Comparison of the Efficacy of Alpha-Blockers and Mirabegron on Symptoms Associated With Double-J Stent Implanted After Retrograde Intrarenal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Stent-Related Pain Score
研究概览
简要总结
This prospective randomized controlled trial investigates the effects of alfuzosin, mirabegron, and their combination on stent-related symptoms and outcomes in patients undergoing DJ stent placement after retrograde intrarenal surgery (RIRS) for renal stones. The primary outcomes include stone-free rate and residual fragment status, while secondary outcomes focus on stent-related pain and lower urinary tract symptoms (LUTS). Patients will be randomly assigned to one of four groups: alfuzosin only, mirabegron only, combination therapy, or control. Pain and LUTS will be assessed using validated questionnaires such as the Ureteral Stent Symptom Questionnaire (USSQ) and IPSS.
详细描述
Retrograde intrarenal surgery (RIRS) is a commonly used minimally invasive procedure for the treatment of renal stones. Postoperative placement of double-J (DJ) stents is often necessary but can result in significant stent-related discomfort and lower urinary tract symptoms (LUTS), which negatively impact patient quality of life. Alfuzosin, an alpha-blocker, and mirabegron, a beta-3 agonist, are pharmacological agents known to reduce stent-related symptoms. This study aims to compare the individual and combined efficacy of these agents on stent-related pain, LUTS, and postoperative stone outcomes. Patients will be evaluated for stone clearance, residual fragments (by imaging), and symptom scores over a follow-up period of 2 to 4 weeks post-RIRS
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergoing RIRS and DJ stenting
- •Ability to provide informed consent
排除标准
- •Neurogenic bladder
- •Prostate volume >40 mL or significant LUTS at baseline
- •Contraindications to alpha-blockers or mirabegron
- •Hepatic or severe renal impairment
结局指标
主要结局
Stent-Related Pain Score
时间窗: Day 7 postoperatively and Day 14 postoperatively.
Pain score ranges from 0 to 39 (higher scores indicate worse pain).
Lower Urinary Tract Symptom (LUTS) Score
时间窗: Day 7 postoperatively and Day 14 postoperatively
IPSS ranges from 0 to 35 (higher scores indicate more severe LUTS).
次要结局
- Stone-Free Rate(Day 14 postoperatively)
- Residual Fragment Status(Day 14 postoperatively)
研究者
Mehmet Öztürk
Assoc. Prof.
University of Gaziantep