Energy Ramping Versus Fixed Dose ESWL on Stone-Free Rate (Comparative Study)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Stone free rate
研究概览
简要总结
This clinical trial compares two techniques of extracorporeal shock wave lithotripsy (ESWL) - energy ramping versus fixed dose - in adult patients with renal stones. The study aims to evaluate stone-free rates, retreatment needs, and safety outcomes across multiple clinical sites in Egypt.
详细描述
This multi-center, randomized controlled trial investigates the impact of energy ramping versus fixed-dose ESWL on stone clearance in patients with solitary renal calculi. Participants will be assigned to either a gradually increasing energy protocol or a constant energy protocol using standardized lithotripter settings. The primary outcome is stone-free rate at two weeks post-treatment, assessed via imaging. Secondary outcomes include retreatment rate, pain scores, adverse events, and procedure duration. The study is conducted under IRB approval from Sohag University and follows international ethical standards for human research.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- — 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults ≥18 years.
- •Radiopaque renal or proximal/mid ureteral stone ≤20 mm.
- •eGFR ≥60 mL/min/1.73 m².
- •Fit for ESWL.
- •Able to give informed consent and complete follow up.
排除标准
- •• Pregnancy.
- •Active, untreated UTI.
- •Uncorrected bleeding disorder or anticoagulation that cannot be stopped.
- •Prior ipsilateral renal surgery.
- •Non radio-opaque stone without reliable imaging.
- •Inability to tolerate ESWL or required anesthesia.
研究组 & 干预措施
fixed-dose ESWL
- Start therapeutic/high energy (e.g., 80-100% device max) from therapeutic phase.
- Total shocks: 2000-3000 adjusted by fragmentation progress and tolerance. Log shocks and cumulative energy.
干预措施: Extracorporeal shock wave lithotripsy (Procedure)
escalating-dose ESWL
- Stepwise escalation: increase energy every 500-1000 shocks (example: 20% → 40% → 60% → 80-100%) until therapeutic energy reached.
- Total shocks: 2000-3000 adjusted by fragmentation progress and tolerance. Log shocks per step and cumulative energy.
干预措施: Extracorporeal shock wave lithotripsy (Procedure)
结局指标
主要结局
Stone free rate
时间窗: 4 weeks
Proportion of participants achieving complete stone clearance as confirmed by imaging (ultrasound or CT).
次要结局
- Number of ESWL sessions to achieve SFR.(4 weeks)
研究者
mohammed Abdelhafez
Urology Resident , sohag hospital university
Sohag University