Shockwave lithotripsy (SWL) is a safe, non-invasive treatment for renal calculi. During SWL
energy is focused on in order to break kidney stones and this energy can be varied in size
from a narrow (or small) focal zone to a wide (or large) focal zone. This is a
multi-centered, randomized study comparing the single treatment success rates of narrow and
wide focal zones during SWL.
||Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
|Ages Eligible for Study:||18 Years|
|Genders Eligible for Study:||Both|
|Accepts Healthy Volunteers:||No|
- Stone must be radiopaque on a KUB radiograph, and located within the renal collecting
- Patients must have had a CT scan within the past 30 days.
- Stones must be solitary, between 5 and 15 mm in maximal diameter.
- Patient must consent to the trial and be willing to return to their respective
lithotripsy unit at 2 weeks and 3 months for follow-up.
- Patients must be treated on the Storz Modulith SLX-F2 machine
- More than one renal calculus on the treated side.
- Radiolucent stones (uric acid, indinavir) or cystine stones.
- Stone size < 5 mm and > 15 mm.
- Previous surgical intervention on upper tracts within past five years.
- Congenital anatomic anomalies of the kidney, ureters or bladder (such as calyceal
diverticulum, horseshoe kidney, etc.)
- Patient currently taking an ?-blocker (alfuzosin, terazosin, doxasosin, tamsulosin,
prazosin), calcium channel blocker (verapamil, diltiazem, nifedipine, nicardipine,
bepridil, mibefradil), or corticosteroids.
- Age < 18 years.
- Active urinary tract infection.
- Patient exceed weight limit for SWL table (>500 lbs)
- Previous SWL treatment for this stone.
- Uncorrected coagulopathy