A Randomized Controlled Trial Evaluating Sildenafil Citrate in Relieving Ureteral Stent Related Symptoms
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Ureteral Stent Symptoms Questionnaire (USSQ) Score
研究概览
简要总结
Despite its beneficial effect, ureteral stents may produce symptoms (such as hematuria, dysuria, frequency, urgency, urge incontinence and suprapubic or flank pain) that affect the quality of life in 70-80%.
This study will be conducted to evaluate the role of Phosphodiestrase 5 inhibitor (Sildenafil Citrate) in relieving these symptoms.
详细描述
Adult patient (>18 years) who will undergo ureteral stent fixation after endoscopic procedures will be randomized between the study arms.
Exclusion criteria:
- Patients who had lower urinary tract symptoms before stent fixation.
- Ureteral stent fixation after open surgery.
- Known contraindications to Sildenafil Citrate
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patient aged >18 years
排除标准
- •Patients who had LUTS before DJ stent fixation
- •DJ stent fixation after open surgery
- •Contraindication to Sildenafil citrate
研究组 & 干预措施
Placebo
Patient in this arm will receive placebo daily after ureteral stent fixation.
干预措施: Placebo (Drug)
Sildenafil
Patient in this arm will receive sildenafil citrate 50 mg tablet once daily after ureteral stent fixation.
干预措施: Sildenafil (Drug)
结局指标
主要结局
Ureteral Stent Symptoms Questionnaire (USSQ) Score
时间窗: 2-4 weeks
Comparison of total USSQ scores between study arms.
次要结局
- Number of participants with treatment-related adverse events(2-4 weeks)
研究者
Ahmed R. EL-Nahas
Urology & Nephrology Center
Mansoura University