Comparison Between Symptoms Related to Polaris Loop Stent Versus Vortek Double J Stent After Uncomplicated Flexible Ureterorenoscopy for Renal Stones
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- USSQ Urinary symptoms scores
研究概览
简要总结
Prospective randomized controlled single-blind parallel-group trial in order to compare symptoms related to loop-tail (Polaris Loop) stents versus conventional double J (Vortek) stents after uncomplicated flexible URS.
详细描述
Patients undergoing RIRS for a single renal stone < 2 cm are asked to participate in a prospective randomized controlled single-blind parallel-group study. Ureteral stent is always placed after flexible URS. Patients are prospectively randomized into two groups with a 1:1 allocation: group LT receive loop-tail stents (Polaris ™ Loop - Boston Scientific, Natick, USA), while group DJ receive conventional double J stents (Vortek ® - Coloplast, Humlebaek, DK). Stent removal is planned 4 weeks after the procedure.
Participants are asked to fill in the Italian validated version of the Ureteral Stent Symptoms Questionnaire (USSQ) 2 days and 4 weeks after surgery. The USSQ is further submitted 4 weeks after stent removal (8 weeks after surgery) and these results are used as baseline evaluation, on the assumption that SRS persist for a few days after removal.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients undergoing flexible ureteroscopy and laser lithotripsy for kidney stones < 2 cm
- •given informed consent
- •WHO PS 0-2
排除标准
- •significant residual fragments at the end of the procedure
- •intraoperative complications (i.e. ureteral damage or ureteral stricture)
- •urinary tract infections
- •anatomic abnormalities
- •chronic diseases or medications potentially influencing pain perception and urinary symptoms (i.e. alpha blockers and antimuscarinics)
- •preoperative ureteral stenting.
结局指标
主要结局
USSQ Urinary symptoms scores
时间窗: 4 weeks
Evaluation of significant differences in Urinary symptoms score between the two groups
次要结局
- USSQ domains scores(2 days)
- USSQ domains' scores adjusted for baseline(8 weeks)
研究者
Andrea Bosio
MD Urologist, PhD
A.O.U. Città della Salute e della Scienza