A Randomized Clinical Trial Comparing Alpha Blacker (Tamsulosin) and Anticholinergic (Solifenacin) in Treatment of Ureteral Stent Related Symptoms
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 131
- 试验地点
- 1
- 主要终点
- The Efficacy of tamsulosin and solifenacin in relieving ureteral stent symptoms will be evaluated by comparing the scores of ureteral stent symptoms questionnaire in the studied groups
研究概览
简要总结
This study will be conducted to compare the effectiveness of alpha blocker (Tamsulosin) and Anticholinergic (Solifenacin) in relieving lower urinary tract symptoms caused DJ ureteral stents.
详细描述
Eligible patients who signed the informed consent will randomly assigned to one of 3 groups; group 1 (control), group 2 (tamsulosin) and group 3 (Solifenacin). Ureteral stent symptom questionnaire (USSQ) will be used to compare health related quality of life scores.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient who will undergo unilateral ureteral stent fixation:
- •To relieve upper urinary tract obstruction caused by ureteric calculi
- •After ureteroscopic lithotripsy for ureteral calculi.
排除标准
- •Patients who had LUTS before stent fixation.
- •Ureteral stent fixation after open or laparoscopic surgery.
- •Bilateral ureteral stents.
- •Patients who developed complications related to the primary endoscopic procedure
- •Patients who developed stent related complications such as hematuria, acute pyelonephritis or stent displacement
研究组 & 干预措施
Group A
Patients in this group will receive placebo
干预措施: Control (Drug)
Group B
Patients in this group will receive Tamsulosin
干预措施: Tamsulosin (Drug)
Group C
Patients in this group will receive Solifenacin
干预措施: Solifenacin (Drug)
结局指标
主要结局
The Efficacy of tamsulosin and solifenacin in relieving ureteral stent symptoms will be evaluated by comparing the scores of ureteral stent symptoms questionnaire in the studied groups
时间窗: 1 year
次要结局
未报告次要终点
研究者
Ahmed R. EL-Nahas
Assistant Professor
Mansoura University