NCT00199550已完成4 期
A Prospective Randomized Clinical Trial of Bipolar vs Monopolar Transurethral Resection of the Prostate (TURP)
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 12
- 主要终点
- Evaluation of efficacy will be determined by comparing pre and post-operative symptom scores.
研究概览
简要总结
This study will prospectively evaluate a new electrosurgical procedure (bipolar transurethral prostatectomy) in men with symptomatic benign prostatic hyperplasia.
详细描述
The purpose of this study is to demonstrate that the Bipolar TURP using the Vista Controlled Tissue Resection System is safe and efficacious as a surgical treatment for men with symptomatic BPH, allowing a reduction in the post-operative hospitalization. It is expected that bipolar TURP will be safe and efficacious for the surgical treatment of BPH and will allow a < 24 hour post-operative hospital stay in > 50% of patients undergoing this procedure.
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
- Single (Participant)
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Symptomatic benign prostatic hyperplasia including patients with acute urinary retention;
- •Peak urinary flow rate < 12 ml/sec;
- •American Urological Association (AUA) symptom score > 12.
排除标准
- •Previous open or transurethral prostatic surgery;
- •History of urethral stricture;
- •Failure to discontinue alpha-adrenergic blocking agents for at least 14 days prior to surgery;
- •Failure to discontinue 5-alpha reductase inhibitor for at least 1 month prior to surgery;
- •Patient interested in future fertility;
- •Patient with known neurogenic bladder dysfunction;
- •Untreated urinary tract infection;
- •American Society of Anesthesiologist (ASA) Class >III;
- •Patients requiring anticoagulation with Coumadin or Heparin;
- •Patient unable or unwilling to comply with follow-up schedule.
结局指标
主要结局
Evaluation of efficacy will be determined by comparing pre and post-operative symptom scores.
时间窗: 6 months
次要结局
- Pre and post-operative objective and subjective data for each treatment group will be assessed to determine safety and efficacy. Complications related to the surgical procedure will be noted by flexible cystoscopy at 6 months.(6 months)
研究者
研究点 (12)
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