A Prospective, Randomized, Double Blind, Controlled Study Comparing Extracorporeal Shock Wave Lithotripsy (ESWL) With and Without Simultaneous Adjunct Controlled Inversion Therapy in the Treatment of Lower Pole Caliceal Stone
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 主要终点
- Number of Participants Who Are Stone Free at 3 Months
研究概览
简要总结
This is a randomized controlled trial comparing extracorporeal shockwave lithotripsy (ESWL) with and without simultaneous adjunct controlled inversion therapy in the treatment of lower pole caliceal stone.
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
- Double (Participant, Outcomes Assessor)
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
- •Solitary lower pole caliceal stone which is > 5 mm and < 20mm
- •Not contraindicated for intravenous urogram (IVU) and subsequent X-rays
- •Patient able to comply strictly with visits/medications
- •Patient willing and agrees to enter study
排除标准
- •Impaired function of the affected kidney
- •Gross hydronephrosis of the affected kidney
- •Associated distal obstruction
- •Multiple stones
- •Stone more than 2 cm in size
- •Diverticular stone
- •Patients who are contraindicated for extracorporeal shockwave lithotripsy e.g.: Pregnancy
- •Patients who are unable to tolerate the procedure
- •Significant cardiac condition that does not allow the administration of force hydration or inversion.
- •Uncontrolled hypertension
研究组 & 干预措施
ESWL, Hydration
ESWL with hydration
干预措施: Hydration (Drug)
Inversion, Hydration, ESWL
ESWL with hydration and inversion
干预措施: Inversion (Procedure)
Inversion, Hydration, ESWL
ESWL with hydration and inversion
干预措施: Shock Wave Lithotripsy (Procedure)
Inversion, Hydration, ESWL
ESWL with hydration and inversion
干预措施: Hydration (Drug)
ESWL, Hydration
ESWL with hydration
干预措施: Shock Wave Lithotripsy (Procedure)
结局指标
主要结局
Number of Participants Who Are Stone Free at 3 Months
时间窗: 3 months
To compare the effectiveness of simultaneous adjunct controlled inversion therapy during extracorporeal shockwave lithotripsy (ESWL) to that of ESWL alone in the treatment of lower pole caliceal stone as measured by stone-free rate(SFR)
次要结局
未报告次要终点
研究者
Shaun Lee Wen Huey
Senior Lecturer
Monash University