Clinical efficacy of Tamsulosin and Solifenacin combination vs Mirabegron and Silodosin Combination in double J ureteral stent related symptoms:A Randomized contorl trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Primary Endpoint:
研究概览
简要总结
Ureteral stents are now very commonly used in various urological disorders Ureteral stents are frequently used to relieve obstruction of urinary tract to secure ureteral anastomoses and to provide effective drainage of upper urinary tract after various urological interventions. The term stent-related symptoms SRS refers to a broad range of symptoms in the early postoperative phase include transient fever hematuria frequency urgency and pain in the flank and or suprapubic area
The symptoms associated with a DJ stent can present clinically like an overactive bladder and are mediated by cholinergic and alpha adrenergic receptors The three main pharmacological types that have been studied over the past few decades and found out to be beneficial in reducing stent associated symptoms are beta 3 agonists alpha blockers and anticholinergics
Tamsulosin and silodosinin are specific alpha1a inhibitors that inhibit the contraction of the lower ureter bladder neck and bladder trigone muscles hence reducing pain and discomfort associated with the lower urinary tract
The only selective beta 3 adrenergic agonist available for treating overactive bladder is mirabegron. It works by reducing patients’ irritation in the bladder when they have a ureteral stent in situ
Ureteral Stent Symptom Questionnaire USSQ is a questionnaire which is self administered and assesses aspects of stent related symptoms Patients will be randomized into two groups 1 to 1 by a computer generated randomization
Group A patients will be given tamsulosin 04 mg and solifencain 10 mg combination once daily Group B patients will be given Silodosin 8 mg and Mirabegron 50 mg combination once daily All patients are to be followed up for 6 weeks from double J stent placement Comparisons of clinical demographic and intraoperative findings will be done and patients will be followed up in terms of symptoms using USSQ score at 1 week post procedure 3 and 6 weeks post procedure
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.All patients who will be undergoing Double J ureteral stent placement during ureterscopic removal of stone 2.All patients who will be undergoing Double J ureteral stent placement during Percutaneous nephrolithotomy 3.Age 18 years to 60 years of all genders consenting for study.
排除标准
- •1.Patients who are already prescribed any of drugs which are being studied in this research either in monotherapy or in combination (tamsulosin, mirabegron, solifenacin or silodosin) 2.Patients who had residual stone fragments after surgical intervention 3.Patients underwent bilateral double J stent placement.
- •4.Pregnant patients.
结局指标
主要结局
Primary Endpoint:
时间窗: six weeks
Mean USSQ score at six weeks
时间窗: six weeks
次要结局
- Secondary Endpoints:(a) Mean USSQ score at one week)
研究者
Dr Abhishek chhabra
AIIMS BATHINDA