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

P

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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