Clinical trial NCT01589484: Impact of Renal Anatomy on Shock Wave Lithotripsy Outcomes for Lower Pole Kidney Stones
Official title: Impact of Renal Anatomy on Shock Wave Lithotripsy Outcomes for Lower Pole Kidney Stones: Results From a Prospective Multifactorial Analysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urolithiasis
Urinary Lithiasis
Kidney Calculi
Keywords: Tomography
Urinary Lithiasis
Kidney Calculi
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2012-05-02
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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).

Primary outcomes:
measure: Stone Clearance
timeFrame: 12 weeks after SWL
Secondary outcomes:
measure: SWL Complications
timeFrame: 12 weeks after SWL
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: University of Sao Paulo
state: SP
Study officials:
affiliation: University of Sao Paulo
name: Fabio CM Torricelli, MD
role: PRINCIPAL_INVESTIGATOR
References: