Urolithiasis Clinical Trial
Official title:
Impact of Renal Anatomy on Shock Wave Lithotripsy Outcomes for Lower Pole Kidney Stones: Results From a Prospective Multifactorial Analysis
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.
Variables in study:
- Age, gender, body mass index (BMI), and waist abdominal circumference
- Noncontrast computed tomography scan (NCCT): stone density (average of 3 measurements),
stone size, stone area, skin to stone distance (average of 3 measurements: zero, 45o
and 90o), and collecting system anatomy: infundibular length, width, and height, and
infundibulopelvic angle
Study design:
All patients will be submitted to a noncontrast computed tomography scan before to SWL. A
radiologist with expertise in urolithiasis will evaluate all exams.
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.
Patients will be followed up as follow:
- One week after SWL: medical visit To evaluate complications such as pain, dysuria,
hematuria, steinstrasse, visit to the emergency department.
- 12 weeks after SWL: new NCCT scan To evaluate kidney stones fragmentation and
clearance.
Univariate (Student's T test) and multivariate analysis (multiple logistic regression) will
be done to assess the impact of patient's corporal habitus (BMI and abdominal waist
circumference), stone characteristics (size, area, density and SSD), and renal collecting
system anatomy (infundibular length, width and height, and infundibulopelvic angle) on SWL
outcomes (fragmentation and stone-free rates).
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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