The Importance of Urinary Tract Anatomy and Radiological Parameters in the Extracorporeal Shockwave Lithotripsy Outcomes

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2012 by University of Sao Paulo
Sponsor:
Information provided by (Responsible Party):
Fabio Cesar Miranda Torricelli, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01589484
First received: April 29, 2012
Last updated: May 2, 2012
Last verified: May 2012
  Purpose

Around 5 to 10% of population will present kidney stone in any time of their life. It may be asymptomatic, however severe pain may be presented due to stone migration through urinary system. In these cases, the gold standard image exam is noncontrast helical computed tomography. The treatment is based on several factors and extracorporeal shockwave lithotripsy (SWL) is an option for urinary calculi lower than 2.0 centimeters.

The investigators aim to evaluate the urinary tract anatomy and radiological parameters as predictive factors for success of extracorporeal shockwave lithotripsy based on noncontrast helical computed tomography in the treatment (fragmentation and elimination) of kidney stones.


Condition Intervention
Urolithiasis
Urinary Lithiasis
Kidney Calculi
Device: SWL - Compact Delta Dornier Med Tech

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Importance of Urinary Tract Anatomy and Radiological Parameters in the Extracorporeal Shockwave Lithotripsy Outcomes: Prospective Study and Multivariate Analysis

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Calculi elimination [ Time Frame: 8 to 12 weeks after SWL ] [ Designated as safety issue: Yes ]
    The endpoint of this study will be the calculi elimination. It will be measurement as follow: stone free = no fragments; complete fragmentation = residual calculi < 4mm; incomplete fragmentation = residual calculi > 4mm; no alteration. It will be reported as good result and success treatment patients stone free or with complete fragmentation.


Estimated Enrollment: 150
Study Start Date: April 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Shockwave lithotripsy (SWL)
All patients will be submitted to a helical computed tomography with urinary tract reconstruction (axial and coronal) prior to SWL. Patients will be submitted to SWL under these conditions: outpatient, general anesthesia under supervision of an anesthesiologist, calculus will be found by ultrasound or simple radiography, 3000 impulses, 90/min, discharged at the same day with alpha blocker (tamsulosin) during 7 days for calculi bigger than 10 mm.
Device: SWL - Compact Delta Dornier Med Tech
Extracorporeal shockwave lithotripsy under these conditions: outpatient, general anesthesia under supervision of an anesthesiologist, calculus will be found by ultrasound or simple radiography, 3000 impulses, 90/min, discharged at the same day with alpha blocker (tamsulosin) during 7 days for calculi bigger than 10 mm.
Other Names:
  • Extracorporeal shockwave lithotripsy
  • Compact Delta Dornier Med Tech
  • Nephrolithotripsy

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • > 18 years
  • Kidney stones from 6 to 20 mm
  • Consent form signed

Exclusion Criteria:

  • Contraindication to SWL (pregnancy, urosepsis, coagulopathy, arrhythmia, abdominal aortic aneurysm > 4 cm)
  • Multiple calculi ipsilateral to the calculus of interest (>2)
  • No complete follow-up
  • Kidney function impairment
  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: NCT01589484

Locations
Brazil
University of Sao Paulo Recruiting
Sao Paulo, SP, Brazil
Contact: Fabio CM Torricelli, MD       fabio_torri@yahoo.com.br   
Principal Investigator: Fabio CM Torricelli, MD         
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Fabio CM Torricelli, MD University of Sao Paulo
  More Information

Additional Information:
No publications provided

Responsible Party: Fabio Cesar Miranda Torricelli, Principal Investigator, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01589484     History of Changes
Other Study ID Numbers: 00795812.8.0000.0068
Study First Received: April 29, 2012
Last Updated: May 2, 2012
Health Authority: Brazil: Ethics Committee

Keywords provided by University of Sao Paulo:
Tomography
Urinary Lithiasis
Kidney Calculi

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

ClinicalTrials.gov processed this record on October 19, 2014