Trospium Chloride vs Tamsulosin in Treatment of Ureteral Stent Related Symptoms: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Ureteral Stent Symptoms Questionnaire (USSQ) score
研究概览
简要总结
This study will be conducted to compare the efficacy and safety of Trospium chloride versus Tamsulosin for treatment of ureteral stent related symptoms.
详细描述
Eligible patients will be randomized to one of the two treatment groups. Group 1 patients will receive 30 mg of Trospium chloride tablet twice daily, while group 2 patients will receive 0.4 mg of Tamsulosin tablet once daily, until the stent is removed. Ureteral Stent Symptoms Questionnaire (USSQ) will be used to evaluate the symptoms of the patients with DJ stent after 2 weeks of inserting the stent.
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, Care Provider)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with double "J" (DJ) stent after ureteroscopy or for drainage of obstructed kidney
排除标准
- •Patients with hypersensitivity to either Trospium chloride or Tamsulosin
- •Patients with complications after DJ insertion (such as fever, hematuria, perforation, stent migration).
- •Patients receiving alpha blockers or anticholinergic medications for any other reason.
- •Patients with history of orthostatic hypotension.
- •Pregnant or breastfeeding females.
- •Patients with hepatic impairment (Child-Pugh score >9).
- •Patients with severe renal impairment with creatinine clearance of less than 15 mL/min.
- •Patients with narrow-angle glaucoma.
- •Patients with history of urinary retention or gastric retention.
研究组 & 干预措施
Trospium
Patients will receive 30 mg of Trospium chloride tablet twice daily
干预措施: Trospium Chloride (Drug)
Tamsulosin
Patients will receive 0.4 mg of Tamsulosin tablet once daily
干预措施: Tamsulosin (Drug)
结局指标
主要结局
Ureteral Stent Symptoms Questionnaire (USSQ) score
时间窗: 14 days
Quantitative assessment of quality of life score
次要结局
- Adverse events(14 days)
研究者
Ahmed R. EL-Nahas
Professor of Urology
Mansoura University