ISRCTN16280334已完成不适用
A Prospective Multicentre Randomised Study Comparing Photoselective Vaporisation of the Prostate with the GreenLight XPS™ Laser System and Transurethral Resection of the Prostate for the Treatment of Benign Prostatic Hyperplasia
American Medical Systems, Inc (USA)0 个研究点目标入组 252 人开始时间: 2010年10月26日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 252
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Subject has provided informed consent
- •2. Subject has diagnosis of benign prostatic hyperplasia
- •3. Subject is willing to be randomised
- •4. Clinical investigator has documented in the subject?s medical record that in his/her judgment the subject is a surgical candidate for either the PVP or the TURP procedure and may be randomised into either arm
- •5. Subject is greater than or equal to 40 years of age
- •6. Subject has an International Prostate Symptom Score (IPSS) score greater than or equal to 12 measured at the baseline visit
- •7. Subject has medical record documentation of a maximum urinary flow rate (Qmax) less than 15ml/s (If uroflow testing documentation is available within 90 days prior to the informed consent date, and the sample is greater than or equal to 125ml, and the Qmax is less than 15ml/s it may be used for the inclusion/exclusion criteria)
- •8. Subject has medical record documentation of a prostate volume of less than or equal to 100g by transrectal ultrasound (TRUS) or abdominal ultrasound (If TRUS or abdominal ultrasound testing documentation is available within the 180 days prior to the informed consent date and the prostate volume is less than or equal to 100g, it may be used for the inclusion/exclusion criteria)
- •9. Subject is classified as American Society of Anesthesiologist (ASA) I, II or III
- •10. Subject has a serum creatinine less than 1.8 mg/dl measured after the date of the informed consent and prior to the surgical procedure
排除标准
- •1. Subject has a life expectancy of less than 2 years
- •2. Subject is currently enrolled in, or plans to enroll in, any concurrent drug or device study unless pre-approved by the sponsor
- •3. Subject has an active infection (eg, urinary tract infection or prostatitis)
- •4. Subject has a history of 2 or more urinary tract infections in the 365 days prior to the informed consent date
- •5. Subject has a diagnosis of chronic bacterial prostatitis or chronic pelvic pain syndrome (eg, non-bacterial chronic prostatitis)
- •6. Subject has been diagnosed with a urethral stricture or bladder neck contracture within the 180 days prior to the informed consent date
- •7. Subject has been diagnosed with 2 or more urethral strictures and/or bladder neck contractures within the 5 years prior to the informed consent date
- •8. Subject has a neurogenic bladder or other neurological disorder that would impact bladder function (eg, multiple sclerosis, Parkinson?s disease, spinal cord injuries)
- •9. Subject has a diagnosis of diabetic cystopathy
- •10. Subject has history of lower urinary tract surgery (eg, urinary diversion, artificial urinary sphincter, penile prosthesis)
- •11. Subject has diagnosis of stress urinary incontinence that requires treatment or daily pad/device use
- •12. Subject has a history of intermittent self catheterisation within the 180 days prior to the informed consent date
- •13. Subject has current diagnosis of bladder stones
- •14. Subject has diagnosis of prostate cancer
- •15. Subject has a history of T1 or CIS bladder cancer
- •16. Subject has damage to external urinary sphincter
- •17. Subject has a medical contraindication for undergoing either TURP or PVP surgery (eg, infection, coagulopathy or significant cardiac or other medical risk factors for surgery)
- •18. Subject has a disorder of the coagulation cascade (eg, haemophilia) or disorders that affect platelet count or function (eg, Von Willebrand?s disease) that would put the subject at risk for intraoperative or postoperative bleeding
- •19. Subject is unable to discontinue anticoagulant and antiplatelet therapy preoperatively (3-5 days)
- •20. Subject has had an acute myocardial infarction, open heart surgery or cardiac arrest less than 180 days prior to the date of informed consent
- •21. Subject is immunocompromised (eg, organ transplant, leukaemia)
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