A Prospective Multicenter Randomized Blinded Study Comparing Aquablation of the Prostate With the AQUABEAM System and TURP for the Treatment of LUTS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 184
- 试验地点
- 33
- 主要终点
- Proportion of Subjects With Adverse Events (Clavien-Dindo Grading System Grade 2 or Higher or Any Grade 1 Event Resulting in Persistent Disability)
研究概览
简要总结
A prospective multicenter randomized blinded study comparing Aquablation of the prostate with the AQUABEAM System and TURP for the treatment of Lower Urinary Tract Symptoms (LUTS). The primary endpoints for safety and effectiveness were measured at 3 and 6 months, respectively, and subjects were followed out to 5 years to collect long-term clinical data.
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, Investigator)
盲法说明
All study subjects and the study site follow-up team are blinded to the assigned treatment until the year 3 follow-up.
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
- •Subject has diagnosis of lower urinary tract symptoms due to benign prostatic enlargement causing bladder outlet obstruction.
- •Age from 45 to 80 years.
- •Subject has medical record documentation of a prostate volume between 30mL and 80mL (inclusive) by transrectal ultrasound (TRUS). (If TRUS testing documentation is available from less than 180 days prior to the informed consent date and the prostate volume is between 30mL and 80mL, it may be used for the inclusion/exclusion criteria.)
- •Subject has an International Prostate Symptom Score (IPSS) score greater than or equal to 12 measured at the baseline visit.
- •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.)
- •Subject has a serum creatinine that is within the normal range for the laboratory at the study center (or documentation of clinical insignificance in the subject's medical record by the investigator if outside the normal range) and measured ≤ 30 days prior to the date of surgery.
- •History of inadequate response, contraindication, or refusal to medical therapy.
排除标准
- •Body Mass Index (BMI) ≥
- •History of prostate cancer or current/suspected bladder cancer.
- •Prostate cancer should be ruled out before participation to the satisfaction of the investigator if Prostate-Specific Antigen (PSA) is above acceptable thresholds.
- •Subjects with a history of actively treated bladder cancer within the past two (2) years.
- •Bladder calculus or clinically significant bladder diverticulum (e.g., pouch size >20% of full bladder size).
- •Active infection, including urinary tract infection.
- •Prostatitis treated with antibiotics within 1 year of enrollment.
- •Ever been diagnosed with a urethral stricture, meatal stenosis, or bladder neck contracture.
- •Subject has damage to external urinary sphincter .
- •Subject has diagnosis of stress urinary incontinence that requires treatment or daily pad or device use.
- •Post-Void Residual (PVR) > 300 mL.
- •Urinary retention at time of enrollment or subject has been catheterized in the 14 days prior to the surgical procedure.
- •Subject has a history of intermittent self-catheterization.
- •Previous prostate surgery or history of other lower urinary tract surgery such as e.g. urinary diversion, artificial urinary sphincter or penile prosthesis.
- •Subjects on anticoagulants (if medication cannot be stopped before and after procedure) or known coagulopathy (except aspirin below 100mg/d).
- •Any severe illness that would prevent complete study participation or confound study results.
- •Participants using systematic immune-suppressants including corticosteroids; unable to withhold non-steroidal anti-inflammatory agents (Nonsteroidal anti-inflammatory drugs (NSAIDs), including aspirin) for 3-5 days prior to treatment except for low dose aspirin (e.g. less than or equal to 100mg).
- •Participants using anticholinergics specifically for bladder problems. Use of medications with anticholinergic properties is allowable provided the patient does not have documented adverse urinary side effects from these medications.
- •Contraindication to general or spinal anesthesia.
- •Subject has any other disease or condition(s) that would interfere with completion of the study and follow up assessments, would increase risks of the procedure, or in the judgment of the investigator would potentially interfere with compliance to this study or would adversely affect outcomes.
- •Subject is unwilling to accept a transfusion should one be required.
结局指标
主要结局
Proportion of Subjects With Adverse Events (Clavien-Dindo Grading System Grade 2 or Higher or Any Grade 1 Event Resulting in Persistent Disability)
时间窗: Three months post-treatment
The primary safety endpoint is the proportion of subjects with adverse events rated as probably or definitely related to the study procedure classified as Clavien-Dindo Grade 2 or higher or any Grade 1 event resulting in persistent disability (e.g. ejaculatory disorder or erectile dysfunction) evidenced through 3 months post treatment. Note that the Clavien-Dindo classification scheme is for grading postoperative complications not events that reflect lack of effective treatment. Results are presented as a percentage rounded to the whole number.
Change Score of IPSS Questionnaire Between Baseline and 6 Months
时间窗: Six months post-treatment
The primary effectiveness endpoint is the IPSS change score from baseline to 6 months. International Prostate Symptom Score (IPSS) ranges from 0 to 35. A higher score indicates a worse outcome.
次要结局
未报告次要终点