Escalating, Constant and Reduction Energy Output in SWL for Renal Stones (SWL)
Primary Purpose
Renal Stones
Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Escalating Energy SWL
Constant Energy SWL
Reduction Energy SWL
Sponsored by
About this trial
This is an interventional treatment trial for Renal Stones focused on measuring Renal stones, SWL
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
Sites / Locations
- King Khalid University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Escalating Energy SWL
Constant Energy SWL
Reduction Energy SWL
Arm Description
50 Patients
50 Patients
50 Patients
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02037906
First Posted
January 6, 2014
Last Updated
March 30, 2016
Sponsor
Princess Al-Johara Al-Ibrahim Cancer Research Center
1. Study Identification
Unique Protocol Identification Number
NCT02037906
Brief Title
Escalating, Constant and Reduction Energy Output in SWL for Renal Stones
Acronym
SWL
Official Title
Comparison of Escalating, Constant and Reduction Energy Output in SWL for Renal Stones: Multi-arm Prospective Randomized Study.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Princess Al-Johara Al-Ibrahim Cancer Research Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Stones
Keywords
Renal stones, SWL
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Escalating Energy SWL
Arm Type
Experimental
Arm Description
50 Patients
Arm Title
Constant Energy SWL
Arm Type
Experimental
Arm Description
50 Patients
Arm Title
Reduction Energy SWL
Arm Type
Experimental
Arm Description
50 Patients
Intervention Type
Radiation
Intervention Name(s)
Escalating Energy SWL
Intervention Description
Dose escalation, 1500 SW at 18 kv, followed by 1500 SW at 20 kv and the following 1500 SW at 22 kv.
Intervention Type
Radiation
Intervention Name(s)
Constant Energy SWL
Intervention Description
Constant dose at 20 kv
Intervention Type
Radiation
Intervention Name(s)
Reduction Energy SWL
Intervention Description
Dose reduction, 1500 SW at 22 kv, followed by 1500 SW at 20 kv and the following at 18 kv.
Primary Outcome Measure Information:
Title
Stone clearance after escalating shockwave lithotripsy
Description
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.
Time Frame
14 days after escalating shockwave lithotripsy
Secondary Outcome Measure Information:
Title
Stone clearance after constant shockwave lithotripsy
Description
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.
Time Frame
14 days after constant shockwave lithotripsy
Other Pre-specified Outcome Measures:
Title
Stone clearance after reduction shockwave lithotripsy
Description
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.
Time Frame
14 days after reduction shockwave lithotripsy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Danny M Rabah, Professor
Organizational Affiliation
College Of Medicine, King Saud University
Official's Role
Principal Investigator
Facility Information:
Facility Name
King Khalid University Hospital
City
Riyadh
Country
Saudi Arabia
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Results will be published in per-reviewed journal
Learn more about this trial
Escalating, Constant and Reduction Energy Output in SWL for Renal Stones
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