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

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.

Study Overview

• Status: Completed
• Conditions: Renal Stones
• Intervention / Treatment: Radiation: Escalating Energy SWL; Radiation: Constant Energy SWL; Radiation: Reduction Energy SWL

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.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Riyadh, Saudi Arabia
    • King Khalid University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Escalating Energy SWL; 50 Patients	Radiation: Escalating Energy SWL; Dose escalation, 1500 SW at 18 kv, followed by 1500 SW at 20 kv and the following 1500 SW at 22 kv.
Experimental: Constant Energy SWL; 50 Patients	Radiation: Constant Energy SWL; Constant dose at 20 kv
Experimental: Reduction Energy SWL; 50 Patients	Radiation: Reduction Energy SWL; Dose reduction, 1500 SW at 22 kv, followed by 1500 SW at 20 kv and the following at 18 kv.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stone clearance 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.	14 days after escalating shockwave lithotripsy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stone clearance 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.	14 days after constant shockwave lithotripsy

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stone clearance after reduction 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.	14 days after reduction shockwave lithotripsy

Collaborators and Investigators

• Sponsor: Princess Al-Johara Al-Ibrahim Cancer Research Center
• Investigators: Principal Investigator: Danny M Rabah, Professor, College Of Medicine, King Saud University

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: January 6, 2014
• First Submitted That Met QC Criteria: January 14, 2014
• First Posted (Estimate): January 16, 2014

Study Record Updates

• Last Update Posted (Estimate): March 31, 2016
• Last Update Submitted That Met QC Criteria: March 30, 2016
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: SWL; Renal stones
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Pathological Conditions, Anatomical; Urolithiasis; Urinary Calculi; Calculi; Kidney Calculi; Nephrolithiasis
• Other Study ID Numbers: 13/3948/IRB (Registry Identifier: Institutional Review Board)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Results will be published in per-reviewed journal