Urologic Diseases Clinical Trial
Official title:
The Alternating Bidirectional Versus The Standard Approach During Shock Wave Lithotripsy For Renal And Upper Lumbar Ureteric Stones. A Randomized Clinical Trial
compare the outcomes of SWL for renal and upper lumbar ureteric stones using the alternating bidirectional approach versus the standard approach.
Shock wave lithotripsy (SWL) has been considered the preferred method for treating upper
urinary tract stones since 1980s due to its minimally invasive characters and low morbidity.
The overall stone free rates have been reported to be 80% to 90% .
In the presence of pregnancy, untreated urinary tract infection, decompensated coagulopathy,
uncontrolled arrhythmia and abdominal aortic aneurysm, other treatment methods should be
considered .
SWL is associated with some complications. The most common complications of SWL are renal
colic (40%), gross hematuria (32%), urinary obstruction (30.9%), symptomatic bacteriuria
(9.7%) and perirenal hematoma or subclinical subcapsular hematoma (4.6%).
There are many factors affecting the success of SWL as patient age, sex, body mass index
(BMI), stone size, site and number, radiological renal features, congenital renal anomalies
and presence of double-J (DJ) ureteric stent .
Regarding the renal stones, stones smaller than 10 mm had a success rate of 90%, while those
larger than 10 mm had a success rate of 70%. Stones located in the renal pelvis and upper
pole had a success rate of 87.3 and 88.5% respectively, while those located in the lower pole
had a success rate of 69.5%. A single renal stone had a 78.3% success rate compared to 62.8%
in multiple renal stones . Regarding the ureteric stones, stone size more than 10 mm was one
of the strongest independent predictors of failure of SWL
Patients appear to have the best chance for successful SWL when they have small BMI and their
stones are single and located in the renal pelvis . Skin to stone distance (SSD) measured by
non-contrast computerized tomography scan (NCCT) has a significant role in the treatment of
renal stones using SWL. Slow shock wave rate (60/min) is associated with increase in the
success rate and decrease in pain, complication and number of session to achieve success when
compared to rapid shock wave rate (120/min)
Some techniques were developed to increase the efficacy of SWL. In 1999, the bidirectional
synchronous twin-pulse technique with variable angles between the shock wave reflectors was
developed and it improved the quality and rate of stone disintegration in vitro and it was
more effective than the traditional single generator and also it decreases the overall
treatment times
The TWINHEADS 101 lithotripter comprises two identical under and over table reflectors to
permit synchronous shock waves emission from two perpendicular directions to the same focal
point. This technique intensifies and localizes the cavitations effects by the interacting
focal zones of both reflectors, resulting in a better quality and rate of stone
disintegration, especially with a right angle between the axes of the reflectors.
The first prospective clinical study was done in 2005 regarding synchronous twin-pulse SWL
and it seems safe and effective for treating patients with renal and upper ureteric stones.
The stone-free rate was 74% after one session and 100% after two sessions within a month
Based on the principle of the TWINHEADS lithotripter, we will use Dornier Gemini lithotripter
to emit the shock waves from two different directions to the same focal point asynchronously
for renal and upper lumbar ureteric stones.
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