Impact of Renal Anatomy on Shock Wave Lithotripsy Outcomes for Lower Pole Kidney Stones

NCT01589484 | Completed Results

• 1 other identifier: 00795812.8.0000.0068
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

Kidney stone disease affects almost 10% of overall population, often requiring a surgical intervention. Currently, shock wave lithotripsy is considered a first-line treatment option for patients suffering from symptomatic kidney stones smaller than 2.0 cm, providing reasonable stone-free rate. Actually, the outcomes from SWL vary largely due to several factors including stone burden, stone density, stone-skin distance (SSD), and patient's body habitus. Furthermore, the imaging exam modality (i.e. ultrasound versus computed tomography scan) performed to assess the presence of residual fragments also impacts on SWL outcome analysis. We aim to perform a well-controlled prospective evaluation of all variables that may impact on fragmentation and clearance of lower pole calculi after SWL. These variables are assessed exclusively by a noncontrast computed tomography scan (NCCT), eliminating the necessity of an intravenous urography to study renal collecting system anatomy; an imaging exam that is not routinely performed anymore for kidney stone patients.

Conditions

Urolithiasis; Urinary Lithiasis; Kidney Calculi

Keywords

Tomography; Urinary Lithiasis; Kidney Calculi

Outcome Measures

Primary Outcomes (1)

• Stone Clearance

  After 12 weeks, all patients will be submitted to a new NCCT scan to evaluate stone fragmentation and stone clearance.

  12 weeks after SWL

Secondary Outcomes (1)

• SWL Complications

  12 weeks after SWL

Study Arms (1)

Shockwave lithotripsy (SWL)

EXPERIMENTAL

All patients will be submitted to a noncontrast computed tomography before to shockwave lithotripsy (SWL). Patients will be submitted to SWL under the following conditions: outpatient, general anesthesia, 3000 impulses, rate of 90/min, discharged from hospital in the same day with alpha-blocker (doxazosin) during 30 days.

Device: SWL - Compact Delta Dornier Med Tech

Interventions

SWL - Compact Delta Dornier Med Tech DEVICE

All patients will be submitted to a noncontrast computed tomography before to SWL. Patients will be submitted to SWL under the following conditions: outpatient, general anesthesia, 3000 impulses, rate of 90/min, discharged from hospital in the same day with alpha-blocker (doxazosin) during 30 days.

Also known as: Extracorporeal shockwave lithotripsy, Compact Delta Dornier Med Tech, Nephrolithotripsy

Shockwave lithotripsy (SWL)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 17 year-old. Symptomatic single stone of 5 to 20mm located in the lower pole of the kidney. Informed consent signed.

You may not qualify if:

• Patients with congenital kidney abnormalities (i.e. horseshoes kidney, pelvic kidney, ectopic kidney), patients with ureteral stent (i.e. Double J stent) in the ipsilateral kidney of the stone in study, patients with chronic kidney disease (glomerular filtration rate \<60 mL/minute/1.73m2 measured by the equation "Modification of Diet in Renal Disease"), and patients with absolute contraindication to SWL (i.e. coagulopathy, pregnancy, urinary tract infection, or abdominal aneurysm \>4.0cm).

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

University of Sao Paulo

São Paulo, São Paulo, Brazil

Location

MeSH Terms

Conditions

Urolithiasis; Kidney Calculi

Interventions

Lithotripsy

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Nephrolithiasis; Kidney Diseases; Urinary Calculi; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Ultrasonic Surgical Procedures; Surgical Procedures, Operative

Results Point of Contact

• Title: Dr. Fabio Torricelli
• Organization: University of Sao Paulo Medical School

fabio_torri@yahoo.com.br

+55 11 94308951

Study Officials

• Fabio CM Torricelli, MD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 29, 2012
• First Posted: May 2, 2012
• Study Start: April 1, 2012
• Primary Completion: August 1, 2014
• Study Completion: December 1, 2014
• Last Updated: January 7, 2015
• Results First Posted: December 12, 2014

Record last verified: 2014-12

Locations

BR (1)