N/A
N=104
Impact of Renal Anatomy on Shock Wave Lithotripsy Outcomes for Lower Pole Kidney Stones
Urolithiasis · Urinary Lithiasis · Kidney Calculi
Bottom Line
View on ClinicalTrials.gov: NCT01589484 ↗Enrolled (actual)
104
Serious AEs
0.0%
Results posted
Dec 2014
Primary outcome: Primary: Stone Clearance — 76 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- SWL - Compact Delta Dornier Med Tech (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Sao Paulo
- Primary completion
- Aug 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Stone Clearance |
76 | — |
| SECONDARY SWL Complications |
7 | — |
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.
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 4.0cm).
Data sourced from ClinicalTrials.gov (NCT01589484). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.