A Single-center Randomized, Controlled Study Evaluating Safety and Effectiveness of Ureteral dj Stent With Magnet (Blackstar, Urotech), Stent-related Symptoms and Pain Level After Stent Removal Compared With Conventional Stent Removal With Flexible Cystoscope
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Body pain
研究概览
简要总结
Evaluation of safety and effectiveness of ureteral DJ stent with magnet (Blackstar, Urotech), severity of stent-association symptoms and pain level syndrome after stent extraction compared with stent extraction by flexible cystoscope
详细描述
Inclusion Criteria:
- age from 18 to 70 years
- males
- Indications for rigid or flexible URS
- ASA score: 1-3
Exclusion Criteria:
- Active urinary tract infection
- taking alpha-1 adreno and M-cholinoblockers
All patients will be randomized into 2 groups:
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 (Investigator)
盲法说明
Patients are to be assigned a randomization number that will match their treatment. Block randomization using 10 blocks is to be performed by a central randomization organization (www.randomize.net) using a computerized algorithm.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •age from 18 to 70 years
- •Indications for rigid or flexible URS
- •ASA score: 1-3
排除标准
- •Active urinary tract infection
- •taking alpha-1 adreno and M-cholinoblockers
结局指标
主要结局
Body pain
时间窗: 30 days
Using VASP to evaluate the pain level in patients with different types of stent extraction
Stent-related symptoms (SRS)
时间窗: 30 days
Using USSQ to evaluate the difference of SRS in patients with different types of stent
次要结局
未报告次要终点
研究者
nariman.gadjiev
Head of endourology department
St. Petersburg State Pavlov Medical University