Ureteral Calculi Clinical Trial
Official title:
External Physical Vibration Lithecbole(EPVL) Versus Traditional Treatment for 4-10 mm Ureteral Stone: A Multi-center Prospective Randomized Controlled Trial
The investigator aims to perform a prospective and randomized controlled trial evaluating the safety and efficacy of External Physical Vibration Lithecbole(EPVL) in treating 4-10 mm ureteral stone.
Patients with ureteral stones less than 10 mm, would receive observation for stone passage,
not requiring immediate surgery. There are many studies evaluating the effect of Medical
expulsive therapy in treating ureteral stones, including a-blockers, and calcium channel
blockers. Most of shuties concluded that the benefit of a-blockers might be among those with
larger (distal) stones. There is no good method for the removal of upper ureteral calculi,
except drinking water and exercising.
Recently, a new extracorporeal physical vibrational lithecbole (EPVL) device named Friend-I
EPVL (Zhengzhou Fu Jian Da Medical Instrument Co., Zhengzhou, China) has proven to be an
effective treatment for upper urinary tract residual calculi. The device was approved by the
Chinese food and drug administration in 2012. A Simple harmonic motion technology in
multi-direction was applied. The Lateral acceleration was provided by the physical vibration
device in the base through the harmonic vibration wave in the horizontal direction, which
induces the urinary stone separate with the kidney or ureter, and expands a moving space for
the stone. Meanwhile, an axial effect was produced to push the stone by the physical
vibration device in the handle through the harmonic vibration wave in the multi- direction.
So, we think that EPVL may be effective in treating ureteral stones.
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