Comparative Efficacy of Tamsulosin and Solifenacin in Managing Double J Stent-Related Symptoms: A Randomized Clinical Study Using the USSQ Tool.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in total USSQ score
研究概览
简要总结
This study evaluates the effects of two medications-tamsulosin and solifenacin-on symptoms associated with double J (DJ) ureteral stents. The research is conducted among patients undergoing unilateral DJ stent placement for ureteric calculi or post-ureteroscopic lithotripsy. Participants are randomly assigned to receive either tamsulosin or solifenacin, and symptom severity is assessed using the Ureteral Stent Symptom Questionnaire (USSQ).
详细描述
Ureteral stents are widely used in urological procedures but are frequently associated with stent-related symptoms such as urinary urgency, pain, and reduced quality of life. These symptoms are believed to arise from mechanical irritation and bladder overactivity. Alpha-blockers and antimuscarinic agents are commonly prescribed to alleviate these effects. This study is designed to compare the effects of tamsulosin, an alpha-1 adrenergic receptor antagonist, and solifenacin, a muscarinic M3 receptor antagonist, in reducing DJ stent-related symptoms.
The study is a single-center, randomized clinical trial conducted at the Department of Urology, Liaquat National Hospital, Karachi. Sixty adult patients who undergo unilateral DJ stent placement for ureteric stones or after ureteroscopic lithotripsy are randomized into two equal groups. Group A receives tamsulosin 0.4 mg daily, and Group B receives solifenacin 5 mg daily. Symptom evaluation is performed on day 14 post-procedure using a culturally adapted version of the Ureteral Stent Symptom Questionnaire (USSQ), which assesses domains such as urinary symptoms, pain, general health, work performance, and sexual health.
The findings from this study aim to inform treatment decisions for managing stent-related symptoms in similar clinical populations.
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
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 20 to 50 years
- •Undergoing unilateral DJ stenting for:
- •Ureteric calculi
- •Post-ureteroscopic lithotripsy
排除标准
- •Bilateral stents
- •History of LUTS or recurrent UTI
- •Urological malignancy or bladder surgery
- •Known hypersensitivity to alpha-blockers or anticholinergics
- •Uncontrolled hypertension, cardiovascular instability
- •Chronic liver or kidney disease
- •Stent complications (migration, encrustation, infection)
研究组 & 干预措施
Tamsulosin
Group A received tamsulosin starting within 24 hours after stent placement.
干预措施: Tamsulosin (Drug)
Solifenacin
Group B received solifenacin starting within 24 hours after stent placement.
干预措施: solifenacin (Drug)
结局指标
主要结局
Change in total USSQ score
时间窗: 14days post stent placement
Total score on the Ureteral Stent Symptom Questionnaire (USSQ), assessing pain, urinary symptoms, general health, work performance, and sexual health.
次要结局
- Pain index score(14days)
- General Health Index score(14days)
- Work Performance Index Score(14days)
- Urinary index score(14days)
- Sexual Function Index Score(14days)
研究者
Fareha Khan
Urology Resident
Liaquat National Hospital & Medical College