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

NCT02037906 | Completed

• 1 other identifier: 13/3948/IRB
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Stones

Keywords

Renal stones; SWL

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Stone clearance after constant shockwave lithotripsy

  14 days after constant shockwave lithotripsy

Other Outcomes (1)

• Stone clearance after reduction shockwave lithotripsy

  14 days after reduction shockwave lithotripsy

Study Arms (3)

Escalating Energy SWL

EXPERIMENTAL

50 Patients

Radiation: Escalating Energy SWL

Constant Energy SWL

EXPERIMENTAL

50 Patients

Radiation: Constant Energy SWL

Reduction Energy SWL

EXPERIMENTAL

50 Patients

Radiation: Reduction Energy SWL

Interventions

Escalating Energy SWL RADIATION

Dose escalation, 1500 SW at 18 kv, followed by 1500 SW at 20 kv and the following 1500 SW at 22 kv.

Escalating Energy SWL

Constant Energy SWL RADIATION

Constant dose at 20 kv

Constant Energy SWL

Reduction Energy SWL RADIATION

Dose reduction, 1500 SW at 22 kv, followed by 1500 SW at 20 kv and the following at 18 kv.

Reduction Energy SWL

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Princess Al-Johara Al-Ibrahim Cancer Research Center: lead

Study Sites (1)

King Khalid University Hospital

Riyadh, Saudi Arabia

Location

MeSH Terms

Conditions

Nephrolithiasis

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases

Study Officials

• Danny M Rabah, Professor

  College Of Medicine, King Saud University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2014
• First Posted: January 16, 2014
• Study Start: January 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: March 31, 2016

Record last verified: 2014-01

Data Sharing

• IPD Sharing: Will share

Locations

SA (1)