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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Princess Al-Johara Al-Ibrahim Cancer Research Center
Sponsor:
Information provided by (Responsible Party):
Princess Al-Johara Al-Ibrahim Cancer Research Center
ClinicalTrials.gov Identifier:
NCT02037906
First received: January 6, 2014
Last updated: January 14, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Renal Stones
Radiation: Escalating Energy SWL
Radiation: Constant Energy SWL
Radiation: Reduction Energy SWL

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Comparison of Escalating, Constant and Reduction Energy Output in SWL for Renal Stones: Multi-arm Prospective Randomized Study.

Further study details as provided by Princess Al-Johara Al-Ibrahim Cancer Research Center:

Primary Outcome Measures:
  • Stone clearance [ Time Frame: 14 days after escalating shockwave lithotripsy ] [ Designated as safety issue: No ]
    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 [ Time Frame: 14 days after constant shockwave lithotripsy ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Stone clearance [ Time Frame: 14 days after constant shockwave lithotripsy ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 150
Study Start Date: January 2014
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   30 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02037906

Locations
Saudi Arabia
King Khalid University Hospital Recruiting
Riyadh, Saudi Arabia
Contact: karim H Farhat, PhD    14679748    farhatscience@yahoo.fr   
Principal Investigator: Danny M Rabah, Professor         
Sub-Investigator: Mostafa Arafa, Professor         
Sponsors and Collaborators
Princess Al-Johara Al-Ibrahim Cancer Research Center
Investigators
Principal Investigator: Danny M Rabah, Professor College Of Medicine, King Saud University
  More Information

No publications provided

Responsible Party: Princess Al-Johara Al-Ibrahim Cancer Research Center
ClinicalTrials.gov Identifier: NCT02037906     History of Changes
Other Study ID Numbers: 13/3948/IRB, 13/3948/IRB
Study First Received: January 6, 2014
Last Updated: January 14, 2014
Health Authority: Saudi Arabia: Ethics Committee

Keywords provided by Princess Al-Johara Al-Ibrahim Cancer Research Center:
Renal stones
SWL

Additional relevant MeSH terms:
Calculi
Kidney Calculi
Pathological Conditions, Anatomical
Nephrolithiasis
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi

ClinicalTrials.gov processed this record on September 18, 2014