Renal Stones Clinical Trial
Official title:
Comparison of Escalating, Constant and Reduction Energy Output in SWL for Renal Stones: Multi-arm Prospective Randomized Study.
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.
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. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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