoms Score (IPSS)

研究概览

简要总结

Benign prostatic hyperplasia (BPH) is one of the most common diseases in men. As BPH progresses, surgical treatments often become necessary. Holmium enucleation of the prostate (HoLEP) is an established procedure in the surgical treatment of BPH, especially for medium to large prostates. The long learning curve, the length of surgery, and expensive equipment still limit the availability of HoLEP to a few specialized centers.

Recently, a new method for treating BPH called aquablation has become commercially available. This technique uses real-time ultrasound imaging in combination with a robotic high-pressure water jet programmed and guided by the surgeon to resect prostate tissue. A RCT has shown functional results similar to transurethral resection of the prostate (TURP) for small to medium size prostates .

However, so far there are no controlled studies assessing whether Aquablation provides patient reported and functional outcomes that are non-inferior compared to HoLEP in medium size to large prostates (the latter cannot be operated by TURP due to its size limitations).

As aquablation offers some obvious advantages compared to HoLEP regarding learning curve and operation time, the aim of this study is to test whether efficacy and safety of aquablation are non- inferior compared to HoLEP in patients with medium to large size prostates, which would clearly support the use of aquablation and change everyday clinical practice.

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
45 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Men ≥45 years of age
  • Patient must be a candidate for HoLEP
  • Refractory to medical therapy or patient is not willing to consider (further) medical treatment
  • Patient has a prostate size of at least 50 ml and not more than 150ml, measured by transrectal ultrasound (TRUS)
  • Qmax ≤ 15 ml/s with a minimum voided volume ≥ 125 ml or patient in urinary retention
  • Written informed consent

排除标准

  • Neurogenic lower urinary tract dysfunction
  • Urethral stenosis
  • Preinterventionally proven adenocarcinoma of the prostate
  • Nickel allergy
  • Not able to complete questionnaires due to cognitive or thought disorders
  • Language skills insufficient for informed consent and / or completion of questionnaires

结局指标

主要结局

International Prostate Symptoms Score (IPSS)

时间窗: 6 months

The International Prostate Symptom Score (IPSS) can be utilized to measure the severity of lower urinary tract symptoms. The IPSS is made up of 7 questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms.

次要结局

未报告次要终点

研究者

发起方
Dr. med. Gautier Müllhaupt
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dr. med. Gautier Müllhaupt

Staff member, Sponsor-Investigator

Cantonal Hospital of St. Gallen

研究点 (2)

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