Clinical trial NCT02037906: Escalating, Constant and Reduction Energy Output in SWL for Renal Stones
Official title: Comparison of Escalating, Constant and Reduction Energy Output in SWL for Renal Stones: Multi-arm Prospective Randomized Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Stones
Keywords: Renal stones
SWL
Lead sponsor: Princess Al-Johara Al-Ibrahim Cancer Research Center
Sponsor class: OTHER
First posted: 2014-01-16
Enrollment: 150
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Stone clearance after escalating shockwave lithotripsy
timeFrame: 14 days after escalating shockwave lithotripsy
Secondary outcomes:
measure: Stone clearance after constant shockwave lithotripsy
timeFrame: 14 days after constant shockwave lithotripsy
Other outcomes:
measure: Stone clearance after reduction shockwave lithotripsy
timeFrame: 14 days after reduction shockwave lithotripsy
Locations:
city: Riyadh
country: Saudi Arabia
facility: King Khalid University Hospital
Study officials:
affiliation: College Of Medicine, King Saud University
name: Danny M Rabah, Professor
role: PRINCIPAL_INVESTIGATOR
References: