WATER III: Aquablation vs. Transurethral Laser Enucleation of Large Prostates (80-180ml) in Benign Prostatic Hyperplasia
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 202
- 试验地点
- 8
- 主要终点
- Primary Safety Endpoint
研究概览
简要总结
Comparative analysis of efficacy and safety of Aquablation (AQUABEAM Robotic System®, PROCEPT BioRobotics, Redwood City, CA, USA) and transurethral laser enucleation as surgical therapy for benign prostatic hyperplasia with large prostates (80-180ml).
详细描述
Prospective randomized and non-randomized cohort, two-arm multicenter trial two arm multicenter trial to evaluate the efficacy and safety of Aquablation (AQUABEAM Robotic System®, PROCEPT BioRobotics, Redwood City, CA, USA) compared to transurethral laser enucleation - the current reference standard of minimal invasive therapy for benign prostatic hyperplasia in large prostates (80-180ml).
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 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age: 45 - 80 years
- •International Prostate Symptom Score (IPSS) ≥ 8
- •Prostate size (measurement by transrectal ultrasound): 80 - 180 mL
- •Subject has diagnosis of LUTS (Lower urinary tract symptoms) due to BPH (Benign Prostatic Hyperplasia)
- •Patient is mentally capable and willing to sign a study-specific consent form
- •Subjects with the ability to follow study instructions and likely to attend and complete all required visits
- •Written informed consent
排除标准
- •Body mass index ≥ 42
- •Suspected or history of prostate cancer
- •Suspected or history of bladder cancer
- •Bladder stone
- •Indwelling catheter for more than 3 months before baseline
- •Active urinary tract infection
- •History of urethral stricture or bladder neck stenosis
- •Damage of the external urethral sphincter
- •Previous prostate surgery or history of lower urinary tract surgery (e.g. urinary diversion, artificial sphincter or penile prosthesis)
- •Use of anticoagulants (if medication cannot be stopped before and after procedure) or known coagulopathy (except ASS 100mg/d).
- •Contraindications for general and spinal anaesthesia
- •The investigator considers a pre-existing condition or the subject's life circumstances to be problematic for the conduct of the study and the completion of the follow-up investigations
- •Subject is unwilling to accept a blood transfusion if required
- •Subject is not able to give consent
- •Subject without legal capacity who is unable to understand the nature, scope, significance and consequences of this clinical trial
- •Simultaneously participation in another clinical trial in the field of urology
- •Known or persistent abuse of medication, drugs or alcohol
结局指标
主要结局
Primary Safety Endpoint
时间窗: Through 3 months after index procedure
Primary safety endpoint is defined as the occurrence of an Adverse Event rated by the investigator as related or unrelated to the study procedure, classified as Clavien Dindo grade 2 or higher or any grade 1 event resulting in persistent disability, such as ejaculatory or erectile dysfunction or incontinence, as evidenced through 3 months after treatment.
Primary Efficacy Endpoint
时间窗: 3 months after index procedure
Primary efficacy endpoint is defined as IPSS (International Prostate Symptom Score) change
次要结局
- Change in IIEF 5/SHIM(3,6,12,24,36,48 and 60 months after index procedure)
- Change in IPSS(1,6,12,24,36,48 and 60 months after index procedure)
- Change in Dysuria Questionnaire(1,3,6,12,24,36,48 and 60 months after index procedure)
- Number of re-interventions(Through 60 months after index procedure)
- Change in ICIQ-UI-SF(1,3,6,12, 24,36,48 and 60 months after index procedure)
- Change in MSHQ-EjD-SF(3,6,12,24,36,48 and 60 months after index procedure)
- Qmax, Uroflowmetry(day 2-5, 3 months, 6 months, 12 months and 36 months after index procedure)
- Prostate volume reduction(comparison of Visit 5 (3 months) and visit 1 (baseline))
- Post void residual urine(day 2-5, 3 months, 6 months, 12 months and 36 months after index procedure)
研究者
Manuel Ritter
Univ.-Prof. Dr. med. Manuel Ritter
University of Bonn