跳至主要内容
临床试验/CTRI/2025/01/079828
CTRI/2025/01/079828已完成4 期

Comparative efficacy of tamsulosin vs. solifenacin vs. mirabegron in relieving double J stent-related lower urinary tract symptoms (LUTS): A randomised control trial

AIIMS JODHPUR1 个研究点 分布在 1 个国家目标入组 123 人开始时间: 2025年2月10日最近更新:

试验速览

阶段
4 期
状态
已完成
发起方
AIIMS JODHPUR
入组人数
123
试验地点
1
主要终点
Using the Ureteric stent symptom score (USSQ), we will be investigating the efficacy of tamsulosin, solifenacin, and mirabegron in lowering DJ stent related symptoms in this study.

研究概览

简要总结

Double-J (DJ) stents, commonly used to relieve ureteral obstructions, often cause lower urinary tract symptoms (LUTS) such as pain, haematuria, and urinary tract infections, significantly impacting patients’ quality of life. These symptoms primarily result from bladder irritation and ureteral spasms caused by the stent’s positioning and movement. While alpha-blockers like tamsulosin and anticholinergics like solifenacin have shown effectiveness in managing these symptoms, the role of beta-3 agonists, such as mirabegron, is less explored despite it’s success in treating overactive bladder (OAB). With limited research comparing the efficacy of these medications for DJ stent-related LUTS, there is a critical need for further studies to address this gap and identify optimal treatment strategies to enhance patient care.

Hypothesis: Compared to other medications, mirabegron shows comparable results on LUTS and performs better on overactive bladder symptoms due to DJ stents. Tamsulosin shows similar results to that of Mirabegron, and there is no additional benefit of using the combination.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Presence of a Double J stent in the urinary tract.
  • • Complaints of lower urinary tract complaints.

排除标准

  • Previous treatment with any of the study medications.
  • Presence of other significant urinary tract pathology.
  • Pregnancy or breastfeeding.
  • Any condition that may interfere with the study assessments or participation.

结局指标

主要结局

Using the Ureteric stent symptom score (USSQ), we will be investigating the efficacy of tamsulosin, solifenacin, and mirabegron in lowering DJ stent related symptoms in this study.

时间窗: Baseline, 2 weeks and 4 weeks.

次要结局

  • To study the impact of LUTS on quality of life (QOL) in patients with DJ stent. To identify the factors that increase the incidence of LUTS in patients with DJ stent.

研究者

发起方
AIIMS JODHPUR
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Ankit Shettar

AIIMS Jodhpur

研究点 (1)

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