Escalating, Constant and Reduction Energy Output in SWL for Renal Stones
- Conditions
- Renal Stones
- Interventions
- Radiation: Constant Energy SWLRadiation: Escalating Energy SWLRadiation: Reduction Energy SWL
- Registration Number
- NCT02037906
- Lead Sponsor
- Princess Al-Johara Al-Ibrahim Cancer Research Center
- Brief Summary
Research Problem: Shock wave lithotripsy (SWL) dramatically changed the management of renal and ureteral calculus disease. In vitro studies suggest that progressive increase in lithotripter energy output voltage could produce the best overall stone comminution in comparison with constant or deescalating energy output. However, it is possible that the beneficial impact of slow rate SWL on comminution of stones and stone free rates has masked any marginal benefits for energy output escalation. The Escalating SW method adds the benefit of less renal tissue injury.
Research Significance:The present study will signifies and evaluates the stone free rates of three groups of patients with renal stones treated with different SWL energy outputs (Escalating, Constant and Reduction energy output).
Research Objectives: The aim of this research project is to study the effect of dose adjustment strategies on success rate of Shock Wave Lithotripsy in the clinical setting and to optimize the conditions for successful Shock Wave Lithotripsy.
Research Methodology: This clinical trial will be conducted at a tertiary care university hospital. 150 patients referred to the Shock wave lithotripsy unit will be evaluated for eligibility to be randomized into three groups (Dose Escalation, Dose reduction and constant dose). Parameter of the three groups will be compared to detect the treatment difference.
- Detailed Description
Escalating SW amplitude treatment protocols have been shown to be safe on long-term with less harm to kidney tissue. This clinical trial will be conducted at a tertiary care university hospital. All patients referred to the SWL unit will be evaluated for eligibility to be randomized. Randomization process "complete" or "unrestricted" randomization was used to allocate patients to the three arms of the clinical trial where one patient was randomly assigned to one of the three arms blindly.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
- Single stone
- Radio opaque
- Less than 2cm in size
- Renal stone
- bleeding disorder,
- urinary tract infection (UTI)
- distal ureteric obstruction
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Constant Energy SWL Constant Energy SWL 50 Patients Escalating Energy SWL Escalating Energy SWL 50 Patients Reduction Energy SWL Reduction Energy SWL 50 Patients
- Primary Outcome Measures
Name Time Method Stone clearance after escalating shockwave lithotripsy 14 days after escalating shockwave lithotripsy All patients undergo for imaging investigation of the kidneys, ureters, or bladder (KUB) plain x-ray film at day 14 to assess stone free rate. Stone free was defined as no stones or painless fragments less than 4mm. In additions all patients received pre and post shockwave lithotripsy renal ultrasound on day 1 prior and day 1 shockwave lithotripsy to evaluate for shockwave lithotripsy related hematoma formation.
- Secondary Outcome Measures
Name Time Method Stone clearance after constant shockwave lithotripsy 14 days after constant shockwave lithotripsy All patients undergo for imaging investigation of the kidneys, ureters, or bladder (KUB) plain x-ray film at day 14 to assess stone free rate. Stone free was defined as no stones or painless fragments less than 4mm. In additions all patients received pre and post shockwave lithotripsy renal ultrasound on day 1 prior and day 1 shockwave lithotripsy to evaluate for shockwave lithotripsy related hematoma formation.
Trial Locations
- Locations (1)
King Khalid University Hospital
🇸🇦Riyadh, Saudi Arabia