A Comparative Study on the Efficacy of Tamsulosin, Solifenacin and Mirabegron in Alleviating Ureteral Stent-related Symptoms: a Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 189
- 试验地点
- 1
- 主要终点
- alleviating Ureteral stent related symptoms
研究概览
简要总结
A comparative study on the efficacy of Tamsulosin, Solifenacin and Mirabegron in alleviating ureteral stent-related symptoms: a randomized controlled trial.
详细描述
Ureteral stent related symptoms can be a major issue in patient undergoing stent placement after any procedure such as- complains of pain, urinary symptoms, sex related and work related and other symptoms. These symptoms can be alleviated with use of drugs such as Tamsulosin, Solifenacin and Mirabegron. Patient recruited in each arm of the study will have their stent related symptoms scoring done using a validated outcome assessment tool to measure the ureteral stent-related symptoms, Ureteral Stent Symptom Questionnaire (USSQ) on day 1, day 7 and day 14 after the stent placement.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible participants were adult patients (aged 19-80 years) who underwent unilateral retrograde rigid ureteroscopy (URS) or retrograde intrarenal surgery (RIRS) with planned ureteric stent insertion for urinary tract stones
排除标准
- •Concomitant use of a-blockers, anticholinergics, corticosteroids, calcium channel blockers, and analgesics
- •Undergoing percutaneous nephrolithotomy, open ureteric surgery or laparoscopic ureteric surgery, including ureterolithotomy
- •Neurogenic bladder, Over Active Bladder (OAB) syndrome, and neurological and psychiatric diseases
- •Preoperative febrile Urinary Tract Infection (UTI)
- •Pregnancy or breastfeeding;
- •A single kidney
- •Moderate or severe cardiovascular or cerebrovascular disease
- •Hepatic dysfunction
- •History of pelvic surgery or irradiation
- •History of bladder or prostate surgery
- •Other acute medical conditions (including acute pancreatitis, acute gastroenteritis, musculoskeletal disorders) that might influence the Ureteral Stent Symptom Questionnaire(USSQ) pain score
- •Allergy to any medication
研究组 & 干预措施
Tamsulosin group
placement of ureteral stents followed by Cap. Tamsulosin 0.4 mg once daily, to relieve the symptom
干预措施: Tamsulosin Hydrochloride 0.4 mg (Drug)
Solifenacin group
placement of ureteral stents followed by Tab Solifenacin 5 mg once daily, to relieve the symptom
干预措施: Solifenacin Succinate 5 mg (Drug)
Mirabegron group
placement of ureteral stents followed by Tab. Mirabegron 25 mg once daily, to relieve the symptom
干预措施: Mirabegron 25 mg (Drug)
结局指标
主要结局
alleviating Ureteral stent related symptoms
时间窗: 2 weeks
mitigating the ureteric stent related symptoms using structured questionnaire
次要结局
- early removal of ureteral stent(before 2 weeks)
研究者
Jainendra Kumar Manoj
M Ch Urology Resident
Bir Hospital