Escalating, Constant and Reduction Energy Output in SWL for Renal Stones

Princess Al-Johara Al-Ibrahim Cancer Research Center

Status: Completed

Conditions: Renal Stones

Treatments: Radiation: Escalating Energy SWL; Radiation: Reduction Energy SWL; Radiation: Constant Energy SWL

Study type: Interventional

Funder types: Other

Identifiers

NCT02037906

13/3948/IRB (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 30 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Single stone
• Radio opaque
• Less than 2cm in size
• Renal stone

Exclusion criteria

• bleeding disorder,
• urinary tract infection (UTI)
• distal ureteric obstruction

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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150 participants in 3 patient groups

Escalating Energy SWL

Experimental group

Description:

50 Patients

Treatment:

Radiation: Escalating Energy SWL

Constant Energy SWL

Experimental group

Description:

50 Patients

Treatment:

Radiation: Constant Energy SWL

Reduction Energy SWL

Experimental group

Description:

50 Patients

Treatment:

Radiation: Reduction Energy SWL