EVALUATION OF TAMSULOSIN VERSUS MIRABEGRON IN URETERIC STENT RELATED SYMPTOMS- A RANDOMISED CONTROLLED TRIAL
试验速览
- 阶段
- 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
- To evaluate the effect of Tamsulosin and Mirabegron in ureteral stent related symptoms.
研究概览
简要总结
Ureteric stents are used often by Urologists followingureteroscopy for prevention of ureteric obstruction from oedema and or stonefragments. They are often associated with pain, need to void often, the need tourinate quickly and finding blood in the urine called "lower urinary tractsymptoms" or LUTS in short. There is randomized studies showing theefficacy of α-blockers such as tamsulosin in relieving"stent symptoms" (pain and LUTS). There is emerging but limitedevidence to show that antimuscarinic medications, used to treat overactivebladder (OAB) have some efficacy in decreasing stent symptoms.
Mirabegron is a beta agonist used to decrease OABsymptoms and has been found to be effective in treating patients with stentrelated symptoms. Mirabegron functions to mediate relaxation of the detrusormuscle. Conventional antimuscarinic medications often have bothersome sideeffects like dry mouth, constipation, blurred vision and cognitive impairment.This may limit their use in some populations. Mirabegron is well-tolerated witha good safety profile and therefore is useful in treating stent symptoms,without the bothersome side effects commonly seen with antimuscarinicmedications. The aim of this study is to compare Tamsulosin and Mirabegron intreating stent related symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients who have underwent semirgid ureteroscopy with DJ stenting.
- •Only patients with uncomplicated ureteric calculi.
- •3 Patients aged 18 years to 60 years.
排除标准
- •Patients with growth in Urine culture or having symptomatic urinary tract infection.
- •Patients who may need bilateral stent insertion for acute obstruction / obstructive uropathy
- •Male patients with history of prostatic enlargement, prostatitis or prostatic cancer related lower urinary tract symptoms
- •Females with lower urinary tract symptoms related to any form of urinary incontinence, uterine/cervical/vaginal prolapse, or obstruction related to malignancy.
- •History of chronic or recent α-blocker or analgesic drug use were excluded.
- •Pregnancy,
- •Bleeding disorders,
- •Patients with concomitant other lower tract pathology like bladder cancer, bladder outlet obstruction with or without stones, urethral stricture.
- •Patients with simultaneous renal calculus.
- •Patients who underwent open surgery for ureteric calculi previously.
- •Patients not fulfilling inclusion criteria.
结局指标
主要结局
To evaluate the effect of Tamsulosin and Mirabegron in ureteral stent related symptoms.
时间窗: 2 weeks
次要结局
- to assess quality of life in patients taking tamsulosin and mirabegron for ureteral stent related symptoms as measured by USSQ quality of life scale(2 weeks)