Evaluation of Mirabegron Versus Tamsulosin or Their Combination in Treatment of Lower Urinary Tract Symptoms Related to Double j Stent in Adults: A Prospective Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Treatment of Ureteral Stent Pain
研究概览
简要总结
Stent related symptoms (SRSs) comprise of complaints such as irritative symptoms, sense of incomplete emptying, flank and suprapubic pain, and incontinence. Mechanical irritation of trigone, urinary reflux, and stent movement are plausible causes for SRSs.
Alpha-blockers are the primary medications for ureteral stent-related symptoms. These medications are suggested to patients by the American Urological Association (AUA)/Endourological Society guideline to reduce stent-related symptoms with moderate recommendation. Nevertheless, there are many side effects associated with alpha-blockers such as dizziness, headache, and orthostatic hypotension
详细描述
Ureteral stents have become an important part of urologic practice since first described the double-J stent . most often urolithiasis. Their use may be associated with significant bothersome symptoms and discomfort. Ureteral stent-related symptoms (SRSs) may occur in up to 88% of patients in mild or more severe degree.
Mirabegron is the first and only selective β3-adrenergic receptor agonist agent currently available and it is one of the treatment options for overactive bladder (OAB). Hence, many urologists have been introducing mirabegron therapy for OAB in recent years and because the SRS are similar to OAB symptoms, it may be another treatment option for reducing bladder irritability in patients indwelling DJ stent.
It is currently unclear whether mirabegron has a place in the treatment of SRSs. Our study aims to systematically evaluate the efficacy and safety of mirabegron in treating SRSs in comparison to Tamsulosin and their combination in adult patients
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
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First time to use Ureteric stent .
排除标准
- •Urinary tract infection.
- •Previous ureteral surgery.
- •Congenital malformation of the ureter.
- •Distal ureteric stricture.
- •Hypersensitivity to the drugs.
- •Pregnancy or lactation.
- •Hepatic insufficiency
- •Non-compliant patients.
- •Age < 18 years old .
研究组 & 干预措施
Tamsulosin 0.4mg
About 100 patients will receive Tamsulosin (0.4mg) once daily for 3 weeks for the treatment of lower urinary tract symptoms related to double j stent in adults
干预措施: Tamsulosin (Drug)
Mirabegron 50mg
About 100 patients will receive Mirabegron (50mg) once daily for 3 weeks for the treatment of lower urinary tract symptoms related to double j stent in adults
干预措施: Tamsulosin (Drug)
combination of tamsulosin 0.4mg and Mirabegron 50mg
About 100 patients will receive A combination of tamsulosin (0.4mg) and Mirabegron (50mg) once daily for 3 weeks for the treatment of lower urinary tract symptoms related to double j stent in adults
干预措施: Tamsulosin (Drug)
结局指标
主要结局
Treatment of Ureteral Stent Pain
时间窗: 4 Weeks
All patients will be evaluated before and after the treatment from the pain by the visual analog pain scale..
次要结局
未报告次要终点
研究者
Avraiem Talaat
Resident at Urology Department
South Valley University