COMPARISON OF SILICONE VERSUS POLYURETHANE URETERAL STENTS: A PROSPECTIVE CONTROLLED STUDY
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- body pain
研究概览
简要总结
From June 2018 to October 2018, patients from two distinct clinical centers were prospectively enrolled in the study and stratified (non-randomly) into either control group A, patients who received polyurethane stents (Rüsch, Teleflex), or experimental group B, patients who received silicone stents (Cook Medical). Each participant completed a survey one hour after stent insertion, in the middle of the stent dwelling period, and before stent removal or ureteroscopy noting body pain and overactive bladder via the visual analog scale pain (VASP) and overactive bladder (OAB) awareness tool, respectively. Additionally, the successfulness of stent placement, hematuria, number of unplanned visits, and stent encrustation rates were assessed within each group.
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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria included age (18 to 60 years old),
- •confirmed ureteral stone
- •prescribed ureteral stent placement for pain syndrome relief
排除标准
- •an active urinary tract infection.
结局指标
主要结局
body pain
时间窗: 4 weeks
At each follow-up appointment, patients completed a survey in which the visual analog scale pain (VASP) was filled
bladder overactivity
时间窗: 4 weeks
At each follow-up appointment, patients completed a survey in which the "bladder awareness tool" (VASP) was filled
次要结局
未报告次要终点
研究者
nariman.gadjiev
Head of endourology
St. Petersburg State Pavlov Medical University