The Ideal Time Interval Between Repeated Shock Wave Lithotripsy Sessions For Renal Stones: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- to identify the ideal time interval between SWL sessions used for treatment of renal stones and subsequent renal damage.
研究概览
简要总结
There is no consensus about the required time intervals between repeated SWL sessions applied for renal stones with some centers waiting for 3 days, others for one week and others up to one month to repeat lithotripsy. In the 2019 EUA guidelines stated that "There are no conclusive data on the intervals required between repeated SWL sessions. However, clinical experience indicates that repeat sessions are feasible (within 1 day for ureteral stones).
The intense use of ESWL currently, the lack of knowledge about acute lesions caused by re-treatment within a short time interval and the empirical way by which treatment is conducted, stimulated us to search for a precise answers to the question What the ideal time interval between SWL sessions in the treatment of renal stone patients should be.
This randomized controlled trial will be conducted at Urology and Nephrology Center in Mansoura, Egypt. Patients more than 18 years old with single primary renal stone fulfilling inclusion criteria will be randomly allocated to 3 groups (50 patients each).Group 1 will undergo SWL with 3 days between each session. Group 2 will undergo SWL with 7 days between each session and Group 3 will undergo SWL with 14 days between each session.
Study parameters will be renal damage including the following items:
- Tubular damage will be assessed through estimation of changes in urinary excretion of renal tubular enzyme kidney injury molecule 1(KIM-1).
- Glomerular damage will be assessed by estimation of proteinuria and changes in GFR calculated by renal isotope scan.
- Renal morphological and haemodynamic changes.
- Treatment success is defined as clinically insignificant residual fragments less than 4 mm size.
详细描述
STUDY DESIGN:
Randomized Trial
STUDY SETTING/LOCATION:
The study will be conducted in a single tertiary center, Urology and Nephrology Centre in Mansoura, Egypt.
STUDY POPULATION:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 16 Years 至 —(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
to identify the ideal time interval between SWL sessions used for treatment of renal stones and subsequent renal damage.
时间窗: 3 months
Renal damage: 1. Tubular damage: Tubular damage will be assessed through estimation of changes in urinary execration of the renal tubular enzyme, Kidney injury molecule -1 (KIM-1). 2. Glomerular damage: Glomerular damage will be assessed by the presence of proteinuria and changes of GFR calculated by renal isotope scan. 3. Renal morphological and hemodynamic changes: * Changes will be assessed by estimation of ERPF by renal isotope scan. * The presence of peri-renal or subcapsular hematomas on non-contrast spiral CT. * Assessment of renal tissue oxygenation using functional MRI.
次要结局
- 3 months stone free rate(3 months)
研究者
Fadala
Fellow of urology , Urology and nephrology center , Mansoura University
Mansoura University
