Prostatic Urethral Lift in Subject With Acute Urinary Retention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 8
- 主要终点
- Successful Trial Without Catheter Peri-procedurally
研究概览
简要总结
Assess feasibility and safety of the Prostatic Urethra Lift (PUL) procedure in patients with acute urinary retention secondary to benign prostatic hyperplasia (BPH).
详细描述
The study is a multi-centre, prospective evaluation of PUL and retrospective review of invasive surgery as potential comparator. The study is intended to be conducted at up to 5 different centres in the United Kingdom to enrol up to 50 subjects. Subject follow-up visits are at post-procedure, 6 weeks, 3 months, 6 months and 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male gender
- •Diagnosis of symptomatic BPH
- •Age ≥ 50 years
- •Prostate volume ≤ 100 cc per ultrasound (US)
- •Acute urinary retention with at least one failed trial without catheter (TWOC) while on alpha blocker
排除标准
- •An obstructive or protruding median lobe of the prostate
- •Previous BPH surgical procedure
- •Previous pelvic surgery
- •Urethral conditions that prevents insertion and delivery of device system into bladder
- •Retention volume of >1500 mL
- •Has not had prostate cancer excluded
- •History of prostate or bladder cancer
- •Biopsy of the prostate within the 6 weeks prior to Index Procedure
- •History of neurogenic or atonic bladder
- •Acute or chronic renal failure
- •Known coagulopathies or subject on anticoagulants within 3 days of index procedure (excluding up to 100mg ASA)
- •Known bladder stones within the prior 3 months or treatment within 12 months
- •Prostatitis requiring treatment (antibiotics) within the last year
- •Other co-morbidities that could impact the study results
- •severe cardiac arrhythmias uncontrolled by medications or pacemaker
- •congestive heart failure New York Heart Association (NYHA) III or IV
- •history of uncontrolled diabetes mellitus
- •significant respiratory disease in which hospitalisation may be required
- •known immunosuppression (i.e. AIDS, post-transplant, undergoing chemotherapy)
- •Life expectancy estimated to be less than 5 years
- •Desire to maintain fertility post procedure
- •Unable or unwilling to complete all required questionnaires and follow up assessments
- •Unable or unwilling to sign informed consent form
- •Currently enroled in any other clinical research trial that has not completed the primary endpoint
结局指标
主要结局
Successful Trial Without Catheter Peri-procedurally
时间窗: 3 days (± 1 day) from index procedure
Success is defined as a spontaneous voided volume of ≥100 mL associated with a post void residual volume by ultrasound \<300 mL 3 days (± 1 day) after the index procedure catheter placement without the need for re-catheterisation.
次要结局
- Number of Participants With Serious Adverse Events Related to Benign Prostatic Hyperplasia (BPH) Intervention(Through 3 months)