A Randomized Controlled Trial Comparing Antimicrobial Coated (Silver Sulfadiazine) Ureteral Stents With Non-coated Stents
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Incidence of urinary tract infection (UTI)
研究概览
简要总结
This study will be conducted to compare the efficacy of antimicrobial coated ureteral stent with non-coated stents in prevention of UTI in patients with ureteral stents
详细描述
The efficacy of antimicrobial coated of ureteral stent with silver sulphadiazine in prevention of UTI in patients with ureteral stents will be studied by comparining the results of urine and stent cultures with patients who had non-coated ureteral stents. The impact of antimicrobeal stent coating on patients' quality of life will be evaluated with comparing the scores of ureteral stent symptom questionnaire between both groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
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
- •Patients who will undergo ureteral stent placement
排除标准
- •Patients allergic to sulpha containing medications
- •Ureteral stent insertion for infected hydronephrosis
- •Patients who developed septic complications requiring antibiotic treatment after stent placement
- •Patients who need bilateral stents
- •Patients with chronic kidney disease grade IV and V (GFR <30ml/min)
- •Immunocompromised patients as those with malignancy or organ transplantation.
结局指标
主要结局
Incidence of urinary tract infection (UTI)
时间窗: up to 3 months
UTI will be diagnosed with urine and stent culture of stent removal
次要结局
- Quality of life(up to 3 months)
研究者
Ahmed R. EL-Nahas
Assisstant Professor
Mansoura University